MyKnee Cutting Blocks are intended to be used as anatomical cutting blocks specific for a single patient anatomy to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of hone before cutting.

MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.

MyKnee Cutting Blocks are intended for single use only.

Device Description

MyKnee Cutting Blocks are designed and manufactured from patient imaging data so that the cutting blocks match the patient's anatomy. The MvKnee Cutting blocks for the patient are used with Medacta's existing GMK Total Knee System.

AI/ML Overview

This 510(k) summary for the MyKnee Cutting Blocks describes performance testing; however, it does not provide detailed acceptance criteria or a specific study designed to "prove" the device meets acceptance criteria in the way one might expect for a software or AI/ML device.

Instead, the documentation focuses on demonstrating substantial equivalence to predicate devices through a combination of non-clinical testing and design validation. Given the nature of the device (patient-matched cutting blocks for total knee replacement), the "acceptance criteria" discussed are largely related to manufacturing quality, material properties, and dimensional accuracy, rather than clinical efficacy as might be assessed with AI.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "MyKnee Cutting Blocks were tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing met all acceptance criteria..." However, the specific acceptance criteria and their corresponding reported performance values are not detailed in this summary.

Based on the text, the following types of performance were evaluated, implying associated acceptance criteria existed:

Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 for external communicating devices with limited contact.	Met applicable ISO 10993 requirements.
Dimensional Accuracy	Specific tolerances for accuracy based on patient imaging data.	Met acceptance criteria (details not provided).
Dimensional Precision	Consistency in dimensions before and after sterilization.	Met acceptance criteria (details not provided).
Mechanical Testing	Sufficient strength and durability for intended surgical use.	Met acceptance criteria (details not provided).
Cleanliness	Adherence to defined cleanliness standards after factory cleaning.	Met acceptance criteria (details not provided).
Shipping Test	Integrity of packaged device after shipping.	Met acceptance criteria (details not provided).
Process Reproducibility	Consistent manufacturing process yielding equivalent products.	Assessed and met acceptance criteria (details not provided).
Software Validation	Software tools used for manufacturing function as intended.	Validated for intended use.

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

The document mentions "a cadaver laboratory" for design validation. This implies the use of human cadavers as a test set. However:

Sample Size: The exact number of cadavers used is not specified.
Data Provenance: This would be from cadaveric studies, likely performed in a laboratory setting. It is retrospective in the sense that the cadavers were not living patients undergoing surgery, but rather preserved specimens. The country of origin is not specified but would typically be the country where the manufacturing or validation studies were performed (likely Switzerland where Medacta is based, or potentially the US if outsourced).

3. Number of Experts and Qualifications

This information is not provided in the summary. While the study involved surgical tools, there is no mention of experts establishing a ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method

This information is not provided in the summary. This type of adjudication is typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), which doesn't appear to be the primary focus of the performance testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done with human readers and AI assistance. This device is a physical cutting block, not an AI diagnostic or assistive tool in that traditional sense. The "patient-matched" aspect refers to the manufacturing process creating a custom physical tool from patient imaging data, not an AI providing clinical interpretations.

6. Standalone (Algorithm Only) Performance

The closest analog to "standalone performance" for this device would be the accuracy and precision of the MyKnee Cutting Blocks themselves in matching the patient's anatomy and guiding cuts. This was part of the "dimensional accuracy and precision" testing, and "software tools used to manufacture the MyKnee Cutting Blocks were validated for their intended use." However, it's not an algorithm only in the sense of a standalone AI model; it's the accuracy of the manufactured physical product derived from digital data. No specific performance metrics are given.

7. Type of Ground Truth Used

For the cadaver laboratory design validation, the ground truth would likely involve:

Physical measurements: Direct measurements of the bone cuts and component positioning on the cadaveric knees after using the MyKnee Cutting Blocks, compared against surgical plans derived from the patient imaging data.
Expert surgical assessment: Evaluation by surgeons to confirm if the blocks facilitate accurate and appropriate resections as intended.

