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General Indications:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures. Specific indications:

1. Metacarpus, proximal and middle phalangeal bones

2. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Deviet Desertifically cleared under K081588, consists of plates and fixation devices used:

General indications:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures. Specific indications:

1. Metacarpus, proximal and middle phalangeal bones

2. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

The purpose of this Special 510k is to expand the plate sizing and geometry options, and to add a marketing claim. The addition of the plate sizes and geometries are intended to give the user more options to better accommodate varying patient anatomy and varying surgical situations. There are 51 additional plates of varying lengths, widths, thicknesses and contours. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. The added marketing claim is designed to highlight the products use in reconstructive procedures of the thorax which is already covered by the specific indications for use of the predicate device.

The provided text describes a Special 510(k) submission for the BioBridge® Plating System, which is a metallic bone fixation device. The purpose of this submission is to expand the plate sizing and geometry options and add a marketing claim. The underlying technology and intended use remain unchanged from the predicate device (K081588).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes mechanical testing of the device modifications. It does not refer to clinical test sets involving patients or patient data. Therefore, questions regarding "sample size for the test set" and "data provenance" in a clinical context are not applicable to this submission. The "test set" in this context refers to the physical samples of the modified plates subjected to mechanical tests. The specific number of samples for each mechanical test (bending, 4-point bend, simulated use) is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the submission focuses on mechanical performance testing of a physical device, not on the interpretation of medical data by experts. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there is no human interpretation of data requiring adjudication. The assessment is based on objective mechanical test results.

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 question is not applicable. The device is a metallic bone fixation system, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing conducted, the "ground truth" would be the physical measurements and engineering specifications for the bending strength, 4-point bend, and simulated use performance of the plates. These are objective, quantifiable metrics.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical testing of a physical medical device.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set.

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