(121 days)
The Arthrex Bio-Composite Suture Anchor Family is intended to be used for Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis. For suture or tissue fixation in the foot, ankle, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications where size is appropriate. See the Indications for Use statements for specific indications.
The Arthrex Bio-Composite Suture Anchors Family is identical to the predicate devices.
This document is a 510(k) summary for the Arthrex Bio-Composite Suture Anchors, specifically for the expansion of indications to include the hip. It does not describe a study involving performance criteria for a device that relies on data analysis or AI/ML.
Instead, it is a submission to the FDA demonstrating substantial equivalence of a medical device (suture anchors) to a previously cleared predicate device. Substantial equivalence means the new device is as safe and effective as a legally marketed device. This is typically based on comparing the design, materials, manufacturing, and intended use, rather than a clinical study with acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of data analysis or AI/ML, as that kind of information is not present in the provided text.
Here's a breakdown of what is in the document, relating to your request where possible, and highlighting what is absent:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe performance metrics in terms of sensitivity, specificity, accuracy, or similar measures that would be used for a diagnostic device or AI/ML system. The basis for clearance is "substantial equivalence" to a predicate device. This typically involves comparison of materials, design specifications, and intended use rather than numerical performance criteria against a specific benchmark.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance in the context of clinical performance evaluation (like for an imaging AI) is mentioned. The submission is based on engineering and material comparisons to a predicate device.
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)
- Not Applicable. No ground truth establishment for a test set is discussed. The FDA's review for substantial equivalence primarily relies on the manufacturer's documentation and comparison to the predicate device, not on expert consensus for clinical interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no test set or adjudication method described.
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
- No. This type of study is completely irrelevant to the clearance of a suture anchor. The device is a surgical implant, not a diagnostic tool or an AI-assisted system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. The device is a physical suture anchor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No quantifiable ground truth is mentioned in this type of submission for a physical implant. The "ground truth" for substantial equivalence would broadly be a demonstration that the new device shares the same fundamental scientific technology, materials, and intended use as the predicate device, and any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm is involved.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary of the provided document:
The document is a 510(k) Premarket Notification from Arthrex, Inc. for their Bio-Composite Suture Anchors. The purpose of this submission (K082810) is to expand the indications for use of these anchors to include the hip, in addition to previously cleared indications.
The key information provided is:
- Manufacturer: Arthrex, Inc.
- Trade Name: Arthrex Bio-Composite Suture Anchors (including PushLock, Tak, and Corkscrew)
- Common Name: Suture Anchor
- Predicate Device: Arthrex Bio-Composite Suture Anchors (K071177)
- Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "The Arthrex Bio-Composite Suture Anchor Family is substantially equivalent to the predicate Arthrex Bio-Composite Suture Anchor Family in which the basic features and intended uses are the same. Any differences between the Bio-Composite Suture Anchor Family and the predicate K071177 are considered minor and do not raise questions concerning safety and effectiveness."
- New Indications for Use (Hip): Capsular Repair, acetabular labral repair.
The FDA's letter confirms that the device is substantially equivalent and can be marketed for the stated indications.
§ 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.