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The BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb with limited range of motion.

The BIOPRO Cobalt Trapeziometacarpal Replacement is a one-piece resurfacing component for the basal thumb joint. It has an anatomically configured tri-flanged stem that fits into the medullary canal at the proximal end of the first metacarpal. This tri-flanged configuration allows for compaction of bone around the implant to provide stable fixation and to prevent rotation of the device. The head is spherical and extends just beyond a hemisphere, slightly medialized on the stem and is at a 20° varus angle to the stem to properly space the joint and allow for sufficient range of motion. The trapezium is resurfaced to contain the head of the implant and this resurfacing is continued into the second metacarpal. Resurfacing the second metacarpal prevents impingement of the implant against that bone and decreases the possibility of dislocation of the joint.

This document is a 510(k) premarket notification for a medical device, specifically a joint replacement implant. It does not describe a study that uses AI or machine learning, nor does it present acceptance criteria or detailed performance data in the way you've outlined for AI/ML device evaluations.

Therefore, I cannot populate the table and answer the questions based on the provided text, as this document pertains to a traditional medical device submission and not an AI/ML device.

Here's why and what information could be derived if this were an AI/ML context:

• Acceptance Criteria & Reported Performance: Not provided for an AI system. The text describes the device's design and intended function, not a data-driven performance metric.
• Sample size (test set) & Data Provenance: Not applicable. The document describes the device itself, not a dataset used to evaluate an algorithm.
• Number of experts & Qualifications: Not applicable. There's no mention of expert review for establishing ground truth of an AI model's output.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

What the document does describe (and why it doesn't fit your AI/ML questions):

• Device Name: BIOPRO Cobalt Trapeziometacarpal Replacement
• Intended Use: Resurface the basal thumb joint for conditions like rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss.
• Predicate Device: Swanson Titanium Condylar Implant (K864488) This is crucial for 510(k) submissions, as the new device's safety and effectiveness are established by demonstrating substantial equivalence to a legally marketed predicate device.
• Device Description: Detailed physical characteristics, material (Cobalt Chrome), design features (tri-flanged stem, spherical head, varus angle), and how it addresses biological mechanics (stable fixation, range of motion, impingement prevention).
• Similarities and Differences to Predicate: This is the core of a 510(k) submission, comparing function, materials, and shapes to argue for substantial equivalence.

In summary, the provided text is a traditional medical device 510(k) summary, not an AI/ML device performance study.

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