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The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:

• Fixation of malunions and nonunions
• Acute fractures
• Avulsion fractures
• Repetitive stress fractures
• Jones Fractures
• Malleolar Fractures
• Talus Fractures
• Greater Tuberosity Fractures

The design features of the 5th Metatarsal Fracture Screw are summarized below:

• Manufactured from Stainless Steel .
• Offered in three diameters: 4.5mm, 5.5mm, and 6.5mm .
• Offered in lengths ranging from 40mm-70mm .

This document is a 510(k) Summary for the 5th Metatarsal Fracture Screw. It outlines the device's intended use, description, and claims of substantial equivalence to a previously cleared predicate device (Multi-Use Compression Screw). The FDA's letter states that the device is substantially equivalent for the indications of use described.

Here's an analysis of the provided text in relation to your request for acceptance criteria and study information:

Acceptance Criteria and Device Performance:

The document does not report specific quantitative acceptance criteria or device performance data in the format you requested for a medical device that might typically undergo clinical trials or performance testing with measurable outcomes (like sensitivity, specificity, accuracy for an AI device).

Instead, this 510(k) summary focuses on establishing substantial equivalence to a previously cleared predicate device. This means the primary "acceptance criterion" is that the new device is as safe and effective as a legally marketed device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Information:

Based on the provided text, there is no detailed study described that measures performance against specific acceptance criteria in the way you might expect for an AI/algorithm-based device. This 510(k) is for a physical medical device (a screw for bone fixation), and the submission focuses on demonstrating substantial equivalence rather than explicit performance metrics from a comparative study.

Here's a breakdown of why many of your requested points are not applicable or cannot be answered from this document:

1. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithm device that uses a "test set" in the computational sense. The "test set" for a physical device like this might involve mechanical testing, but such details are not provided here.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are not relevant for demonstrating substantial equivalence of a physical bone screw based on design, material, and intended use.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. This device is not an AI assistant to human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For this physical device, "ground truth" would relate to mechanical properties, biocompatibility, and clinical outcomes for the intended use, which are typically established through existing standards, mechanical testing, and clinical experience of similar devices. The document states "analysis data" was provided, which likely refers to engineering and material testing.
7. The sample size for the training set: Not applicable. This is not an AI/algorithm device that uses a "training set."
8. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) filing for a 5th Metatarsal Fracture Screw demonstrates substantial equivalence to a predicate device. It does not contain the detailed performance metrics or study information typically found for AI-driven clinical devices, as it is a physical implant. The "acceptance criterion" here is primarily regulatory: that the device is shown to be as safe and effective as a device already on the market. The "study" proving this involves comparing its design, materials, and intended use to the predicate device, along with "materials information" and "analysis data" (likely mechanical and biocompatibility testing results, not presented in this summary).

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