(83 days)
The Osteo Austin Moore Endoprosthesis System is a one-piece, hemi-hip replacement component. It is intended for cemented use only.
Indications
- Femoral head/neck fractures .
- Aseptic necrosis of the femoral head .
- Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular . involvement.
The Osteo Austin Moore Endoprosthesis System comes in a range of sizes to address variations in patient anatomy, and is intended for hemi-hip replacement procedures. It is intended to articulate with the natural acetabulum, and is intended for cemented use only.
The provided text describes a 510(k) summary for the Osteo Austin Moore Endoprosthesis System, but it is focused on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific performance acceptance criteria for an AI/algorithm-driven medical device in the way your request outlines.
Therefore, many of the requested fields cannot be directly extracted from this document, as the study performed is a mechanical performance test for an orthopedic implant, not a study involving AI, human readers, or ground truth establishment for diagnostic accuracy.
Here's an attempt to answer based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Withstand anticipated in-vivo loading conditions | All specimens successfully endured 10 million cycles of physiologically relevant loading. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated as a numerical sample size. The text mentions "All specimens successfully endured," implying multiple specimens were tested but specific number not given.
- Data provenance: Not applicable in the context of clinical data. This was a mechanical laboratory test of physical device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to the type of performance data presented. Ground truth in the context of diagnostic accuracy, as implied by your question, is not relevant here. The "ground truth" for a mechanical test is simply whether the device fractured or failed to meet predefined mechanical stress limits.
4. Adjudication method for the test set
- Not applicable. This was a mechanical test, not an assessment requiring clinical adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, this was not done. This study is a mechanical performance test of an orthopedic implant, not an MRMC study related to AI or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this was not done. This study is a mechanical performance test of an orthopedic implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this mechanical performance test was the physical integrity of the device after stress cycling. The device either fractured/failed or it did not. This is a pass/fail criterion based on engineering standards for material endurance.
8. The sample size for the training set
- Not applicable. There is no AI training set mentioned or implied in this document.
9. How the ground truth for the training set was established
- Not applicable. There is no AI training set.
Summary of what the document does provide:
The document describes a submission for a Class II medical device (orthopedic implant), the Osteo Austin Moore Endoprosthesis System. The core of the FDA submission (510(k)) is to demonstrate substantial equivalence to a predicate device (Howmedica Austin Moore Endoprosthesis) based on:
- Intended Use: Hemi-hip replacement for specific indications (femoral fractures, aseptic necrosis, arthritis with minimal acetabular involvement), cemented use only.
- Materials: Both made from cobalt chromium alloy.
- Design: Both feature the classic Austin-Moore design, fixed-head, fenestrations for cement interdigitation.
- Performance Data: The Osteo Austin Moore Endoprosthesis System was subjected to mechanical testing. It successfully endured 10 million cycles of physiologically relevant loading, demonstrating its ability to withstand anticipated in-vivo conditions. This mechanical endurance test is the primary "study" mentioned for performance.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.