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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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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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The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

The iFUSE Hammertoe System by OrthoPro is a single piece metal implant that is surgically inserted into the intramedullary canal of the bones in the toe, finger or small bones, designed to create a fusion.

The provided text does not contain information about a study proving the device meets acceptance criteria in the way typically required for AI/ML device submissions (i.e., with performance metrics, ground truth establishment, or human-in-the-loop studies).

Instead, this document is a 510(k) summary for a medical device (iFUSE Hammertoe System), which is a premarket submission to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. For this type of device (a bone fixation screw), substantial equivalence is primarily demonstrated through non-clinical testing (mechanical properties) and comparison to predicate devices, rather than clinical studies or performance against acceptance criteria derived from a complex AI/ML algorithm.

Here's why the provided text doesn't fit the requested criteria and what it does say:

1. Acceptance Criteria & Device Performance Table: Not applicable. The submission focuses on demonstrating substantial equivalence through mechanical testing rather than meeting specific performance thresholds against a diagnostic benchmark. The non-clinical tests performed are:

   • Pullout strength
   • Four-point bending and fatigue strength
     The document states: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." This is the "performance" relative to the "acceptance criteria" of being equivalent to predicates for mechanical properties.

2. Sample Size for Test Set & Data Provenance: Not applicable for a clinical test set. The "testing" refers to mechanical properties of the device itself (hardware), not observational data.

3. Number of Experts & Qualifications / Adjudication Method: Not applicable. There was no clinical study involving human readers or expert radiologists for establishing ground truth from medical images.

4. MRMC Comparative Effectiveness Study: Not applicable. This device is a surgical implant, not an AI diagnostic tool.

5. Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.

6. Type of Ground Truth Used: Not applicable for a clinical study. For the mechanical tests, the ground truth would be the established engineering standards for strength and fatigue, and data from the predicate devices.

7. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There's no AI/ML algorithm requiring training data.

Key Information from the Document that Relates to "Proof" of Meeting "Acceptance Criteria" for this specific device:

• Acceptance Criteria (Implicit): The primary "acceptance criterion" for this 510(k) submission is that the iFUSE Hammertoe System is substantially equivalent to legally marketed predicate devices (Stayfuse, Pioneer Surgical Technology, K990804 and OthoPro Stemman Pins and Kirschner Wires, OrthoPro LLC, K070555) in terms of:
  • Intended use
  • Design
  • Materials used
  • Mechanical safety
  • Performance
• Study Proving Device Meets Acceptance Criteria: The "study" was non-clinical testing:
  • Tests Performed: Pullout strength; Four-point bending and fatigue strength.
  • Results/Conclusion: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." And "The conclusions drawn from the comparison between the devices demonstrate that the iFUSE Hammertoe System is as safe, as effective, and performs as well as the predicate devices."
  • Clinical Studies: "No clinical studies were performed."

In summary, the provided text describes the submission for a Class II metallic bone fixation fastener, where "acceptance criteria" and "proof" primarily revolve around demonstrating mechanical equivalence to existing devices through non-clinical laboratory testing, not through clinical trials or performance metrics of an AI/ML system.

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