(51 days)
The HEALIX ADVANCE KNOTLESS BR 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 BR ANCHOR is a cannulated, threaded knotless anchor designed to secure soft tissue to bone. The proposed anchor is manufactured from the absorbable material "Biocryl® Rapide™" (15/85% B - TCP/PLA PGA copolymer) loaded on a disposable inserter driver with #2 ORTHOCORD® suture (K040004, K043928). The anchors are offered in two sizes (4.75 mm and 5.5 mm).
The provided text is a 510(k) summary for a medical device (HEALIX ADVANCE KNOTLESS BR ANCHOR) and does not contain the detailed information necessary to answer all aspects of your request. Specifically, it lacks a dedicated "acceptance criteria" section and a detailed study report.
However, based on the Safety and Performance section, we can infer some aspects related to device performance and the type of study conducted to support substantial equivalence.
Here's an attempt to answer your questions based on the available information, with clear indications where information is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance requirement of the proposed device is to secure soft tissue to bone during soft tissue healing period." It then states that "Fixation force testing was performed under in vitro condition throughout two times of healing period." The conclusion is that "The data shows that the proposed device performs similarly to the predicate devices."
Therefore, the implicit acceptance criteria would be for the device's fixation force to be "similar to the predicate devices" during and after the specified healing period. The reported performance is that it "performs similarly to the predicate devices."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Fixation force of the proposed device should be similar to the predicate devices (K112249 Mitek Healix Knotless BR Anchor) under in vitro conditions for two times the healing period. | The data shows that the proposed device performs similarly to the predicate devices (K112249 Mitek Healix Knotless BR Anchor) during fixation force testing. |
| Material biocompatibility confirmed. | Material biocompatibility has been also confirmed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document only mentions "in vitro condition" for the fixation force testing.
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/provided. The study described is an in vitro performance test, not a clinical study involving human or animal data that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. The study described is an in vitro performance test.
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
This information is not applicable. The device is a bone anchor, not an AI-powered diagnostic tool, and therefore no MRMC study involving human readers and AI assistance would be conducted for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a bone anchor, not an algorithm. The "standalone" performance here would refer to the mechanical performance of the anchor itself, which was evaluated as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "fixation force testing," the "ground truth" would be the measured mechanical properties (e.g., maximum load to failure, displacement, stiffness) of the device and its predicate, obtained through controlled engineering tests. For "material biocompatibility," the ground truth would be established through standard biocompatibility testing as per ISO or ASTM standards.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable.
§ 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.