(256 days)
The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. This 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) joint. 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 against the saddle surface of the trapezium, allowing for flexionextension, abduction-adduction and opposition motions.
The prosthesis is available in five 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 ioint prosthesis .
- System specific instrumentation .
The provided document is a 510(k) summary for the Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set. It describes a medical device, and 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with specific acceptance criteria, sample sizes, and ground truth methodologies that would be common for AI/Software as a Medical Device (SaMD) clearances.
Therefore, much of the requested information regarding acceptance criteria and study particulars for device performance in the context of an AI/SaMD product is not applicable to this traditional medical implant submission.
However, I can extract information related to the demonstration of "performance" as it pertains to showing substantial equivalence.
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance (supporting substantial equivalence) |
|---|---|
| Intended Use: Device intended for specific CMC joint replacement cases. | "The Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set is substantially equivalent to the predicate devices identified in this premarket notification." |
| Indications for Use: Matches predicate devices. | Intended Use: "intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion." |
| Materials: Similar to predicate devices. | "Similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging." Device made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem. |
| Design (fundamental scientific technology): Similar to predicate devices. | "Hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) joint. ... highly polished, saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal." |
| Performance (general biomechanical/functional): Consistent with predicate devices. | "Engineering analysis and cadaveric testing demonstrated that the Stablyx CMC Arthrodesis Implant Set is substantially equivalent to devices currently marketed." |
| Sterility & Packaging: Similar to predicate devices. | "Similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging." (Device is packaged and provided sterile). |
| No new issues of safety or effectiveness. | "does not present any new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of a "test set" as understood for AI/SaMD. The document mentions "cadaveric testing," but the number of cadavers or specific samples tested is not provided.
- Data Provenance: "Cadaveric testing" implies human cadaveric tissue. The country of origin is not specified. The study is implicitly prospective as it involves testing of the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A): This type of information (experts for ground truth) is not relevant for a 510(k) submission for a mechanical implant. The assessment of "performance" is based on engineering analyses and biomechanical testing, compared against established standards or predicate device performance. There isn't a "ground truth" establishment in the sense of expert labeling for an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A): Adjudication methods are typically for consensus building among experts on image or data interpretations, which is not relevant for this device submission.
5. 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
- No: An MRMC comparative effectiveness study is not relevant for this type of medical implant. These studies are typically conducted for AI-powered diagnostic or assistive tools to evaluate their impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This refers to AI algorithm performance. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (N/A) / Different Context: The concept of "ground truth" in this context would likely refer to established biomechanical principles, engineering standards, and the known performance characteristics of predicate devices. The "performance testing" referenced "engineering analysis and cadaveric testing" which would generate data amenable to such comparisons, rather than a "ground truth" derived from expert consensus on clinical data.
8. The sample size for the training set
- Not Applicable (N/A): This refers to AI model training data. This device is a physical implant, not an AI model.
9. How the ground truth for the training set was established
- Not Applicable (N/A): This refers to AI model training data. This device is a physical implant, not an AI model.
§ 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.