(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."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K180730
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: May 25, 2018 Received: June 1, 2018
Dear Alayne Melancon:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
July 11, 2018
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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K180730
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, post-traumatic, or degenerative arthritis.
The INVISION™ Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgerv.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K180730 Page 1 of 2
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971
wmt.com
510(k) SUMMARY
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) MANUFACTURER IDENTIFICATION
| Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|
| Date: | March 19, 2018 |
| Contact Person: | Alayne MelanconRegulatory Affairs Specialist IIOffice: (901)290-5986Fax: (901)867-4190 |
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | INVISION™ Total Ankle Revision System |
|---|---|
| Common Name: | Ankle Joint metal/polymer semi-constrainedcemented prosthesis |
| Classification Name & Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code & Panel: | HSN - Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
| INVISION Total Ankle Revision System – Primary Predicate | K171067 |
|---|---|
| INVISION Total Ankle Revision System | K153008 |
| INBONE Total Ankle System | K103374, K133585 |
(a)(4) DEVICE DESCRIPTON
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.
(a)(5) INTENDED USE
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.
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INDICATIONS
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.
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject devices are talar fixation line extension components for the talar construct intended to be used with the existing INVISION Total Ankle Revision System talar domes. As such, the subject devices have identical intended use, indications for use, size offerings, and principles of operation to the predicates to maintain the modularity of the system. Table 1 below shows a comparison of technological characteristics.
| SUBJECT | PREDICATES | ||
|---|---|---|---|
| INVISION Total AnkleRevision System | INVISION Total AnkleRevision System- K171067, K153008 - | INBONE Total Ankle System- K10086, K103374,K133585 - | |
| Material | Plate: ASTM F136, ASTM F1580Central Peg/Plug: ASTM F136Locking Peg/Plug: ASTM F136+TiN ( peg head only ) | Plate: ASTM F136, ASTMF1580 | Dome: ASTM F1537,ASTMF1580Central Stem: ASTM F136 |
| Plate Sizes | 1, 2, 3, 4, 5 | Identical | 1, 2, 3, 4, 5, 6 |
| Plate LengthOptions | Standard and Long | Identical | N/A |
| Orientation | Left and Right | Identical | Universal |
Table 1 Subject vs Predicate Technological Comparison
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The following evaluations were conducted to support the safety and efficacy of the INVISION Total Ankle Revision System:
-
-Fatigue Testing
-- -
Shear Testing
-
Torsion Testing
-
-Pyrogen
-
MR Safety Labeling ।
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
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. From the evidence submitted in this 510(k), 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.