(112 days)
The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.
The provided text describes the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture, which is a medical device for soft tissue to bone fixation. However, the document does not contain information about specific acceptance criteria or a dedicated study providing quantitative performance metrics by which the device's performance can be explicitly measured against pre-defined criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture) through non-clinical testing. This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than conducting a de novo study against specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document. Below is a summary of what is available and what is not:
HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Device Performance Summary
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not Explicitly Stated) | Device Performance (Based on Non-Clinical Testing and Equivalence) |
|---|---|
| Mechanical Performance: | Demonstrated suitability for intended use through: |
| - Anchor fixation strength | - Anchor fixation testing |
| - Torque strength | - Torque testing |
| - Suture tensile strength | - Suture testing per USP (non-absorbable, oversized diameter) |
| - Suture approximation force | - Suture approximation force testing |
| Biocompatibility: | Pass |
| - Biocompatibility evaluation | - In-vivo testing |
| Sterility: | Pass |
| - Sterility | - Sterility testing |
| Endotoxins: | Pass |
| - Endotoxin limits | - Bacterial endotoxin testing |
| Packaging Integrity/Shelf-life: | Demonstrated |
| - Packaging and shelf-life stability | - Packaging and shelf-life testing |
| _(Specific quantitative thresholds for "Pass" | |
| are not provided in this document)_ |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the document. The non-clinical testing refers to "anchor fixation testing," "in-vitro testing," "torque testing," "suture testing per USP," "suture approximation force testing," and "in-vivo testing," but the number of samples or specimens for each test is not provided.
- Data Provenance: The testing was "performed on the proposed device and/or its predicates." No information on country of origin or whether it was retrospective or prospective is given. Given the nature of mechanical/biocompatibility testing, it would generally be prospective laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable for this type of submission. This device is a physical implant, and its performance is evaluated through mechanical, chemical, and biological testing, not by expert review of data like in an AI/imaging study. Ground truth is established by standardized testing methods and measurements.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, this device's performance is determined by objective physical and biological tests, not by human expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant for this product.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This phrase typically refers to the performance of an AI algorithm in isolation. This is a physical device, and its performance is assessed directly through non-clinical testing.
7. The Type of Ground Truth Used:
- Objective Test Results / Standardized Measurements: Ground truth for this device's performance is established by the results of various non-clinical tests (e.g., tensile strength in Newtons, torque in Nm, presence/absence of bacterial endotoxins within specified limits, biocompatibility as determined by in-vivo models). These are direct measurements or observations against established material and biological standards (e.g., USP standards).
8. The Sample Size for the Training Set:
- Not applicable. This submission does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for this 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.