The Continuum Patellar is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of fractures that are unmanageable using other techniques. This device is intended for use with bone cement.

Device Description

The Continuum Patellar is fabricated from Hedrocel® and UHMWPE. The UHMWPE is direct compression molded into the Hedrocel®, thereby creating the articulation surface. The Continuum Patellar is intended for use with bone cement when performing total knee arthroplasty or revisions with legally marketed Implex Continuum Femoral and Tibial components.

AI/ML Overview

The Implex Continuum Patellar is a knee joint patellofemorotibial prosthesis. The 510(k) summary states that "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices." This implies that the acceptance criteria for the device are met if its performance is comparable or non-inferior to the predicate devices.

However, the provided text does not explicitly define specific "acceptance criteria" in terms of quantitative metrics or performance thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices.

Here's an analysis of the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from "Substantial Equivalence")	Reported Device Performance
Material Composition	Equivalent to predicate devices (Hedrocel® and UHMWPE)	Uses Hedrocel® and UHMWPE
Design and Geometry	Similar and/or identical to predicate devices	Two-part design and articulating surface geometry similar and/or identical to predicate devices.
Intended Use	Identical to predicate devices	Intended use is consistent with predicate devices for total knee arthroplasty or revisions.
Safety and Effectiveness	Equivalent to predicate devices	Performance testing demonstrates equivalence to claimed predicate devices.
Fixation Method	Intended for use with bone cement	Intended for use with bone cement. Crucially, the FDA explicitly states it "may not be labeled or promoted for non-cemented use" and "Any non-cemented fixation of this device is considered investigational."

Study Information

The document mentions "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices," but it does not provide details about a specific study in the format of a clinical trial or a detailed bench testing report. It's a summary statement rather than a detailed study description.

Based on the provided text, the following information is not available or implicitly handled by the substantial equivalence argument:

Sample size used for the test set and the data provenance: Not specified. The "performance testing" is not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This typically applies to image-based diagnostic devices. For a prosthetic device, "ground truth" would likely refer to engineering specifications, material properties, and clinical outcomes, which are not outlined in a study format here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
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: Not applicable. This is a prosthetic device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a prosthetic device, "ground truth" would generally involve meeting engineering specifications, material tests, and potentially biomechanical evaluations, comparing them to established predicate devices. The document only states "Performance testing" without detailing methodology.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided K971789 document details a 510(k) submission where "substantial equivalence" to predicate devices is the primary means of demonstrating safety and effectiveness. It does not contain detailed information about a specific quantitative study with predefined acceptance criteria, sample sizes, and expert panel ground truth verification as typically seen for diagnostic devices or more complex clinical trials. The "performance testing" mentioned is general and not elaborated upon in this summary document. The FDA's decision emphasizes the "cemented use only" limitation as a critical aspect of its substantial equivalence finding.

Summary

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JUL 2 4 1997

K971789

510(k) SUMMARY - CONTINUUM PATELLAR

Submitter Name:	Implex Corp. (Implex)
Submitter Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	Robert CohenVice President, Product Development
Phone Number:	(201) 818-1600
Fax Number:	(201) 818-0567
Date Prepared:	July 22, 1997
Device Trade Name:	Continuum Patellar
Device CommonName:	Prosthesis, Patellar
Classification Name:	Knee Joint Patellofemorotibial Polymer/Metal/PolymerSemi-Constrained Cemented Prosthesis
Predicate Device(s):	Patellar Component of Continuum Knee System (CKS),Implex Corp. (K882322); Porous Genesis Patellar,Richards Medical Company (K890132); Duracon InsetPatella with Central Peg, Howmedica (K961482).
Device Description:	The Continuum Patellar is fabricated from Hedrocel® andUHMWPE. The UHMWPE is direct compression moldedinto the Hedrocel®, thereby creating the articulation surface.The Continuum Patellar is intended for use with bonecement when performing total knee arthroplasty or revisionswith legally marketed Implex Continuum Femoral and Tibialcomponents.
Intended Use:	The Continuum Patellar is intended as the patellarcomponent of the Continuum Knee System whoseindications for use include: 1) noninflamatory degenerativejoint disease including osteoarthritis or traumatic arthritis,2) rheumatoid arthritis, 3) correction of functionaldeformity, 4) revision procedures where other treatments ordevices have failed, and 5) treatment of fractures that areunmanageable using other techniques. This device isintended for use with bone cement.

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_510(k) Summary (continued)

DeviceTechnologicalCharacteristics andComparison toPredicate Device(s):	The two-part design and articulating surface geometry of theContinuum Patellar is similar and/or identical to the claimedpredicate devices from Implex Corp., Richards MedicalCompany, and Howmedica.
Performance Data:	Performance testing of the Continuum Patellar demonstratesits equivalence to the claimed predicate devices.
Conclusion:	The Continuum Patellar is substantially equivalent to thepredicate devices in terms of intended use, safety, andeffectiveness.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 1997

Glenn N. Byrd, MBA Associate Director of Requlatory Affairs Authorized Regulatory Agent for Implex Corporation -----------Advanced Bioresearch Associates 1700 Rockville Pike, Suite 450 Rockville, Maryland 20852

Re: K971789 Implex Continuum Porous Patellar Regulatory Class: II Product Code: JWH Dated: May 14, 1997 Received: May 14, 1997

Dear Mr. Byrd:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitation:

1. This device may not be labeled or promoted for non-cemented use.
1. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.

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Page 2 - Glen N. Byrd, MBA

Any non-cemented fixation of this device is 3. considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption --------(IDE) regulation under 21 CFR, Part 812. All users ^ of the device for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws on Regulations .

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

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Page 3 - Glenn N. Byrd, MBA

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

lmplex Continuum Porous Patellar

Indications For Use:

The Implex Continuum Porous Patellar is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of fractures that are unmanageable using other techniques. This device is intended for use with bone cement.

-- K971789

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

	Concurrence of CDRH; Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K971789

Prescription Use	X	OR...	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.