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

Device Description

The Accolade® HFx femoral stem is a tapered cobalt chrome stem. The Accolade® HFx femoral stem is collarless and flat bodied, and will be available in sizes 1 through 8. The proximal body is textured Is conaress and hit boured, and firm of a increase the surface area of the stem to accommodate a press-fit fixation.

AI/ML Overview

This document describes the Accolade® HFx Femoral Stem, a total hip joint replacement prosthesis. This submission is a 510(k) premarket notification, which aims to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve the rigorous clinical trials and statistical analyses found in AI device studies.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable in this context. The 510(k) process for this device relies on demonstrating chemical, mechanical, and material equivalency through non-clinical testing, rather than studies of diagnostic accuracy or clinical effectiveness in the way an AI device would be evaluated.

Here's why each point isn't directly addressed by this document:

1. A table of acceptance criteria and the reported device performance: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance metrics against pre-defined acceptance criteria, as would be done for an AI device. The "performance" being evaluated is primarily related to material properties, design, and intended use, which are deemed equivalent to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. Clinical trials with test sets, as understood in AI device evaluation, are not part of a standard 510(k) pathway for a medical implant like a hip stem. Equivalence is usually shown through comparison of specifications, materials, and non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish in the context of an AI-like diagnostic accuracy study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the AI sense, and thus no adjudication of results.
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 implant, not an AI diagnostic tool that assists 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 implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a hip stem's safety and effectiveness is established through its design, materials testing, and comparison to existing, cleared devices, not through diagnostic accuracy relative to a clinical outcome.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the K051741 submission:

The Accolade® HFx Femoral Stem is a Class II device. The submission successfully demonstrated substantial equivalence to the predicate device, the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). The determination of substantial equivalence was based on similarities in:

Intended Use: Both devices are for cementless fixation within the prepared femoral canal for conditions such as noninflammatory degenerative joint disease, rheumatoid arthritis, functional deformity correction, revision procedures, and specific types of proximal femur fractures.
Design: The Accolade® HFx is described as a tapered cobalt chrome stem, collarless and flat-bodied, with a textured proximal body to increase surface area for press-fit fixation, similar to the predicate.
Sterilization: Implied to be similar to the predicate device.

The FDA's decision to clear the device indicates their agreement that it is substantially equivalent to the predicate, and therefore as safe and effective as the legally marketed predicate device. No new "studies" in the AI or clinical trial sense were required or presented in this summary to prove performance against specific acceptance criteria.

Summary

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SEP 26 2005

325 Corporate Drive Mahwah, NJ USA 07430

Howmedica

OSTEONICS

STITUKE

K 051741

510(k) Summary of Safety and Effectiveness for the Accolade® HFx Femoral Stem

Proprietary Name:	Accolade® HFx Femoral Stem
Common Name:	Total Hip Joint Replacement Prosthesis
Classification Name and Reference	Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis,21 CFR §888.3360
	Hip joint, metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prostheses,21 CFR §888.3353
Regulatory Class:	Class II
Device Product Code:	87 KWL - prosthesis, hip, hemi-, femoral, metal
	87 LWJ - prosthesis, hip, semi-constrained,metal/polymer, uncemented
	87 LZO - prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented
For Information contact:	Tiffani RogersRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5412Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:	June 27, 2005

05 174 را

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Image /page/1/Picture/0 description: The image shows the logos of Stryker, Howmedica, and Osteonics. Stryker is in a bold, sans-serif font, while Howmedica and Osteonics are stacked on top of each other in a similar font. The logos are all in black and white and are arranged horizontally.

325 Corporate Drive Mahwah, NJ USA 07430

Device Description

Intended Use:

The Accolade® HFx hip stem is a single-use, sterile device intended for cementless fixation within the prepared femoral canal.

Indications

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

Substantial Equivalence

The determination of the substantial equivalence of the Accolade® hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). Predicate device information is located in Appendix E.

K051741
p²/₂

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards, representing health, services, and people. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the perimeter of the circle.

Public Health Service

SEP 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tiffani D. Rogers Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K051741 Trade/Device Name: Accolade® HFx Femoral Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, LWJ, KWL Dated: June 27, 2005 Reccived: June 28, 2005

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed 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 for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the corney 2011 de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diere, mains of the Act include requirements for annual registration, listing of general controls proficition 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 if your device is exassinon von ontrols. Existing major regulations affecting your device can may oe subject to oach adderal 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 r lease be deviloed that the mination that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I cacial statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set El K Fat 801); accems (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. Tiffani D. Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough manieting of substantial equivalence of your device to a legally premarket notification: "The PDF intemsessification 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 If you desire specific acries ion 10. Jour 2012 - 120. Also, please note the regulation entitled, Comaci the Office of Compuners and (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general involmation on your respended its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millikan

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ KOS1741

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerson

(Division Sign-Off) estorative, Division of General, F Division of Ogical Devices

510(k) Number_

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.