The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.

Indications:

Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed. ●

Device Description

The existing Accolade™ TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem is an addition to the existing hip stems. It features a 127° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® Plus HA Size 0 Hip Stem is intended for smaller size patient populations. The subject hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a CP Titanium plasma spray coating and PureFix™ HA.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for a hip stem, which is a physical medical device. It does not contain information about an AI/ML powered medical device, therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices (like sensitivity, specificity, human reader performance, training set details, etc.) are not applicable.

However, I can extract the relevant information regarding the device's performance based on the provided text.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Proper strength requirements	"Testing demonstrated that this hip stem component successfully maintains the proper strength requirements."

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing mentioned refers to mechanical or physical performance testing of the hip stem component itself. Therefore, sample size and data provenance are not applicable in the way they would be for an AI/ML device or a clinical trial.

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

Not applicable. The "ground truth" for a physical device like a hip stem would be its measurable physical properties (e.g., strength, material composition) as determined by engineering and material science standards, not clinical expert consensus in the typical sense.

4. Adjudication Method for the Test Set

Not applicable, as the testing was for mechanical properties, not clinical assessment requiring adjudication.

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 device is a physical hip stem, not an AI-powered system designed to assist human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical hip stem, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's performance would be engineering and material science standards for "proper strength requirements." This would involve objective measurements against predefined specifications.

8. The Sample Size for the Training Set

Not applicable. This refers to the development of a physical product, not a machine learning model.

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

Not applicable. This refers to the development of a physical product, not a machine learning model.

Summary of the Study:

The document briefly mentions a "Testing Summary" stating: "Testing was employed to evaluate the Accolade™ TMZF® Plus HA Size 0 Hip Stem component. Testing demonstrated that this hip stem component successfully maintains the proper strength requirements."

This indicates that mechanical and/or material testing was conducted to ensure the hip stem met predetermined strength specifications. The nature of these tests (e.g., fatigue testing, static load testing) and the specific standards applied are not detailed in the provided text. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, and the testing summary is provided to support that conclusion regarding the new size/variation of the hip stem.

Summary

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

OCT 0 9 2002

K02 3/02

Line Extension to the Accolade™ Hip System – Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem

Special 510(k) Premarket Notification

Special 510(k) Summary

Line Extension to the Accolade™ Hip System – Accolade™ TMZF® PLUS HA 127° Size 0 Hip Stem

Proprietary Name:	Accolade™ TMZF® Plus HA 127° Size 0 HipStem
Common Name:	Artificial Hip Component
Classification Name and Reference:	Hip joint, metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis,21 CFR §888.3353
Proposed Regulatory Class:	Class II
Device Product Code:	87 MEH
Predicate Proprietary Name:	Accolade™ TMZF® Plus HA Hip Stem
Predicate Regulatory Class:	Class II
Predicate Product Code:	87 MEH
For Information contact:	Debra BingHowmedica Osteonics Corp.59 Route 17Allendale, New Jersey 07401-1677Phone: (201) 831-5413Fax: (201) 831-6038

Description/Technological Comparison

Page 3

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hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a CP Titanium plasma spray coating and PureFix™ HA.

Intended Use

Indications:

Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed. ●

Testing Summary

Testing was employed to evaluate the Accolade™ TMZF® Plus HA Size 0 Hip Stem component. Testing demonstrated that this hip stem component successfully maintains the proper strength requirements.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human profiles facing right, arranged in a stacked, flowing manner. The profiles are connected and appear to be part of a single, continuous form.

OCT 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William J. Cymbaluk Vice President . Quality Assurance, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics 59 Route 17 South Allendale, N.J. 07401

Re: K023102

Trade/Device Name: Accolade™ TMZF® Plus HA 127° Size 0 Hip Sem Regulation Number: 21 CFR 888.3353

Regulation Name: Hip Joint Metal/ceramic/Polymer Semi-Constrained Cemented or Nonporous Uncemented Prosthesis

Regulatory Class: Class II Product Code: MEH Dated: September 17, 2002 Received: September 18, 2002

Dear Mr. Cymbaluk:

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 (OS) 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 - Mr. William J. Cymbaluk

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 and additionally 21 CFR Part 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Hyatt Rhodes

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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510(k) Number (if known):

Device Name: Line Extension to the Accolade™ Hip System - Accolade™ TMZF® Plus 127° Size 0 Hip Stem

Indications:

Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including . osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed. .

(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
(Optional Format 1-2-96)
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
510(k) Number K023102

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.