The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; .
Correction of functional deformity; .
Revision procedures where other treatments or devices have failed. .

Device Description

The Apex Knee System is a primary or revision total knee replacement. This knee replacement is intended for use with bone cement and single use implantation. This knee system consists of a range of sizes of cobalt chrome femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a size-for-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

AI/ML Overview

This document focuses on the Apex Knee System, a total knee replacement device. The provided text is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study evaluating acceptance criteria of a novel device. Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission.

However, I can extract information related to the device's characteristics and its comparison to existing devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify "acceptance criteria" in the sense of performance metrics for a novel device, nor does it present "reported device performance" from a study. Instead, it demonstrates substantial equivalence to predicate devices. The table below summarizes the design and material characteristics of the Apex Knee system and compares them to two predicate devices. This comparison serves as the basis for claiming substantial equivalence, implying that if the predicate devices are "accepted," then a device with similar characteristics also meets the necessary safety and effectiveness profile.

Characteristic	Apex Knee System (Reported)	Acceptance Criteria (Implied by Predicate Devices)
Intended Use	Primary and revision, 3-compartment, cemented	Primary and revision, 3-compartment, cemented
Porous coated	No	No
Asymmetric femur, anatomic patellar groove	Yes	Yes
Anatomic (asymmetric) tibial tray	Yes	Yes (for Natural-Knee® II), No (P.F.C. ® Sigma)
Metal-backed UHMWPE tibial component	Yes	Yes
Tibial insert designs	CR and Ultra	CR ("Curved") / CR ("Congruent") and Ultra ("Ultracongruent")
Tibial tray distal features	Central post and 2 keels	Central post and 2 short keels / Central post, 4 keels, and 4 pegs
Patella design	Round, single radius dome, 3 pegs	Round, single radius dome, 3 pegs / Round, partial dome, 3 pegs
Cobalt chrome femur	Yes	Yes
CoCr tibial tray	Yes	Yes (for Natural-Knee® II), No (ti alloy for P.F.C. ® Sigma)
All-poly patella	Yes	Yes
UHMWPE	Sheet molded GUR 1020	Sheet molded GUR 1020
Highly cross-linked UHMWPE (sterilization)	No (EtO)	No (y irradiation in vacuum / in nitrogen)

Note: The "Acceptance Criteria" column above is an interpretation of the characteristics present in the predicate devices that the Apex Knee System is demonstrating equivalence to. The direct performance metrics for "acceptance" are not explicitly stated as they would be in a clinical trial or performance study report.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable. This is a 510(k) submission, which relies on demonstrating substantial equivalence to legally marketed predicate devices, not on a separate "test set" of patients or data for a novel performance study. The "data" here refers to the design specifications and material properties of the Apex Knee System being compared.
Data Provenance: Not applicable in the context of human data. The "data" consists of the design and material specifications of the Apex Knee System and the predicate devices. This information is typically generated through engineering design, material testing, and manufacturing processes. The document does not mention human data from trials or registries.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. Ground truth for a clinical test set is not established in a 510(k) submission that relies on predicate device comparison. The "ground truth" for this submission is implicitly the established safety and effectiveness of the existing predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" in the context of clinical data for adjudication here. The comparison is against predicate device specifications, which is a regulatory review process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is a knee prosthesis, not an imaging diagnostic device that would typically involve human readers for interpretation. Therefore, an MRMC study is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device (total knee replacement), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth," in the context of a 510(k) for a physical device, is effectively the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the Apex Knee System is substantially equivalent in its design, materials, and intended use to these predicates, it shares the same safety and effectiveness profile.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of developing this physical medical device. Device design and material selection are based on engineering principles, biomechanical testing, and historical clinical performance of similar devices, not machine learning training data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set in the machine learning sense.

Summary

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K060192

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EXHIBIT A 510(K) Summary

Apex Knee System

January 23, 2006

Submitter: OMNI life science™, Inc. 1390-A Decision Street Vista, CA 92081

Contact: Ms. Christine Otis Requlatory and Quality Systems (760) 734-1550 x134 (voice) (760) 734-1577 (fax)

2. Device Name

Proprietary Name:	Apex Knee System
Common Name:	Knee prosthesis, cemented
Classification Name:	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulatory Class:	Class II per 21 CFR §888.3560

3. Intended Use

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; .
Correction of functional deformity; .
Revision procedures where other treatments or devices have failed. .

4. Device Description

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5. Predicate Device Comparison

Substantial equivalence is claimed to the P.F.C. Sigma Fixed Bearing Cruciate-Substantial equivalence is clauned to the 1. . . . . Relaining Rilee System uistibuted by Dr. ay Orthopsterior distributed by Zimmer, Inc. The Cruciale Retaining and Postoner Stablishes and differences between the Apex Knee System and these predicate devices:

	Apex Knee	P.F.C. ® Sigma*(K943462, K961685)	Natural-Knee® II*(K973412, K021578)
INTENDED USE
Primary and revision, 3compartment, cemented	Yes	Yes	Yes
DESIGN
Porous coated	No	No	No
Asymmetric femur,anatomic patella groove	Yes	Yes	Yes
Anatomic (asymmetric)tibial tray	Yes	No	Yes
Metal-backed UHMWPEtibial component	Yes	Yes	Yes
Tibial insert designs	CR and Ultra	CR ("Curved")	CR ("Congruent")and Ultra("Ultracongruent")
Tibial tray distal features	Central post and2 keels	Central post and2 short keels	Central post, 4keels, and 4 pegs
Patella design	Round, singleradius dome, 3pegs	Round, singleradius dome, 3pegs	Round, partialdome, 3 pegs
MATERIALS
Cobalt chrome femur	Yes	Yes	Yes
CoCr tibial tray	Yes	No - ti alloy	Yes
All-poly patella	Yes	Yes	Yes
UHMWPE	Sheet moldedGUR 1020	Sheet moldedGUR 1020	Sheet moldedGUR 1020
Highly cross-linkedUHMWPE (sterilization)	No (EtO)	No (y irradiationin vacuum)	No (y irradiation innitrogen)

The most significant difference between these devices is that the Apex Knee employs The most sighthoum unforonoo bother tibial tray using two parallel "dovetail" rails on INVI E «blar hoons the predicate devices employ UHMWPE inserts that are snapfit into the tibial tray.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 2006

OMNI life science, Inc. % Edward J. Cheal, Ph.D. Vice President of Research 175 Paramount Drive, Suite 302 Raynham, Massachusetts 02767

Re: K060192

Trade/Device Name: Apex 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: May 15, 2006 Received: May 16, 2006

Dear Dr. Cheal:

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 such 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): good manufacturing practice requirements as set

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Page 2 - Edward J. Cheal, Ph.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ohtain 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.

Sincerely yours,

Barbara Mnechuk

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Apex Knee™ System

Indications For Use:

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; .
Correction of functional deformity;
Revision procedures where other treatments or devices have failed.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __

(Division Sign-Division of General, estorative. and Neurological De

510(k) Number.__

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.