(306 days)
The Arthrex Short Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.
The Arthrex Short Suture Anchors share the same design features, materials, and intended use as the predicate. The anchors consist of cannulated anchors with an integral or separate eyelet. They are pre-loaded on a handle inserter. Suture, with or without needles, and a suture threader may be provided. The anchors are made from polyetheretherketone (PEEK) and range from 2.0mm - 2.4mm in diameter and 8.6 - 9.0mm in length (including eyelet).
This document (K151092) is a 510(k) premarket notification for a medical device called "Arthrex Short Suture Anchors." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than describing a study with acceptance criteria for a new AI/software device. Therefore, many of the requested fields are not applicable to the content of this document.
However, I can extract the relevant information from the document regarding the device's performance demonstration.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance meets or exceeds predicate device for desired indications | "The submitted tensile testing data demonstrates that the performance of the proposed devices meets or exceeds the predicate device for the desired indications." This implies that the tensile strength of the Arthrex Short Suture Anchors was at least equivalent to, if not better than, the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in the provided document. The document refers to "tensile testing data," but does not specify the number of anchors or tests performed.
- Data provenance: Not explicitly stated. Given that it's a submission for a medical device, it's highly likely that the testing was conducted in a controlled laboratory environment. The document is from the US.
- Retrospective or prospective: Not applicable for mechanical testing of a physical medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would be the measured tensile strength, which is objectively quantifiable through mechanical testing, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically relevant for subjective evaluations or complex medical interpretations, not for objective mechanical tensile testing.
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 document is about a physical medical device (suture anchors), not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software. The "standalone" performance here refers to the device's mechanical properties, which were evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would be the measured tensile strength from mechanical testing.
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.
§ 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.