(29 days)
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:
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Metacarpus, proximal and middle phalangeal bones
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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:
-
Metacarpus, proximal and middle phalangeal bones
-
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
| Acceptance Criteria (Defined in Design Control Activities Summary) | Reported Device Performance |
|---|---|
| Bending strength | Met acceptance criteria (through worst-case analysis, 4-point bend testing, and simulated use testing) |
| 4-point bend testing | Met acceptance criteria |
| Simulated use testing | Met acceptance criteria |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.