The TruMatch™ Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting.

The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.

The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.

The TruMatch™ Patient Specific Instruments are intended for single use only.

Device Description

Subject of this premarket notification are TruMatch™ Patient Specific Instruments which are designed and manufactured from patient imaging data and used with other DePuy Orthopaedics implants.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the TruMatch™ Personalized Solutions, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "The tests results demonstrate that all acceptance criteria were met." However, it does not explicitly list the specific acceptance criteria or the quantitative reported performance metrics for each test. It only names the types of non-clinical tests performed.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document claims all acceptance criteria were met for the following tests:	Not explicitly stated in the document. The document claims successful completion of the following studies:
	TruMatch™ Dimensional Stability Test
	Cadaver Accuracy Study
	Design Process and Design Software Repeatability Study
	Software Validation and Verification Summary

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for any of the non-clinical tests or provide details about the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions a "Cadaver Accuracy Study."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for any test set or their qualifications. The studies described are non-clinical, focusing on device performance rather than clinical interpretation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method as it does not involve human interpretation or subjective assessment that would require such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done or mentioned. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the TruMatch™ Patient Specific Instruments and the predicate devices."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary focus of the document is on the physical instruments and their design/software validation. While "Software Validation and Verification Summary" is mentioned, the text does not elaborate on a standalone algorithm-only performance study in the context of interpreting medical images or making diagnostic judgments. The instruments assist in surgical positioning, but the decision-making and interpretation of CT data for their creation likely involve human oversight.

7. The Type of Ground Truth Used

The document does not detail the specific "ground truth" used for each non-clinical test. However, based on the nature of the tests:

TruMatch™ Dimensional Stability Test: Ground truth would likely be established through engineering specifications and measurements using calibrated equipment.
Cadaver Accuracy Study: Ground truth would likely be established through physical measurements and anatomical landmarks on the cadaver, potentially compared to pre-operative imaging or established surgical standards.
Design Process and Design Software Repeatability Study: Ground truth would involve comparing outputs against known input parameters or established design tolerances.
Software Validation and Verification Summary: Ground truth would be based on software requirements, specifications, and expected outputs based on established algorithms and calculations.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is likely because the device is a patient-specific surgical instrument, and its development focuses on design, manufacturing, and accuracy based on individual patient imaging data, rather than a machine learning model trained on a large dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of the device's development or studies, this information is not applicable and therefore not provided in the document. The instruments are designed using individual patient CT data directly, rather than being "trained" on a dataset.

Summary

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510(k) Summary

AUG 16 2011

Applicant / Sponsor:	DePuy Orthopaedics Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration No.: 1818910
Contact Person:	Nancy S. FriddleProject Manager, Regulatory AffairsTel: (574) 371-4923Fax: (574) 371-4987
Proprietary Name:	TruMatch™ Personalized Solutions
Common Name:	Total Knee Prosthesis
Classification Name:	21 CFR 888.3560: Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis.Class II
Product Code:	JWH
Subsequent Product Code:	OOG

Device Description:

Subject of this premarket notification are TruMatch™ Patient Specific Instruments which are designed and manufactured from patient imaging data and used with other DePuy Orthopaedics implants.

Indications and Intended Use:

The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.

The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.

The TruMatch™ Patient Specific Instruments are intended for single use only.

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Summary of Technologies/Substantial Equivalence:

The TruMatch™ Patient Specific Instruments have the same indications, intended use, similar design and are substantially equivalent to the Smith & Nephew's Patient Matched Cutting Blocks and also to the traditional instruments that are associated with the Sigma® and Attune™ cleared knee implant systems. The TruMatch™ Patient Specific Instruments are used in conjunction with the DePuy Orthopaedics, Inc Sigma and Attune implant systems identified in the table below.

System	510k	Clearance Date
Sigma Total Knee System	K882234	10/20/1988
Sigma Total Knee System	K884796	3/29/1989
Sigma Total Knee System	K943462	12/21/1994
Sigma Total Knee System	K950010	5/15/1995
Sigma Total Knee System	K944538	9/26/1995
Sigma Total Knee System	K961685	7/10/1996
Sigma Total Knee System	K961685	7/10/1996
Sigma Total Knee System	K971189	7/17/1997
Sigma Total Knee System	K971189	7/17/1997
Sigma Total Knee System	K082500	11/18/2008
Attune Total Knee System	K101433	12/10/2010

Non-Clinical Testing:

The following testing was performed to demonstrate the substantial equivalence of the TruMatch™ Patient Specific Instruments to the predicate devices.

TruMatch™ Dimensional Stability Test .
. Cadaver Accuracy Study
Design Process and Design Software Repeatability Study .
Software Validation and Verification Summary �

The tests results demonstrate that all acceptance criteria were met.

Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the TruMatch™ Patient Specific Instruments and the predicate devices.

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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 depiction of a bird-like symbol with three curved lines, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

DePuy Orthopaedics, Inc. % Ms. Nancy S. Friddle Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw. Indiana 46581-0988

AUG 1 6 2011

Re: K110397

Trade/Device Name: DePuy TruMatch™ Patient Specific Instruments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OOG Dated: June 15, 2011 Received: June 16, 2011

Dear Ms. Friddle:

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.

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. Nancy S. Friddle

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.fdgg.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.html 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/ReportalProblem/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

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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K110397

2. INDICATIONS FOR USE

510(k) Number (if known):

Device Name: DePuy TruMatch™ Patient Specific Instruments

Indications for Use:

The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.

The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.

The TruMatch™ Patient Specific Instruments are intended for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melleuson

(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110397

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.