(233 days)
The INVISION™ Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The INVISION™ Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The subject INVISION™ Total Ankle Revision System is a fixed-bearing system that is specifically designed considering revision procedures. Based on the INBONE® Total Ankle System platform, INVISION™ Total Ankle Revision System includes tibial trays that are compatible with the INBONE® Total Ankle System talar stems and INBONE® Sulcus Poly Inserts. To accommodate various patients' boney defects, the INVISION™ tibial trays are available in two heights: +4 mm and +8 mm, which are an additional 4 mm or 8 mm above the current INBONE® height.
This document is a 510(k) premarket notification for the INVISION™ Total Ankle Revision System. It describes the device, its intended use, and its equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to the requested information:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI/software medical devices. This document concerns a physical orthopedic implant.
The document states "Dimensional comparisons were used to demonstrated that the tibial trays of the INVISION™ Total Ankle Revision System does not present a new worst-case compared to the tibial trays of the INBONE® Total Ankle System." This can be interpreted as the performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not present a new worst-case compared to predicate device's tibial trays in terms of dimensions. | Demonstrated that the tibial trays of the INVISION™ Total Ankle Revision System do not present a new worst-case compared to the tibial trays of the INBONE® Total Ankle System through dimensional comparisons. |
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 document refers to an orthopedic implant, and the primary evidence for substantial equivalence is based on dimensional comparisons to predicate devices, not on data from a "test set" in the context of diagnostic or AI performance.
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. The ground truth, in this context, would be the design specifications and established safety/performance of the predicate devices. Expert consensus for performance metrics is not mentioned as part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this device's 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
Not applicable. This device is an ankle prosthesis, not an AI-powered diagnostic tool. Hence, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly used for establishing substantial equivalence for a physical device like this is primarily engineering specifications and established performance characteristics of the predicate devices. Dimensional comparisons are used to show the new device is within the safe and effective range established by the predicate.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is mentioned or relevant to this device.
§ 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.