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The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.

The Instratek ToeTac™ 10° Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver, as well as a single packaged implant.

The provided text is a 510(k) summary for the ToeTac™ 10° Hammertoe Fixation System. It describes the device and its intended use, but it does not contain information about acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information from the text. The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics, supported by general performance testing.

Here's how I would structure the answer if the information were available:

Acceptance Criteria and Study for the ToeTac™ 10° Hammertoe Fixation System

The provided text does not contain the specific acceptance criteria or detailed study results to address the requested information. The document is a 510(k) summary focused on establishing substantial equivalence, and while it mentions "Performance testing consisted of tests for pull out, torque and static and dynamic bend strength," it does not provide the quantitative criteria, the reported device performance against those criteria, or the methodology of the study in detail.

Therefore, I cannot populate the table or answer most of the specific questions.

If the information were present, it would typically look like this:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: (Information not provided in the text)
• Data provenance: (Information not provided in the text, but for mechanical testing, it would likely be laboratory-generated data.)

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

• This question is more applicable to studies involving human interpretation (e.g., imaging studies, clinical outcomes). For mechanical device testing, the "ground truth" is typically defined by engineering standards and measurement accuracy, not expert consensus. Information is not provided in the text.

4. Adjudication method for the test set

• Not applicable for typical mechanical device testing. Information is not provided in the text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, the text mentions "Performance testing consisted of tests for pull out, torque and static and dynamic bend strength," which are biomechanical tests, not clinical MRMC studies.

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

• Not applicable as this is a physical medical device, not an AI algorithm.

7. The type of ground truth used

• For the mentioned performance tests (pull-out, torque, bending), the "ground truth" would be established by validated mechanical testing methodologies and instrumentation, typically referencing relevant ASTM or ISO standards for medical device testing.

8. The sample size for the training set

• Not applicable for a physical medical device in this context. There is no information about an "AI training set."

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

• Not applicable.

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