(25 days)
The Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 6.5 mm and 5 mm anchors may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.
The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a bone punch and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Self-Tapping Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material. The Model 6500 Self-Tapping Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Axya Model 6500) | Predicate Device Performance (Axya Model 2000 & Arthrex Corkscrew) |
|---|---|---|
| Anchor Pull-Out Strength | Compared favorably | - Included in in-vitro study for comparison |
| Failure Mode | Predominately the same | - Predominately the same |
| Sterilization Process | Equivalent to original suture manufacturer's | - Implied to be acceptable for predicate devices |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the sample size (number of anchors tested) for the in-vitro study evaluating anchor pull-out strength.
- Data Provenance: The study was conducted in-vitro. This suggests a laboratory setting rather than using human or animal biological samples for the primary evaluation of pull-out strength. The country of origin is not specified but is presumably the US, given the submission to the FDA.
3. Number of Experts and Their Qualifications for Establishing Ground Truth (Test Set)
This information is not provided in the document. The study described is an in-vitro mechanical test. Ground truth in this context would likely be based on physical measurements and engineering standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/provided. As the study is an in-vitro mechanical test, there would be no need for expert adjudication in the traditional sense, which typically applies to subjective interpretations of medical images or clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is an in-vitro mechanical test of device performance, not a study involving human readers or clinical cases.
6. Standalone (Algorithm Only) Performance Study
No, a standalone study was not done. This device is a mechanical bone anchor, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance (specifically pull-out strength) was based on physical measurements and engineering principles as specified in the "FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)." This is a form of objective, quantitative data derived from a controlled laboratory setting.
8. Sample Size for the Training Set
This information is not applicable/provided. This device is a mechanical product, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The "training" in manufacturing would relate to process validation and quality control, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
§ 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.