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Osteosynthesis of Per-Trochanterian Fractures is intended for use in the fixation and osteosynthesis of per-trochanterian fractures.
This device is indicated for use in the fixation of pertrochanteric fractures.

The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Per-Trochanterian Fractures is an implantable orthopedic trauma device to be used in procedures.

The provided text is a 510(k) summary for the Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanterian Fractures. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study evaluating specific acceptance criteria and device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text.

The document describes the device, its intended use, and technological characteristics, and then directly compares it to pre-existing, legally marketed devices to establish substantial equivalence for regulatory approval. It does not contain information about:

1. Acceptance criteria and reported device performance: This document does not specify quantitative acceptance criteria or provide performance data for the Fixano D.S.S. system.
2. Sample size and data provenance for a test set: No information regarding a specific test set, its size, or origin is present.
3. Number and qualifications of experts for ground truth: There is no mention of experts establishing ground truth.
4. Adjudication method for the test set: No test set means no adjudication method is described.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is not mentioned.
6. Standalone (algorithm-only) performance: As this is a physical medical device (hip screw system), an algorithm-only performance assessment is not applicable.
7. Type of ground truth used: No ground truth is described.
8. Training set sample size: No training set is mentioned.
9. How ground truth for the training set was established: Not applicable, as no training set is described.

The 510(k) summary format is designed for regulatory submission to demonstrate that a new device is as safe and effective as devices already on the market, usually by comparing features and materials, not typically by presenting detailed performance study results against predefined acceptance criteria for a new clinical study.

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