(112 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.
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.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | "adequate for its intended use" |
| Mechanical Testing | "functionality and safety... adequate for its intended use" |
| Cyclic Testing | "met the predetermined specifications" |
| Pull-out Testing | "met the predetermined specifications" |
| Ultimate Pull-out Strength | "comparable to that of the predicate device" |
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.
§ 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.