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The TriMed X-Fix System is a unilateral external fixation device. It is intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

The X-Fix System is a unilateral external fixation device. It includes various size components to accommodate various anatomies and injuries. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use.

The X-Fix System is made of aluminum, black carbon composite and F-138 surgical grade stainless steel.

This document describes the X-Fix System, a medical device, and its regulatory clearance. It does not contain information about acceptance criteria or a study proving its performance in the context of device performance metrics typically associated with AI/ML, clinical trials with statistical endpoints, or extensive testing against specific performance targets.

Instead, this document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "summary of safety and effectiveness" for this type of submission is primarily concerned with establishing that the new device is as safe and effective as a device already on the market, rather than proving performance against predefined quantitative metrics in a detailed study.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not Applicable / Not Provided. This document does not describe specific acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) for the X-Fix System itself, nor does it provide a report of such device performance. The "acceptance" here refers to regulatory acceptance by the FDA based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. No "test set" in the context of performance evaluation (like in an AI/ML study or a clinical trial) is mentioned. The submission is based on a comparison to a predicate device, not on new performance data from a specific test set.

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)

• Not Applicable / Not Provided. No "ground truth" establishment by experts for a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No test set or 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

• Not Applicable / Not Provided. This is a hardware medical device (external fixator). MRMC studies are typically relevant for diagnostic AI/ML devices where human readers interpret results. This type of study would not apply to the X-Fix System.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided. The X-Fix System is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. There is no mention of ground truth in the context of performance testing for this device.

8. The sample size for the training set

• Not Applicable / Not Provided. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. No training set or ground truth establishment is mentioned.

Summary of what the document does provide regarding "acceptance" and "proof":

The document serves as a "Summary of Safety and Effectiveness" for a 510(k) submission to the FDA. The "proof" the device met "acceptance criteria" here is that the FDA determined it was substantially equivalent to a legally marketed predicate device.

• Acceptance Criteria (Implicitly by FDA): The primary "acceptance criteria" for a 510(k) submission is demonstrating that the new device is as safe and effective as a predicate device already on the market, and does not raise new questions of safety or effectiveness. This is achieved by comparing indications for use, technological characteristics (design, materials), and performance (if applicable, through non-clinical or clinical data) to the predicate.
• Study Proving Acceptance (Implicit): The "study" here is the comparison made by the submitter (TriMed, Inc.) and reviewed by the FDA.
  • Device Compared To: Avanta Orthopaedics External Fixator (K974911/K981716).
  • Basis of Equivalence: "The X-Fix is equivalent in dimensions, design and materials." (Section III. Substantial Equivalence).
  • FDA Determination: The FDA reviewed the submission and found the device "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

In essence, the document serves as regulatory clearance, not a performance study report in the typical sense of testing against specific quantitative performance metrics.

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