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The AFX® Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

The AFX Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.

The provided texts describe a medical device, the AFX Femoral Implant with Inserter, and its clearance process with the FDA. However, the document does NOT contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically associated with diagnostic algorithms or AI models.

This document is a 510(k) summary for a device modification, not a new diagnostic device. The substantial equivalence is demonstrated through non-clinical testing (mechanical, biocompatibility, sterilization, pyrogenicity, and shelf-life) compared to a predicate device, and not through clinical performance metrics against a predefined acceptance criterion.

Therefore, many of the requested items (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or not present in this document because the device is a medical implant, not a diagnostic tool requiring such evaluations.

Here’s a breakdown based on the information available in the document:

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

The document does not present a formal table of acceptance criteria for clinical performance that would typically be seen for a diagnostic device. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.

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, as this is a medical implant cleared via non-clinical testing for a device modification, not a diagnostic algorithm with a clinical test set. The document refers to "testing" which is mechanical and other non-clinical evaluations, not human-patient-based test sets.

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 for diagnostic performance is not relevant for this type of device clearance which relies on non-clinical engineering and materials testing.

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

Not applicable.

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 is not a diagnostic device or an AI-assisted tool.

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

Not applicable.

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

The "ground truth" for this device's performance is based on engineering and material standards, and benchmarked against the predicate device's established performance in non-clinical tests (e.g., mechanical strength, biocompatibility).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The document describes Non-Clinical Testing conducted to demonstrate that the modified AFX® Femoral Implant with Inserter is substantially equivalent to its predicate device (AFX® Femoral Implant with Inserter, K161033).

• Type of Study: Non-clinical (bench testing) and other non-human evaluations (biocompatibility, sterilization, pyrogenicity, shelf-life).
• Purpose: To demonstrate that revisions to the implant (combining wedge and deployment screw, rounding the screw top, increasing length) and the inserter (adding red indicator, locking mechanism) do not raise new questions of safety or efficacy and that the modified device performs comparably to the predicate.
• Methods:
  • Mechanical Testing: Included cyclic and pull-out tests on the subject device. The results were assessed against "predetermined specifications" and compared to the "ultimate pull-out strength" of the predicate device.
  • Biocompatibility: Evaluated for substantial equivalence to the predicate device.
  • Sterilization: Evaluated for substantial equivalence to the predicate device.
  • Pyrogenicity: Evaluated for substantial equivalence to the predicate device.
  • Shelf-Life: Evaluated for substantial equivalence to the predicate device.
• Results: The non-clinical testing demonstrated that the functionality and safety of the subject AFX femoral implant are adequate for its intended use. Mechanical testing met predetermined specifications, and ultimate pull-out strength was comparable to the predicate device. Biocompatibility, sterilization, pyrogenicity, and shelf-life also demonstrated substantial equivalence.
• Conclusion: The testing concluded that the modified device is substantially equivalent to the predicate device, given "Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy."

Clinical Testing: The document explicitly states: "Clinical testing was not used to establish substantial equivalence to predicate device." This means no human subject studies were conducted or relied upon for this specific 510(k) clearance.

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The AFX™ Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

The AFX Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.

Modifications to the predicate device, AperFix AM Femoral Implant with Inserter, that are the subject of this submission are confined solely to a line extension consisting of a metal free version of the original 24mm implant.

The screws of the modified 24mm implant differ from that of the original 24mm implant in that the combination of two PEEK screws, compression and deployment, in the modified 24mm implant play the role of the metal central screw in the original 24mm implant. In both the original 24mm and modified 24mm versions of the implant, lateral deflection of the body occurs as the implant is secured in position, however, in the original 24mm implant this occurrence is caused by advancing the head of the metal central screw and in modified 24mm implant this occurrence is caused by advancing the compression screw. In the subject 24 mm device, the unibody engages the wall of the femoral tunnel upon deploying the deployment screw. In the predicate 24 mm device the wings engage the wall of the femoral tunnel upon deploying the central screw.

This document describes a 510(k) premarket notification for a medical device called the "AFX™ Femoral Implant with Inserter." The submission focuses on a modification to an existing device, creating a metal-free version.

Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:

The document explicitly states: "Clinical testing was not used to establish substantial equivalence to predicate device." This means that many of your requested points, which pertain to clinical studies involving human patients, expert ground truth, and reader studies, are not applicable to this submission.

The primary method for demonstrating substantial equivalence in this 510(k) was through non-clinical testing.

Here's a breakdown of the available information:

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

The document doesn't provide a specific table with numerical acceptance criteria and a direct comparison of reported performance against those criteria. Instead, it offers a summary statement regarding the non-clinical testing.

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

• Sample Size: Not specified in the document.
• Data Provenance: The testing was non-clinical (mechanical, biocompatibility). While the manufacturer (Cayenne Medical, Inc.) is based in Scottsdale, Arizona, USA, the specific location and retrospective/prospective nature of the non-clinical testing are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as clinical testing with human subjects and expert ground truth was not performed or used for substantial equivalence. The "ground truth" for non-clinical tests would be the established engineering/material science standards and predicate device performance.

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

• Not applicable as clinical testing was not performed.

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 device is a physical implant, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for the non-clinical tests would be:
  • Engineering specifications: For cyclic and pull-out testing, specific thresholds or performance ranges would have been set based on relevant standards and the functional requirements of the device.
  • Predicate device performance: For ultimate pull-out strength, the performance of the legally marketed predicate device (AperFix® AM Femoral Implant with Inserter) served as a benchmark for comparison.
  • Biocompatibility standards: For biocompatibility, established ISO standards (e.g., ISO 10993 series) would define the acceptable criteria.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable.

In summary, the provided document explicitly emphasizes that clinical testing was not used for this 510(k) submission. The substantial equivalence was established through non-clinical testing (biocompatibility and mechanical testing) comparing the modified device to its predicate.

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