(113 days)
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 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 a fixed-bearing ankle replacement prosthesis that restores mobility to a failing ankle joint. This modular system is comprised of a tibial tray, talar domes, talar plates, and a poly insert. These components are assembled together to create the two-piece prosthesis. Based on patient anatomy, a number of component sizes and design configurations can be selected.
This document describes the INVISION™ Total Ankle Revision System, a medical device, and its substantial equivalence to predicate devices, which is a regulatory pathway for approval. The information provided does not pertain to an AI device or a study that evaluates the performance of a device against acceptance criteria in the context of an AI system. Instead, it focuses on the safety and efficacy of the ankle implant and its components through non-clinical testing.
Therefore, many of the requested categories related to AI device acceptance criteria and study details cannot be fulfilled from the provided text.
Here's an attempt to extract relevant information and note the missing parts:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| Fatigue Testing | Conducted to support safety and efficacy. Specific results/acceptance levels not provided. |
| Shear Testing | Conducted to support safety and efficacy. Specific results/acceptance levels not provided. |
| Torsion Testing | Conducted to support safety and efficacy. Specific results/acceptance levels not provided. |
| Pyrogen | Testing conducted. Specific results/acceptance levels not provided. |
| MR Safety Labeling | Evaluation conducted. Specific results/acceptance levels not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes non-clinical engineering tests (fatigue, shear, torsion, pyrogen, MR safety) for a physical medical implant, not a data-driven AI device. There is no mention of a "test set" in the context of data for an algorithm.
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)
This information is not applicable. The ground truth for engineering tests is typically defined by industry standards, material properties, and design specifications, not by human experts in a clinical data review setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. This refers to a method used in clinical data annotation or review, which is not relevant to the non-clinical tests described.
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
This information is not applicable. The document explicitly states "SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A," indicating no human clinical studies were performed for this 510(k) submission. Therefore, an MRMC study for AI assistance is entirely outside the scope of this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This describes a physical ankle implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described (Fatigue, Shear, Torsion, Pyrogen, MR Safety Labeling), the "ground truth" or acceptance criteria would be based on established engineering standards, material specifications, and regulatory requirements for medical implants, not clinical data from pathology or outcomes.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this document is about a physical medical device approval process via substantial equivalence, not an AI model.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of what the document does provide regarding the device approval:
The document, K180730, describes a 510(k) premarket notification for the INVISION™ Total Ankle Revision System. This system is a fixed-bearing ankle replacement prosthesis. The submission seeks to demonstrate "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective as existing approved devices.
Instead of clinical trials demonstrating specific acceptance criteria against, for example, a disease diagnosis or patient outcome, the document focuses on non-clinical evidence to support safety and efficacy. This includes:
- Fatigue Testing
- Shear Testing
- Torsion Testing
- Pyrogen Testing
- MR Safety Labeling Evaluation
The conclusion drawn is that "The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case." It states that "the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent."
§ 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.