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® Total Knee System and its 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® Total Knee System, and thereby reduce the overall number of surgical steps required during total knee arthroplasty. The guides serve to position and align the ADVANCE® implants in a comparable position to traditional ADVANCE® instruments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PROPHECY® Pre-Operative Navigation Alignment Guides. This type of submission relies on proving substantial equivalence to a predicate device, rather than conducting new clinical efficacy studies with specific acceptance criteria and performance metrics in the same way a PMA or a de novo device would. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices.

Therefore, many of the requested data points (like an explicit table of acceptance criteria and reported device performance, sample sizes for training/test sets, expert adjudication methods for ground truth, or MRMC studies) are not provided in this type of submission. The "performance data" mentioned refers to engineering and cadaver testing to validate the design and manufacturing process, not a clinical study to establish performance against pre-defined clinical acceptance criteria.

Here's a breakdown of the information that is available based on the provided text, and where gaps exist due to the nature of a 510(k) submission:

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of clinical outcomes or specific performance metrics for the device itself. The submission aims to demonstrate substantial equivalence to a predicate device (ADVANCE® Total Knee System instruments) in assisting with surgical alignment.	The submission claims that the PROPHECY® Guides serve to position and align the ADVANCE® implants in a comparable position to traditional ADVANCE® instruments. This is supported by: Cadaver testing by end users analyzing placement location and orientation.Repeatability testing across design engineers.Detailed software descriptions and documentation.Biocompatibility testing.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The "cadaver testing" likely involved a limited number of cadavers, but the exact count is not provided.
- Data Provenance: The cadaver testing and repeatability testing are internal studies conducted by Wright Medical Technology, Inc. No country of origin for specific data is mentioned beyond the company's US headquarters. The studies are prospective (conducted to validate the device).
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 document mentions "end users" for cadaver testing, implying surgeons or individuals knowledgeable in total knee arthroplasty, but their number and specific qualifications (e.g., years of experience, board certification) are not detailed.
- Qualifications of Experts: The document implies "end users" would be those who perform surgical procedures, suggesting they are qualified to assess placement and orientation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. Given the nature of cadaver testing and engineering repeatability testing, it's unlikely a formal adjudication method like 2+1 or 3+1 was used in the clinical trial sense. The focus would have been on measurement consistency and adherence to predetermined design goals.
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. This device is a physical surgical guide, not an AI-based diagnostic or assistive software that would typically involve human readers interpreting images. The closest analog would be comparing surgical outcomes with and without the guides, but this was not an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The "device design algorithm" mentioned is part of the manufacturing process to create the patient-specific guides. "User repeatability testing and cadaver testing" were done to ensure the repeatability of this design algorithm's execution and guide performance in a simulated surgical environment. However, this is not a "standalone" clinical performance assessment in the sense of a medical imaging AI algorithm. The device requires a human (surgeon) to use it.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the cadaver testing, the "ground truth" would likely be based on surgical measurements and anatomical landmarks, aiming to achieve specific alignment angles and implant positions as determined by established surgical principles or desired targets. For repeatability testing, the ground truth would be the consistent output of the manufacturing process or design algorithm. It's not pathology or outcomes data from live patients.
The sample size for the training set:
- Training Set Sample Size: Not applicable in the context of this device's validation. The device is manufactured based on individual patient imaging data (MRI, CT). While the design algorithm might have been developed using existing knowledge of knee anatomy and surgical principles, there's no "training set" in the machine learning sense explicitly described for the device itself.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable, as there's no explicitly defined training set for the device in this document. The "ground truth" for the design of the guides would implicitly be based on established anatomical parameters and surgical objectives for total knee replacement, drawing upon decades of orthopedic knowledge and experience.

Summary

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K093405 (1 of 2)

Create Motion."

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 2 5 2010

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® Pre-Operative Navigation Alignment Guides.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd.Arlington, TN 38002
Date:	May 21, 2010
Contact Person:	Sarah Holtgrewe
	Manager, 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	ADVANCE® Total Knee System(K061223, K972626)

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 905.826.1600 Canada 011.33.1.45.13.24.40 France 011.49.211.862.9990 Germany 011.39.0250.678.227 Italy 011.81.3.3538.0474 Japan 011.44.1483.721.404 UK

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K093405(2 of 2)

DEVICE INFORMATION

A. DEVICE DESCRIPTION

B. INTENDED USE

C. PERFORMANCE DATA

011.39.0250.678.227 It

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 .
Biocompatibility testing .

D. SUBSTANTIAL EQUIVALENCE INFORMATION

011 81 3 3538 0474 Japa

The main differences between the subject and predicate devices are in the patient-specific The safety and efficacy of the PROPHECY® Pre-Operative design and materials. 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® design goal, a comparison with traditional surgical technique, user repeatability testing and cadaver testing to ensure repeatability of design algorithm execution, a battery of biocompatibility tests to address material safety, and evidence that the material is sterilizable and its performance is unchanged by the sterilization process.

headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com international subsidianes 011.32.3.378.39.05 Belgis 011.33.1.45.13.24.40 France

011 44 1483 721 404 UK

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

MAY 2 5 2010

Re: K093405

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: II Product Code: MBH, JWH, OOG Dated: May 14, 2010 Received: May 17, 2010

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. 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. Sarah Holtgrewe

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 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/ucm11.5809.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,

for
Mark 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):

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 Eva

1 of 1

Snatic for nxm
(Division Signer)

Division of Surgic and Restorative D

510(k) Number K093405

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.