The MOTO PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases:

Osteoarthritis, post-traumatic arthritis, polyarthritis, severe chondrocalcinosis of the patellofemoral joint.

Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation). History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.

Degeneration induced by dysplasia.

If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.

Device Description

The MOTO PFJ System, subject of this submission, consists of:

o Patello Femoral Joint, made of Cobalt-Chromium-Molybdenum alloy
MOTO Patella, made of UHMWPE ●

The MOTO PFJ System is intended for replacement of the femoral trochlea of the patellafemoral joint affected by injury and/or disease process.

The MOTO PFJ System is intended for cemented use only.

The MOTO PFJ System may be used alone or in combination with the MOTO Partial Knee System Unicompartmental Prosthesis (Medial K161741 and Lateral K183029) and GMK UNI Prosthesis (K162084), to treat multiple conditions of patellofemoral and tibiofemoral regions of the natural knee. The Patello Femoral Joint component is designed to articulate with natural patella or with the dedicated MOTO Patella.

AI/ML Overview

The provided document is a 510(k) summary for the Medacta International SA MOTO PFJ System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, this document does not describe an AI/ML medical device. It details a knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML medical device (such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable or present in this document.

The document focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, which is typical for implantable medical devices of this type.

Here's an analysis of what is available and what is not for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

For an AI/ML device: This would typically involve metrics like sensitivity, specificity, accuracy, F1-score, AUC, etc., with pre-defined thresholds for acceptance.
For this device: The acceptance criteria are based on mechanical and material performance, and biological safety. The "performance" is demonstrated through various non-clinical tests.
- Acceptance Criteria (Implied from tests): The device must demonstrate sufficient fatigue endurance under walking and squatting scenarios, proper articular surface congruence, acceptable range of motion, comparable constraints to predicate, comparable contact pressure and areas to predicate, and acceptable wear behavior. Biocompatibility (pyrogenicity, LAL test) is also an acceptance criterion.
- Reported Device Performance:
  - Non-Clinical Studies (Validation & Characterization):
    - Shape and Dimension Validation
    - Cadaveric workshop validation
    - Fatigue Endurance Test (Walking Scenario) - Test Reports A3
    - Fatigue Endurance Test (Squatting Scenario) - Test Reports A4
    - Articular Surface Fully Congruent - Test Report B1
    - Range of Motion - Test Report B2
    - Comparison within Medacta MOTO Patella and Zimmer NexGen Patella Constraints - Test Report B3
    - Comparison within Medacta MOTO Patella and Zimmer NexGen Patella in relation to Contact Pressure and Areas - Test Report B4
    - Wear Behaviour - Test Report B5
    - Bacterial Endotoxin Test (LAL test) - passed (equivalent to USP chapter <85>)
    - Pyrogen test - passed (according to USP <151>)
Table (Reinterpreting for this hardware device):

Acceptance Criterion (Implied)	Reported Device Performance
Adequate Shape and Dimension Validation	Test Report A1 (passed)
Functional validation in cadaveric workshop	Test Report A2 (passed)
Meets Fatigue Endurance (Walking Scenario)	Test Reports A3 (passed)
Meets Fatigue Endurance (Squatting Scenario)	Test Reports A4 (passed)
Articular Surface Fully Congruent	Test Report B1 (passed)
Adequate Range of Motion	Test Report B2 (passed)
Comparable Constraints to Predicate (Zimmer NexGen Patella)	Test Report B3 (passed)
Comparable Contact Pressure/Areas to Predicate (Zimmer NexGen Patella)	Test Report B4 (passed)
Acceptable Wear Behavior	Test Report B5 (passed)
Non-pyrogenic (meets Bacterial Endotoxin Test and Pyrogen Test)	Passed LAL test (European Pharmacopoeia §2.6.14/USP chapter <85>); Passed Pyrogen test (USP chapter <151>)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

For an AI/ML device: This would refer to the number of cases/images in the independent test set.
For this device: The "test set" here refers to the number of physical devices or components subjected to mechanical and biological testing. The document does not specify the exact number of samples for each test (e.g., how many femoral components were tested for fatigue), nor the specific origin of these physical samples beyond being manufactured by Medacta International SA (Switzerland). The testing is "prospective" in the sense that the tests were performed on newly manufactured devices.

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

For an AI/ML device: This refers to human expert annotations.
For this device: "Ground truth" is established by engineering specifications, biomechanical principles, and established international standards (e.g., ISO, ASTM, Pharmacopoeia) for material properties and mechanical performance. Experts would be engineers, material scientists, and toxicologists interpreting these results. The document does not list the number or qualifications of these experts analyzing the test results, as it's typically part of the company's internal quality system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

For an AI/ML device: This refers to resolving disagreements between human annotators.
For this device: Not applicable. Performance is measured against physical and chemical standards, not subjective human interpretations.

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

For an AI/ML device: Refers to studies evaluating AI's impact on human performance.
For this device: Not applicable, as this is a physical implant, not a diagnostic AI. The document explicitly states: "No clinical studies were conducted."

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

For an AI/ML device: Refers to algorithm performance metrics without human interaction.
For this device: Not applicable. There is no algorithm. The performance is the inherent mechanical and biological performance of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For an AI/ML device: Refers to the definitive determination of the condition being detected/diagnosed.
For this device: The 'ground truth' is based on engineering and material science standards and protocols. For example, fatigue endurance is measured against a specific load cycle standard, wear is measured according to a wear test standard, and biocompatibility is measured against pharmacopoeia standards. There is no "disease state" ground truth for this type of device.

