(20 days)
VERSALOCK Anchor is indicated for use in the following: Shoulder: Rotor Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment
The Versalok Peek Anchor System includes the Versalok Peek Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system is provided with and without a Orthocord#2 suture.
Here's the breakdown of the acceptance criteria and study information for the Versalok Peek Anchor, based on the provided 510(k) summary:
This device is a bone anchor, not an AI/software device. Therefore, many of the typical AI-related study components (like expert ground truth, MRMC studies, training sets, etc.) are not applicable in this context. The "acceptance criteria" here refers to the performance standards demonstrably met by the device to prove substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Performance | Pull Out Testing | Not explicitly detailed with numerical values, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices." |
| Material Safety | Biocompatibility | Not explicitly detailed, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices." |
| Product Stability | Shelf Life | Not explicitly detailed, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices." |
| Sterility Assurance | Sterilization | Not explicitly detailed, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of anchors, test specimens) used for the nonclinical testing (pull-out, shelf life, sterilization, biocompatibility).
- Data Provenance: The data is generated from nonclinical testing of the device or its predicates. The country of origin for the data is not specified but is implicitly associated with the manufacturer (DePuy Mitek, Inc. in Raynham, MA, USA). The testing is prospective for the Versalok Peek Anchor to demonstrate its performance against established standards and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable: For a physical medical device like a bone anchor, "ground truth" in the context of expert consensus (as used for imaging or diagnostic AI) is not relevant. The ground truth for mechanical and material properties is established by validated engineering and scientific testing standards and methodologies.
4. Adjudication Method for the Test Set:
- Not Applicable: Adjudication is typically associated with human reviewer discrepancies (e.g., in medical image interpretation). For nonclinical testing of a physical device, the "adjudication" is inherent in the objective nature of the test results themselves against predefined pass/fail criteria or comparison to predicate performance.
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 an AI/software-specific study type. The Versalok Peek Anchor is a physical implantable medical device, not an AI or software product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable: This is an AI/software-specific study type. The Versalok Peek Anchor is a physical implantable medical device.
7. The Type of Ground Truth Used:
- For the nonclinical studies, the "ground truth" is based on:
- Objective physical measurements and chemical analyses according to recognized standards (e.g., ASTM, ISO standards for pull-out strength, material characterization, biocompatibility testing guidelines).
- Performance of legally marketed predicate devices (Trident Anchor, Versalok Ti Anchor, Arthrex Pushlock Anchor) as benchmarks for substantial equivalence.
8. The Sample Size for the Training Set:
- Not Applicable: This is an AI/software-specific concept. There is no "training set" for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As above, there is no "training set."
Summary of the Study Proving Acceptance Criteria:
The study proving the Versalok Peek Anchor meets acceptance criteria is a series of nonclinical performance and safety tests. These tests were conducted on the implant or its predicates and included:
- Pull Out Testing: To evaluate the mechanical strength and fixation capability of the anchor.
- Shelf Life Testing: To ensure the device maintains its properties over its intended storage duration.
- Sterilization Testing: To confirm the effectiveness of the sterilization process and ensure the device remains sterile until use.
- Biocompatibility Testing: To assess the biological safety of the materials in contact with body tissues.
The document states that the "results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This substantial equivalence, based on these verified tests and comparison to the predicate devices (Trident Anchor, Versalok Ti Anchor, and Arthrex Pushlock Anchor), forms the basis for the FDA's clearance. The "acceptance criteria" are implicitly met by confirming these performance and safety characteristics are comparable or equivalent to the already cleared predicate devices.
§ 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.