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The Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

The Life Spine Hammertoe Correction System is an implant with a dual threaded design and is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint. The implant is fabricated and manufactured from the following:

• 1. Titanium (Ti 6A1-4V ELI)
     All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the HAMMERTOE Correction System components with components from any other system or manufacturer. The HAMMERTOE Correction System implants should never be reused under any circumstances.

This appears to be a 510(k) summary for a medical device (Hammertoe Correction System), not a study evaluating an AI/ML powered medical device. Therefore, much of the requested information about acceptance criteria, study design for AI devices, sample sizes, expert ground truth, and MRMC studies is not applicable.

However, I can extract the information related to the performance data of this specific medical device.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance numbers for each criterion in the way it would for an AI/ML device. Instead, it states that various tests "were included to demonstrate the substantial equivalency" to predicate devices. This implies that the acceptance criteria are met if the device's performance is comparable to or better than the predicate devices for the measured parameters.

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

• Sample Size: Not specified for any of the individual tests (torsional strength, bending strength, axial pullout, driving torque).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are bench-top tests, so the concept of "country of origin of data" is less applicable than for clinical data.

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

• Not Applicable: This is a mechanical device, and its performance is evaluated through engineering tests (Finite Element Analysis, Bench Top Validations). "Ground truth" in the context of expert review for medical imaging or diagnostics is not relevant here. The "ground truth" is established by the physical properties and mechanical behavior of the device.

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

• Not Applicable: Adjudication methods are used to resolve disagreements among human reviewers (e.g., radiologists). This is a bench-top mechanical testing scenario.

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:

• No: This is not an AI/ML device. MRMC studies are not relevant.

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

• Not Applicable: This is not an AI/ML algorithm.

7. The type of ground truth used:

• For the mechanical tests: The "ground truth" is defined by the physical and mechanical properties of the materials and the design as measured through various engineering tests and simulations (Finite Element Analysis, Bench Top Validations). The comparison is against predicate devices and established standards.
• For biocompatibility: Material standards (ASTM F136 for titanium) and specific bacterial endotoxin testing (BET) define the "ground truth" for material safety.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no "training set."

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

• Not Applicable: As there is no training set.

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