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K Number
K171067
Device Name
INVISION Total Ankle Revision System
Manufacturer
Wright Medical Technology, Inc.
Date Cleared
2017-09-11

(154 days)

Product Code
HSN
Regulation Number
888.3110
Type
Traditional
Panel
OR
Reference & Predicate Devices
K142117,K153008,K141740
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

The INVISION Total Ankle Revision System is a fixed-bearing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes multiple tibial and talar components that are assembled together to create the two-piece prosthesis. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

AI/ML Overview

This document is a 510(k) summary for the INVISION™ Total Ankle Revision System. It describes the device and its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, there is no acceptance criteria or study that proves device performance against specific acceptance criteria in the context of an AI/algorithm-based medical device. This document is for a physical medical device (an ankle prosthesis), not a software or AI device.

Therefore, many of the requested points are not applicable to this document. I will answer the applicable points based on the information provided.

Not Applicable for an AI/Algorithm-based Device:

  • A table of acceptance criteria and the reported device performance
  • Sample sizes used for the test set and the data provenance
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  • Adjudication method for the test set
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  • If a standalone (algorithm only without human-in-the-loop performance) was done
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  • The sample size for the training set
  • How the ground truth for the training set was established

Applicable Information from the Document:

  1. A table of acceptance criteria and the reported device performance:

    • N/A. This document does not present acceptance criteria for a software/AI device or a study demonstrating performance against such criteria. The "Substantial Equivalence - Non-Clinical Evidence" section mentions engineering analysis and rationale for shear strength, fatigue strength, and torsional stability, as well as MR testing for displacement force, torque, artifact, and RF heating, and pyrogenicity testing. However, specific numerical acceptance criteria or performance metrics are not provided in this summary.

  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • N/A. This is a physical orthopedic implant. There is no "test set" in the context of an AI/algorithm. Non-clinical evidence was gathered through engineering analysis and rationale, and MR testing. The document does not specify sample sizes for these tests, nor data provenance in the way it would for clinical data or AI training/test data.

  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):

    • N/A. Ground truth for AI/algorithm is not applicable here.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • N/A. Adjudication method for AI/algorithm is not applicable here.

  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:

    • N/A. This is not an AI device, so MRMC studies are not relevant. The document explicitly states under "(b)(2). Substantial Equivalence- Clinical Evidence": "N/A".

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • N/A. Not an AI/algorithm device.

  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

    • N/A. Ground truth for AI/algorithm is not applicable here. Non-clinical evidence was based on engineering analysis, material properties, and specific performance tests (shear strength, fatigue strength, torsional stability, MR compatibility and RF heating, pyrogenicity).

  8. The sample size for the training set:

    • N/A. Not an AI/algorithm device, so there is no training set.

  9. How the ground truth for the training set was established:

    • N/A. Not an AI/algorithm device, so there is no training set or its associated ground truth establishment.

§ 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.