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The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.

The GraMedica opti-Toe is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. The implants are offered in two sizes, small and large, and the middle phalangeal component is offered with and without a 10 degree angulation.

The document provided is a 510(k) premarket notification from the FDA for a medical device called "opti-Toe". This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the information typically requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML devices is not present in this regulatory filing.

However, I can extract the non-clinical performance testing information that was conducted to support the substantial equivalence claim for the opti-Toe device.

Here's a summary of the non-clinical performance testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a numerical or categorical format for the non-clinical tests. Instead, the testing was performed to demonstrate the device's functional integrity and similarity to predicate devices. The "reported device performance" is the successful completion of these tests.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Cadaveric Simulated Use Study: The document does not specify the number of cadavers used.
• Assembly/Disassembly Force, Static/Dynamic Bending: The document does not specify the number of devices or iterations tested for these mechanical evaluations.
• Data Provenance: The testing was non-clinical (laboratory and cadaveric) and conducted for regulatory submission purposes. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical trial with patient data.

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

Not applicable. For non-clinical tests like mechanical and cadaveric studies, "ground truth" as it relates to expert consensus on clinical findings is not established. The "ground truth" for these tests would be the measured physical properties and observations of functionality.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically for clinical trials or expert label review, not for non-clinical mechanical or cadaveric testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is a type of clinical study generally used for diagnostic devices involving human readers evaluating medical images. This document describes a K-wire equivalent fixation device and its non-clinical testing, so an MRMC study was not conducted or applicable.

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

Not applicable. This device is a physical medical implant (a toe fixation device), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical tests:

• Cadaveric Simulated Use Study: "Ground truth" was the observed functionality and ease of use in a cadaveric model.
• Mechanical Testing (Assembly/Disassembly Force, Static/Dynamic Bending): "Ground truth" was the objective measurements of force and bending properties according to established engineering standards or internal protocols, likely compared against predicate device performance or relevant industry standards for similar devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for an AI/ML device, this question is not relevant.

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