(81 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 Healix Knotless™ Anchor is a once piece implantable cannulated, threaded anchor proposed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed Healix Knotless™ Anchor is molded from absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). The proposed Healix Knotless™ Anchor will be provided in one size with outer diameter of 4.75mm.
The provided text describes the DePuy Mitek, Inc. Healix Knotless™ Anchor, a medical device intended for reattachment of soft tissue to bone. The submission is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, rather than proving de novo safety and efficacy through extensive clinical trials with acceptance criteria directly tied to performance metrics in that context. Therefore, the information provided focuses on demonstrating substantial equivalence through nonclinical testing, rather than reporting against specific clinical acceptance criteria in the manner one might expect for a novel therapeutic device.
Here's an analysis based on the provided document:
-
Table of Acceptance Criteria and Reported Device Performance:
Feature/Requirement Acceptance Criteria (Implied for Substantial Equivalence) Reported Device Performance/Comparison to Predicate Indications for Use Same or similar to predicate devices. Indicated for rotator cuff and biceps tenodesis procedures in the shoulder, similar to the predicate devices. Technological Characteristics (Design) Substantially equivalent to predicate devices, with documented differences and justification. Smaller in length than Arthrex PushLock Anchor (K061863), different thread profile, and has a slot on one side of the anchor wall (Proximal End). These differences are mentioned and presumably addressed to ensure substantial equivalency. Technological Characteristics (Material) Same or substantially equivalent materials as predicate devices. Uses the same absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP) material as the predicate DePuy Mitek's Gryphon BR Anchor (K073412). Mechanical Performance: Insertion Torque Demonstrates appropriate insertion torque for safe and effective use; comparable to predicate or within acceptable industry standards. Performed. Results demonstrated safety and performance (implying suitability for the intended use and substantial equivalence to predicates). No specific torque values provided. Mechanical Performance: Anchor Pullout (at T=0, 6, and 12 week in-vitro physiological aging) Maintains adequate pullout strength over time, comparable to predicate devices or within acceptable industry standards to secure soft tissue to bone. Performed. Results demonstrated safety and performance (implying suitability for the intended use and substantial equivalence to predicates). No specific pullout values provided. Mechanical Performance: Torque to Failure Demonstrates adequate resistance to torque before failure, comparable to predicate devices or within acceptable industry standards. Performed. Results demonstrated safety and performance (implying suitability for the intended use and substantial equivalence to predicates). No specific torque values provided. Material Specifications Meet specified material requirements, comparable to predicate devices. Substantially equivalent to predicate DePuy Mitek's Gryphon BR Anchor (K073412). Packaging Adequate for maintaining sterility and product integrity; comparable to predicate devices. Substantially equivalent to predicate DePuy Mitek's Gryphon BR Anchor (K073412). Sterilization Method Effective in sterilizing the device without compromising material properties; comparable to predicate devices. Substantially equivalent to predicate DePuy Mitek's Gryphon BR Anchor (K073412). Overall Safety and Performance Demonstrate substantial equivalence to legally marketed predicate devices to ensure safety and effectiveness for its intended use. Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate device. -
Sample Size used for the test set and the data provenance:
The document mentions "Product Design Verification activities" including Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure. However, specific sample sizes for these tests are not provided in the summary. The data provenance is described as "in-vitro physiological aging," implying laboratory testing rather than human or animal studies, and thus the concept of "country of origin of the data" in a patient context is not applicable here. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the type of nonclinical testing described. These were engineering/mechanical tests on the device itself, not evaluations based on expert interpretation of clinical data or images. -
Adjudication method for the test set:
This information is not applicable as the tests were nonclinical mechanical property tests, not assessments requiring adjudication of clinical findings or interpretations. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The submission is for a medical implant (suture anchor) relying on nonclinical bench testing to demonstrate substantial equivalence to existing devices, not a diagnostic or AI-assisted product requiring human reader evaluation. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this is not an artificial intelligence or algorithmic device. It is a physical implantable medical device. -
The type of ground truth used:
For the nonclinical tests, the "ground truth" would be the measured physical properties (e.g., actual pullout strength, torque values, material composition) of the device and its predicate devices, as determined by standardized engineering testing methods. -
The sample size for the training set:
This information is not applicable as there is no "training set" in the context of a physical medical device undergoing nonclinical bench testing for 510(k) submission. -
How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
§ 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.