The Ascent™ All-Poly PS Tibial Bearings are for the painful and disabled knee joint resulting form osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement.

Device Description

The Ascent™ All-Poly PS Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The one-piece posterior stabilized (PS) tibial components are available in varying thicknesses and widths. The Ascent™ All-Poly PS Tibial Bearings are used in conjunction with the Ascent™ Femoral Components (K982869).

AI/ML Overview

This document describes a 510(k) premarket notification for the Ascent™ All-Poly PS Tibial Bearing. For this type of device, substantial equivalence is typically established through non-clinical testing and comparison to a predicate device, rather than through clinical trials with specific acceptance criteria and detailed performance metrics as one might find for a novel therapeutic device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be entirely filled out in the conventional sense for a clinical study.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance (Summary)
Material Properties	Equivalent to predicate device (UHMWPE, ArCom®)	Manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE).
Design	Similar to predicate devices (one-piece, PS, varying thicknesses/widths)	One-piece posterior stabilized (PS) tibial components available in varying thicknesses and widths.
Sizing	Similar to predicate devices	Similar to predicate devices.
Indications for Use	Aligned with predicate devices	Indications for use are similar or identical to predicate devices.
Biomechanical Safety	No new risks identified compared to predicate device.	Determined through Engineering Justifications and Finite Element Analysis (FEA) that the device presented no new risks.
Substantial Equivalence	Demonstrates equivalence to a legally marketed predicate device (Kirschner Performance Total Knee System K934589) based on design, materials, and indications for use.	FDA's finding of substantial equivalence based on the provided information.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. No clinical test sets were used for this 510(k) submission. The evaluation was primarily based on non-clinical engineering justifications.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. No ground truth was established by external experts in a clinical study context for this submission. The "ground truth" for substantial equivalence was based on engineering analysis and comparison to a legally marketed predicate device, reviewed by the FDA.
Qualifications of Experts: Not applicable for a clinical test set. The review and approval were conducted by the FDA, including the Division of General, Restorative and Neurological Devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: None. No clinical test set requiring adjudication was performed.

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

MRMC Study: No. This is a medical device (knee implant component), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant.

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

Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth: For the purpose of this 510(k) submission, the "ground truth" was established by demonstrating that the device is substantially equivalent to a legally marketed predicate device (Kirschner Performance Total Knee System K934589) in terms of materials, design, sizing, and indications for use, and that non-clinical testing (engineering justifications and Finite Element Analysis) showed no new risks. This is a regulatory "ground truth" rather than a clinical one derived from patient data.

8. The sample size for the training set

Sample Size: Not applicable. No training set was used as this is a physical medical device and not an AI/machine learning system.

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

Ground Truth Establishment: Not applicable. No training set was used.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the Ascent™ All-Poly PS Tibial Bearing meets its "acceptance criteria" (which in this context are the requirements for demonstrating substantial equivalence to a predicate device) is defined by the Non-Clinical Testing described in the document:

Engineering Justifications: This involves a detailed analysis of the device's design, materials, and manufacturing processes, comparing them to the predicate device. This would include assessing mechanical properties, wear characteristics, and biocompatibility.
Finite Element Analysis (FEA): This is a computational method used to predict how a product reacts to real-world forces, vibration, heat, fluid flow, and other physical effects. For a tibial bearing, FEA would be used to model stress distribution, deformation, and potential failure points under various loading conditions representative of human activity.

The conclusion from these non-clinical tests was that "the Ascent™ All-Poly PS Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device." This finding, along with the device's similar "materials, design, sizing, and indications" to existing devices, formed the basis for the FDA's determination of substantial equivalence. The document explicitly states: "No clinical testing was provided as a basis for substantial equivalence."

Summary

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JUN 0 5 2002

021559

CORPORATE UARTERS

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Dalene T. BinkleyTelephone: (574) 267-6639
Proprietary Name:	Ascent™ All-Poly PS Tibial Bearing
Common Name:	All-Polyethylene Tibial Bearing

Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (21 CFR 888.3560)

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Kirschner Performance Total Knee System (K934589).

Device Description: The Ascent™ All-Poly PS Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The one-piece posterior stabilized (PS) tibial components are available in varying thicknesses and widths.

The Ascent™ All-Poly PS Tibial Bearings are used in conjunction with the Ascent™ Femoral Components (K982869).

Indications for Use: The indications for the Ascent™ All-Poly PS Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Ascent™ All-Poly PS Tibial Bearings are for use with bone cement.

Summary of Technologies: The Ascent™ All-Poly PS Tibial Bearings -the materials, design, sizing, and indications are similar or identical to the predicate devices.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - - -

.

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639 FAX 219.267.8137 000038

E-MAIL biomet@biomet.com

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Summary of Safety & Effectiveness All-Polyethylene Tibial Bearing Page 2

Non-Clinical Testing: Engineering Justifications and a Finite Element Analysis (FEA) determined that the Ascent All-Poly PS Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device.

Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

000039
0000

OFFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@biomet.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN 0 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K021559

Trade Name: Ascent™ All-Poly PS Tibial Bearings Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 6, 2002 Received: May 13, 2002

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket 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) 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 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.

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Page 2 - Ms. Dalene T. Binkley

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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Sincerely yours,

Mark N Melkenson

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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Page 1 of 1

510 (k) NUMBER (IF KNOWN): _ kod | 559

DEVICE NAME: Ascent™ All-Poly PS Tibial Bearings

INDICATIONS FOR USE:

This device is for use with bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Mark N. Milkman

Restorative and North of Callerical Devices

510(k) Number

Over-The-Counter-Use (Optional Format 1-2-96)

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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.