· Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
· Inflammatory degenerative joint disease including rheumatoid arthritis;
· Correction of functional deformity;
· Revision procedures where other treatments or devices have failed; and
· Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

· Moderate varus, valgus, or flexion deformities
Additional indications for Physica PS components are:
· Iigamentous instability requiring implant bearing surface geometries with increased constraint (preserved and well functioning collateral ligaments are required);
· absent or not-functioning posterior cruciate ligament.

Device Description

Physica LMC knee system is a modular knee system which consists of a Physica LMC tibial liner used in combination with the Physica CR femoral components (K151266) and the Physica tibial plate (K141934); the Physica patellar component and the Physica tibial stem, cleared in K141934, can optionally be used with the Physica LMC knee system. The Physica LMC knee system components are intended to be used with bone cement.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Physica LMC Knee System." This document is a regulatory submission for a medical device and does not detail an AI/ML study with acceptance criteria, human reader performance, or ground truth establishment in the way typically associated with diagnostic algorithms.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and non-clinical mechanical testing.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and AI/ML specific metrics cannot be found in this document.

Here's what can be extracted based on the provided text, with clarifications where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Mechanical Testing	Substantially equivalent to predicate devices in:	"Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices"
	- Contact area / pressure at the femoral component and tibial liner coupling (FDA guideline, ASTM F2083)	(Specific quantitative results not provided, only statement of equivalence)
	- Wear of the articulating surfaces (ISO 14243)	(Specific quantitative results not provided, only statement of equivalence)
	- Constraint of the femoral component and tibial liner coupling (FDA guideline, ASTM F1223)	(Specific quantitative results not provided, only statement of equivalence)
Clinical Performance	(Not applicable; clinical testing was not deemed necessary for this 510(k) submission to demonstrate substantial equivalence.)	"Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica LMC knee system to the predicate devices."

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

Sample Size for Test Set: Not applicable. This document describes mechanical testing, not a diagnostic algorithm's performance on a test set of data. The "test set" in this context refers to the physical devices undergoing mechanical tests, not medical imaging or clinical data.
Data Provenance: Not applicable in the context of an AI/ML diagnostic study. The testing described is mechanical, involving physical components of the knee system.

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

Not applicable. Ground truth as typically understood for diagnostic AI/ML (e.g., expert consensus on image interpretation, pathology reports) is not relevant to the mechanical testing described. The "ground truth" for mechanical testing would be defined by engineering standards and measurement techniques applied by qualified engineers or technicians, but the document does not specify their number or qualifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts in diagnostic studies. This document discusses mechanical engineering tests, where results are typically objective measurements against standards.

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 study was not done. This submission is for a knee implant, not a diagnostic AI/ML device that assists human readers.

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

No. A standalone algorithm performance study was not done. This submission is for a knee implant, not a diagnostic AI/ML device.

7. The type of ground truth used

The "ground truth" for the mechanical testing would be established by validated engineering methodologies and standards (e.g., ASTM F2083, ISO 14243, ASTM F1223) that define acceptable performance parameters for knee implants. This is distinct from ground truth in diagnostic AI/ML, which typically refers to clinical outcomes, pathology, or expert consensus on interpretations.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this document does not describe the development or evaluation of an AI/ML algorithm.

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

Not applicable. There is no mention of a training set or its ground truth.

Summary

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January 31, 2020

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

Limacorporate S.p.A % Lacey Harbour Regulatory Manager Lima USA Inc. 2001 NE Green Oaks Blvd., Ste. 100 Arlington, Texas 76006

Re: K193284

Trade/Device Name: Physica LMC Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, HRY Dated: November 15, 2019 Received: November 27, 2019

Dear Lacey Harbour:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 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) K193284

Device Name Physica LMC knee system

Indications for Use (Describe)

Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

· Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
· Inflammatory degenerative joint disease including rheumatoid arthritis;
· Correction of functional deformity;
· Revision procedures where other treatments or devices have failed; and
· Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

· Moderate varus, valgus, or flexion deformities
Additional indications for Physica PS components are:

· Iigamentous instability requiring implant bearing surface geometries with increased constraint (preserved and well functioning collateral ligaments are required);

· absent or not-functioning posterior cruciate ligament.

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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Summary of Safety and Effectiveness

Date: January 27, 2020

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy

U.S. Contact Person: Lacey Harbour, MB(ASCP)CM US Regulatory Manager Lacey.harbour@limacorporate.com Limacorporate S.p.A. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006 USA www.limacorporate.com Office Phone: 817.385.0777 ext.200 Cell Phone: 432.638.6615 FAX: 817.385.0377

Product	Product Code	Regulation and Classification Name
Physica LMC knee System	JWH	Knee joint PatellofemorotibialPolymer/Metal/Polymer Semi-ConstrainedCemented Prosthesis per 21 CFR 888.3560
	HRY	Knee joint Femorotibial Metal/PolymerSemi-Constrained Cemented Prosthesis per21 CFR 888.3530

Description:

Intended Use:

Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic ● arthritis, or avascular necrosis;
Inflammatory degenerative joint disease including rheumatoid arthritis;
Correction of functional deformity; ●
Revision procedures where other treatments or devices have failed; and ●
Treatment of fractures that are unmanageable using other techniques. ●

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Additional indications for Physica LMC component are:

Moderate varus, valgus, or flexion deformities
Additional indications for Physica PS components are:
ligamentous instability requiring implant bearing surface geometries with increased ● constraint (preserved and well functioning collateral ligaments are required);
absent or not-functioning posterior cruciate ligament. ●

Predicate Devices:

Company	Device name	Cleared via
LIMACORPORATE	Physica Knee System	K151266, K141934, K152008
ZIMMER	VANGUARD®	K050222, K113550
ZIMMER	PERSONA®	K150090

Summary of technology comparison:

The intended use, design, and materials of Physica LMC knee system are substantially equivalent to the ones of the predicate devices. Design Control Activities have been successfully completed.

Non-clinical testing:

Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:

Contact area / pressure at the femoral component and tibial liner coupling (FDA guideline, ASTM F2083)
Wear of the articulating surfaces (ISO 14243) ●
Constraint of the femoral component and tibial liner coupling (FDA guideline, ASTM ● F1223)

Clinical testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica LMC knee system to the predicate devices.

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.