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:

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.
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.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication method for AI/algorithm is not applicable here.
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".
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an AI/algorithm device.
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).
The sample size for the training set:
- N/A. Not an AI/algorithm device, so there is no training set.
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.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117

September 11, 2017

Re: K171067

Trade/Device Name: INVISION™ Total Ankle Revision System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: July 20, 2017 Received: July 25, 2017

Dear Ms. Myles:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171067

Device Name

INVISION™ Total Ankle Revision System

Indications for Use (Describe)

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: In the United States, the ankle prosthesis is intended for cement use only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Image /page/4/Picture/1 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red, block letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.

1023 Cherry Road Memphis, TN 38117 wright.com

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the INVISION™ Total Ankle Revision System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	March 31, 2017
Contact Person:	Val MylesRegulatory Affairs SpecialistOffice (901) 290-5162Fax (901) 867-4190
(a)(2). Proprietary Name:	INVISIONTM Total Ankle Revision System
Common Name:	Total Ankle Prosthesis
Classification Name and Reference:	21 CFR 888.3110 - Class II
Device Product Code, Device Panel:	HSN - Orthopedic
(a)(3). Predicate Device:	K142117, K153008 - INVISION Total AnkleRevision SystemK141740 - INBONE and INFINITY Total AnkleSystems

(a)(4). Device Description

(a)(5). Intended Use

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.

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Indications for Use

previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

(a)(6). Technological Characteristics Comparison

The subject INVISION Total Ankle System includes thicker talar domes and talar plates with additional peg sizes and orientations. The subject system has identical indications, utilizes similar instrumentation, is made from identical materials, and has identical sterilization methods when compared to the legally marketed predicate devices. Labeling modifications include a statement regarding the compatibility of the device with MR environments and contraindication updates.

(b)(1). Substantial Equivalence- Non-Clinical Evidence

Engineering analysis and rationale was performed to demonstrate substantial equivalence in shear strength, fatigue strength, and torsional stability. MR testing and analysis related to displacement force, torque, artifact, RF heating testing were also used to demonstrate substantial equivalence. Pyrogenicity testing was also conducted.

(b)(2). Substantial Equivalence- Clinical Evidence

N/A

(b)(3). Substantial Equivalence- Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices. In addition, the subject device is expected to pose minimal risk to patients when place in an MR environment and is categorized as MR Conditional.

Regulation Number and Section

§ 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.