The NEO CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing surgery for total knee replacement due to:

Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.
Neo CR Knee System components are indicated for use only with cement and are single use devices.

Device Description

The NEO CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial trays, patellar components and surgical instrumentation. The Neo CR Knee System femoral component, when used with the Neo CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

AI/ML Overview

The provided text describes a 510(k) summary for the NEO CR Knee System, a total knee replacement device. It establishes substantial equivalence to predicate devices based on design and performance testing. However, the document does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria in the context of AI device performance.

Specifically, the document focuses on regulatory clearance for a physical medical device (a knee implant) and not an AI medical device. The criteria listed are for the mechanical and material performance of the knee implant itself, and the "performance testing" mentioned refers to engineering tests, not studies of AI algorithm efficacy or diagnostic accuracy.

Therefore, I cannot provide the requested information from the given text.

Here's why the required information is missing:

Acceptance Criteria for AI/Performance: The document discusses performance testing for the knee implant's mechanical properties (fatigue strength, locking mechanism, range of motion, contact stress), not diagnostic accuracy, sensitivity, specificity, or other metrics typically used for AI device acceptance.
Study Proving Acceptance Criteria: The document mentions "performance testing" was done, but it does not detail specific studies, sample sizes, ground truth establishment, or expert evaluation methods relevant to AI performance.
Sample Size (Test Set/Training Set) and Data Provenance: This information is not present as the "device" in question is a physical implant, not an AI algorithm.
Number of Experts/Qualifications/Adjudication Method: These are relevant for establishing ground truth in AI diagnostic studies, which is not applicable here.
MRMC Comparative Effectiveness Study: Such studies are conducted to evaluate the human-AI interaction or impact of AI assistance on human readers. This is not mentioned.
Standalone Performance: This refers to the AI algorithm's performance without human interaction. Not applicable here.
Type of Ground Truth: For AI, this would be pathology, expert consensus on images, clinical outcomes, etc. For a mechanical implant, ground truth relates to engineering specifications and physical measurements.
Ground Truth for Training Set: This is specific to AI model training, which is not relevant to a physical knee implant.

In summary, the provided 510(k) summary is for a traditional medical device (knee implant) and thus does not contain the details pertaining to acceptance criteria and studies for an AI-powered medical device.

Summary

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K 12.0313 (1/2)

APR 2 0 2012

NEO CR Knee System 510(k) Summary

NEO CR Knee System Device Proprietary Name:

Total Knee System Common Name:

888.3560 Classification regulation:

Device Class: Class II

Product Codes:

JWH (cemented knees)

Submitter's Name: Pipeline Orthopedics 3 Wing Drive, Suite 200, Cedar Knolls, NJ 07927 Address: Robert C. Cohen Contact Person: Telephone Number: (973) 267-8800 (973) 267-8810 Fax Number:

April 17, 2012 Date Summary Prepared:

Device Description:

The NEO CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial trays, patellar components and surgical instrumentation.

The Neo CR Knee System femoral component, when used with the Neo CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

Intended Use

The Neo CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing surgery for total knee replacement due to:

Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate . deformities and femoral condyle osteonecrosis.
Failed osteotomies, failed partial knee replacement, or failed total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result.
Post-traumatic loss of joint configuration, particularly when there is . patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities. .

NEO CR Knee System components are indicated for use only with cement and are single use devices.

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NEO CR Knee System 510(k) Summary

Predicate Devices:

The NEO CR Knee System is similar to several predicates including the following.

Trade/Proprietary Name	Manufacturer	510(K) #	ClearanceDate
NexGen Complete Knee SolutionCruciate Retaining (CR)-Flex FemoralComponents	Zimmer	K023211	10/17/2002
Gender Solutions Natural-Knee FlexSystem	Zimmer	K073286	03/07/2008
Triathlon Cruciate Retaining (Cr) TotalKnee System	Stryker	K040267	5/5/2004

Technological Characteristics:

The metals and standard UHMWPE material from which the components are manufactured are the same materials used in the predicate knee systems and comply with applicable implantable materials standards. A comparison of design features of the NEO CR Knee System to the predicate knee systems and performance testing confirm that the NEO CR Knee System is capable of withstanding the anticipated physiological conditions associated with the indications for use and is substantially equivalent to the predicate devices.

Performance Testing:

The NEO Knee System has been evaluated for tibial tray fatigue strength, insert locking mechanism strength, femorotibial range of motion, femorotibial range of constraint, patellofemoral range of constraint, femorotibial contact areas/contact stress, and patellofemoral contact area and contact stress.

Substantial Equivalence Information:

The NEO CR Knee System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the NEO CR Knee System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Pipeline Orthopedics, Incorporated % M Squared Associates Ms. Terry Sheridan Powell Consultant 901 King Street, Suite 200 Alexandria, Virginia 22314

Received: February 1, 2012

Re: K120313

Trade/Device Name: NEO CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: JWH Dated: January 30, 2012

Dear Ms. Powell:

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.

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 that I Dr man matures and regulations administered by other Federal agencies. You must or any I vith 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

APR 2 0 2012

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Page 2 - Ms. Terry Sheridan Powell

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/AboutFD/VCentersOffices/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/ReportalProblem/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.

Sincerely yours,

for Datha

Mrs. Linda

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:

To be assigned K120313

NEO CR Knee System Device Name:

The NEO CR Knee System components are indicated for use in Indications for Use: skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing surgery for total knee replacement due to:

Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate . deformities and femoral condyle osteonecrosis.
Failed osteotomies, failed partial knee replacement, or failed total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result.
Post-traumatic loss of joint configuration, particularly when there is . patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities. .

Neo CR Knee System components are indicated for use only with cement and are single use devices.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

· Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number: K120313

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.