IDE External Submission Attachment Manifest¶
| Field | Value |
|---|---|
| Purpose | External package inventory and controlled evidence locators |
| Baseline | ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Software package source | 719d64b3b24fe359bf78e0fc8d2d7a59e218e654 |
| Status | Release software artifacts finalized; sponsor eCopy assembly, transfer record, and submission locator remain |
| Date | 2026-09-08 |
External Attachments for Final Assembly¶
| Attachment | Controlled source | SHA-256 / pages | External disposition |
|---|---|---|---|
| IDE Software Submission Core PDF | IDE_Software_Submission_Core.pdf |
f3c97979220f3d6fa26d6e711aeab9b53952b400f66a77e1e9173b1db7aa76c4; 34 pages; 691,714 bytes |
Include |
| IDE Software Technical Appendices PDF | IDE_Software_Technical_Appendices.pdf |
b2779962e7f495d8eb1d0f2d3b4d1d123f036c2798835f3131ea33331a03ca8f; 348 pages; 3,027,369 bytes |
Include |
| Final protocol | Study-team controlled Clinical Protocol BLS Clean-final.docx; Version 1.0, dated 2026-09-01 |
4bfb09542230c94c00dc5b5331a969657b5961b1c4bbd5a2759519a00f71d264; 41 rendered pages |
Include in the protocol section of the sponsor submission |
| Final informed consent | Study-team controlled Consent Form BLS Clean -final.docx; consent version date 2026-09-01 |
6a0e1759997944522fa5dd9ba8dd9e9928cccb64ed7e6e4455b65f40c56a22cf; 19 rendered pages |
Include in the informed-consent section of the sponsor submission |
| Final device labeling | Study-team controlled IDE Submission Package/008_Device_Labeling.pdf; BionicLoop 1.0 Build 843 / IFU-BL-001 revision 1.17, dated 2026-09-04 |
561c4cd26171888454c27d2350162680a867190754a448fd4096d1dd8b10fe0c; 3 pages; 230,910 bytes |
Include; identity verified and closed under D14 |
| IFU-BL-001 PDF | Docs/Quality/IFU/IFU-BL-001.pdf (document revision 1.17, approved 2026-09-04) |
8fced39838e062154cbc878af7a9ddcd96845aeb09b00050f8f99cd58826fcc9; 56 pages; 9,310,731 bytes |
Include; issue the immutable release copy as IFU-BL-001_Rev1.17.pdf |
| Build 843 machine-readable SBOM | Docs/Quality/Cybersecurity_SBOM_Build_843.cdx.json |
c1c7b65127cb03be20aeba645e0a68253556f0f9cc76a3e242215e1fd55310ff; 5,670 bytes |
Include or retain per sponsor format decision |
Retained Build and Evidence Artifacts¶
| Artifact | Controlled locator | SHA-256 | Package role |
|---|---|---|---|
| Build 843 archive | ReleaseArtifacts/Build-843/BionicLoop-1.0-843.xcarchive.zip |
80449b03c92dbc6aa21b5f255722522757f767ee84d303ab3af2b3b86f836ac0 |
Retained configuration artifact; not embedded in Git narrative PDFs |
| Build 843 dSYMs | ReleaseArtifacts/Build-843/BionicLoop-1.0-843.dSYMs.zip |
2e3f2040ef45d3f6397723cb1bb5789dc28f0b48dee5d89c8b6ec48ff4b54152 |
Retained crash-symbolication artifact |
| Export options | ReleaseArtifacts/Build-843/BionicLoop-1.0-843-ExportOptions.plist |
ed42eb4a3d30780b5e0864a84dd0cfdf3dc4788c517f58bce6a911b40866f9d2 |
Retained archive/export configuration |
| Raw upload/export log | ReleaseArtifacts/Build-843/BionicLoop-1.0-843.xcdistributionlogs.zip |
174f428e90e7dfb1abd6654c449887598374df445e07bbaf11066188d6c737ee |
Retained distribution evidence |
| Algorithm freeze evidence | Docs/Quality/Evidence/Formal/STR-ALG-001/2026-08-21-ide-freeze-alg-baseline-r2/ |
Directory manifest and artifacts.sha256 |
Appendix A07 locator |
| Automated app/UI freeze evidence | Docs/Quality/Evidence/Formal/STR-AUTO-001/2026-08-21-ide-freeze-auto-baseline-r2/ |
Controlled bundle checksums | Appendix A07 locator |
| Simulation freeze evidence | Docs/Quality/Evidence/Formal/STR-SIM-001/2026-08-21-101509-14034-ide-freeze-sim-baseline/ |
checksums.txt |
Appendix A07 locator |
| Security freeze evidence | Docs/Quality/Evidence/Formal/STR-SEC-001/2026-08-21-ide-freeze-tv-sec-001/ |
checksums.txt |
Appendix A07 locator |
Final Assembly Controls¶
- Recalculate every attachment hash from the actual file transferred.
- Record byte size, final filename, eCopy/submission locator, preparer, and transfer date in the sponsor submission index.
- Do not substitute working evidence for formal evidence without an explicit acceptance record.
- Do not include raw participant data unless the protocol, privacy controls, and submission purpose authorize it.