8. The sample size for the training set

For an AI/ML device: Refers to the data used to train the algorithm.
For this device: Not applicable, as there is no AI/ML algorithm requiring a training set. The "training" for such devices would be the iterative design and manufacturing process, and knowledge gained from previous designs, but not in the context of data used to train a machine learning model.

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

For an AI/ML device: Refers to how training data was annotated or labeled.
For this device: Not applicable.

Summary

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April 20, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K200122

Trade/Device Name: MOTO PFJ System Regulation Number: 21 CFR 888.3540 Regulation Name: Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRR, JWH, NPJ Dated: January 17, 2020 Received: January 21, 2020

Dear Chris Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200122

Device Name MOTO PFJ System

Indications for Use (Describe)

Osteoarthritis, post-traumatic arthritis, polyarthritis, severe chondrocalcinosis of the patellofemoral joint.

Degeneration induced by dysplasia.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. Submitter

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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: January 17, 2020

II. Device

Device Proprietary Name:	MOTO PFJ System
Common or Usual Name:	Total Knee Prosthesis
Classification Name:	Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
Primary Product Code:	KRR
Secondary Product Codes:	JWH, NPJ
Regulation Number:	21 CFR 888.3540 and 21 CFR 888.3560
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

A Patellofemoral joint prosthesis, K070695, Zimmer
A NexGen Prolong All-poly patella, K072281, Zimmer

In addition, the following Reference device is cited within the submission:

A GMK (K090988), Medacta International SA

IV. Device Description

The MOTO PFJ System, subject of this submission, consists of:

o Patello Femoral Joint, made of Cobalt-Chromium-Molybdenum alloy
MOTO Patella, made of UHMWPE ●

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The MOTO PFJ System is intended for replacement of the femoral trochlea of the patellafemoral joint affected by injury and/or disease process.

The MOTO PFJ System is intended for cemented use only.

V. Indications for Use

Osteoarthritis, post-traumatic arthritis, polyarthritis, severe chondrocalcinosis of the ● patellofemoral joint.
Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle o elevation, cartilage transplantation).
0 History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.
Degeneration induced by dysplasia. ●

VI. Comparison of Technological Characteristics

0 Patello Femoral Joint

The subject Patello Femoral Joint and the predicate Patellofemoral joint prosthesis share the following characteristics:

indication for use; ●
shape: ●
fixation and stability features; ●
material: ●
o biocompatibility;
o device usage:
sterility:
shelf life: and ●
packaging. ●

The only difference between the subject Patello Femoral Joint and the predicate device concerns the sizes.

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o MOTO Patella

The subject MOTO Patella and the predicate NexGen Prolong All-poly patella share the following characteristics:

indication for use; ●
sizes:
shape; ●
fixation and stability features; ●
material; ●
biocompatibility; ●
device usage; ●
sterility; ●
shelf life; and ●
packaging.

There are no differences between the subject MOTO Patella and the predicate device.

Discussion

Medacta International SA has not made any change to the intended use, shape, device usage, materials, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.

The range of product of the Patello Femoral Joint was divided in 6 sizes, with respect to the 5 sizes of the predicate device, in order to cover all the antero-posterior (AP) and medio/lateral (ML) dimensions identified on the basis of a comparative analysis of all PFJ implants currently on the market.

The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the MOTO PFJ System implants to the identified predicate devices.

VII. Performance Data

Based on the risk analysis, design validation and characterization testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:

Non-Clinical Studies

DESIGN VALIDATION
- 0 Shape and Dimension Validation of the MOTO PFJ Femoral Component Test Report A1.
- o MOTO PFJ system Validation cadaveric workshop Test Report A2.

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o CHARACTERIZATION TESTING

o Fatigue Endurance Test of the MOTO PFJ Femoral Component Walking Scenario according to Test Reports 00812-009638-1 and 00812-009638-2 and Test Protocols IL 07.09.459 and IL 07.09.465. Test report A3
o Fatigue Endurance Test of the MOTO PFJ Femoral Component Squatting Scenario according to Test Reports 00812-007625-3 and 00812-007625-4 and Test Protocols IL 07.09.479 and IL 07.09.480. Test report A4
o Articular Surface Fully Congruent within MOTO PFJ & MOTO. Test report BI
0 MOTO PFJ & MOTO Patella Range of Motion. Test report B2
o Comparison within Medacta MOTO Patella and Zimmer NexGen Patella Constraints according to Test Reports 00812-009640-1 and 00812-009640-2 and Medacta Test protocols IL 07.09.552 and IL 07.09.555. Test report B3
o Comparison within Medacta MOTO Patella and Zimmer NexGen Patella in relation to Contact Pressure and Areas according to Test Reports 00812-009634-1 and 00812-007185-1 and Test Protocols IL 07.09.551 and IL 07.09.461. Test report B4
o Wear Behaviour MOTO PFJ & MOTO Patella. Test report B5
PYROGENICITY: o
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
- o Pyrogen test according to USP chapter <151> for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.

Clinical Studies:

No clinical studies were conducted. ●

VIII. Conclusion

The information provided above supports that the MOTO PFJ System is as safe and effective as the predicate devices. Therefore, it is concluded that the MOTO PFJ System is substantially equivalent to the predicate device.

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Regulation Number and Section

§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”