(60 days)
Wright's PROPHECY® Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in quiding 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.
PROPHECY® Preoperative Navigation Alignment Guides are patient-specific quides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The quides are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The PROPHECY® Guides serve as an alternative to traditional alignment instrumentation used with Wright's INBONE® and INFINITY™ Total Ankle Systems, and thereby reduce the overall number of surgical steps reguired during total ankle arthroplasty. The quides serve to position and align the implants comparable to that attainable with traditional instrumentation.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format. However, the study aims to demonstrate that the PROPHECY® INFINITY™ Preoperative Navigation Alignment Guides achieve comparable placement and alignment to traditional instrumentation. The conclusion across all evaluations was that the subject alignment guides are "substantially equivalent to the predicates."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Guide Design Repeatability | Concluded to be substantially equivalent to predicates. |
| Guide Placement Repeatability | Concluded to be substantially equivalent to predicates. |
| Placement Location and Orientation (Cadaver Evaluation) | Concluded to be substantially equivalent to predicates. |
| Software Validation | Concluded to be substantially equivalent to predicates. |
2. Sample Size and Data Provenance
The document does not specify the exact sample sizes for the "Guide design repeatability," "Guide placement repeatability," and "Software validation" tests.
For the cadaver evaluation, the sample size is not explicitly stated. The data provenance is implied to be experimental, likely conducted in a lab setting, which would be considered prospective. The country of origin is not specified but is presumably the US, where Wright Medical Technology is located.
3. Number of Experts and Qualifications
For the cadaver evaluation, the document states "Cadaver evaluation by end users analyzing placement location and orientation." It does not specify the number of end users or their exact qualifications beyond being "end users," which implies surgical professionals who would typically use such alignment guides.
For the guide design repeatability, it mentions "Guide design repeatability across design engineers." It does not specify the number or qualifications of these design engineers.
4. Adjudication Method
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for any of the evaluations. The evaluations conclude with a general statement of "substantial equivalence to the predicates," suggesting a consensus or qualitative assessment rather than a formal adjudication process with multiple independent reviewers and a defined conflict resolution mechanism.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The evaluations focus on the performance of the alignment guides themselves, not on the improvement of human readers with AI assistance.
6. Standalone Performance (Algorithm Only)
The device described is a physical patient-specific alignment guide manufactured based on imaging data, not solely an algorithm. The "Software validation" was done as part of the overall device evaluation, but it is not presented as a standalone algorithm performance study. The device is intended to be used by a human surgeon in the operating room.
7. Type of Ground Truth Used
- Guide design repeatability: The ground truth would likely be established by comparing multiple designs generated from the same patient imaging data against a predetermined set of design specifications or against each other for consistency.
- Guide placement repeatability: The ground truth would involve comparing repeated placements of the guide on a model or cadaver to a known, ideal placement or to each other.
- Cadaver evaluation: The ground truth for placement location and orientation would be established by direct anatomical measurement or imaging of the implant and guide placement relative to anatomical landmarks on the cadavers, likely verified by surgical experts.
- Software validation: The ground truth would involve comparing software outputs (e.g., guide design, measurements) against known correct values or established benchmarks.
8. Sample Size for the Training Set
The document does not provide information about a "training set" in the context of an algorithm. The alignment guides are designed and manufactured from individual patient imaging data (CT), implying a real-time process for each patient rather than a pre-trained algorithm in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a traditional "training set" for an algorithm, this question is not applicable in the context of the provided document. The patient-specific nature of the guides means each guide's design is based on the individual patient's CT scan, not a pre-trained model on a large dataset.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in all capital letters. Below the word is a stylized graphic that resembles a "W". The graphic is black and has a textured appearance.
JUL 0 5 2013 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 PROPHECY® INFINITY™ Preoperative Navigation Alignment Guides.
| Submitted By: | Wright Medical Technology, Inc.5677 Airline Rd, Arlington TN, 38002Phone: (800) 238-7188Fax: (901)867-4190 |
|---|---|
| Date: | May 3, 2013 |
| Contact Person: | Danielle MuellerProject Manager Regulatory Affairs |
| Proprietary Name: | PROPHECY® INFINITY™ Preoperative NavigationAlignment Guides |
| Common Name: | Alignment Guides |
| Classification Name and Reference: | 21 CFR 888.3110 Ankle joint metal/polymersemi-constrained cemented prosthesis Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/ HSN, OYK |
| Predicate Devices: | PROPHECY® INBONE® Preoperative AlignmentGuides [K110360]INFINITY™ Total Ankle System [K123954] |
DEVICE INFORMATION
A. Intended Use
Wright's PROPHECY® Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in quiding 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.
{1}------------------------------------------------
B. Device Description
PROPHECY® Preoperative Navigation Alignment Guides are patient-specific quides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The quides are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The PROPHECY® Guides serve as an alternative to traditional alignment instrumentation used with Wright's INBONE® and INFINITY™ Total Ankle Systems, and thereby reduce the overall number of surgical steps reguired during total ankle arthroplasty. The quides serve to position and align the implants comparable to that attainable with traditional instrumentation.
The following evaluations were conducted to support the safety and efficacy of the PROPHECY® INFINITY™ quides:
- Guide design repeatability across design engineers ।
- -Guide placement repeatability
- . Cadaver evaluation by end users analyzing placement location and orientation
- Software validation
These evaluations concluded the subject alignment quides are substantially equivalent to the predicates.
C. Substantial Equivalence Information
The main difference between the subject and predicate PROPHECY® guides is the addition of use with the INFINITY™ Total Ankle System. The design features and materials of the subject devices are substantially equivalent to those of the predicates. The fundamental scientific technology has not changed relative to the predicate devices. The safety and efficacy of the PROPHECY® quides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification.
{2}------------------------------------------------
Image /page/2/Picture/0 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
July 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated % Ms. Danielle Mueller Project Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002
Re: K131283
Trade/Device Name: PROPHECY® INFINITY™ Preoperative Navigation Alignment Guides Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN, OYK Dated: May 3, 2013 Received: May 6, 2013
Dear Ms. Mueller:
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. Iisting 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
{3}------------------------------------------------
Page 2 - Ms. Danielle Mueller
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, plcase 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/Safcty/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director, Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): K131283
Device Name: PROPHECY® INFINITY™ Preoperative Navigation Alignment Guides
Indications For Use:
Wright's PROPHECY® Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in quiding 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.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1
§ 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.