Wright's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee 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® Pre-Operative Navigation Alignment Guides are intended for single use only.

Device Description

PROPHECY® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal femoral and tibial plateau anatomy. The guides are designed and manufactured from patient imaging data (MRI, CT), and are available in two versions: alignment and alignment and resection. The guides are made from biocompatible nylon, and the resection slots are biocompatible stainless steel. The PROPHECY® Guides serve as a alternative to traditional alignment instrumentation used with Wright's ADVANCE® and EVOLUTION™ Total Knee Systems, and thereby reduce the overall number of surgical steps required during total knee arthroplasty. The guides serve to position and align the ADVANCE® or EVOLUTION™ implants in a comparable position to traditional instrumentation.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the PROPHECY® Pre-Operative Navigation Alignment Guides, based on the provided text:

Important Note: The provided 510(k) summary (K10359B) is from 2011 and describes a Class II device. For such devices, the regulatory requirements for "performance data" are often less stringent than for higher-risk devices or more recent AI/Machine Learning devices, which typically require extensive validation studies with specific endpoints and statistical power. The information provided heavily emphasizes equivalence to a predicate device rather than de novo performance validation.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Clinical accuracy/precision in component placement and alignment (implicit through comparison to predicate and traditional instrumentation)	"The guides serve to position and align the ADVANCE® or EVOLUTION™ implants in a comparable position to traditional instrumentation."
Repeatability of design/manufacturing process (implied for consistency)	"Repeatability testing across design engineers"
Biocompatibility of materials	"made from biocompatible nylon, and the resection slots are biocompatible stainless steel."
Functional integrity (no adverse events when used)	Not explicitly stated as a criterion, but assumed as part of safety and efficacy.
Software functionality and accuracy (for guide design)	"Detailed software descriptions and documentation"

Study Details

The provided document describes performance data rather than a single, comprehensive "study" in the typical clinical trial sense. The data presented focuses on establishing substantial equivalence to a predicate device (K093405) and supporting the expansion of indications for use to include the EVOLUTION™ knee system.

Sample Size used for the test set and the data provenance:
- Test Set (for performance data): The document specifically mentions "Cadaver testing by end users analyzing placement location and orientation."
  - Sample Size: Not specified. The number of cadavers used is not detailed.
  - Data Provenance: Retrospective (cadaver-based testing). The country of origin is not specified but is presumably the US, given the submission to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The phrase "Cadaver testing by end users" implies that surgeons or other relevant medical professionals were involved.
- Qualifications of Experts: Not explicitly stated. The term "end users" suggests surgeons or surgical technicians experienced in knee arthroplasty, but their specific qualifications (e.g., years of experience, board certification) are not provided.
Adjudication method for the test set:
- Adjudication Method: Not specified. With "cadaver testing by end users," it's unclear if there was any formal adjudication process or if a single assessment per cadaver was performed by the "end user."
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical surgical guide for total knee replacement, not an AI-based diagnostic tool requiring human-in-the-loop performance measurement. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The core function of the device (patient-specific surgical guides designed from imaging data) is fundamentally a "standalone algorithm" in terms of its design and manufacturing process. The "Detailed software descriptions and documentation" and "Repeatability testing across design engineers" relate to the internal consistency and accuracy of this design process.
- However, the performance data listed explicitly includes "Cadaver testing by end users," indicating that human interaction (surgical use) was part of the overall assessment of the final product's effectiveness. So, while the guide design is a standalone process, its validation involved human use in a simulated environment.
The type of ground truth used:
- For the cadaver testing: The "ground truth" would be the measured achieved alignment and component placement in the cadaver after using the guides, compared to pre-defined surgical plans or ideal anatomical alignments. This is a form of empirical measurement against an intended outcome.
- For the design process (software/repeatability): The ground truth would be the consistency of the design outputs (guide geometry) against repeated inputs or design specifications.
The sample size for the training set:
- Training Set Sample Size: Not applicable/not specified. This device is not an AI/Machine Learning model in the modern sense that requires a "training set" for learning patterns from data. The guides are designed using patient-specific imaging data (MRI, CT) and pre-defined algorithms/rules embedded in the software, not learned from a training set.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As explained above, there isn't a "training set" and associated ground truth in the context of an AI/ML model for this device. The software relies on established biomechanical principles and anatomical landmarks identifiable on patient imaging scans as its "knowledge base" for generating the guides.

Summary

{0}------------------------------------------------

OCT 1 7 2011

Create Motion.+

Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized design that resembles a stylized "W". The design is composed of two diagonal lines that intersect in the middle, with a small dot below the intersection.

K10359B ( 1/2

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 PROPHECY® Pre-Operative Navigation Alignment Guides.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd.Arlington, TN 38002
Date:	December 7, 2010
Contact Person:	Sarah HoltgreweManager, Regulatory Affairs
Proprietary Name:	PROPHECY® Pre-Operative NavigationAlignment Guides
Common Name:	Alignment and Resection Guides
Classification Name and Reference:	21 CFR 888.3565 --Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis--Class II
	21 CFR 888.3560 --Knee joint patellofemorotibialpolymer/metal/polymer/semi-constrained cementedprosthesis--Class II
Device Product Code and Panel Code:	Orthopedics/87/ MBH, JWH, OOG
Predicate Device	PROPHECY® Pre-Operative NavigationAlignment Guides(K093405)

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone

international subsidiaries 011.32.3.378.39.05 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan

011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

www.wmt.com

011.49.211.862.9990 Germany

{1}------------------------------------------------

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® Pre-Operative Navigation Alignment Guides:

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

D. SUBSTANTIAL EQUIVALENCE INFORMATION

The main difference between the subject and predicate devices is in the addition of the EVOLUTION™ knee system to the indications for use. The safety and efficacy of the PROPHECY® Pre-Operative Navigation Alignment Guides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone

www.wmt.com

international subsidiaries 011.32.3.378.39.05 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada
011.81.3.3538.0474 Japan

011.33.1.45.13.24.40 France 11.44.1483,721.404 UK

011.49.211.862.9990 Germany

{2}------------------------------------------------

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

Wright Medical Technology, Inc. c/o Ms. Sarah Holtgrewe Regulatory Affairs Project Specialist 5677 Airline Road Arlington, Tennessee 38002

OCT 1 7 2011

Re: K103598

Trade/Device Name: Prophecy Pre-Operative Navigation Alignment Guides Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OOG 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 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.

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

{3}------------------------------------------------

Page 2 - Ms. Sarah Holtgrewe

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/CDRH/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

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K | 03598

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)

1 of 1

Michael Owens for MXM

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

510(k) Number K103598

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.