(44 days)
The Smith & Nephew KINSA RC Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Deltoid Repairs
Rotator Cuff Tear repairs
Biceps tenodesis
The KINSA RC Anchor is a suture anchor manufactured from PEEK polymer. The design incorporates a suture knot within the anchor body and a suture loop with a tension suture extending from the top of the anchor. This design allows the surgeon to implant the anchor, pass the suture loop through the tissue and using the tensioning suture, complete the repair without the need for knot tying.
The provided text describes a 510(k) summary for the Smith & Nephew KINSA RC Suture Anchor. It establishes substantial equivalence by comparing it to a predicate device (Smith & Nephew KINSA Suture Anchor, K061154).
However, the document does not contain the specific information requested regarding acceptance criteria, device performance, or details of a study involving ground truth, expert review, or sample sizes related to AI or algorithm performance.
This document is a regulatory submission for a medical device (suture anchor), and its performance assessment is based on demonstrating substantial equivalence to a previously cleared device, not typically on the kind of clinical study details requested for an AI/algorithm-based device.
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
Here is what can be inferred or explicitly stated from the provided text, recognizing that it does not directly address many of the questions:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparison to Predicate Device: The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew KINSA Suture Anchor (K061154). The differences in the new device and the predicate device do not raise any new issues of safety and efficacy. |
Missing Information: Specific numerical acceptance criteria (e.g., tensile strength thresholds, pull-out force minimums) and corresponding numerical performance data are not provided in this summary. The "performance" here refers to demonstrating equivalence rather than meeting specific quantifiable clinical or engineering thresholds.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but generally, such comparison testing would occur internally at Smith & Nephew. The nature of this 510(k) is about device equivalence, generally based on mechanical or animal testing, not human clinical trial data for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The "ground truth" for a mechanical device like a suture anchor is typically based on engineering specifications and mechanical testing standards, not expert clinical consensus in the way an AI diagnostic tool would be evaluated.
4. Adjudication method for the test set:
- Not applicable/Not specified.
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 is not an AI-based device, nor is it a diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- The "ground truth" implicitly used for this device's approval is its mechanical and material properties meeting established engineering standards and demonstrating equivalence to a legally marketed predicate device. This would involve physical testing data (e.g., pull-out strength, material composition verification) rather than clinical outcomes or expert consensus on medical images.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
Summary based on the provided text:
The Smith & Nephew KINSA RC Suture Anchor gained 510(k) clearance by demonstrating substantial equivalence to a predicate device (Smith & Nephew KINSA Suture Anchor, K061154). The study involved performance testing that showed the new device is substantially equivalent in design, materials, function, and intended use to the predicate and that its differences do not raise new safety or efficacy issues. The type of "ground truth" relied upon for this clearance would be engineering and mechanical testing data confirming the properties and performance of the device against a known standard (the predicate device). Details regarding specific numerical acceptance criteria, test sample sizes, or any human expert review for establishing ground truth are not included in this 510(k) summary, as it's a submission for a mechanical implantable device, not a diagnostic or AI-driven system.
§ 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.