Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Signature™ Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system.

The Signature™ guides are intended for single use only.

Device Description

Signature тм Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of total knee replacement components.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it refers to validation against intended use and substantial equivalence to predicate devices. The performance is broadly stated as "adequate."

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy performance adequate for intended use (e.g., precise pin placement for total knee replacement components).	"Testing verified that the accuracy and performance of the system is adequate to perform as intended."
Guide deformation verification after sterilization adequate for intended use.	"guide deformation verification after sterilization was performed to determine substantial equivalence."
Substantial equivalence to predicate devices (SurgiCase K073449 and Zimmer Patient Specific Instruments System 2.0 K093533).	"Device comparison showed that the proposed device is substantially equivalent to the predicate devices... Testing verified that the accuracy and performance of the system is adequate to perform as intended."

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

Test Set Sample Size: The text states "cadaveric trials" were performed. However, it does not provide a specific number or range of cadavers used for these trials.
Data Provenance: The cadaveric trials imply a prospective data collection for the performance testing. The country of origin for the cadavers is not specified.

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

The document does not mention the use of experts to establish ground truth for the CADAVERIC test set. The evaluation appears to be based on direct measurement of device output (e.g., pin placement accuracy). If human judgment was involved, it is not detailed.

4. Adjudication Method for the Test Set

As the document does not detail the use of experts or a subjective assessment for the test set's ground truth, an adjudication method is not described. The assessment seems to be based on objective measurement during the cadaveric trials.

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, an MRMC comparative effectiveness study was not mentioned in this 510(k) summary. The device, Signature™ Planner, is a software for pre-surgical planning and the Signature™ guides are patient-specific templates. The focus is on the accuracy of these tools directly, not on improving human reader performance with AI assistance.

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

Yes, in spirit. The "Signature™ Planner software... has been validated for its intended use" and "Accuracy performance testing by means of cadaveric trials" was performed. While a surgeon uses the software to "inspect, fine-tune and approve the pre-surgical plan," the performance testing described seems to primarily evaluate the system's (software + guides) ability to accurately transfer the plan to the physical space (cadaver) without explicitly measuring the impact of human fine-tuning on the accuracy results reported in the cadaveric trials. The accuracy reported ("adequate") is the outcome of the system's ability to produce precise pin locations.

7. The Type of Ground Truth Used

The ground truth for the cadaveric trials would likely be established through direct, precise measurement of the actual pin placements on the cadaveric bones relative to the intended pre-surgical plan. This would involve highly accurate measurement techniques (e.g., CMM, optical tracking, or high-resolution CT scans of the cadaver after pin insertion) to determine the deviation from the planned positions. This falls under objective physical measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This is typical for medical device submissions focusing on predicate pathway and substantial equivalence, especially for technologies predating the widespread use of deep learning models that require large training datasets. The "Signature™ Planner" likely relies on established geometric algorithms and imaging processing techniques rather than a machine learning model that requires a distinct training phase with labeled data.

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

As no training set is mentioned (see point 8), no information is provided on how its ground truth would have been established.

Summary

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K102795 (1/3)

FEB - 2 2011

510(k) Summary

Submitter information

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Postal code	3001
Country	Belgium
Phone number	+32 16 39 62 80
Fax number	+32 16 39 66 06
Contact name	Alexandra Razzhivina
Contact title	Regulatory affairs officer
Contact e-mail address	alexandra.razzhivina@materialise.be

Submission date

The date of the Traditional 510(k) submission is 24th September 2010.

Submission information

Trade Name	Signature™ PlannerSignature™ guides
Common Name	knee prosthesis
Classification Name	- Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis-Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis
Product code	JWH/OIY (21 CFR § 888.3560), MBH (21 CFR§ 888.3565), OOG

Predicate devices

Predicate Device
Trade or proprietary or model name	SurgiCase
510(k) number	K073449
Decision date	04/16/2008
Product code	LLZ
Manufacturer	Materialise N.V.

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Predicate Device
Trade or proprietary or model name	Zimmer Patient Specific InstrumentsSystem 2.0
510(k) number	K093533
Decision date	02/17/2010
Product code	JWH, MBH
Manufacturer	Materialise N.V.

Device Information

Description of the device

Functioning of the device

Signature ти Personalized Patient Care System generates a pre-surgical plan based on MRI or CT imaging data using the Signature™ Planner (software component). The software is then used preoperatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Signature™ guides are designed and manufactured based on the approved pre-surgical plan. Signature™ guides are patient specific templates that transfer the pre-operatively determined pin locations for positioning of the total knee replacement components to the patient intra-operatively. The surgical guides are used to accurately place the guide pins used to position the cutting blocks.

Intended use

The Signature Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system.

The Signature™ guides are intended for single use only.

Summary of technological characteristics

Device comparison showed that the proposed device is substantially equivalent to the predicate devices, in that the device materials are identical to the predicate; and, like the predicate device, the subject device is matched to the patient using software.

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Performance data

Non-clinical tests

The Signature™ Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices.

Accuracy performance testing by means of cadaveric trials, and guide deformation verification after sterilization was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended.

Clinical data

Not applicable.

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

Materialise N.V. % Ms. Alexandra Razzhivina Technologielaan 15 3001 Leuven, Belgium

FEB - 2 2011

Re: K102795

Trade/Device Name: Signature™ Personalized Patient Care System (Signature™ Guides, Signature™ Planner) 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, OIY, MBH, OOG Dated: December 23, 2010 Received: December 27, 2010

Dear Ms. Razzhivina:

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 indivions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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 I.c. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you; however, that device labeling must be truthful and not michery

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 (1 h 1 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.

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Page 2 - Ms. Alexandra Razzhivina

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 liusing (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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the economic 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/ucm1118001/jp/dfast 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" (215FR Paul 807.97). For questions regarding the reporting of adverse events under the MIR 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-freen mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

A.j. B. rita
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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510(k) Number K102795:

Device Name: Signature™ Personalized Patient Care System (Signature™ guides, Signature™ Planner)

Indications for Use:

The Signature™ guides are intended for single use only.

Prescription Use X _ AND/OR Over-The-Counter Use _____________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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)

Ar. M. Melkersm
Page 1

ical, Orthopedic, Division of Surg and Restorative Devices

Page 1 of _1

510(k) Number _

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.