The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR® Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty.

Indications:

For use as a bipolar hip replacement

Femoral head/neck fractures or non-union, .
Aseptic necrosis of the femoral head, ●
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular ● involvement or distortion,
Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
. Salvage of failed total hip arthroplasty
Femoral Neck Fractures .

For use as a total hip replacement

Painful, disabling joint disease resulting from: degenerative arthritis, theumatoid arthritis, . post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other . procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
Clinical circumstances that require an altered femoral resection level due to proximal fracture, . bone loss, or calcar lysis.

Device Description

The subject and predicate hip stems are both hip fracture stems intended for cemented use. The subject devices and the predicate 6076 series hip stems (K954598) are forged from ASTM F-799 cobalt chromium alloy.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Omnifit® HFx Hip Stem Series), which is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. This type of document typically focuses on substantial equivalence based on technological characteristics and performance data, not clinical trial results with specific acceptance criteria that would include metrics like sensitivity, specificity, accuracy, or expert consensus.

Therefore, much of the requested information regarding acceptance criteria, performance metrics (like sensitivity, specificity, accuracy), sample sizes for test and training sets, expert qualifications, and ground truth methodologies (which are typical for AI/software-as-a-medical-device studies) is not present in this document because it is not applicable to the type of device and regulatory submission described.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not outline specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it's a mechanical device, not a diagnostic algorithm. The "performance" assessment focuses on mechanical integrity.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength of Neck and Body Regions	Evaluated using Finite Element Analysis (FEA) to assess strength. (Specific quantitative results or comparison to predicate not detailed in this summary.)
Intended Use	Device intended for single use, with or without bone cement. Various uses with other components (Endo Head and Neck Extension, UHR® Universal Head, C-Taper cobalt chromium head and acetabular component) for hemi-hip or total hip arthroplasty.
Indications for Use	Matches the indications for bipolar hip replacement and total hip replacement as outlined in the summary (e.g., femoral head/neck fractures, aseptic necrosis, arthritis, salvage of failed arthroplasty, revision).
Material Compatibility	Forged from ASTM F-799 cobalt chromium alloy, similar to predicate.

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

Sample Size: Not applicable in the context of clinical trials with patient data. The "test set" for this device was based on Finite Element Analysis (FEA), which is a computational simulation. The number of simulations or models is not specified, but it's a computational simulation rather than patient data.
Data Provenance: Not applicable as it's a mechanical simulation, not patient data.

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

Not applicable. The "ground truth" for mechanical strength in FEA is typically based on engineering principles, material properties, and established computational models, not expert clinical consensus from human readers.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication" for mechanical testing (like FEA) would involve engineering verification and validation against known material properties and physical laws, not a multi-reader (human) adjudication process.

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. This is a mechanical hip stem, not an AI or diagnostic imaging device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or performed.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used:

For the Finite Element Analysis, the "ground truth" is implicitly derived from engineering principles, material science (ASTM F-799 cobalt chromium alloy properties), and established biomechanical models used in the FEA software. It's about predicting mechanical failure modes and stress distribution under simulated loads.

8. The Sample Size for the Training Set:

Not applicable. This is a mechanical device, not a machine learning model. There is no "training set" in the context of AI.

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

Not applicable. There is no training set or associated ground truth as this is not an AI/ML device.

Summary of what was done according to the document:

The regulatory submission primarily relies on demonstrating substantial equivalence to predicate devices (Osteonics ODC/ODC Plus Hip Stems, Omnifit X (Eon) Hip Stems) based on:

Intended Use and Indications: The proposed device has the same intended use and indications as the predicate devices.
Technological Characteristics: Both subject and predicate hip stems are intended for cemented use and are forged from ASTM F-799 cobalt chromium alloy.
Performance Data (Mechanical Testing): Finite Element Analysis (FEA) was used to evaluate the strength of the neck and body regions of the hip stems. This is a common engineering validation method for orthopedic implants to assess their mechanical integrity under anticipated physiological loads. No specific quantitative results from the FEA are provided in this summary, but the mention of its use implies it met the necessary engineering standards for substantial equivalence.

Summary

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AUG - 8 2003

Omnifit® HFx Hip Stcms

Image /page/0/Picture/2 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K031744" on the first line. The second line contains the words "page 10 of 2" with "s10(k)" written below the number 2. The handwriting appears to be somewhat rough and uneven.

510(k) Summary: Omnifit® HFx Hip Stem Series

Proprietary Name:	Omnifit® HFx Hip Stem Series
Common Name:	Femoral Hip Stems
Classification Name and Reference:	Hip joint, metal/polymer semi-constrained,cemented prosthesis21 CFR §888.3350Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis21 CFR §888.3360
Proposed Regulatory Class:	Class II
Device Product Code:	87 – JDI: Prosthesis, hip, semi-constrained,cemented87 – LWJ: Prosthesis, hip, semi-constrained,metal/polymer, uncemented
Predicate Proprietary Name(s):	Osteonics ODC/ODC Plus Hip Stems, Omnifit X(Eon) Hip Stems
Predicate Regulatory Class:	Class II
Predicate Product Code(s):	87 JDI, KWL
Submitted By:	Howmedica Osteonics Corp.59 Route 17Allendale, New Jersey 07401-1677(201) 825-4900
Contact Information:	Debra BingPhone: (201) 831-5413Fax: (201) 831-6038
Date Summary Prepared:	July 23, 2003

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Omnifit® HFx Hip Stems

Description/Technological Comparison

031744

Intended Use

Indications:

For use as a bipolar hip replacement

Femoral head/neck fractures or non-union, .
Asentic necrosis of the femoral head, ●
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acctabular . involvement or distortion,
Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
Salvage of failed total hip arthroplasty .
Femoral Neck Fractures .

For use as a total hip replacement

Painful, disabling joint disease resulting from: degenerative arthritis, rheumatoid arthritis, ● post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other . procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results,
Clinical circumstances that require an altered femoral resection level due to proximal ● fracture, bone loss, or calcar lysis.

Testing Summary

Finite Element Analysis was used to evaluate the strength of the neck and body regions of the hip stems.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized horizontal lines above a wavy line, resembling a stylized human figure.

Public Health Service

AUG - 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra Bing Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401

Re: K031744 Trade/Device Name: Omnifit® HFx Hip Stem Series Regulation Number: 21 CFR 888.3350 and 21 CFR 888.3360 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis and Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: JDI, LWJ, and KWL Dated: June 4, 2003 Received: June 5, 2003

Dear Ms. Bing:

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. Debra Bing

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,

Miriam C. Provost

Celia 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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510(k) Number (if known):

Device Name: Omnifit® HFx Hip Stem Series

Indications:

For use as a bipolar hip replacement

Femoral head/neck fractures or non-union, .
Aseptic necrosis of the femoral head, ●
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular ● involvement or distortion,
Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
. Salvage of failed total hip arthroplasty
Femoral Neck Fractures .

For use as a total hip replacement

Painful, disabling joint disease resulting from: degenerative arthritis, theumatoid arthritis, . post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other . procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
Clinical circumstances that require an altered femoral resection level due to proximal fracture, . bone loss, or calcar lysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
------------------	--

Over-The-Counter Use		(Per 21 CFR 801.109)
----------------------	--	----------------------

(Optional Format 1-2-96)

Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number	K031744
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TOTAL P.21

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.