(30 days)
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.
| Acceptance Criteria (Implied from Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| - Meet predetermined specifications | Met specifications |
| - Ultimate pull-out strength comparable to predicate | Was comparable to predicate |
| Biocompatibility: | |
| - Substantial equivalence to predicate | Demonstrated |
| Sterilization: | |
| - Substantial equivalence to predicate | Demonstrated |
| Pyrogenicity: | |
| - Substantial equivalence to predicate | Demonstrated |
| Shelf-Life: | |
| - Substantial equivalence to predicate | Demonstrated |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.