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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

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."

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Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE® INFINITY® and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Wright Medical's PROPHECY INVISION Preoperative Navigation Alignment System (K162795) is being expanded to include patient-specific guides for the INVISION Total Ankle System. Like the predicates PROPHECY INFINITY and PROPHECY INBONE guides, the subject patient-specific guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the reusable instruments, facilitate positioning of INVISION Total Ankle Implants.

I apologize, but the provided text from the FDA 510(k) K170968 does not contain the detailed study information required to answer your request about acceptance criteria and device performance.

The document is a 510(k) summary for a pre-operative navigation system. While it mentions that evaluations were conducted to support safety and efficacy, it only lists the types of evaluations (e.g., "Pre-operative vs Post-operative Analysis of Implant Placement," "Guide Placement Repeatability Inter-surgeon Variability"). It explicitly states "N/A" for clinical evidence ("SUBSTANTIAL EUIVALENCE – CLINICAL EVIDENCE N/A").

To provide the information you've requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, ground truth establishment, etc., I would need access to the full submission or specific study reports that detail the results of these evaluations. This 510(k) summary only provides a high-level overview and states that the device is substantially equivalent based on non-clinical evidence.

Therefore, I cannot populate the table or answer the specific questions about the study design and results from the provided text.

Ask a specific question about this device

Wright's PROPHECY® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE®, INFINITY® and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

PROPHECY® Preoperative Navigation Alignment System provides the surgeon a template of the patient's distal tibial and proximal talar anatomy. The PROPHECY® alignment report serves as a template for traditional alignmentation used with Wright's INBONE®, INFINITY , and INVISION® Total Ankle Systems.

The provided document does not contain information regarding a specific study with acceptance criteria and a detailed analysis of device performance against those criteria. The document is a 510(k) summary for the PROPHECY® INVISION® Preoperative Navigation Alignment System, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, I cannot provide the requested information. The sections concerning sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this document.

The "Design repeatability across design engineers" and "Software validation" mentioned in section 7 ("Substantial Equivalence- Non-Clinical Evidence") are very high-level statements and do not provide the detailed performance metrics, acceptance criteria, or study methodologies that would allow for a comprehensive answer to your request.

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