(224 days)
The Ensemble CMC is intended to replace the first metacarpal and the trapezium in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
The Ensemble CMC implant is a single use, uncemented, one-piece interpositional joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis of the carpometacarpal joint (CMC). The Ensemble CMC is not intended to interact with other devices. It has upper and lower surfaces that are saddle (toroidal) shaped to match the anatomy of the base of the first metacarpal and the trapezium. The design of the Ensemble CMC allows for flexion-extension, abduction-adduction, and circumduction motions. The implant is manufactured with an On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels.
A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary:
This device (Ensemble CMC) is a medical implant, not an AI/ML algorithm or a diagnostic tool. Therefore, the concept of a "test set," "ground truth," "expert consensus," "MRMC study," or "standalone algorithm performance" as described in the prompt's context for AI/ML devices is not directly applicable to this submission. The "study" here refers to non-clinical mechanical testing, not a clinical trial or performance evaluation against a diagnostic standard.
Here's an analysis of the provided text in the requested format, interpreting "acceptance criteria" as the performance aspects evaluated for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Aspects Evaluated) | Reported Device Performance |
|---|---|
| Material Characteristics | Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing. |
| Joint Biomechanics | Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing. |
| Static Testing | Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing. |
| Endurance Testing | Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing. |
| Allowable Range of Motion | Confirmed through cadaveric testing. |
| Prevention of Impingement | Confirmed through cadaveric testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- The document mentions "cadaveric testing" for range of motion and impingement, but does not specify the sample size (i.e., number of cadavers or samples tested).
- For the other mechanical tests (material, joint biomechanics, static, endurance), the document refers to "non-clinical mechanical testing" but does not specify sample sizes of implants tested.
- Data Provenance: The cadaveric testing implies biological samples, but the country of origin is not specified. Given it's an FDA submission, it's likely conducted in or for the US market, but this is an inference. The other mechanical testing is laboratory-based; provenance is not applicable in the same way as clinical data.
- Retrospective or Prospective: Not applicable as this is not a study on clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable in the context of AI/ML ground truth. For an implant, "ground truth" would relate to accepted engineering and biomechanical principles, as well as the physical properties of the materials. No "experts" are noted in the role of establishing diagnostic ground truth or labeling data. The engineers and scientists conducting the mechanical tests would be qualified in their respective fields.
4. Adjudication Method
- Not applicable. This relates to diagnostic interpretation consensus, which is not relevant for an orthopedic implant's mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI/ML device for diagnostic assistance, so an MRMC study comparing human readers with and without AI assistance was not conducted.
6. Standalone (Algorithm Only) Performance
- No. This is a physical medical device (an implant), not an algorithm.
7. Type of Ground Truth Used
- For the mechanical and cadaveric testing, the "ground truth" is defined by:
- Engineering specifications and standards: For material, static, and endurance testing.
- Biomechanical principles and anatomical observation: For joint biomechanics, range of motion, and impingement confirmed through cadaveric studies.
- Comparison to predicate devices: The overall goal was to demonstrate "substantial equivalence" to established, legally marketed predicate devices, meaning performance characteristics were compared to these existing devices.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The device itself is manufactured, not "trained."
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm.
§ 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.