(77 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 PERMATAPETM Suture consists of a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of one strand of #2 PERMACORDTM suture and one strand of PERMATAPETM suture to bone. HEALIX ADVANCETM Anchors with PERMATAPETM 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 PERMATAPETM Suture is provided sterile and is for single use only.
The provided text is a 510(k) Summary for the HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria from scratch.
Therefore, the information I can extract regarding acceptance criteria and a definitive "study that proves the device meets the acceptance criteria" is limited to the comparative testing performed to show substantial equivalence. The document doesn't outline a set of predefined acceptance criteria in the same way a de novo clearance or a clinical trial for an AI device might, nor does it conduct a standalone multi-reader multi-case (MRMC) study or a comprehensive standalone algorithm performance study.
However, I can extract the relevant performance testing and safety assessments that were performed to support substantial equivalence.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are implied by the performance of the predicate devices and general standards for such implants. The reported device performance is based on comparative testing against these predicates.
| Acceptance Criteria (Implied/Comparative) | Reported Device Performance (Comparative to Predicates) |
|---|---|
| Functional Equivalence: Device performs its intended function (soft tissue to bone fixation) adequately. | The device is similar to predicate devices in its intended use, anchor design and materials, and principle of operation. |
| Mechanical Strength/Integrity: Sufficient pull-out strength, insertion, and failure torque to securely fix soft tissue to bone. | Pull-out testing, insertion and failure torque, and in-vitro testing were performed. The results "demonstrated that the proposed devices are suitable for their intended use." (Specific quantitative values are not provided in this summary but would be in the full submission). |
| Biocompatibility/Safety: Materials are safe for implantation and do not pose a biological risk (e.g., endotoxin levels). | Bacterial endotoxin testing was completed, and results "demonstrated that the proposed devices meet the endotoxin limits." |
| Sterility: Device is sterile and maintains sterility for its shelf life. | The device is provided sterile. Implied, through similarity to predicates, that the sterilization method is validated and effective. (Specific validation results are not in this summary, but would be in the submission). The shelf life is also stated as similar to predicates. |
Study Proving Acceptance Criteria (Substantial Equivalence Study):
The "study" to prove the device meets acceptance criteria in this context is the non-clinical performance testing conducted to support substantial equivalence to predicate devices. This is NOT a study in the sense of a clinical trial or an AI performance study with a test set, experts, and ground truth in the way you might expect for an imaging AI device.
- Study Name: Non-clinical (bench) testing and comparisons to predicate devices.
- Objective: To demonstrate that the HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture is substantially equivalent to legally marketed predicate devices, specifically the K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture and K100012, K073412 Gryphon™ BR Anchor with Orthocord® Suture.
Detailed Responses to Your Specific Questions:
- A table of acceptance criteria and the reported device performance: Refer to the table above.
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated in the summary. For bench testing of mechanical properties (pull-out, torque), standard engineering practices would involve a certain number of samples per test condition (e.g., 5-10 units).
- Data Provenance: The testing is "non-clinical testing" and "in-vitro testing," meaning it was conducted in a lab environment (bench testing) rather than on patients or patient data. Therefore, country of origin of data or retrospective/prospective status is not applicable in the human data sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. This is a mechanical device, and ground truth is established by physical measurement tools and engineering standards, not by expert interpretation of medical images or patient outcomes.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as this is bench testing of a mechanical implant, not an AI diagnostic device requiring expert adjudication.
- 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 device is a surgical implant, not an AI diagnostic tool, so an MRMC study is not relevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from physical measurements (e.g., force in Newtons for pull-out, torque in N·cm) and material properties testing against established engineering and regulatory standards for mechanical implants, and comparison to the performance of predicate devices.
- The sample size for the training set: Not applicable. This device does not use a training set as it is not an AI/machine learning product.
- How the ground truth for the training set was established: Not applicable.
Summary of the Device's Approach to Meeting Criteria:
The HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture demonstrates that it meets the necessary safety and performance criteria by establishing substantial equivalence to existing, legally marketed predicate devices. This is done through:
- Design and Material Similarity: Showing that its intended use, anchor design, materials (absorbable BR and non-absorbable PEEK), suture (PERMATAPE™) which is also similar to a reference device (PERMACORD™), device assembly, sterilization method, and shelf life are comparable to predicates.
- Non-Clinical Performance Testing: Conducting bench-top tests like pull-out testing, insertion and failure torque, and in-vitro testing. The results of these tests indicated the device is "suitable for its intended use" when compared to the performance characteristics expected for such devices and demonstrated by its predicates.
- Safety Testing: Completing bacterial endotoxin testing to ensure biocompatibility and safety regarding endotoxin levels.
The core of this 510(k) submission is to show that the new device does not raise new questions of safety and effectiveness compared to devices already on the market, thereby implying it meets the accepted performance and safety "criteria."
§ 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.