(17 days)
The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
Rotator Cuff .
. Biceps Tenodesis
The proposed Healix Advance Knotless 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 anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless PEEK Anchor is manufactured from PEEK (Polyetheretherketone) material.
The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) is a medical device designed for reattachment of soft tissue to bone. This submission (K131683) is for a larger version (6.5mm) of previously cleared predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors).
Acceptance Criteria and Device Performance Study:
Since this FDA submission is a Special 510(k) based on substantial equivalence to predicate devices, formal acceptance criteria and a single study proving the device meets them in the traditional sense (e.g., a clinical trial with specific performance endpoints) are not presented in the provided documents. Instead, the submission focuses on demonstrating that the new device has the same design, technological characteristics, and safety/performance profile as the predicate devices, despite the size change.
The "Substantial Equivalence" framework in 510(k) submissions relies on showing that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" here can be inferred as showing that the new device performs equivalently or comparably to the predicate in non-clinical tests relevant to its function.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred fromPredicate Equivalence) | Reported Device Performance (Non-clinical Testing) |
|---|---|
| Similar Mechanical Properties: | |
| - Insertion Torque (comparable to predicate) | Performed; demonstrated substantial equivalence |
| - Torque to Failure (comparable to predicate) | Performed; demonstrated substantial equivalence |
| - Anchor Pullout Strength (comparable to predicate) | Performed; demonstrated substantial equivalence |
| Biocompatibility: | Manufactured from PEEK material, same as predicate; inherently considered biocompatible based on predicate. |
| Sterility: | Not explicitly mentioned but assumed to meet standards for implantable devices. |
Explanation: The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors). The non-clinical testing performed (Insertion Torque, Torque to Failure, Anchor Pullout) aimed to show that the 6.5mm anchor's mechanical performance is comparable to the predicate devices, thus meeting the "acceptance criteria" for safety and effectiveness in the context of a Special 510(k).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "Product Design Verification and Design Validation activities," but does not detail the number of samples used for each test (Insertion Torque, Torque to Failure, Anchor Pullout).
- Data Provenance: The testing was "Non-clinical Testing" performed by the manufacturer, DePuy Mitek. The country of origin of the data is not specified, but it would have been generated in a controlled laboratory setting by the company. It is retrospective in the sense that the testing was conducted prior to submission to demonstrate equivalency.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in this context. The "ground truth" for non-clinical mechanical testing is derived from the physical properties and performance characteristics of the devices themselves, measured through established engineering and biomechanical methods. No human experts are used to interpret the "ground truth" of these test results; rather, engineers and scientists conduct and analyze the tests against predetermined specifications or predicate performance.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostic evaluations where human interpretation of outcomes is involved. For non-clinical mechanical testing, results are quantitative and objective, and thus do not require an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data (e.g., radiologists reading mammograms with and without AI assistance). The Healix Advance Knotless PEEK Anchor is an implantable surgical device, and its performance is evaluated through biomechanical testing and clinical outcomes, not through human reader interpretation of data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone (algorithm only) study was not done. This type of study is specifically for evaluating the performance of AI algorithms. The device described is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for the non-clinical testing was based on objective, quantitative mechanical measurements (e.g., torque values, force measurements for pullout strength). These measurements establish the intrinsic performance characteristics of the device. The comparison of these measurements to the predicate device's known performance serves as the basis for the substantial equivalence claim.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The concept of a "training set" is relevant to machine learning models.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
§ 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.