8. Sample Size for the Training Set

The phrase "training set" is typically used for machine learning models. For this device, the "training" for the manufacturing process comes from the engineering design, material science, and manufacturing protocols. There isn't a "training set" of data in the AI/ML sense. The "patient imaging data" for each individual patient is used to design their specific cutting blocks, not to train a general model.

9. How Ground Truth for Training Set Was Established

Given that there is no "training set" in the AI/ML sense, this question is not applicable to the MyKnee Cutting Blocks device as described. The "ground truth" for the overall design and manufacturing process would be established through engineering specifications, material properties testing, and verification of the manufacturing process (as implied by process reproducibility and software validation).

Summary

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K093806 (1/3)

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a bold, sans-serif font, with two triangular shapes above the "M". Below the word "Medacta" is the word "International" in a smaller font. To the right of the word "International" is a plus sign.

APR - 8 2010

510(k) Summar

Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX

Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com

Date Prepared: April 7, 2010

DEVICE INFORMATION

Trade/Proprietary Name: MyKnee Cutting Blocks

Common Name: Total Joint Replacement /Classification Name: Knee Joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

21 CFR 888.3560 Class II Device Product Code: JWH, OOG

K082358 Smith & Nephew, Inc. Patient Matched Predicate Devices: Cutting Blocks K090988 GMK Total Knee System
MyKnee Cutting Blocks 510(k)

Section 5 - Page 2 of 4

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Product Description:

Intended Use and Indications for Use:

MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.

MyKnee Cutting Blocks are intended for single use only.

Comparison to Predicate Devices

MyKnee Cutting Blocks have the same intended use as the Smith & Nephew's Patient Matched Cutting Blocks except for use with the Medacta GMK system instead of the Smith & Nephew's cleared total knee systems. Both are manufactured from the same material using the type of process where the cutting blocks are matched to the patient's anatomy using data from patient imaging files.

MyKnee Cutting Blocks are also substantially equivalent to the standard distal femoral and proximal tibial cutting blocks used in conjunction with the GMK Total Knee system cleared under K090988. MyKnee Cutting Blocks are used with the GMK Total Knee System for the indications for use for which the GMK Total Knee System is cleared.

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the MyKnee Cutting Blocks was conducted in accordance with various international standards and FDA quidance documents.

Non-clinical testing included biocompatibility testing to ISO 10993 applicable to external communicating devices with limited (<=24 hrs) contact duration. dimensional accuracy and precision before and after sterilization, mechanical testing, cleanliness following factory cleaning, and a shipping test of the packaged device. Process reproducibility was assessed. The software tools used to manufacture the MyKnee Cutting Blocks were validated for their intended use.

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K093806(3/3)

MyKnee Cutting Blocks were tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that the performance of the MyKnee Cutting Blocks are substantially equivalent to the predicate devices.

Design validation was accomplished with a cadaver laboratory.

Conclusion:

The data and information provided in this submission support the conclusion that the MyKnee Cutting Blocks are substantially equivalent to its predicate devices, the Smith & Nephew, Inc. Patient Matched Cutting Blocks and/or the GMK Total Knee System with respect to intended use, design, materials, and operational principles.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract representation of a human figure or a caduceus.

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

Medacta International % Ms. Natalie Kennel Consultant 13721 Via Tres Vista San Diego, California 92129

Re: K093806

Trade/Device Name: MyKnee Cutting Blocks Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, OOG Dated: April 2, 2010 Received: April 5, 2010

APR - 8 2010

Dear Ms. Kennel:

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

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Page 2 - Ms. Natalie Kennel

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/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.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Mark McMillan

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 Statement

510(k) Number (if known): K093806

Device Name: MyKnee Cutting Blocks

Indications for Use:

MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.

MyKnee Cutting Blocks are intended for single use only.

Prescription Use メ Over-The-Counter Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souita for mxm

Page __ of

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

510(k) Number K093806

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.