(24 days)
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart 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 ADVANCE Anchor with DYNA+TAPE Sutures is a threaded suture anchor preloaded on a disposable inserter assembly intended for soft tissue fixation with one strand of #2 DYNACORD Suture and one strand of PERMATAPE Suture to bone. HEALIX ADVANCE with DYNA+TAPE Anchors are available in absorbable Biocryl Rapide® (BR) and non-absorbable PEEK materials. The HEALIX ADVANCE with DYNA+TAPE Sutures is provided sterile and is for single use only.
This document describes the regulatory clearance of the HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures, a medical device for soft tissue to bone fixation. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically seen for AI/ML-based devices. Therefore, much of the requested information regarding AI/ML study specifics will not be available in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., tensile strength, pull-out force) for the proposed device against its predicates. Instead, it refers to "performance testing included evaluation of fixation strength following cyclic loading." The reported device performance is broadly stated as: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."
The comparison is primarily qualitative, asserting that the proposed device has "the same anchor materials, design, principle of operation, intended use, sterilization method, and shelf life, as the predicate HEALIX ADVANCE with DYNACORD Anchors (K173859) and the predicate HEALIX ADVANCE with PERMATAPE Anchors (K170639)."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for any specific mechanical testing. It merely states "Verification activities were performed on the proposed device and / or its predicates." There is no mention of data provenance (country of origin, retrospective/prospective).
3. 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)
This information is not applicable. The device is a physical medical implant, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication for human-in-the-loop or AI/ML evaluations.
5. 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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of physical implant, "ground truth" typically relates to objective mechanical properties and biological responses, measured through engineering tests (e.g., universal testing machines for strength) and potentially biological compatibility studies, rather than expert consensus on medical images or pathology. The document indicates "performance testing included evaluation of fixation strength following cyclic loading."
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm.
Summary of what is available from the document regarding acceptance criteria and study:
The provided document describes a 510(k) Premarket Notification for a medical device (suture anchor). The primary goal of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is typically achieved by showing that the new device has "the same technological characteristics" or "different technological characteristics but is as safe and effective as the predicate device, and the differences do not raise different questions of safety and effectiveness."
In this case, the acceptance criteria and study are defined by the need to demonstrate substantial equivalence:
- Acceptance Criteria (Implied): The proposed device's mechanical performance (specifically fixation strength following cyclic loading) and material properties must be comparable to or better than the identified predicate devices, and the device must be non-pyrogenic as per specified standards. No specific quantitative thresholds are provided in this summary.
- Study Proving Acceptance: The document refers to "Verification activities... on the proposed device and / or its predicates. Performance testing included evaluation of fixation strength following cyclic loading." It also mentions pyrogenicity testing: "The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method."
The conclusion is that the "results of performance testing have demonstrated that the proposed devices are suitable for their intended use." This suitability, coupled with the assertion of "similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices," forms the basis of the substantial equivalence determination.
§ 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.