The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Device Description

The MOTO™ Partial Knee System is a knee prosthesis designed for cemented use in medial compartment partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The femoral component is made of cobalt-chromiummolybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal baseplate component (Ti-6Al-4V per ISO 5832-3). The MOTO™ Partial Knee System implants are offered sterile (via gamma irradiation or ethylene oxide), are intended for single use only, and may not be re-sterilized.

The Anatomic Femoral Component (cemented) is anatomically shaped and designed with two (2) fixation pegs for sizes 1 to 7 and three (3) fixation pegs for sizes 8 to 10. Available in ten (10) sizes (1 - 10), the femoral component is offered in both Right Medial (RM) and Left Medial (LM) options for each size.

The Medial Fixed Tibial Insert has a fixed design and is available in five (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).

The Medial Fixed Tibial Tray (cemented) has a fixed bearing design with one fixation keel and peg to ensure primary stability. Available in five (8) sizes (1 - 8), the Medial Fixed Tibial Tray are offered in both Right Medial (RM) and Left Medial (LM) options for each size.

AI/ML Overview

The document provided is a 510(k) premarket notification for the MOTO™ Partial Knee System, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria for device performance in a clinical setting in the way an AI/ML device submission would.

Therefore, the specific information requested in your prompt (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is not applicable to this type of device submission.

The "performance testing" section refers to bench testing and validation of the device's physical properties and manufacturing processes, not clinical or diagnostic performance.

Here's a breakdown of what is available in the document related to "acceptance criteria" and "device performance" in the context of this orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria and performance in a table for clinical metrics like sensitivity or specificity. Instead, the "performance testing" section lists various validation studies conducted to ensure the device meets engineering, material, and manufacturing standards. The implied "acceptance criteria" for these tests are generally compliance with the relevant ASTM/ISO standards. The "reported device performance" is essentially that the device passed these tests and is thus considered substantially equivalent to the predicate.

Performance Test	Implied Acceptance Criteria	Reported Device Performance
Fatigue under dynamic physiological loads	Compliance with ASTM F1800	Device passed, deemed substantially equivalent to predicate
Excessive wear	Compliance with ASTM F2083	Device passed, deemed substantially equivalent to predicate
Sterilization validation (Gamma Radiation)	Compliance with ANSI/AAMI/ISO 11137-1:2006, ANSI/AAMI/ISO 11137-2:2006	Validation performed, ensuring sterility for sterile products
Sterilization validation (Ethylene Oxide)	Compliance with ISO 11135-1:2007 (for the Fixed Tibial Insert)	Validation performed, ensuring sterility for sterile products
Accelerated and real-time aging	Demonstrate device integrity and material stability over its specified shelf life (5 years)	Device passed, ensuring long-term performance and shelf life
Packaging validation	Ensure packaging maintains sterility and device integrity	Validation performed, ensuring device protection and sterility
Limulus Amebocyte Lysate (LAL) testing (Pyrogenicity)	Meet pyrogen limit specifications	Device meets pyrogen limit specifications

2. Sample size used for the test set and data provenance:

Not applicable for clinical performance. The "test set" here refers to samples of the device components used in bench testing. The specific number of samples for each engineering test (e.g., number of femoral components tested for fatigue) is not provided in this summary document.
Data Provenance: Not specified, but standard for device manufacturers conducting in-house or contracted lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This relates to clinical diagnostic performance. For mechanical and material testing, the "ground truth" is established by the test standard itself and the measurements taken by qualified technicians/engineers against the specified parameters.

4. Adjudication method for the test set:

Not applicable. Adjudication is relevant for subjective assessments or disagreements in clinical interpretation, not for objective engineering measurements.

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:

Not applicable. This is an orthopedic implant, not an AI/ML diagnostic device with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is an orthopedic implant, not a standalone AI algorithm.

7. The type of ground truth used:

Not applicable for clinical performance. For the engineering tests, the "ground truth" is defined by the physical properties of the materials and the mechanical behavior of the device components as measured against established scientific and engineering principles and standards (e.g., ASTM, ISO).

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this device's submission as it's not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a sans-serif font.

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

January 3, 2017

Medacta International SA % Elizabeth Wheeler Manager, Regulatory Affairs Mapi USA, Inc 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

Re: K162084 Trade/Device Name: Moto Partial Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: November 16, 2016 Received: November 17, 2016

Dear Elizabeth Wheeler:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Lori A. Wiggins -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K162084

Device Name

MOTO™ Partial Knee System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two blue triangles on the left, followed by the word "Medacta" in blue. A yellow line is underneath the word "Medacta". The word "International" is in a smaller font below the yellow line, and a Swiss flag is on the right.

