(74 days)
The Sutureless Anchor is intended for soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder.
The Sutureless Anchor is a biodegradable bone anchor intended for soft tissue to bone fixation in the repair of shoulder injuries. The device is offered in one size, 7.0mm. The Sutureless Anchor implant consists of three components: a sleeve, pin and washer. Upon deployment, the pin is driven through the center of the washer into the sleeve, expanding the sleeve radially to gain bone fixation. Simultaneously, a shearing mechanism releases the implant from the deployment shaft. The washer, fastened to the implant by the pin head, remains above the bone surface, tacking the soft tissue to the bone.
The provided text describes specific performance data for the "Sutureless Anchor" device, focusing on its ultimate holding strength compared to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Ultimate Holding Strength | To demonstrate substantially equivalent performance to the predicate device (SureTac). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for the Bone Model Testing. It refers to "the ultimate holding strength" and "holding strength mean," implying multiple tests were performed, but the number of samples is not given.
- Data Provenance: The testing was "in-vitro," meaning it was conducted in a controlled laboratory environment, not on live subjects. The country of origin of the data is not specified but given the submitter's address (Marlborough, MA, USA), it can be inferred the testing was likely conducted in the USA or supervised by the US-based company. The data is retrospective in relation to the submission date as it was performed to support the 510(k) application.
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 provided in the text. The study described is a mechanical performance test (bone model testing), not one requiring expert human interpretation. The "ground truth" here is the measured holding strength, a quantitative metric.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable to the described study. The study is a quantitative mechanical test measuring ultimate holding strength, which does not involve human adjudication for ground truth.
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 provided and is not applicable. The provided document describes a pre-market notification for a medical device (Sutureless Anchor) and its mechanical performance testing. It does not involve AI, human readers, or image interpretation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This information is not provided and is not applicable. The device is a mechanical anchor; there is no algorithm involved in its function or performance testing as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the test set was based on quantitative measurement of ultimate holding strength in a bone model.
8. The sample size for the training set:
- This information is not provided and is not applicable. The device is a mechanical implant, not an AI-driven system that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not provided and is not applicable, as there is no training set for a mechanical implant.
§ 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.