(251 days)
The INBONE and INFINITY Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE and INFINITY Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The Inbone® and Infinity® Total Ankle Systems consist of tibial trays, talar domes and tibial inserts. The tibial trays and talar domes have modular stem connections. The tibial trays are manufactured from titanium alloy; the talar domes are manufactured from cobalt chrome; and the tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE).
The Inbone® and Infinity® Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
The design features of the Inbone® and Infinity® Total Ankle Systems are substantially equivalent to the design features of other-devices previously cleared for market.
This document is a 510(k) premarket notification for the INBONE and INFINITY Total Ankle System. It does not describe a study involving an AI device or present acceptance criteria in the typical format for AI performance. Instead, it is for a medical implant and focuses on demonstrating substantial equivalence to previously marketed predicate devices. Therefore, a direct answer to your request in the context of an AI device and its acceptance criteria as proven by a study is not possible from the provided text.
However, I can extract information related to the device and its intended use, which might be analogous to general "acceptance criteria" for a physical medical device. Also, I can explain why other requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone studies, etc.) is not applicable here.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the format of quantitative performance metrics for the device itself, as would be expected for an AI algorithm. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices. The "performance" is described in terms of its intended function and safety under specific conditions.
| Acceptance Criterion (Implicitly from substantial equivalence) | Reported Device Performance/Characteristics |
|---|---|
| Intended Use: Limited mobility, pain reduction, alignment restoration, flexion/extension movement replacement. | INBONE and INFINITY Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. |
| Indications for Use: Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis; patients with failed previous ankle surgery. | The device is indicated for these patient populations. |
| Safety: Minimal risk under labeled conditions of use, including in an MR environment. | Testing in an MR environment found minimal risk regarding radio frequency heating or magnetically induced displacement. Device is categorized as MR Conditional. |
| Technological Characteristics: Similar to legally marketed predicate devices. | No design modifications are being made to the subject INBONE and INFINITY Total Ankle Systems compared to predicate devices. |
| Material Composition: Tibial trays (titanium alloy), Talar domes (cobalt chrome), Tibial inserts (UHMWPE). | These materials are specified for the components. |
| Cement Use Only: | The ankle prosthesis is intended for cement use only. |
2. Sample size used for the test set and the data provenance
- Not Applicable: This document describes a medical implant, not an AI device. There is no "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to physical and environmental testing (e.g., MR compatibility), not data-driven performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: As there is no "test set" for an AI algorithm, there are no experts establishing ground truth in this context. The "ground truth" for the device's safety and effectiveness is established through adherence to recognized standards, predicate device comparison, manufacturing quality systems, and clinical experience with similar devices, rather than expert labeling of data.
4. Adjudication method for the test set
- Not Applicable: No test set or associated adjudication method for an AI algorithm is 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
- Not Applicable: This is a physical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance are involved in its evaluation as described in this document. The document explicitly states "N/A" under "Substantial Equivalence - Clinical Evidence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an AI system.
7. The type of ground truth used
- For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence relies on:
- Predicate Device Comparison: The primary "ground truth" is the established safety and effectiveness of legally marketed predicate devices (K123059 Inbone® II Total Ankle System, K123954 and K140749 Infinity® Total Ankle System).
- Material Science and Engineering Principles: The physical and mechanical properties of the device components.
- Environmental Testing: Specifically, MR compatibility testing to ensure safety under those conditions.
8. The sample size for the training set
- Not Applicable: This is a physical medical device, not an AI system. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: No training set or associated ground truth establishment is applicable to this medical implant device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117
March 5, 2015
Re: K141740
Trade/Device Name: INBONE and INFINITY Total Ankle 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: January 17, 2015 Received: February 3, 2015
Dear Ms. Redden:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Jeanine Redden
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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 vours.
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
510(k) Number (if known)
Device Name INBONE and INFINITY Total Ankle System
Indications for Use (Describe)
The INBONE and INFINITY Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE and INFINITY Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: 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)
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Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
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 INBONE® and INFINITY® Total Ankle Systems.
| (a)(1). Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
|---|---|
| Date: | March 4, 2015 |
| Contact Person: | Jeanine Redden Director, Regulatory Affairs Office (901) 867-4522 Fax (901) 867-4190 |
| (a)(2). Proprietary Name: | Inbone® Total Ankle System; Infinity® Total Ankle System |
| Common Name: | Total Ankle System |
| Classification Name and Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code, Device Panel: | HSN - Orthopedic |
| (a)(3). Predicate Device: | K123059 Inbone® II Total Ankle System K123954 and K140749 Infinity® Total Ankle System |
(a)(4). Device Description
The Inbone® and Infinity® Total Ankle Systems consist of tibial trays, talar domes and tibial inserts. The tibial trays and talar domes have modular stem connections. The tibial trays are manufactured from titanium alloy; the talar domes are manufactured from cobalt chrome; and the tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE).
The Inbone® and Infinity® Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
The design features of the Inbone® and Infinity® Total Ankle Systems are substantially equivalent to the design features of other-devices previously cleared for market.
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(a)(5). Intended Use
The Inbone® and Infinity Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Indications for Use
The Inbone and Infinity Total Ankle Systems are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The Inbone® and Infinity® Total Ankle Systems are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The indications are similar to the legally marketed predicate device.
(a)(6). Technological Characteristics Comparison
No design modifications are being made to the subject Inbone® and Infinity® Total Ankle Systems. Modification of the Instructions For Use (IFU) were made include a statement regarding the compatibility of the device with MR environments.
(b)(1). Substantial Equivalence- Non-Clinical Evidence
Testing in a MR environment has found that the subject device poses minimal risk under labeled conditions of use with regard to radio frequency heating or magnetically induced displacement.
(b)(2). Substantial Equivalence- Clinical Evidence
N/A
(b)(3). Substantial Equivalence- Conclusions
As no design changes are being made to the subject device, the design characteristics of the subject device does not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k) regarding testing in a MR environment, the subject device is expected to pose minimal risk under labeled conditions of use to patients when place in an MR environment and is categorized as MR Conditional.
§ 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.