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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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Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

The Arthrosurface Inc's Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The taper lock pin provides a press fit connection between the two screws with light contact pressure. The implant components are manufactured using implant grade titanium alloy and cobaltchrome alloy.

The provided text is a 510(k) summary for the Arthrosurface Inc's Hammertoe Correction System. This document focuses on demonstrating substantial equivalence to existing devices through comparative mechanical testing and cadaveric testing, rather than an independent study proving device performance against acceptance criteria with a focus on AI or algorithmic performance.

Therefore, many of the requested categories (especially those related to AI algorithm performance, ground truth, experts, and training/test sets) are not applicable to this type of regulatory submission as they are for a surgical implant, not an AI software medical device.

I will provide information relevant to the acceptance criteria and supporting studies as much as possible from the given text.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Comparative Mechanical Testing study and Cadaveric Testing. The primary goal of these studies, in the context of a 510(k) submission, is to demonstrate substantial equivalence to predicate devices already on the market, not necessarily to meet pre-defined standalone performance metrics against an absolute standard.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for specific tests. The text mentions "Comparative Mechanical Testing was performed per relevant recognized standards" and "Data from cadaveric testing were also reported." The sample sizes for these tests are generally dictated by the chosen standards (e.g., ISO, ASTM) or internal protocols for cadaveric work, but the exact numbers are not provided in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that this is a 510(k) submission to the FDA for a US market, it is reasonable to infer the testing was conducted in facilities compliant with US regulatory requirements (e.g., GLP for non-clinical testing). The studies would be considered prospective as they were conducted specifically to support this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is Not Applicable in this context. The "ground truth" for a mechanical implant device is primarily established through objective physical measurements and material science standards, not by expert consensus in a diagnostic sense. For cadaveric testing, the "ground truth" would be the observed biomechanical performance or failure modes. There is no mention of human interpretation being the primary ground truth.

4. Adjudication Method for the Test Set

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepant expert opinions are resolved, which is relevant for diagnostic or AI performance evaluations, not for mechanical testing of an implant.

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 section is Not Applicable. This request pertains to AI software performance evaluation. The submitted device is a physical surgical implant, not an AI or diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is Not Applicable. The device is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily:

• Mechanical Performance Data: Objective measurements obtained from standardized mechanical tests (static and dynamic cantilever bending, torque to failure, pull-out force, insertion-removal torque, axial disassembly force).
• Material Specifications: Adherence to implant-grade material standards (titanium alloy, cobalt-chrome alloy).
• Biomechanical Observation/Data: Observations and measurements from cadaveric testing that simulate in-vivo conditions.
• Comparative Dimensional Analysis: Measurement and comparison of device dimensions to predicate devices.

8. The Sample Size for the Training Set

This section is Not Applicable. There is no "training set" in the context of mechanical testing for a physical implant. The device design and materials are based on established engineering principles and prior knowledge.

9. How the Ground Truth for the Training Set Was Established

This section is Not Applicable. As there is no training set for a mechanical implant, there is no ground truth to establish for it.

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