Search Results

Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.

Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation and rotational control for fractures of the proximal humerus and distal tibia. The plates feature a low profile limited contact dynamic compression plate (LC-DCP®) design and dynamic compression unit (DCU) screw holes. The blade portion of the plate is cannulated to accept a 2.0 mm guide wire. The plates are available in various sizes to accommodate varying patient anatomy.

This document is a 510(k) premarket notification for the Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates (LC-ABP). It establishes substantial equivalence to predicate devices but does not contain acceptance criteria or a study demonstrating the device meets such criteria.

The provided text is related to regulatory approval for a medical device (bone fixation plates), specifically a 510(k) submission to the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data with specific acceptance criteria and detailed performance metrics.

Therefore, most of the requested information cannot be extracted from this document. The document primarily identifies the device, its intended use, classification, and predicates, and confirms its substantial equivalence for marketing.

Here's a breakdown of why the requested information is absent:

1. A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria or detailed performance data from a clinical or non-clinical study. Its purpose is regulatory clearance based on substantial equivalence, not performance benchmarking against specific criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, clinical data, or information regarding data provenance is included in this 510(k) summary.

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): As there is no clinical test set described, there is no information on experts or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set 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: Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a surgical implant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical studies or ground truth establishment are described.

8. The sample size for the training set: Not applicable as this is a medical device approval document, not a report on an AI model's development.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory clearance letter and summary for a Class II medical device, focused on substantial equivalence. It does not contain the detailed clinical study data, acceptance criteria, or performance metrics typical of a clinical trial report or an evaluation of a diagnostic AI system.

Ask a specific question about this device