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The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Device Description

The Interphalangeal Joint Fusion Device Range consists of metallic devices intended to stabilize two bone fragments until bone fusion. They are available in several lengths and angulations. All the implants are made of titanium alloy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Interphalangeal Joint Fusion Device Range." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving improved diagnostic accuracy or effectiveness through clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria for AI performance (like sensitivity, specificity, or AUC), and the detailed methodology of studies proving device performance with AI, is not applicable to this submission.

Here's why and what information is available:

Device Type: This is a physical implant (metallic bone fixation fastener), not an AI/software device.
Regulatory Pathway: The 510(k) pathway for traditional medical devices relies heavily on demonstrating substantial equivalence to existing devices based on technological characteristics and performance data, often through non-clinical (mechanical) testing.
Focus of the Submission: The submission highlights similarities in intended use, materials, design, dimensions, sterilization, and performance specifications compared to predicate devices.

Given this context, I will address the relevant points from your prompt based on the provided document.

Acceptance Criteria and Study for Interphalangeal Joint Fusion Device Range

The acceptance criteria for this device, as demonstrated through the 510(k) submission, revolve around establishing substantial equivalence to existing predicate devices. This is primarily achieved by showing comparable or superior mechanical performance and similar technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use	Device's intended use is substantially equivalent to predicate devices.	The Interphalangeal Joint Fusion Devices and all predicates have similar intended uses.
Materials	Device materials are the same as or comparable to predicate devices and conform to recognized standards (e.g., ISO, ASTM).	Fabricated from Titanium alloy per ISO 5832-3 / ASTM F136, the same material as the predicate devices.
Design Features/Functions	Device's basic design features and functions are similar to predicate devices.	Shares similar basic design features and functions with cited predicate devices.
Dimensions	Device dimensions are similar to predicate devices.	Dimensionally similar to the cited predicate devices.
Sterilization	Device sterilization method and state (sterile/non-sterile) are consistent with predicate devices.	Provided sterile, as are the cited predicate devices.
Mechanical Performance (Non-Clinical)	Device demonstrates equivalent or superior mechanical performance compared to predicate devices under specified test conditions (e.g., static bending, dynamic bending, axial pull-out).	Mechanical testing confirmed the Interphalangeal Joint Fusion Devices demonstrated as good or better performances than the cited predicate devices under the same test conditions. Results indicated they are as strong or stronger than predicate devices.

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of clinical patient data or AI performance. For mechanical testing, the "samples" would refer to the number of devices tested. The document does not specify the exact number of devices tested for each mechanical test (static bending, dynamic bending, axial pull-out).
Data Provenance: The mechanical tests were performed by the manufacturer (NEOSTEO). No other provenance information (e.g., country of origin, retrospective/prospective) is relevant as these are laboratory-based engineering performance tests on the device itself.

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

Not applicable. This submission does not involve AI performance evaluation or a "ground truth" established by human experts in the diagnostic sense. The "ground truth" for the mechanical tests would be the established engineering standards and physical measurements.

4. Adjudication Method for the Test Set

Not applicable. There was no human expert adjudication of results, as this was mechanical testing of a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted as this is a physical medical device submission, not an AI-assisted diagnostic or prognostic tool. The concept of "human readers improve with AI vs without AI assistance" does not apply.

6. Standalone (Algorithm Only) Performance

No. This is not an AI/algorithm-only device. Therefore, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used

Mechanical Test Standards/Measurements: The "ground truth" for proving the device meets performance criteria relies on objective measurements from mechanical tests (static bending, dynamic bending, axial pull-out) and comparison against the performance of predicate devices under the same test conditions. Compliance with recognized material standards (ISO 5832-3 / ASTM F136) also contributes to the "ground truth" for material properties.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable. As there is no AI algorithm or training set, this question is not relevant.

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