(85 days)
The Ascension® PyroHemiSphere™ 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.
The Ascension PyroHemiSphere (PHS) is single-use, uncemented, onc-component prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is available in five sizes and is provided sterile in packaging containing a single component.
This document is a 510(k) summary for a medical device called the Ascension PyroHemiSphere, a carpometacarpal (CMC) implant. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a study. Therefore, the requested information cannot be fully extracted as it pertains to AI/algorithm performance and clinical study methodology typically found in reports for such devices, not a 510(k) summary for a physical implant.
However, based on the provided text, here's an attempt to address the points where applicable, noting that many crucial details are not present in the given document:
1. Table of acceptance criteria and the reported device performance
This document describes a physical implant, not an AI or algorithmic device. It relies on demonstrating "substantial equivalence" of design features and performance tests to predicate devices rather than meeting predefined acceptance criteria for a specific outcome measure like accuracy or sensitivity. The document does not provide a table of acceptance criteria or specific performance metrics from a study in the context typically seen for AI/algorithm performance.
If "performance" refers to mechanical properties, the document states: "A comparison of the design features as well as performance tests demonstrate that the Ascension PyroHemiSphere is substantially equivalent to the predicate device." However, the results of these performance tests (e.g., tensile strength, wear, durability) and their acceptance criteria are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is for a physical orthopedic implant. There is no "test set" in the context of data for an algorithm. The 510(k) summary does not describe any clinical study involving human subjects or data sets for performance evaluation in this manner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is a physical implant, there's no "ground truth" to be established by experts in the context of data interpretation for an algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication method mentioned for a clinical study related to data interpretation.
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
Not applicable. This document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no "ground truth" in the context of data interpretation mentioned in this document. For a physical implant, "ground truth" might refer to clinical outcomes, but no such study is detailed here.
8. The sample size for the training set
Not applicable. This is for a physical orthopedic implant and does not involve a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As above, this document does not refer to an algorithm or a training set.
Summary of what is available regarding "acceptance criteria" and "study":
The document states that "A comparison of the design features as well as performance tests demonstrate that the Ascension PyroHemiSphere is substantially equivalent to the predicate device." This implies that the 'acceptance criteria' were met by demonstrating equivalence in design and performance to existing, legally marketed devices (K864488, K960659, K964472). The "study" mentioned is likely a series of engineering or pre-clinical bench tests (e.g., mechanical testing, material compatibility) rather than a clinical trial with human subjects. The details of these tests, specific parameters measured, and the numerical results are not provided in this 510(k) summary. The primary "proof" of meeting criteria for this type of device in a 510(k) submission is the demonstration of substantial equivalence, not necessarily a new clinical trial proving independent efficacy against pre-defined performance metrics.
§ 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.