(29 days)
Lateral Trochanteric Plates: extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.
The Modified BMP™ Trochanteric Plates consist of crimps and trochanteric plates. The crimps are made of either 316LVM stainless steel or Co-Cr-Mo. The CoCr crimps are to be used in conjunction with CoCr wire and stainless steel crimps are to be used in conjunction with stainless steel wire.
The trochanteric plates are made of CoCrMo and are available in two different lengths. The shorter plate is available in both right and left configurations while the longer plate will be straight and have a different contour in the trochanter region than the shorter plates.
The provided text is a 510(k) summary for the "Modified BMP™ Trochanteric Plates" and concerns the regulatory clearance of a medical device, not a study design or performance evaluation of a device using AI, statistical analysis, or reader studies. Therefore, most of the requested information cannot be extracted from this document, as it describes a clearance process based on substantial equivalence to a predicate device, not performance against acceptance criteria proven by a study.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not contain acceptance criteria or reported device performance in the manner typically seen for clinical studies or AI/software evaluations. It is a regulatory clearance document stating that the device is "substantially equivalent" to legally marketed predicate devices. Substantial equivalence means that the device has the same intended use as a predicate device, and the same technological characteristics as the predicate device; or has different technological characteristics from the predicate device and the information submitted demonstrates that the device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness than the predicate device.
The "Indications For Use" section could be considered the "intended use" aspect of the device, which must align with the predicate device for substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: For use in lateral trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies. | Device is "substantially equivalent" to devices marketed prior to May 28, 1976, for the stated indications for use, implying it meets the same safety and effectiveness profile. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This document is a 510(k) submission for substantial equivalence. It does not describe a clinical study or test set with specific sample sizes or data provenance for performance evaluation. Substantial equivalence is often demonstrated through comparative testing to a predicate device, material characterization, or non-clinical testing rather than human subject data, unless safety/effectiveness cannot be demonstrated by other means.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The clearance is based on substantial equivalence, not on establishing ground truth for a discrete diagnostic or therapeutic outcome through expert consensus.
4. Adjudication Method:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This document does not describe an MRMC study or any study comparing human readers with and without AI assistance.
6. Standalone Performance Study:
Not applicable. This document does not describe a standalone algorithm performance study.
7. Type of Ground Truth Used:
Not applicable. In the context of a 510(k) for this type of device (a bone fixation appliance), "ground truth" would relate more to the mechanical properties, biocompatibility, and functional equivalence to predicate devices, rather than a diagnostic or interpretive ground truth established by experts or pathology.
8. Sample Size for the Training Set:
Not applicable. This document does not describe an AI or algorithm that would have a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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.