RELIANCE LONG STEM FEMORAL COMPONENTS by HOWMEDICA, INC.

The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.

Device Description

The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the Reliance® Long Stem Femoral Components. It focuses on establishing substantial equivalence to previously marketed devices rather than detailing a specific study to prove the device meets acceptance criteria through performance metrics as might be found in clinical trials or software validation studies.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. This document highlights engineering testing (fatigue load capacity) rather than detailed clinical performance studies in the way modern AI/software device submissions would.

Here's what can be extracted based on the provided text, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Notes
Fatigue Load Carrying Capacity: Exceeds minimum ISO load requirements.	The fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements.	This is the primary performance metric explicitly stated. The specific ISO standard and quantitative "minimum load requirements" are not provided, nor is the exact quantitative value by which the device exceeds these requirements. The phrase "exceeds" indicates compliance.
Material Equivalence: Meets ASTM specification F 799.	Manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.	This is a material specification compliance, not an operational performance metric.
Substantial Equivalence (General): Equivalent in intended use, materials, design, and relative indications and contraindications to predicate devices.	Stated as substantially equivalent to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893), and Modular Replacement System (K952970).	This is the overarching goal of a 510(k) submission, demonstrating similarity to legally marketed devices. It's an acceptance criterion for market clearance, not a performance metric from a "study."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "testing" for fatigue load, but does not provide details on the number of units tested, the statistical methods, or the sample size used.
Data Provenance: Not applicable in the context of this engineering test. This refers to material and mechanical testing, not clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. Material and mechanical testing (like fatigue) typically relies on standardized test methods and machine measurements rather than expert consensus on a "ground truth" derived from clinical assessment.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This type of study assesses human reader performance (often with and without AI assistance) across multiple cases, which is not relevant for the mechanical testing of a hip prosthesis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is a physical implant, not a software algorithm. The "standalone" performance here refers to the device's mechanical integrity, which was assessed, but not in the context of an algorithm or AI.

7. The Type of Ground Truth Used

Type of Ground Truth: For the fatigue testing, the "ground truth" would be defined by the ISO standard's minimum load requirements and the physical measurements obtained from the mechanical testing equipment. For the material, it's compliance with ASTM F 799. This is objective, measurement-based truth, not expert consensus, pathology, or outcomes data in a direct clinical sense for performance evaluation.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The key study mentioned is mechanical fatigue testing. The document states:

"Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements."

This inference of meeting an acceptance criterion (exceeding ISO standards) is based on this engineering study. The 510(k) submission relies on this and the direct material compliance (ASTM F 799) to establish substantial equivalence to predicate devices, rather than a prospective clinical trial proving superior patient outcomes for a novel technology.

Summary

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JUN 2 6 1998

R980813

510(k) Summary

Proprietary Name: Reliance® Long Stem Femoral Components

Common Name: Hip Prosthesis

21 CFR 888.3353 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis.

Proposed Regulatory Class: Class II

Device Product Code: LZO

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 3-3-98

The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.

These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.

The substantial equivalence of the Reliance® Long Stem Femoral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893) and Modular Replacement System (K952970).

Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1998

Mr. Frank Maas 'Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K980813 Re: Reliance Long Stem Femoral Components Trade Name: Regulatory Class: II Product Code: JDI Dated: May 29, 1998 June 2, 1998 Received:

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank Maas

This letter will allow you to begin marketing your device as described in your 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 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 ene regarderon choroned) 1125Randing mj Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

-Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K980813

Device Name: Reliance Long Stem Femoral Components

Indications for Use:

The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, revision surgery for pationis lesions, or traumatic femoral fractures. These avascular norooto, motablances to be used with Howmedica's V40™ femoral femoral components, and acetabular components, and acetabular components.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

signature

(Optional Format 1-2-96

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980813

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.