The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559 and K032264.

Device Description

Premarket notification K954559 described the Modular Replacement system (MRS) Porous Coated Humeral Stem system. Special premarket notification K032264 expanded this product line to include non-porous coated humeral stems. Both of these stems are fabricated from cobaltchromium alloy that conforms to ASTM F-1537. It is the intention of Howmedica Osteonics Corp. to fabricate the non-porous coated humeral stems in the MRS system from a slightly different type of cobalt-chromium - this material also conforms to ASTM F-1537, but has slightly different metallurgical properties.

AI/ML Overview

This document is a Special 510(k) Premarket Notification for a medical device, specifically Modular Replacement System (MRS) Humeral Stems. It describes an alternate material for an existing device.

Here's an analysis based on your request:

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

The provided document does not explicitly state acceptance criteria or device performance in measurable terms for this specific Special 510(k). This type of submission, a Special 510(k), is typically used for modifications to a previously cleared device where the change does not significantly alter the device's fundamental technology or safety/effectiveness.

In this case, the change is to an "alternate material" for existing non-porous coated humeral stems. The core of the submission focuses on demonstrating that the new material has similar properties and does not negatively impact the intended use or performance compared to the predicate device's material.

The document states:

"It is the intention of Howmedica Osteonics Corp. to fabricate the non-porous coated humeral stems in the MRS system from a slightly different type of cobalt-chromium - this material also conforms to ASTM F-1537, but has slightly different metallurgical properties."
"The intended usc of the subject device is not changed by this material change."

Therefore, the "acceptance criteria" here are implicitly tied to demonstrating that the new material meets the same ASTM F-1537 standard as the original material and that any "slightly different metallurgical properties" do not compromise the device's original performance characteristics (e.g., mechanical strength, biocompatibility, durability).

Acceptance Criteria (Inferred from context):

Criteria	Reported Device Performance (Inferred)
Material Conformance	New cobalt-chromium material conforms to ASTM F-1537 (same as the predicate device's material).
Preservation of Intended Use	The intended use of the device remains unchanged with the new material.
Equivalence to Predicate Device	The device with the alternate material is substantially equivalent in safety and effectiveness to the predicate device (implied by 510(k) clearance).
Biocompatibility	(Implicitly maintained through material standards and substantial equivalence)
Mechanical Properties/Durability	(Implicitly maintained through material standards and substantial equivalence)

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

This document does not describe a clinical study with a "test set" in the sense of patient data. Special 510(k)s for material changes typically rely on bench testing and material characterization studies, not clinical trials with human subjects.

Therefore, "sample size used for the test set" would refer to the number of material samples tested or the devices subjected to mechanical testing. This information is not provided in the document.

Data provenance (country of origin, retrospective/prospective) is also not applicable as there is no human subject data referenced.

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)

This information is not applicable as there is no "ground truth" derived from expert consensus on clinical data. The "ground truth" in this context would be the objective physical and chemical properties of the material, assessed through laboratory testing by material scientists and engineers. Their specific number and qualifications are not mentioned.

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

This information is not applicable as there is no expert review or adjudication of clinical cases or images.

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

This document is for a physical orthopedic implant (humeral stem), not a diagnostic imaging device utilizing AI. Therefore, an MRMC study and AI assistance are not applicable.

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

This concept is not applicable to this device.

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

The "ground truth" (or basis for claiming safety and effectiveness for this type of submission) comes from:

Material Standards Conformance: The new material's compliance with ASTM F-1537.
Substantial Equivalence: Comparison to the known performance and safety profile of the legally marketed predicate device, as confirmed through the existing regulatory clearances (K954559 and K032264).
Bench Testing Data: Although not detailed in this summary, a Special 510(k) for a material change would be supported by in-vitro material characterization and mechanical testing to demonstrate that the new material performs equivalently to the predicate's material.

8. The sample size for the training set

This concept is not applicable as there is no machine learning component or "training set" for this device.

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

This concept is not applicable as there is no training set for this device.

Summary

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MAR 2 6 2004

Modular Replacement System Humeral Stems - Alternate Material

K040128

Special 510(k) Premarket Notification

Special 510(k) Summary

Proprietary Name:	Modular Replacement System (MRS) Humeral Stems
Common Name:	Modular Humeral Stems
Classification Name and Reference:	Prosthesis, shoulder, hemi-, humeral, metallic uncemented21 CFR §888.3690
Proposed Regulatory Class:	Class II
Device Product Code:	87 HSD
Predicate Proprietary Name:	MRS Humeral Stems
Predicate Regulatory Class:	Class II
Predicate Product Code:	87 HSD
For Information contact:	Margaret F. CroweHowmedica Osteonics Corp.DBA Stryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5580Fax: (201) 831-6038

Description/Technological Comparison

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040148
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Special 510(k) Prem

slightly different metallurgical properties.

Intended Use

The intended usc of the subject device is not changed by this material change: The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humcrus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559 and K032264.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K040128

Trade/Device Name: Modular Replacement System Humeral Stems - Alternate Material Regulation Number: 21 CFR 888.3690 Regulatory Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: March 4, 2004 Received: March 8, 2004

Dear Ms. Crowe:

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

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Page 2 - Margaret F. Crowe

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), 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.

b. Mark N. Millman

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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Special 510(k) Premarket Notification- Modular Replacement System Humeral Stems -Alternate Material

510(k) Number (if known): K. NUI l 27

Device: Modular Replacement System Humeral Stems - Alternate Material

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (/ OR Over-the Counter-Use (per 21 CFR 801.109)

Mark N. Millman

al. Restorative, Division of Gene and Neurological Devices

510(k) Number K040128

1,11

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.