(27 days)
The SURETAC III is intended for soft tissue to bone approximation.
The indications for the SURETAC III are rotator cuff repair, repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.
The SURETAC® III is a bioabsorable fixator utilized for soft tissue to bone approximation.
The provided document is a 510(k) summary for the SURETAC® III device, a bioabsorbable fixator for soft tissue to bone approximation. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, detailed study designs, or performance metrics in the way a clinical study report would.
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document does not describe a standalone algorithm performance study.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable: This document does not specify quantitative acceptance criteria or report performance metrics from a study designed to meet such criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance data against pre-defined acceptance criteria for a new clinical study.
2. Sample size used for the test set and the data provenance:
- Not Applicable: The document does not refer to a test set in the context of device performance evaluation in a clinical study. The 510(k) submission is based on demonstrating substantial equivalence through comparison of technological characteristics to predicate devices and adherence to regulatory requirements.
- Data Provenance: Not specified as no performance data from a dedicated test set is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No test set or related ground truth establishment is described.
4. Adjudication method for the test set:
- Not Applicable: No test set or related adjudication method is 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 document does not describe an MRMC comparative effectiveness study. The device is a physical bioabsorbable fixator, not an AI-assisted diagnostic or therapeutic tool for which such a study would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This document does not describe a standalone algorithm performance study. The device is not an algorithm.
7. The type of ground truth used:
- Not Applicable: As no specific performance study against a ground truth is reported in this document, this information is not available.
8. The sample size for the training set:
- Not Applicable: The concept of a "training set" is not relevant to this 510(k) submission for a physical medical device. This term is typically used for machine learning or AI models.
9. How the ground truth for the training set was established:
- Not Applicable: See point 8.
§ 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.