Search Results
Found 2 results
510(k) Data Aggregation
(25 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 Fractures several sizes of distal radius plates as well as various styles of locking, non-locking, 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-6Al-4V ELI) per ASTM F136.
I'm sorry, but based on the provided FDA 510(k) clearance letter for the "BPS Wrist Fracture System," this device is a physical medical implant (a metallic bone fixation appliance) and not an AI or software-based medical device.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not present in this document.
The 510(k) summary explicitly states:
- "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."
- "The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136."
- The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section only mentions "cleaning, sterilization, biocompatibility, mechanical and performance characteristics," which are typical for physical implants, not AI/software.
None of the provided text suggests any AI or software component requiring the kind of study details you've asked for.
To answer your specific questions related to AI/software, I would need a 510(k) clearance letter or similar documentation for an AI/software medical device.
Ask a specific question about this device
(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.
Ask a specific question about this device
Page 1 of 1