1 510(k) Summary

Applicant/Sponsor:	Medacta International SA
	Strada Regina
	6874 Castel San Pietro (CH)
	Switzerland
	Phone (+41) 91 696 60 60
	Fax (+41) 91 696 60 66

Contact Person: Stefano Baj Regulatory Affairs Manager Phone: +41 91 696 60 60 Fax: +41 91 696 60 66 Email: baj@medacta.ch

Date Prepared:	July 26, 2016
Date Revised:	November 16, 2016

DEVICE INFORMATION

Trade/Proprietary Name:	MOTO™ Partial Knee System
Common or Usual Name:	Unicompartmental Knee prosthesis
Classification Name:	Knee joint femorotibial metal/polymer/ non-constrained cementedprosthesis
Product Code:	HSX
Regulation Number:	21 CFR 888.3520
Device Class:	II

PREDICATE DEVICE INFORMATION

Primary predicates:

510(k)	Product	510(k) Holder
K073175	Journey	Smith & Nephew

Additional predicates:

510(k)	Product	510(k) Holder
K102069	Journey	Smith & Nephew
K033363	UNI	Zimmer

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DEVICE DESCRIPTION

The Medial Fixed Tibial Insert has a fixed design and is available in five (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).

INDICATIONS FOR USE

The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease. previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Discussion:

The Indications for Use Statement is similar to the predicate device. The only difference is that the subject device calls out the requirements for "evidence of sufficient sound bone to seat and support the components", and the predicate device cites specific example of degenerative joint disease ("osteoarthritis, traumatic arthritis, or avascular necrosis"). These differences do not create new intended uses for the subject device: the subject and predicate devices are all prostheses intended for use in knee arthroplasty.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The design features, and materials of the subject devices are substantially equivalent to those of the predicate devices. The tables below compare characteristics of the subject and predicate devices.

Feature	MOTO™ Partial KneeSystem - AnatomicFemoral Component(cemented)	Smith & NephewJourney(K073175)	Zimmer UNI(K033363)
Sizes	10 sizes (Size 1-10)	7 sizes (Size 1 -7)	7 sizes (Size A - G)
Configuration	RM and LM	RM/LL and LM/RL	RM/LL and LM/RL
Material	CoCrMo - ISO 5832-4	Same(with an oxiniumoxidized zirconiumcoating)	Same
Cemented?	Yes	Same	Same
Device Usage	Single Use	Same	Same
Sterility	Provided sterile viaGamma Radiation	Same	Same
Shelf Life	5 Years	Same	> 5 Years
Stabilizationpegs	Anatomic Femoralcomponent is cementedwith two (2) pegs forsizes 1-7 and three (3)pegs for sizes 8-10	2 Pegs	2 Pegs

Feature	MOTO™ Partial Knee System-Fixed Tibial Insert	Zimmer UNI(K033363)
Sizes	8 sizes (from 1 to 8)	6 sizes (from 1 to 6)
Thickness	Each size is offered in 6 levels ofthickness (8, 9, 10, 11, 12, 14 mm)	Same
Material	UHMWPE (ISO 5834 -2) Type 1	Same
Device Usage	Single Use	Same
Sterility	Provided sterile via Ethylene Oxide	Same
Shelf Life	5 years	> 5 years

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Feature	MOTO™ PartialKnee System - FixedPlus Tibial Tray(cemented)	Smith & NephewJourney (K102069)	Zimmer UNI(K033363)
Sizes	8 sizes (from 1 to 8)	6 sizes	6 sizes (from 1 to 6)
Configurations	RM and LM	RM/LL and LM/RL	Same
Material	Ti-6Al-4V (ISO 5832-3)	Same	Ti-6Al-4V with PMMAprecoat
Cemented	Cemented	Same	Same
Device Usage	Single Use	Same	Same
Sterility	Provided sterile viaGamma Radiation	Unknown	Same
Shelf Life	5 years	Unknown	> 5 years
Stabilization	Stabilized with peg andkeel	Same	Same
Fixed Bearing?	Yes	Same	Same

The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

PERFORMANCE TESTING

The following studies were performed to support substantial equivalence:

Fatigue under dynamic physiological loads according to ASTM F1800
Excessive wear according to ASTM F2083 .
Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006. ● ANSI/AAMI/ISO 11137-2:2006 and ISO 11135-1:2007
Accelerated and real time aging
. Packaging validation
Limulus Amebocyte Lysate (LAL) testing was evaluated to establish the device meets . pyrogen limit specifications.

Conclusion:

Based on the above information, the MOTO™ Partial Knee System can be considered substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.