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The MDPO Frame System is indicated for use in the lower extremity for: open and closed long bone fracture fixation, to include tensioned wire fixation of periarticular fractures, arthrodesis, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities, dislocations, arthrodiastasis, and Charcot foot reconstruction and Lisfranc dislocations.

The MDPO Frame System is an external fixation system that can be made into various configurations for lower limb application. The MDPO Frame System includes the following components: Half Pins, Wires, Footplate consisting of the Connecting Plate/Assembly with interchanging Medial and Lateral Arch Plates/Assemblies, Matching Rings, Open Rings, Closed Circular Rings, Columns, Threaded Rods, Sockets, Screws, Bolts, Nuts, Washers, Posts, and Cubes. The components of the MDPO Frame System are made from stainless steel, carbon fiber, Radel or aluminum. All components are designed for single use only.

This request pertains to the MDPO Frame System (K093753), an external fixation system for lower limb application.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it describes a comparative study to demonstrate substantial equivalence to predicate devices. The performance is reported in terms of being "at least equivalent."

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

The document does not specify the sample size used for the construct fatigue testing or in-plane compression strength testing.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, as a 510(k) summary, the testing would generally be conducted by the manufacturer or a contracted lab to meet regulatory requirements prior to submission.

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

Not applicable. This device is a mechanical medical device, and its performance evaluation relies on engineering-based mechanical testing (fatigue, compression strength) against established ASTM standards and predicate device performance, not on expert adjudication of diagnostic images or clinical outcomes that would require ground truth established by medical experts.

4. Adjudication Method for the Test Set:

Not applicable. See point 3. The evaluation is based on objective mechanical stress and strain measurements, not subjective interpretation.

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

No. An MRMC study is relevant for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance. This is a mechanical device, and its safety and effectiveness were demonstrated through mechanical testing.

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

Not applicable. This is a mechanical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this type of device is the measured mechanical properties (e.g., fatigue life, compression strength) obtained through standardized engineering tests, and their comparison to established benchmarks (e.g., ASTM standards, predicate device performance for equivalency).

8. The Sample Size for the Training Set:

Not applicable. This is a mechanical device. There is no concept of a "training set" as it would apply to machine learning algorithms. Design and material selection for external fixation systems are based on engineering principles and material science, not a data-driven training process.

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

Not applicable. See point 8.

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