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KLS-Martin Sternal Plating System is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.

KLS - Martin Sternal Plating System consists of plates having a thickness of 1.0mm to 3.0mm and screws having a diameter of 2.3mm to 3.2mm.

The KLS-Martin Sternal Plating System is a Class II device intended for stabilization and fixation of anterior chest wall fractures, including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it establishes substantial equivalence and superiority based on specific biomechanical performance compared to a predicate device and cerclage wires.

2. Sample Size Used for the Test Set and Data Provenance

Only one specific study with biomechanical testing is detailed: "Biomechanical Study of Sternal Closure Using Rigid Fixation Techniques in Human Cadavers. Ozaki et al.".

• Sample Size: Not explicitly stated for the cadaver tests in the provided text.
• Data Provenance: Human cadavers were used for the biomechanical study. The location or institution where the study was conducted is not specified beyond listing "Ozaki et al.". The study appears to be retrospective in the sense that existing systems were compared, but the testing itself was prospective on the cadaveric samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This device's acceptance is based on biomechanical testing and comparison to predicate devices, not on a diagnostic accuracy study requiring expert adjudication of "ground truth" in the traditional sense of medical image analysis. Therefore, this question is not directly applicable. The "ground truth" here is the physical measurement of strength, stiffness, and displacement.

4. Adjudication Method for the Test Set

Not applicable. The biomechanical study involved quantitative measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided document concerns a Sternal Plating System, which is a surgical implant, not an AI or imaging device that would typically undergo MRMC studies. The "clinical studies" mentioned (Sargent et al., Cheng et al., Buchman et al.) refer to studies on sternal plating in general versus wiring, not a specific MRMC study comparing human performance with and without this particular device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used

For the Ozaki et al. biomechanical study, the "ground truth" was established through physical biomechanical measurements of stiffness and lateral displacement on human cadavers. For the overall claim of substantial equivalence, it was based on comparison of performance data against predicate devices and clinical literature assessment.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as above.

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