(20 days)
The Healix Knotless™ Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
- . Rotator Cuff
- Biceps Tenodesis
The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in one size. The proposed DePuy Mitek's Healix Knotless™ Anchor is molded with PEEK (Polyetheretherketone) material.
The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor will be provided in one size with outer diameter of 4.75mm.
The provided text is a 510(k) summary for the DePuy Mitek's Healix Knotless™ PEEK Anchor. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials with detailed performance criteria.
Therefore, much of the requested information (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) is not applicable or not provided in this type of regulatory submission.
The document emphasizes nonclinical testing to demonstrate that the proposed device performs comparably to its predicate devices in terms of mechanical properties.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the sense of predefined thresholds for clinical or diagnostic performance metrics. Instead, "performance" is assessed through a comparison to predicate devices, indicating that the new device should function at least as well as the established devices in key mechanical properties.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Insertion Torque | Comparable to predicate devices | Performed during "Product Design Verification and Design Validation activities." Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." |
| Anchor Pullout (at T=0) | Comparable to predicate devices | Performed during "Product Design Verification and Design Validation activities." Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." |
| Torque to Failure | Comparable to predicate devices | Performed during "Product Design Verification and Design Validation activities." Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." |
Note: The phrase "substantially equivalent" is the primary acceptance criterion in this context, meaning the new device performs as safely and effectively as a legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The nonclinical testing performed (Insertion Torque, Anchor Pullout, Torque to Failure) would typically involve a certain number of device samples, but the exact count is not detailed in this summary.
- Data Provenance: Not applicable in the context of clinical data. The nonclinical tests are laboratory-based mechanical tests performed on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. These are mechanical tests, not assessments requiring expert interpretation of clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a study requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices involving human readers, which is not relevant for a surgical anchor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device (surgical anchor), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Ground Truth: For nonclinical testing, the "ground truth" would be the directly measured physical properties (e.g., torque values, force required for pullout) of the device and its predicate counterparts, assessed against engineering specifications. There is no biological "ground truth" in this context.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not a machine learning or AI device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.