Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged: nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

Device Description

The Zimmer® M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty. It is flat, collarless, and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region.

AI/ML Overview

This document, K032726, is a 510(k) premarket notification for a medical device called the "Zimmer® M/L Taper Hip Prosthesis." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving safety and effectiveness through extensive clinical trials with acceptance criteria for device performance as would be seen for novel devices or those undergoing a PMA.

Therefore, the requested information about acceptance criteria, detailed study designs, sample sizes, expert involvement, and ground truth establishment, does not directly apply in the same way as it would for a study proving the efficacy and safety of a novel device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

There are no explicit quantifiable acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) reported for this device in this 510(k) summary, as it is a hip prosthesis, not a diagnostic AI device.

Instead, the "performance" demonstrated is substantial equivalence to predicate devices based on non-clinical testing.

Acceptance Criteria (Implied for 510(k) substantial equivalence): The device must demonstrate similar material properties, mechanical performance (e.g., fatigue strength, fixation), and intended use as the predicate devices. It must not raise new questions of safety or effectiveness.
Reported Device Performance:
- "Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis met performance requirements and is as safe and effective as the predicate devices."

2. Sample Size for Test Set and Data Provenance:

Test Set Description: The document refers to "Non-clinical testing." This typically involves laboratory testing of physical device samples (e.g., in vitro mechanical tests, material characterization). It's not a "test set" in the context of clinical data for AI algorithms.
Sample Size: The document does not specify the number of hip prostheses samples tested.
Data Provenance: Not applicable in the context of clinical data. It would be lab-generated data.
Retrospective/Prospective: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This pertains to establishing ground truth for diagnostic or prognostic algorithms, not for the mechanical testing of a hip implant. The "ground truth" here would be established by validated engineering testing standards and protocols.

4. Adjudication Method:

Not applicable. Adjudication relates to expert consensus on clinical data for algorithms.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, this was not done. MRMC studies are specific to evaluating diagnostic imaging systems or AI algorithms with human readers. This device is a hip prosthesis.

6. Standalone (Algorithm Only) Performance:

No, this was not done. This device is a physical hip prosthesis, not an algorithm.

7. Type of Ground Truth Used:

Engineering Standards and Benchmarking against Predicate Devices: The "ground truth" for this device's performance would be established through adherence to recognized international and national standards for orthopedic implants (e.g., ISO, ASTM standards for fatigue, material properties) and comparison to the known performance characteristics of the predicate devices. This is implied by "Non-clinical testing."

8. Sample Size for Training Set:

Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device.

9. How Ground Truth for Training Set Was Established:

Not applicable. As above, there is no "training set" in this context.

In summary, for K032726, the "study" demonstrating the device meets "acceptance criteria" is a set of non-clinical (laboratory/mechanical) tests to show substantial equivalence to already cleared predicate devices. The 510(k) pathway does not typically require or present the kind of detailed clinical efficacy and safety data, expert reviews, and ground truth establishment that would be seen for novel diagnostic algorithms or drugs.

Summary

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K032726

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Laura D. Williams, RACSr. Associate, Regulatory AffairsTelephone: (574) 372-4523Fax: (574) 372-4605
Date:	August 28, 2003
Trade Name:	Zimmer® M/L Taper Hip Prosthesis
Common Name:	Total Hip Prosthesis
Classification Name	Hip joint metal/polymer/metal semiconstrainedporous coated uncemented prosthesis
Reference and Product Code:	21 CFR § 888.3358, LPH
Predicate Device:	1. Biomet Taperloc, K921301, cleared 2-16-94; andK020963, cleared 4-16-022. Zimmer ZMR® Hip System Porous Revision,K994286, cleared 3-10-003. Zimmer VerSys® Hip System Fiber Metal TaperHip Prosthesis, K964769, cleared 3-13-97
Device Description:	The Zimmer® M/L Taper Hip Prosthesis is amodular, titanium alloy femoral stem designed toreplace the proximal human femur in total hiparthroplasty. It is flat, collarless, and features aproximal-to-distal taper in the mediolateral (M/L)plane. The wedge-shaped prosthesis is designed forcementless use and is circumferentially porous-coated with titanium alloy plasma spray over theproximal body region.
Intended Use:	Total hip replacement for the following: severe hippain and disability due to rheumatoid arthritis,osteoarthritis, traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of the

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femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip: elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The M/L Taper Hip Prosthesis is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices.

Performance Data (Nonclinical and/or Clinical):

Comparison to Predicate Device:

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis met performance requirements and is as safe and effective as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and the letters "USA" are included in the seal.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Ms. Laura D. Williams, RAC Sr. Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Re: K032726

Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis, 7711 Series Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: September 2, 2003 Received: September 3, 2003

Dear Ms. Williams:

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.

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. Laura D. Williams, RAC

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). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark A. Milkerson

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

K032726

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510(k) Number (if known):

Device Name:

Zimmer® M/L Taper Hip Prosthesis

Indications for Use:

Mark N. Milkersen

Division Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number K032726

(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

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

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.