(67 days)
The Arthrex Bio-Composite SutureTak Anchors family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Please see indications for use form for specific indications.
The Arthrex Bio-Composite SutureTak Anchors family is similar to the predicate devices in overall design. The difference lies in the introduction of smaller SutureTak models made with Bio-Composite material (PLLA or PLDLA combined with TCP).
The provided document, K091844 for Arthrex Bio-Composite SutureTak Anchors, is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this 510(k) summary. These types of detailed studies are generally part of the design validation phase and are summarized or referenced in the 510(k) submission, but the full details are not typically provided in the public summary document.
The document states that the new device is "substantially equivalent" to its predicate based on "basic features and intended uses" being the same, and any differences are "minor and do not raise questions concerning safety and effectiveness." This indicates that the equivalence was likely established through a combination of design comparison, material characterization, and potentially some mechanical testing to ensure performance similar to the predicate, rather than a clinical study with detailed performance metrics against pre-defined acceptance criteria as one might see for an AI/ML device.
Here's a breakdown of why each point of your request cannot be fully addressed by this document:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or report specific performance metrics from a study against such criteria. The comparison is made to the predicate device, K071177.
- Sample sized used for the test set and the data provenance: No information on test set sample sizes or data provenance is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a medical device (suture anchor) and not an AI/ML diagnostic system requiring expert-established ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML diagnostic device for image interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML diagnostic. For a mechanical device like a suture anchor, ground truth would typically relate to mechanical properties, biocompatibility, and clinical performance (e.g., healing rates, retear rates), which are not detailed here. The ground truth for proving substantial equivalence to the predicate would be demonstrations of equivalent design, materials, and functional performance.
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable (no AI/ML training set).
In summary, the provided K091844 document demonstrates substantial equivalence, not a detailed performance study against specific acceptance criteria as you would typically find for an AI/ML device.
§ 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.