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External Fixation is useful in many areas of orthopedic surgery. Following are the major categories of application:

• 1. Limb salvage from traumatic injury.
• 2. Fracture treatment (i.e. long bone fracture, including the tibia, femur, humerous, radius, and ulnar bones).
• 3. Reconstruction of extremities with deformity and dysfunction.

4. Arthrodesis.
   The surgeon must carefully evaluate the purpose for external fixation in the individual patient if the treatment is to be successful. Consideration should be given to the following factors necessary for the successful application of an external fixator. Fracture osteotmy stability, soft tissue viability, adjacent function or injury, and functional demands of the patient.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Alphatec Wire External Fixation System. This type of document declares "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a device already on the market.

It is important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not necessarily on presenting a comprehensive study with acceptance criteria and a detailed performance study in the way a Premarket Approval (PMA) application would.

Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, and detailed study methodologies is not explicitly present in the provided FDA letter or its enclosed "Indications for Use" statement. The letter refers to the "510(k) premarket notification" as containing the description of the device and how it was deemed substantially equivalent. The detailed study data would be within that notification, not in the FDA's summary letter itself.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the FDA letter. For a 510(k), compliance with predicate device characteristics and relevant standards (e.g., mechanical strength, biocompatibility) would be assessed. The letter does not specify quantitative acceptance criteria or reported device performance metrics in a tabular format.

2. Sample size used for the test set and the data provenance:

This information is not provided in the FDA letter. 510(k) submissions typically include bench testing, and sometimes animal or limited clinical data if necessary to demonstrate equivalence or address specific safety concerns. The letter does not detail any such specific study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the FDA letter.

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

This information is not provided in the FDA letter.

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:

This is not applicable to the Alphatec Wire External Fixation System, which is a physical orthopedic device, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been performed.

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

This is not applicable as it's a physical device, not an algorithm.

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

This information is not provided in the FDA letter. For a 510(k) for a physical device, substantial equivalence is often based on design, materials, and performance characteristics compared to a predicate, as well as adherence to relevant standards. The "ground truth" would implicitly be the established safety and efficacy of the predicate device under its intended use.

8. The sample size for the training set:

This information is not provided in the FDA letter. As this is a physical device, there would not be a "training set" in the context of machine learning or AI development.

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

This information is not provided in the FDA letter. Again, this concept is not directly applicable to a physical medical device.

In summary, the provided FDA letter for the Alphatec Wire External Fixation System is a declaration of substantial equivalence based on a 510(k) submission. It does not contain the detailed study data, acceptance criteria, or performance metrics in the format you've requested. Such information would be contained within the larger 510(k) submission document itself, which is not provided here. The letter confirms that the device is deemed substantially equivalent to legally marketed predicate devices for the stated "Indications for Use" (limb salvage, fracture treatment, reconstruction of extremities, arthrodesis). The approval assumes compliance with good manufacturing practices and other general controls.

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