The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.

Device Description

The Durasul Bipolar consists of a polyethylene insert/liner and an outer CoCr shell. In vivo, the CoCr shell articulates directly with well-preserved articular cartilage while the Durasul insert articulates directly with a 22 or 26mm femoral head. The Durasul Bipolar components are available in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a hip hemi-arthroplasty.

AI/ML Overview

This document describes the Durasul® Bipolar hemi-hip prosthesis and its regulatory clearance. It does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the way you've defined, which typically applies to AI/ML software or diagnostic devices with quantifiable performance metrics (e.g., sensitivity, specificity, AUC).

Instead, this document is a 510(k) summary for a traditional medical device (a prosthetic hip component). The "acceptance criteria" here are related to proving substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than specific performance metrics from a clinical study as you might expect for an AI/ML product.

Therefore, I cannot fill out your requested table and information points as they pertain to AI/ML or diagnostic device performance studies. The document states:

"Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices."

This broadly refers to engineering and material testing, and potentially comparison to the existing clinical history of the predicate devices. It does not describe a clinical study with a test set, ground truth established by experts, or statistical performance metrics.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Substantial equivalence to predicate devices (Centerpulse Orthopedics, Inc. Bipolar (K873815) and Exactech's AcuMatch L-Series Bipolar (K013211)). This means demonstrating similar design, materials, manufacturing processes, and intended use, and not raising new questions of safety or effectiveness.
Reported Device Performance: The document states, "Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices." This indicates the device passed the necessary tests to be deemed substantially equivalent, but no specific quantitative performance metrics (like sensitivity, specificity, accuracy) are reported for clinical use in this document.

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

Not applicable/Not mentioned. This is a traditional device submission, not an AI/ML software submission that would typically involve a "test set" in this context. The "performance tests" would likely refer to bench testing (e.g., wear testing, fatigue testing) rather than a clinical dataset.

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):

Not applicable/Not mentioned. Ground truth as understood for AI/ML models is not described here.

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

Not applicable/Not mentioned.

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:

Not applicable/Not mentioned. This is not an AI/ML diagnostic assistance device.

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

Not applicable/Not mentioned. This is a physical prosthetic device, not an algorithm.

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

Not applicable/Not mentioned. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their history and testing.

8. The sample size for the training set:

Not applicable/Not mentioned. This device does not use a "training set" in the AI/ML sense.

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

Not applicable/Not mentioned.

In summary, this 510(k) pertains to a traditional orthopedic implant, and the regulatory process for such devices focuses on demonstrating substantial equivalence to already-approved predicate devices through engineering tests and regulatory comparisons, not on clinical performance metrics from a "study" with test sets and ground truth in the context of AI/ML or diagnostic accuracy.

Summary

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KD40947

AUG 2 7 2004

510(k) SUMMARY

SPONSOR NAME:	Zimmer9900 Spectrum DriveAustin, TX 78717
510(k) CONTACT:	Audrey SwearingenPhone: (512) 432-9255Audrey.Swearingen@Zimmer.com
TRADE NAME:	Durasul® Bipolar
COMMON NAME:	Hemi-Hip
CLASSIFICATION:	Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented orUncemented Prosthesis (87 KWY) are Class II per 21 CFR§888.3390.

PREDICATE DEVICES:

Centerpulse Orthopedics, Inc. Bipolar (K873815) and .
Exactech's AcuMatch L-Series Bipolar (K013211). .

DEVICE DESCRIPTION:

INTENDED USE:

BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 2004

Ms. Audrey Swearingen Manager, Regulatory Affairs Zimmer Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K040947 Trade/Device Name: Durasul® Bipolar Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: August 6, 2004 Received: August 9, 2004

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to that 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices that have been rouire approval of a premarket approval application (PMA). and Costiere Act (110.) that to nevice, subject to the general controls provisions of the Act. The I ou may, therefore, mans. of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 n your device is elassinod (tional controls. Existing major regulations affecting your device can may oc subject to back acceral 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 r lease oc devilod that I Dr o last is to the complies with other requirements of the Act that I Dr Has Intacted 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 Orth 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. Audrey Swearingen

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to ogin mailing of substantial equivalence of your device to a legally premarket notheation: "The PDF mining of dassification 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), please If you desire specific advice for your ac (301) 594-4659. Also, please note the regulation entitled, Colliation of Gollippiante in (Set notification" (21CFR Part 807.97). You may obtain Misoranung Uy Telefone to premainter to premainter the Act from the Division of Small other general 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,

Mark A. Melleson

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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Indications for Use

510(k) Number (if known): K040947

Device Name: Durasul® Bipolar

Indications for Use:

X Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation for ODE)

Mark A Mulkeren

Division of General, Restorative, and Neurological Devices

Page 1 of 1

K040947 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.