The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised 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, partial knee replacement, or failed prior 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™ PS Total Knee System components are indicated for use only with cement and are single use devices.

Device Description

The NEO PS Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation:
The Neo PS Knee System femoral component, when used with the Neo PS 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 medical device, the NEO PS Knee System, and its clearance process through the FDA's 510(k) pathway. This pathway establishes substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic accuracy or performance, is not directly applicable to this submission.

However, based on the provided document, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission as demonstrating substantial equivalence to predicate devices through various performance tests.

Here's an analysis of the information that can be extracted or reasonably inferred from the document:

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

Since this is a 510(k) submission for a knee implant, the "acceptance criteria" are not reported as specific statistical thresholds for diagnostic accuracy (e.g., sensitivity, specificity). Instead, they are implied to be achieving comparable or acceptable performance in mechanical and functional tests as benchmarked against predicate devices and relevant industry standards.

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (from "Performance Testing" section)
Mechanical Strength & Durability (comparable to predicate devices and standards)	Evaluated for: - Tibial tray fatigue strength - Insert locking mechanism strength - PS post strength
Functional Range of Motion (comparable to predicate devices and patient needs)	Evaluated for: - Femorotibial range of motion - Femorotibial range of constraint - Patellofemoral range of constraint
Contact Mechanics (comparable to predicate devices to minimize wear and stress)	Evaluated for: - Femorotibial contact areas/contact stress - Patellofemoral contact area and contact stress
Material Compliance (meeting established biomedical standards)	"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."
Overall Substantial Equivalence	"All evaluations determined that the NEO PS Knee System is substantially equivalent to the predicate devices."

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

Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic performance. The "test set" here refers to the physical devices undergoing various mechanical and material tests. The specific number of physical samples tested for each mechanical test is not disclosed in this summary.
Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer (Pipeline Orthopedics) or a contract testing laboratory. The country of origin for these tests is not specified but is presumably the US, where the company is based. The data would be considered prospective in the sense that the tests are designed and performed to evaluate the new device's characteristics.

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

This information is not applicable to this type of submission. "Ground truth" in the context of a 510(k) for a medical implant refers to established engineering principles, material standards, and the performance characteristics of legally marketed predicate devices. The "experts" involved are likely biomechanical engineers, material scientists, and regulatory experts who interpret test results against these standards and predicate device data. The document does not specify the number or detailed qualifications of such experts involved in the testing or the substantial equivalence determination beyond the general regulatory process.

4. Adjudication method for the test set:

This concept is not applicable here. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of medical data (e.g., image readings). For a medical implant's mechanical testing, the "adjudication" is inherent in the test protocols themselves, the calculation of results, and the comparison against predefined acceptance criteria or predicate device performance. Any discrepancies would relate to test execution or interpretation which would be resolved through standard engineering and quality control procedures.

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:

This is not applicable. An MRMC study is relevant for diagnostic devices (e.g., imaging software) where human interpretation is involved and improved with AI assistance. The NEO PS Knee System is a joint implant, not a diagnostic tool.

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

This is not applicable. This question pertains to AI/algorithm performance. The NEO PS Knee System is a physical knee implant.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is primarily established through:

Predicate Device Performance: Benchmarking against the mechanical and functional characteristics of the legally marketed predicate devices (NEO CR Knee System, NexGen® LPS-Flex Knee System, Triathlon PS Knee System).
Industry Standards: Compliance with "applicable implantable materials standards" (e.g., ASTM, ISO standards for biocompatibility, mechanical properties, etc., though not explicitly named).
Engineering Principles: The tests conducted (fatigue, strength, ROM, contact stress) are based on established biomechanical and engineering principles to ensure the device can withstand anticipated physiological conditions.

8. The sample size for the training set:

This is not applicable. A "training set" refers to data used to train an AI algorithm. The NEO PS Knee System is a physical implant.

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

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

Summary

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K122500 (Page 1 of 2)

NEO PS Knee System 510(k) Summary

MAY 0 3 2013

Device Proprietary Name:	NEO PS Knee System
Common Name:	Total Knee System
Classification regulation:	888.3560
Device Class:	Class II
Product Codes:	JWH (cemented knees)
Submitter's Name:Address:Contact Person:Telephone Number:Fax Number:	Pipeline Orthopedics3 Wing Drive, Suite 200, Cedar Knolls, NJ 07927Robert C. Cohen(973) 267-8800(973) 267-8810

Date Summary Prepared: August 6, 2012

Device Description:

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

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

Intended Use

. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
. Failed osteotomies, partial knee replacement, or failed prior 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™ PS Total Knee System components are indicated for use only with cement and are single use devices.

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NEO PS 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) #	Clearance Date
NEO CR Knee System	Pipeline	K120313	4/20/2012
NexGen® LPS-Flex Knee System	Zimmer	K072619	11/21/2007
		K042271	10/13/2004
		K991581	07/30/1999
Triathlon PS Knee System	Stryker	K031729	9/2/2003

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 PS Knee System to the predicate knee systems and performance testing confirm that the NEO PS 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 PS Knee System has been evaluated for tibial tray fatigue strength, insert locking mechanism strength, femorotibial range of motion, PS post strength, 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 PS 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 PS Knee System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

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

May 3, 2013

Pipeline Orthopedics % M Squared Associates, Incorporated Ms. Terry Sheridan Powell 901 King Street, Suite 102 Alexandria, Virginia 22314

Re: K122500

Trade/Device Name: NEO PS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH . Dated: April 24, 2013 Received: April 25, 2013

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. 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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.

Erin DKeith

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

Enclosure

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K122500

Indications for Use Statement

510(k) Number: To be assigned

Device Name: NEO PS Knee System

Indications for Use:

. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
. Failed osteotomies, partial knee replacement, or failed prior 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™ PS Total 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)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet际比:Frank -S

Division of Orthopedic Devices

Page 1 of __ 1__ 1__

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.