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Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

• supracondylar fractures, including those with intraarticular extension
• ipsilateral hip/shaft fractures
• ipsilateral femur/tibia fractures .
• femoral fractures in multiple trauma patients .
• fractures proximal to total knee arthroplasty .
• fractures distal to a hip implant .
• fractures in the morbidly obese
• fractures in osteoporotic bone .
• impending pathologic fractures .
• malunions and nonunions

Synthes Retrograde/Antegrade Femoral Nail System is composed of femoral nails, spiral blades and end caps. Depending on the length of the nail, the nail may be inserted from a retrograde approach or from either a retrograde or antegrade approach. Spiral blades, end caps and Synthes commercially available locking bolts and screws are used to secure the nail in the bone, preventing rotation and axial compression.

This document, a 510(k) summary for the Synthes (USA) Retrograde/Antegrade Femoral Nail System, is a premarket notification for a medical device seeking clearance based on substantial equivalence to previously marketed devices. It does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for AI/software-based devices.

Instead, this document focuses on demonstrating that the new device is "substantially equivalent" to existing predicate devices already cleared by the FDA. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are not relevant to a 510(k) submission for a physical orthopedic implant like a femoral nail.

Here's an explanation based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document does not present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity) for a software or AI device. The "acceptance criteria" for a 510(k) submission for a physical device like a femoral nail are around demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and mechanical properties.
• Reported device performance: The document states "Documentation is provided which demonstrates that the Synthes Retrograde/Antegrade Femoral Nail System is substantially equivalent* to other legally marketed devices." This "performance" is about meeting the FDA's criteria for substantial equivalence, not clinical or algorithmic performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This pertains to studies for software or AI performance. For a physical device like a femoral nail, typical testing might involve mechanical bench testing, but the document does not provide details of such tests, their sample sizes, or data provenance. The assessment here is primarily regulatory based on equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth establishment for a diagnostic or AI algorithm is not part of this type of 510(k) submission for a physical orthopedic implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This relates to expert review for AI/software performance, not a physical device submission.

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

• Not applicable. This applies to AI-assisted diagnostic or decision support systems.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This applies to AI/software performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. This relates to AI/software performance evaluation. The "ground truth" for a physical device is generally its conformity to design specifications and mechanical properties, demonstrated through engineering tests and material analyses, which are not detailed here beyond the claim of substantial equivalence.

8. The sample size for the training set

• Not applicable. This applies to AI/software development.

9. How the ground truth for the training set was established

• Not applicable. This applies to AI/software development.

In summary, the provided document is a 510(k) summary for a physical medical device (a femoral nail system), seeking market clearance based on substantial equivalence to existing devices. It does not contain the type of performance evaluation data (acceptance criteria, study details, expert review, AI performance metrics) that would be found in a submission for a software or AI-driven diagnostic device.

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