The LPS - Continuum® TM Hybrid Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the LPS -Continuum® TM Hybrid Tibia is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.

Device Description

The LPS - Continuum TM Hybrid Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).

AI/ML Overview

This document (K012095) is a 510(k) summary for a medical device called "The LPS - Continuum TM Hybrid Tibia," a component for total knee arthroplasty. It is a submission to the FDA for market clearance, stating that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the specific information requested about acceptance criteria for device performance and a study proving it meets those criteria. The provided text is a regulatory submission for market clearance based on substantial equivalence, not a detailed technical report on performance testing.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated from the provided text:

A table of acceptance criteria and the reported device performance:
- Not available in the provided document. The document is a 510(k) summary, which focuses on substantial equivalence to predicate devices, not specific performance criteria and test results.
Sample size used for the test set and the data provenance:
- Not applicable/Not available. A "test set" in the context of performance criteria is not described in this regulatory submission. Animal or human clinical trial data with specific sample sizes for performance evaluation are not mentioned as part of this 510(k) summary focusing on substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. "Ground truth" is typically established in studies evaluating diagnostic or predictive devices. This document describes an orthopedic implant, not a diagnostic tool requiring such ground truth.
Adjudication method for the test set:
- Not applicable/Not available. As above, this is for diagnostic/predictive device evaluation, not an orthopedic implant's 510(k) summary.
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/Not available. This is an orthopedic implant, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not available. This is an orthopedic implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not available. "Ground truth" is not established for the purpose described in this 510(k) summary. The "truth" for substantial equivalence is comparison to legally marketed predicate devices, and the document explicitly states the device is "substantially equivalent to the identified predicate devices."
The sample size for the training set:
- Not applicable/Not available. There is no mention of a "training set" as this device is not a machine learning or AI algorithm.
How the ground truth for the training set was established:
- Not applicable/Not available. As above, no training set or ground truth in that context is mentioned.

Summary of what the document does provide:

Device Name: The LPS - Continuum TM Hybrid Tibia
Manufacturer: Implex Corp.
Intended Use/Indications: For cemented total knee arthroplasty in cases of severe degeneration, trauma, or other pathology of the knee joint, and specifically for knee instability caused by a compromised or non-functional posterior cruciate ligament.
Device Description: Manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE), intended for use with Zimmer NexGen LPS Femoral components.
Regulatory Clearance: K012095, cleared by FDA on July 26, 2001, based on substantial equivalence to predicate devices.

Summary

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Implex Corp.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The LPS - Continuum TM Hybrid Tibia
Submitter Name:	Implex Corp.
Submitter Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	Robert Poggie
Phone Number:	(201) 818-1800
Fax Number:	(201) 995-9722
Date Prepared:	June 29, 2001
Device Trade Name:	The LPS - Continuum TM Hybrid Tibia
Device CommonName:	Articular Surface and Tibial Components
Classification Numberand Name:	21 CFR § 888.3560
SubstantialEquivalence:	The term "substantial equivalence" as used in this510(k) notification is limited to the definition ofsubstantial equivalence found in the Federal Food,Drug and Cosmetic Act, as amended and as appliedunder 21 CFR 807, Subpart E under which a devicecan be marketed without premarket approval orreclassification. A determination of substantialequivalency under this notification is not intended tohave any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters.No statements related to, or in support of substantialequivalence herein shall be construed as anadmission against interest under the US Patent Lawsor their application by the courts.
Device Description:	The LPS - Continuum TM Hybrid Tibia is manufacturedfrom Trabecular Metal (Hedrocel Porous Tantalum) withdirect compression molded ultra-high molecular weightpolyethylene (UHMWPE).

These tibial components are intended for use with Zimmer NexGen LPS Femoral components.

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510(k) Summary (Continued)

Indications for Use:

The LPS - Continuum® TM Hybrid Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the LPS - Continuum TM Hybrid Tibia is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.

Conclusion:

The LPS - Continuum TM Hybrid Tibia is substantially equivalent to the identified predicate devices.

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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 and Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The eagle is facing right. 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 6 2001

Dr. Robert A. Poggie Director of Applied Research Implex Corp. 80 Commerce Drive. Allendale, New Jersey 07401

Re: K012095

Trade Name: The LPS-Continuum ™ Hybrid Tibia Regulatory Class: II Regulation Number: 888.3560 Product Code: JWH Dated: July 3, 2001 Received: July 5, 2001

Dear Dr. Poggie:

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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (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 or regulations.

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

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Page 2 - Dr. Robert A. Poggie

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific a in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This anagliestions on the promotion and advertising of your device, (2017) 594-4639. Rudinonary, 10. queens at (301) 594-4639. Also, please note the regulation prease connact the office or Scrence to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Machluurks

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

Enclosure

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510(k) Number (if known) :

l2.PT

Device Name:

The LPS- Continuum® TM Hybrid Tibia

Indications For Use:

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Bhatthee to tai iun

(Division Sign-O Division of General, Restorative and Neurological Devices Counter Use 510(k) Number KO12099

Prescription 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.