(64 days)
The Ascension® PyroSphere™ CMC/TMT is intended to replace the joint between the first metacarpal and the trapezium 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.
The Ascension® PyroSphere™ CMC/TMT is also intended for use in the 4th /5th tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis presents:
- . decreased motion
- . arthritic changes and/or subluxation
- . unstable, stiff, or painful joints
- degenerative joint disease of the midfoot associated with gout or pseudogout .
The Ascension Ascension® PyroSphere™ CMC/TMT is a single-use, spherical, interpositional prosthesis intended for use in the carpometacarpal (CMC) basal thumb joint or the the 4" /5th tarsometatarsal (TMT) joint involvement. It articulates against recesses prepared in the base of the first metacarpal and the trapezium or the tarsometatarsal joint.
The provided text is a 510(k) summary for the Ascension® PyroSphere™ CMC/TMT, a pyrocarbon spherical implant. This document is a regulatory submission for medical device approval and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study that establishes acceptance criteria and proves the device meets them in the way a clinical performance study would for an AI/software device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable or available within the provided text.
The document describes the device, its intended use, and states that its basis for substantial equivalence is a comparison of design features and performance tests. However, it does not detail these performance tests in a way that aligns with the questions posed for an AI/software device's validation study.
Here's a breakdown of why each requested point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, F1-score) or reported device performance metrics in the context of an AI/software evaluation. It discusses the device's intended use and design, but not performance in a measurable way relevant to AI.
- Sample size used for the test set and the data provenance: Not applicable. There is no mention of a "test set" in the context of evaluating an algorithm. The document pertains to a physical implant.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is relevant for diagnostic or AI imaging products. This is a physical implant.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve discrepancies in expert-generated ground truth for AI/software evaluations.
- 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. MRMC studies are used to assess the impact of AI on human readers' performance in diagnostic tasks. This device is a physical implant, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/software algorithm evaluation. "Ground truth" for a physical implant would relate to its physical properties, biocompatibility, and clinical outcomes, but not in the way requested for an AI/software device.
- The sample size for the training set: Not applicable. This device is a physical implant and does not involve AI training.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a physical medical implant (Ascension® PyroSphere™ CMC/TMT) and its regulatory submission for substantial equivalence, not the validation study of an AI/software device. Therefore, the requested information cannot be extracted from the text.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.