(58 days)
The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fracture System features several sizes of distal radius plates as well as various styles and sizes of locking, nonlocking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6AI-4V ELI) per ASTM F136.
This 510(k) summary does not contain information about software, AI, or any studies related to human reader performance or ground truth establishment. It focuses on the mechanical performance of a bone fixation system. Therefore, I cannot provide the details you requested regarding acceptance criteria and studies that prove a device meets criteria related to AI or diagnostic performance.
The document describes the BPS Wrist Fracture System, a device for bone fixation, and its performance data relates to mechanical testing.
Here's the information that is available based on the provided text, formatted as closely as possible to your request for clarity:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Acceptance Criteria (as outlined in FDA Guidance documents) | Reported Device Performance |
|---|---|---|
| Static Four-Point Bending (per ASTM F382) of worst-case subject plates | Performance criteria as outlined in "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" | Met the performance criteria. |
| Torsional yield strength (per ASTM F543) of worst-case subject screws | Performance criteria as outlined in "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" | Met the performance criteria. |
| Driving torque (per ASTM F543) of worst-case subject screws | Performance criteria as outlined in "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" | Met the performance criteria. |
| Axial Pullout Strength of worst-case subject screws (evaluated using an engineering analysis) | Performance criteria as outlined in "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" | Met the performance criteria. |
Regarding your other requested information:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to mechanical samples of the device components (plates and screws), not patient data. The provenance of these mechanical tests is not specified beyond being "conducted per ASTM" standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are mechanical tests, not clinical studies requiring expert ground truth for interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study requiring adjudication.
- 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 a bone fixation system, not an AI or imaging device, so MRMC studies are irrelevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for mechanical tests is the quantitative measurement against the established ASTM standards.
- The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 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.