(57 days)
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The tibial tray is manufactured using additive manufacturing technology.
The provided document is a 510(k) summary for the INFINITY Total Ankle System. It focuses on demonstrating substantial equivalence to predicate devices and outlines non-clinical bench testing. It explicitly states that "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices." Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on clinical data.
Based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document discusses non-clinical bench testing for a medical device (Total Ankle System) rather than an AI/ML-driven device with clinical performance metrics. The listed non-clinical tests (e.g., Chemical Analysis, Abrasion Resistance, Fatigue Testing) are intended to show substantial equivalence to predicate devices, not to meet specific clinical performance acceptance criteria.
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. No clinical test set was used as clinical studies were not required. The document refers to non-clinical bench testing.
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. No clinical test set or human expert review for ground truth was involved since clinical studies were not required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process was involved.
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. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices." This device is a total ankle system, not an AI/ML diagnostic tool for which MRMC studies are typically conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical implant (Total Ankle System), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Since no clinical studies were performed and clinical performance was not assessed in this submission, there is no discussion of ground truth based on clinical data. The "ground truth" for the non-clinical tests would be defined by engineering specifications and material standards, which are not detailed in this summary.
8. The sample size for the training set
Not applicable. This document pertains to a physical medical device. There is no mention of a training set as would be relevant for an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned for an AI/ML device, the establishment of ground truth for a training set is not discussed.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.