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The FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.

The FastForward device, consisting of Titanium (Ti-6AL-4V ELI), is a button designed to be implanted on the lateral aspect of the 200 metatarsal with suture or suture tape.

The provided text is a 510(k) summary for the MedShape FastForward device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparative testing of mechanical properties, rather than clinical performance studies typically associated with AI/software-based devices. Therefore, much of the requested information regarding clinical acceptance criteria, human reader studies, and AI-specific ground truth will not be present.

Based on the provided text, here's the information that can be extracted:

Acceptance Criteria and Device Performance

The 510(k) summary indicates that the device's performance was evaluated through pullout/fracture strength testing, monotonic and cyclic tension, and shear testing. The overall acceptance criterion for these tests was substantial equivalence to the predicate device (Arthrex Mini Tightrope, K061925).

Study Details

Given the nature of a 510(k) for a metallic bone fixation appliance, the "study" referred to is primarily benchtop mechanical testing.

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

   • The document does not specify the exact sample sizes (i.e., number of FastForward devices or predicate devices) used for the pullout, fracture, tension, and shear testing.
   • The data provenance is not explicitly stated as country of origin, but it is implied to be from MedShape's internal testing or a contract lab. The test data is retrospective in the sense that it was conducted as part of the device development and submission.

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

   • This question is not applicable as the "ground truth" was established purely through objective mechanical testing measurements (e.g., force at failure, displacement under load) rather than expert interpretation of medical images or clinical outcomes.

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

   • None. Adjudication methods are relevant for subjective assessments (e.g., reading medical images) where human agreement is required to establish ground truth. As this was mechanical testing, objective measurements were taken.

4. 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:

   • No. An MRMC study is not mentioned. This type of study is relevant for AI-powered diagnostic or interpretive devices, not for a mechanical bone fixation device like the FastForward. There is no AI component mentioned for this device.

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

   • No. This device does not involve an algorithm or AI.

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

   • The "ground truth" for this device's performance evaluation was based on quantitative mechanical measurements (e.g., force, displacement) obtained during pullout/fracture strength, monotonic and cyclic tension, and shear testing. The performance was then compared to a predicate device's performance using these objective measurements.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this device is a mechanical implant and does not involve machine learning or AI.

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

   • This is not applicable. There is no training set for a mechanical device.

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