(20 days)
The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis or post fracture deformation or bone loss which present as either painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.
The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) ioint. The single piece prosthesis has a highly polished. saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates aqainst the saddle surface of the trapezium, allowing for flexion-extension, abduction-adduction and opposition motions. The prosthesis is available in fixe sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile. The Stablyx CMC Arthroplasty System is comprised of: Multiple sized hemi joint prosthesis System specific instrumentation
The provided text is a Fragment of a 510(k) Pre-market Notification for a medical device called the "Stablyx CMC Arthroplasty Implant System". This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required by the FDA.
Based on the information provided, it is not possible to answer the detailed questions regarding acceptance criteria and a study proving the device meets those criteria. The document states:
- "Engineering analysis and testing demonstrated that the Stablyx CMC Arthroplasty System is substantially equivalent to the predicate device currently marketed."
- "Characterization testing, including gravimetric testing and analysis established equivalency."
- "Therefore, the subject device is as safe and effective as legally marketed predicate devices."
This indicates that comparisons were made to a predicate device (Stablyx CMC Arthroplasty Implant System (K111068)) to establish substantial equivalence. However, the document does not provide:
- A table of acceptance criteria with reported device performance.
- Details about a sample size used for a test set or data provenance in a clinical study.
- Information about experts establishing ground truth.
- An adjudication method.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Details of a standalone performance study.
- The type of ground truth used.
- Sample size for a training set or how its ground truth was established, as these are typically associated with machine learning or AI device development, which is not indicated here.
The "Performance Testing" section vaguely refers to "Engineering analysis and testing" and "Characterization testing, including gravimetric testing and analysis" to establish equivalency. This likely refers to bench testing (e.g., mechanical properties, wear resistance, dimensional analysis) to ensure the new device performs similarly to the predicate device and meets relevant performance standards for orthopedic implants.
In summary, the provided FDA 510(k) document is a regulatory submission focused on substantial equivalence based on engineering and characterization testing, not on clinical study data with acceptance criteria as typically defined for performance studies of AI/ML-driven devices or devices requiring extensive human reader involvement.
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.