Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthoplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

Device Description

The Zimmer Trabecular Metal Humeral Stem is intended to be a single use only implant that is used to replace a shoulder joint. This humeral stem uses Trabecular Metal around the proximal part of the stem for biological ingrowth. It also has an anti-rotational fin, a proximal stem collar, suture holes, and a distal fluted stem body. Stems are available in sizes ranging in diameter from 9-18mm and in the lengths of 130mm and 170mm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Zimmer Trabecular Metal™ Humeral Stem. This submission aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to set or meet specific performance acceptance criteria through the kind of study described in the prompt's requested information.

Therefore, the information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this 510(k) submission.

A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device through comparisons of:

Intended use
Technological characteristics (materials, design, manufacturing processes)
Performance data (often non-clinical bench testing, but sometimes limited clinical data if necessary to address new questions of safety or effectiveness).

In this specific case, the "Performance Data (Nonclinical and/or Clinical)" section (within {1}) states:

"Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem is as safe and effective as the predicate devices."

This indicates that a study was performed, but its purpose was to support the claim of safety and effectiveness equivalent to the predicate devices, rather than to meet predefined performance acceptance criteria for a novel functionality. Without more details on the non-clinical testing, it's impossible to provide the specific information requested in the prompt.

Summary of available information relevant to "study that proves the device meets the acceptance criteria":

Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) review, which doesn't typically involve new, device-specific performance acceptance criteria in the way a PMA might. Instead, the "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. The reported performance from non-clinical testing was that the device is "as safe and effective as the predicate devices."
Study Type: Non-clinical testing was performed.
Purpose: To demonstrate substantial equivalence to predicate devices (New Zimmer Shoulder System (Bigliani/Flatow) K982981 and Bio-Modular Shoulder System by Biomet, Inc. K992119).
Missing Information: The provided text does not contain details about:
- Specific quantitative acceptance criteria.
- The exact nature of the non-clinical tests (e.g., mechanical testing specifications).
- Sample sizes used for testing.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance.
- Type of ground truth used.
- Training set size or ground truth establishment for a training set (as this is non-clinical and not an AI/algorithm-based device).

Summary

{0}------------------------------------------------

K041549 142

SEP - 1 2004

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dalene T. Binkley, RACAssociate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605
Date:	August 27, 2004
Trade Name:	Zimmer Trabecular Metal™ Humeral Stem
Common Name:	Total Shoulder System
Classification Nameand Reference:	Shoulder joint metal/polymer non-constrainedcemented prosthesis. 21 CFR § 888.3650Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis. 21 CFR § 888.3690
Predicate Device:	The predicate and design basis for the ZimmerTrabecular Metal" Humeral Stem is the NewZimmer Shoulder System (Bigliani/Flatow)(K982981, cleared Dec.17, 1998) and the Bio-Modular Shoulder System by Biomet, Inc.(K992119, cleared Sept. 13, 1999).
Device Description:	The Zimmer Trabecular Metal Humeral Stem isintended to be a single use only implant that is usedto replace a shoulder joint.
	This humeral stem uses Trabecular Metal aroundthe proximal part of the stem for biologicalingrowth. It also has an anti-rotational fin, aproximal stem collar, suture holes, and a distalfluted stem body. Stems are available in sizesranging in diameter from 9-18mm and in the lengthsof 130mm and 170mm.

{1}------------------------------------------------

KO9154t

effective as the predicate devices.

2002

Intended Use: Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthoplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable. Comparison to Predicate Device: The Zimmer Trabecular Metal Humeral Stem 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 Non-Clinical Performance and Conclusions: and/or Clinical): Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem is as safe and

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2004

Ms. Dalene Binkley, RAC Associate, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K041549

Trade/Device Name: Trabecular Metal Humeral Stem Regulation Number: 21 CFR 888.3650; 21 CFR 888.3690 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis; Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Regulatory Class: Class II Product Code: KWT, HSD Dated: June 3, 2004 Received: June 9, 2004

Dear Ms. Binkley:

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 10 woo wavenor 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); labcling (21 CFR Part 801); good manufacturing practice requirements as set Crrc rate 877, accems (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 Binkley, 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 H. Milliken

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):

Device Name:

Zimmer Trabecular Metal™ Humeral Stem

Indications for Use:

Prescription Use X (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 if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative

and Neurological Devices

510(K) Number K041549 Page 1 of 1

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid 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. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”