The subject hip stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. These devices are intended for use with any currently available Howmedica Osteonics acetabular component and V40® femoral heads labeled for use with V40® Titanium stems. The indications for use remain identical to those of the predicate devices, and are restated here.

Indications:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, .
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

Device Description

The subject Accolade™-J Hip Stems feature the geometry of the predicate TMZF® HA Hip Stems and Accolade™ TMZF® Plus HA Hip Stems, but feature the same substrate material and same HA coating as the predicate Omnifit® M-HA Hip Stems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Accolade™-J Hip Stem Series. A 510(k) submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested elements (acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not applicable in this context, as this submission is for a medical device that has demonstrated substantial equivalence through a non-clinical testing summary.

Here's an analysis based on the provided document:

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

Acceptance Criteria (Not explicitly stated as such, but inferred from testing)	Reported Device Performance
Mechanical Strength (Neck and Body Regions) (Inferred from FEA)	Evaluated using Finite Element Analysis (FEA) to confirm strength.

Explanation: The document states, "Finite Element Analysis (FEA) was used to evaluate the strength of the neck and body regions of the subject Accolade™-J Hip Stems." This type of testing is used to demonstrate that the device's mechanical properties are comparable and acceptable, often against internal specifications or established industry standards, but specific numerical acceptance criteria and performance results directly from the FEA are not provided in this summary. The goal of a 510(k) is to show equivalence, implying that if the predicate was deemed safe and effective, and the new device performs similarly on relevant non-clinical tests, it is also safe and effective.

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

Sample Size for Test Set: Not applicable. Finite Element Analysis (FEA) is a computational simulation and does not typically involve a "test set" of physical devices in the context of clinical studies. It would involve a model of the device.
Data Provenance: Not applicable. FEA is a simulation based on engineering properties and designs.

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)

Not applicable. This is a non-clinical submission, and ground truth as defined for diagnostic performance is not relevant. The "truth" in FEA is based on engineering principles and material science.

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

Not applicable. Adjudication methods are not relevant for Finite Element Analysis.

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 hip stem, a mechanical implant, not a diagnostic AI device requiring MRMC studies.

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. However, the "standalone" performance could be considered the results of the FEA simulation, which predicts the device's mechanical behavior without human interaction during its operation.

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

Not applicable. The "ground truth" for the FEA would be the physical laws governing material behavior and structural mechanics, validated through prior understanding of similar designs and materials, and potentially physical testing of components (though not described in this summary).

8. The sample size for the training set

Not applicable. There is no "training set" for FEA, as it is a deterministic simulation based on engineering models, not machine learning.

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

Not applicable. See point 8.

Summary

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

032300

Accolade™-J Hip Stem Series

ﻴ

510(k) Premarket Notification

OCT - 9 2003

510(k) Summary

Accolade™-J Hip Stem Series

Proprietary Name:	Accolade™-J Hip Stem Series
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, LZO
Predicate Proprietary Name:	Accolade™ TMZF® HA Hip Stems and Accolade™TMZF® HA Plus Hip StemsOmnifit® M-HA Hip Stems
Predicate Regulatory Class:	Class II
Predicate Product Code:	87 MEH
For Information contact:	Lorraine MontemurroHowmedica Osteonics Corp.59 Route 17Allendale, New Jersey 07401-1677Phone: (201) 831-5892Fax: (201) 831-6038

Description/Technological Comparison

Page 1 of 2

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Intended Use

Indications:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, .
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

Testing Summary

Finite Element Analysis (FEA) was used to evaluate the strength of the neck and body regions of the subject Accolade™-J Hip Stems.

Page 4

Page 2 of 2

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2003

Ms. Lorraine Montemurro Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K032300

Trade/Device Name: Accolade™-J Hip Stem Series Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. Regulatory Class: II Product Code: MEH and LZO Dated: July 24, 2003 Received: August 6, 2003

Dear Ms. Montemurro:

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. Lorraine Montemurro

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 vours.

Sincerely yours,

for Mark N. Milken

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): _Ko32308

Device Name: Accolade™-J Hip Stem Series

Indications:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, ●
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, .
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

(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) (Optional Format 1-2-96)

Mark N Milken

I. Restorative

510(k) Number K032300

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.