(205 days)
The INVISION® Total Ankle Revision System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
The INVISION® Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INVISION® Total Ankle Revision 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 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 stems, talar domes, talar plates, and tibial trays.
The provided text describes the INVISION® Total Ankle Revision System, a medical device, and its FDA 510(k) summary of safety and effectiveness. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-based diagnostic or prognostic device.
The document is a traditional 510(k) submission for a physical medical implant (an ankle prosthesis). The "acceptance criteria" and "study" mentioned in your request, along with details like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set sample size," are all relevant to the evaluation of AI/Machine Learning-based medical devices, particularly those that generate diagnostic or prognostic outputs.
The information provided in the document focuses on:
- Device Description: What the total ankle revision system is.
- Intended Use and Indications for Use: The conditions for which the device is intended.
- Technological Characteristics Comparison with Predicate Devices: Comparing the new system to previously approved ankle prostheses, noting similarities in indications, instrumentation, materials, and sterilization, and a minor difference in talar plate fixation.
- Non-Clinical Evidence for Substantial Equivalence: This includes mechanical testing (fatigue, shear, wear, torsional, torque-off, pull-off testing) to show the new device performs at least as well as or better than predicate systems.
- Clinical Evidence: Stated as "N/A," indicating no new human clinical trials were conducted for this 510(k) submission to demonstrate substantial equivalence, likely relying on the established performance of the predicate devices.
- Conclusion: The device is substantially equivalent to predicate devices based on the submitted non-clinical evidence.
Therefore, I cannot provide the requested table or detailed answers for an AI/algorithm study as the document describes a physical medical implant approval.
§ 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.