Wright's PROPHECY® INBONE® Pre-Operative 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 guiding the marking of bone before cutting. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for use with Wright's INBONE® 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® INBONE® Pre-Operative Navigation Alignment Guides are intended for single use only.

Device Description

PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides 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® Total Ankle System, and thereby reduce the overall number of surgical steps required during total ankle arthroplasty. The guides serve to position and align the INBONE® implants in a comparable position to that attainable with traditional INBONE® instrumentation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides:

The provided document does not contain specific numerical acceptance criteria for the device's performance. Instead, it describes general performance tests and states that the data supports the safety and efficacy of the device as substantially equivalent to a predicate device. Therefore, the "Reported Device Performance" column in the table below will reflect the type of validation performed rather than a specific numerical value against a pre-defined threshold.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Acceptance Criteria Category (Implied)	Reported Device Performance / Validation Method
Design Integrity & Repeatability	Repeatability testing across design engineers.
Guide Placement Accuracy	Guide placement repeatability testing.
Clinical Performance (Surgical Use)	Cadaver testing by end users analyzing placement location and orientation.
Software Functionality	Detailed software descriptions and documentation.
Substantial Equivalence	Device design algorithm illustrates PROPHECY® INBONE® design goal, comparison with traditional surgical technique, user repeatability testing, and cadaver testing to ensure repeatability of design algorithm execution.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the "cadaver testing" or the "repeatability testing." It also does not define the data provenance (e.g., country of origin, retrospective/prospective). Given that the device is manufactured in the US, it's highly probable the testing was conducted within the US, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document refers to "end users" for cadaver testing. However, it does not specify the number of these "end users" or their explicit qualifications (e.g., "radiologist with 10 years of experience"). It can be inferred that "end users" would be surgeons or individuals with relevant surgical experience, but this is not detailed.

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

The document does not describe any specific adjudication method used for the performance testing.

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

No MRMC study is mentioned. The device is a patient-specific surgical guide, not an AI or imaging diagnostic tool that would typically involve "human readers" in the sense of image interpretation. Its function is to assist in the physical positioning and alignment of implants.

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

The device itself (the physical guide) is designed from "patient imaging data (CT)" using a "device design algorithm." The "detailed software descriptions and documentation" and "device design algorithm" mentioned point to standalone performance of the algorithm in generating the guide design. The "repeatability testing across design engineers" likely validates the consistent output of this algorithm regardless of the engineer. However, the ultimate "performance" of the guide is human-in-the-loop (surgical use).

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

For the "cadaver testing," the ground truth was "placement location and orientation" as determined by "end users." This implies an expert-based or intra-operative assessment of the guide's accuracy in achieving desired implant positioning. It's an direct measurement of physical alignment outcomes.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device design beyond the use of "patient imaging data (CT)" to create individual guides. There is no information regarding a distinct training set size for the software/algorithm that generates the guides.

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

As no explicit "training set" with established ground truth is described (beyond the patient's own CT data serving as the basis for design), this information is not available in the provided text. The "ground truth" for each patient's guide design essentially derived from their specific anatomical landmarks identifiable on their CT scans.

Summary

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DEC 1 6 2011

K110360 '1/2

Create Motion.

Image /page/0/Picture/3 description: The image shows the word "WRIGHT." in bold, sans-serif font. Below the word is a stylized graphic that resembles a "W" shape, created with thick, black lines. The overall impression is of a logo or branding element, with a clean and modern design.

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 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd.Arlington, TN 38002
Date:	December 12, 2011
Contact Person:	Sarah HoltgreweManager, Regulatory Affairs(901) 867-4476
Proprietary Name:	PROPHECY® INBONE® Pre-OperativeNavigation Alignment Guides
Common Name:	Alignment Guides
Classification Name and Reference:	21 CFR 888.3110--Ankle joint metal/polymer semi-constrained cemented prosthesis--Class II
Device Product Code and Panel Code:	Orthopedics/87/ HSN, OYK
Predicate Devices:	INBONE® Total Ankle Replacement (K051023)

headquarters 5677 Airline Road Arlington, TN 38002 9901.867.9971 phone www.wmt.com Wright Medical Technology, Inc. international subsidiaries 011.33.1.45.13.24.40 France 011.49.211.862.9990 Germany 905.826.1600 Canada 011.32.3.378.39.05 Belgium 011.44.1483.721.404 UK 011.81.3.3538.0474 Japan 011.39.0260.678.227 Italy

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DEVICE INFORMATION

A. DEVICE DESCRIPTION

B. INTENDED USE

C. PERFORMANCE DATA

The following performance data was used to support the safety and efficacy of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides:

Repeatability testing across design engineers .
Guide placement repeatability testing .
. Cadaver testing by end users analyzing placement location and orientation
Detailed software descriptions and documentation ●

D. SUBSTANTIAL EQUIVALENCE INFORMATION

The main differences between the subject and predicate INBONE® system are in the patientspecific design and materials. The safety and efficacy of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k), including the following: a device design algorithm to illustrate the PROPHECY® INBONE® design goal, a comparison with traditional surgical technique, and user repeatability testing and cadaver testing to ensure repeatability of design algorithm execution.

headquartersWright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002		901.867.9971 phone	www.wmt.com
international subsidiaries011.32.3.378.39.05 Belgium011.39.0250.678.227 Italy	905.826.1600 Canada011.81.3.3538.0474 Japan		011.33.1.45.13.24.40 France011.44.1483.721.404 UK	011.49.211.862.9990 Germany

K110360

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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 stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Posted

. ... ..

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

Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe 5677 Airline Road Arlington, TN 38002

DEC 1 6 2011

Re: K110360

K 10200
Trade/Device Name: PROPHECY INBONE Pre-Operative Navigation Alignment Guides Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HSN, OYK Dated: September 29, 2011 Received: September 30, 2011

Dear Ms. Holtgrewe:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 ro(t) premeine is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard management date of the Medical Device American Prus commence provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices had have been roomstilled in approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The I ou may, incretore, market the device, babyer of the courements for annual registration, listing of general connois provisions of the field ing, and prohibitions against misbranding and ac vices, good manufacturing practice, and evaluate information related to contract liability adulteration. Tease note: ODTET assement 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 your device is classifica (300 above) interest major regulations affecting your device can be
it may be subject to additional controls. Existing major 1999 it may be subject to additional controlor simoning might of any of the 21, In addition, FDA may found in the Code of I caeral regarants in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuance of a bacevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that I DA has made a decertifications administered by other Federal agencies. You must of ally it ederal statures and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: registration an comply with an the Act 3 requirements, more and so the reporting (reporting of medical

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Page 2 - Ms. Sarah Holtgrewe

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin Keith

ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): |< \0360

Device Name: PROPHECY® Pre-Operative Navigation Alignment Guides

Indications For Use:

Prescription Use XXX (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)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K110360 510(k) Number_

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.