· 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.
Physica CR knee system is intended for cemented fixation.

Device Description

The Physica CR Knee Replacement System is a total knee replacement system consisting of a femoral component, a UHMWPE tibial liner, a tibial plate, and an all polyethylene patellar component. Modular tibial stems are provide for optional use as needed. The Physica CR knee system devices are intended to be used with bone cement.
The femoral components are made of CoCrMo (ISO 5832-4 / ASTM F75). The articulating surface is polished and with symmetrical condyles. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available.
Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial and lateral hemi-plateau. The liner is attached to the tibial plate through a snap-fit mechanism. The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexion-extension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in a symmetrical version for left and right knees.
The tibial plates and all polyethylene patellar components are the tibial plates and patellar components used for the Physica KR Knee Replacement System (K141934).
Tibial stems can be optionally used and are the same as those cleared for the Physica KR knee system in K141934.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Physica CR Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, much of the information typically associated with acceptance criteria and standalone studies for AI/software devices is not present.

Based on the document, here's what can be extracted and what is explicitly stated as not applicable:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:	"the testing results demonstrated the device's ability to perform under expected clinical conditions."
- Contact areas & pressures	Tested on tibio-femoral and patello-femoral interfaces.
- Wear testing	Tested.
- Constraint tests	Tested at tibio-femoral and patello-femoral interfaces.
- Fatigue tests	Performed on tibial plate and tibial plate-tibial stem coupling (for Physica KR, applicable to CR).
- Locking strength	Tested between tibial plate and tibial liner (for Physica KR, applicable to CR).
- Static shear test	Performed on patella (for Physica KR, applicable to CR).
Material Equivalence:	"The Physica CR knee system components share the same materials...as those of the predicate devices."
- Femoral components material	CoCrMo (ISO 5832-4 / ASTM F75)
- Liners material	Standard UHMWPE (ISO 5834-2 / ASTM F648)
Design Equivalence:	"share the same ... basic design features as those of the predicate devices."
- Intended Use Equivalence:	"The Physica CR knee system components share the same ... intended use...as those of the predicate devices."

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

This information is not applicable as no clinical or "test set" data in the context of AI/software performance is described. The "test set" mentioned in the document refers to mechanical testing of physical components. "Mechanical testing was performed on worst case components or constructs." No specific sample size for these mechanical tests is given. Data provenance is not mentioned beyond the manufacturer's location in Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a physical knee prosthesis, not an AI/software device requiring expert-established ground truth for its performance assessment.

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

This is not applicable for the same reasons as point 3.

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

There was no MRMC comparative effectiveness study done. This is not an AI-assisted device.

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

A standalone performance evaluation in the context of an algorithm or AI was not done. This is a physical knee replacement system.

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

For the mechanical testing, the "ground truth" (or reference standard) is the established engineering and biomechanical principles and standards (e.g., ISO, ASTM) that govern the performance of such medical implants, and the performance of the legally marketed predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not an AI/software system.

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

This is not applicable for the same reasons as point 8.

Study Proving Device Meets Acceptance Criteria

The study referenced in the document to prove the device meets acceptance criteria is a series of non-clinical mechanical tests. The document states:

"The following tests were performed on Physica CR knee system devices: Contact areas and pressures at tibio-femoral and patello-femoral interfaces; Wear testing; Constraint tests at tibio-femoral and patello-femoral interfaces."
"Fatigue tests on the tibial plate, fatigue resistance of the tibial plate-tibial stem coupling, test on the locking strength between the tibial plate and the tibial liner and static shear test on the patella were performed for the Physica KR system and are applicable to Physica CR knee system."
"Mechanical testing was performed on worst case components or constructs. The testing results demonstrated the device's ability to perform under expected clinical conditions."

The basis for acceptance is demonstrating substantial equivalence to predicate devices (Physica KR, Vanguard, Scorpio) through these mechanical tests and by establishing that the new device shares the same materials, intended use, and basic design features as the predicates. No clinical testing was deemed necessary for this 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black against a white background.

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

October 6. 2015

Limacorporate S.p.A. % Dr. Stephen Peoples President People & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K151266 Trade/Device Name: Physica CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 8, 2015 Received: September 9, 2015

Dear Dr. Peoples:

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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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/Resourcesfor You/Industry/default.htm. 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 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 yours,

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151266

Device Name Physica CR Knee System

Indications for Use (Describe)

Physica CR 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.

Physica CR knee system is intended for cemented fixation.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Summary of Safety and Effectiveness

Date: October 10, 2015

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

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512

Product	CommonName	ProductCode	Regulation and Classification Name
Physica CRknee system	Total KneeSystem	JWH	Knee joint PatellofemorotibialPolymer/Metal/Polymer Semi-Constrained Cemented Prosthesis per 21CFR 888.3560

Description

The femoral components are made of CoCrMo (ISO 5832-4 / ASTM F75). The articulating surface is polished and with symmetrical condyles. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available.

Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial and lateral hemi-plateau. The liner is attached to the tibial plate through a snap-fit mechanism. The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexion-extension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in a symmetrical version for left and right knees.

The tibial plates and all polyethylene patellar components are the tibial plates and patellar components used for the Physica KR Knee Replacement System (K141934).

Traditional 510(k) - Physica CR knee system

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Tibial stems can be optionally used and are the same as those cleared for the Physica KR knee system in K141934.

Intended Use

Physica CR 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.

All components of the Physica CR knee system are intended for cemented fixation.

Predicate Devices

Physica KR (Limacorporate, K141934); ●
Vanguard (Biomet, K113550); ●
Scorpio (Stryker, K974556). ●

Basis of Substantial Equivalency

The Physica CR knee system components share the same materials, intended use and basic design features as those of the predicate devices. Non-clinical testing demonstrates that the subject components perform at least as well as the cited predicates.

Non-Clinical Testing

The following tests were performed on Physica CR knee system devices:

Contact areas and pressures at tibio-femoral and patello-femoral interfaces; ●
Wear testing: ●
Constraint tests at tibio-femoral and patello-femoral interfaces.

Fatigue tests on the tibial plate, fatigue resistance of the tibial plate-tibial stem coupling. test on the locking strength between the tibial plate and the tibial liner and static shear test on the patella were performed for the Physica KR system and are applicable to Physica CR knee system.

Mechanical testing was performed on worst case components or constructs. The testing results demonstrated the device's ability to perform under expected clinical conditions.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Physica CR 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.