Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Revision procedures where other treatment or devices have failed

Device Description

The PAR 5 Acetabular Component is a hemispherical metallic acetabular cup, which can accept a modular hook, ilium flange, and/or a modular ischial blade. The shell accepts a standard Ringloc® liner. The outer surface of the shells has porous coating. The shells are also available with or without hydroxyapatite (HA) coating.

AI/ML Overview

The provided documentation is a 510(k) premarket notification for a medical device, the PAR 5 Acetabular Component, and focuses on demonstrating substantial equivalence to a predicate device. It explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."
"Non-Clinical Testing: Substrate testing with an Engineering Justification determined that the modified PAR 5 Acetabular Components presented no new risks and were, therefore, substantially equivalent to the predicated device."

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets those criteria (especially related to AI/software performance) is not present in this document. This submission relies on an engineering justification and comparison to a predicate device rather than extensive clinical or statistical performance studies in humans.

Here's a breakdown of why each requested point cannot be answered:

A table of acceptance criteria and the reported device performance: Not applicable. There are no performance metrics or acceptance criteria for a clinical or AI study described. The "performance" being evaluated is substantial equivalence based on material properties and design similarity to a predicate device.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for performance comparison is described.
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): Not applicable. There is no test set requiring ground truth establishment by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set is described.
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 medical device (hip implant component), not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established for device performance in this context. The "ground truth" for this 510(k) is the existing predicate device and its established safety and effectiveness.
The sample size for the training set: Not applicable. No machine learning model or training set is involved.
How the ground truth for the training set was established: Not applicable. No machine learning model or training set is involved.

In summary, this 510(k) submission for the PAR 5 Acetabular Component does not contain information about clinical performance studies or AI/software validation. The basis for its substantial equivalence is an engineering justification and comparison to a previously approved predicate device.

Summary

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JUL 2 5 2002

KQ22094
page 1 of 1

SUMMARY OF SAFETY AND EFFECTIVE

Sponsor:	Biomet, Inc.
	56 East Bell Drive
	P.O. Box 587
	Warsaw, IN 46581-0587

Contact Person: Tracy J. Bickel (574) 267-6639
Proprietary Name: PAR 5 Acetabular Components

Common Name: Acetabular Component(s)

Hip joint metal/polymer semi-constrained cemented prosthesis (888.3350) Classification Name:

Substantially Equivalent Devices: PAR 5 Acetabular Components- K000254

Device Description: The PAR 5 Acetabular Component is a hemispherical metallic acetabular cup, which can accept a modular hook, ilium flange, and/or a modular ischial blade. The shell accepts a standard Ringloc® liner. The outer surface of the shells has porous coating. The shells are also available with or without hydroxyapatite (HA) coating.

The indications for the PAR 5 Acetabular Component(s) are as follows: Indications:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
Correction of functional deformity 3)
Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal 4) femur with head involvement, unmanageable using other techniques
1. Revision procedures where other treatment or devices have failed

Summary of Technologies: Hydroxyapatite coated implants and an additional ilium flange are being added to the current PAR 5 System. The PAR 5 Acetabular Components- the material's, design, sizing, and indications are identical to the predicate device(s).

Non-Clinical Testing: Substrate testing with an Engineering Justification determined that the modified PAR 5 Acetabular Components presented no new risks and were, therefore, substantially equivalent to the predicated device.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures in profile, facing to the right, with three parallel lines above them.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2002

Ms. Tracy J. Bickel Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0578

Re: K022094

Trade/Device Name: PAR 5 Acetabular Component Regulation Number: 21 CFR §888.3350 Regulation Name: Hip joint metal/polymer metal semi-constrained cemented prosthesis and Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II

Product Code: JDI and LPH Dated: June 24, 2002 Received: June 27, 2002

Dear Ms. Bickel;

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.

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Page 2 - Ms. Tracy J. Bickel

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.

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

for Mark M. Milkins

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

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Page 1 of 1

510(k) Number (if known): Device Name: PAR 5 Indications for Use:

The indications for the PAR 5 Acetabular component are as follows:

Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
Rheumatoid arthritis 2)
1. Correction of functional deformity
Treatment of nonunion, femoral neck fractures, and trochanteric fractures of 4) the proximal femur with head involvement, unmanageable using other techniques
Revision procedures where other treatment or devices have failed ર)

(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 A. Millers

al. Restorative

s k, ur
K 022

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

00010

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.