The subject devices are single-use devices intended for use with any currently available Howmedica Osteonics acetabular component, unipolar component, or bipolar component. They may be used with any Howmedica Osteonics cobalt chromium alloy femoral head that can be mated with a 5°40' BG Taper. They may also be used with the Howmedica Osteonics Alumina C-Taper Heads when used with the Adapter Sleeve for V40 to C-Taper Ceramic Head. The devices continue to be compatible with the predicate distal ring centralizers. The femoral stem is intended for cemented fixation.

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.

Device Description

The subject Accolade™ C Femoral Stems are forged from cobalt chromium alloy. They are straight, neutral stems with medial collars. They come in 127° and 132° neck angles. Crescent shaped indentations on the anterior and posterior surfaces provide rotational stability and enhanced mechanical interlock of the cement. The lateral shoulder features a non-threaded hole for connection to an insertion tool. The distal tip of the stems features a recess for optional use with a cement spacer.

The subject Accolade™ C Femoral Stems differ from the predicate Accolade™ C Femoral Stems only in that they feature a recess in the distal tip to allow use with the predicate Howmedica Osteonics Universal Distal Spacers or Universal Distal Hole Plugs. All other design features, materials, and intended uses are the same as for the predicate Accolade™ C Femoral Stems.

AI/ML Overview

The provided text describes a Special 510(k) submission for a modification to an existing medical device, the Accolade™ C Femoral Stems. This process focuses on demonstrating that the modified device is substantially equivalent to the predicate device, not on proving de novo performance against acceptance criteria for a new, unproven technology.

Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth establishment, which are typical for studies validating the performance of new or significantly changed devices, is largely not applicable in the context of this Special 510(k) submission.

Here's an explanation based on the provided document:

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

Not Applicable in the traditional sense. For a Special 510(k), the primary "acceptance criterion" is proving substantial equivalence to the predicate device, especially regarding safety and effectiveness.
Reported Device Performance: The primary "performance" reported is the outcome of a stress analysis.
- Acceptance Criteria (Implied): The incorporation of a distal recess "does not adversely affect the integrity of the subject devices."
- Reported Device Performance: "Analysis of stresses in the subject hip stems was performed to ensure that the incorporation of a distal recess does not adversely affect the integrity of the subject devices." This statement implies that the analysis confirmed that the integrity was not adversely affected, thereby meeting the implied criterion.

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

Not Applicable. The study involved a "stress analysis," which typically refers to engineering simulations (e.g., Finite Element Analysis) or mechanical testing on physical prototypes, not clinical trials with human subjects. Therefore, concepts like "sample size for a test set" or "data provenance" in the clinical sense do not apply.

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. For mechanical stress analysis, "ground truth" is established through engineering principles, material science, and possibly recognized testing standards. It doesn't involve clinical expert consensus. The "experts" would be engineers or biomechanical specialists conducting the analysis.

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

Not Applicable. Adjudication methods are used in clinical trials to resolve discrepancies in expert opinions on outcomes or diagnoses. This was a technical stress 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 device is a femoral stem, not an AI-assisted diagnostic tool. MRMC studies are completely irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. As mentioned, this is not an AI algorithm.

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

For the stress analysis, the "ground truth" would be the physical and mechanical properties of the cobalt chromium alloy and the design's structural integrity under simulated physiological loads, as determined by engineering principles, material testing standards (e.g., ASTM, ISO), and potentially computational modeling results validated against known biomechanical data.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of mechanical stress analysis for a medical implant modification.

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

Not Applicable. (See point 8)

In summary: The provided document is for a medical device (hip implant) modification that underwent a Special 510(k) pathway. The primary evidence presented is a stress analysis to ensure the modified design's integrity. Concepts related to AI, clinical trials, and general acceptance criteria for novel devices are not relevant to this specific submission.

Summary

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Kodd555

AUG 2 6 2002

Special 510(k)
page 1 of 2

Special 510(k) Summary

Modification to Accolade™ C Femoral Stems

Proprietary Name:	Accolade™ C Femoral Stems
Common Name:	Femoral Hip Stems
Classification Name and Reference:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis21 CFR §888.3353
Proposed Regulatory Class:	Class II
Device Product Code:	87 LZO
Predicate Proprietary Name(s):	Accolade™ C Femoral Stem
Predicate Regulatory Class:	Class II
Predicate Product Code(s):	87 LZO
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:	August 15, 2002

Description/Technological Comparison

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K022555
page 2 of 2
Special 510(k)

Modification to Accolade™ C. Femoral Stems with a cement spacer.

Intended Use

The subject devices retain the same intended use as the predicate devices. The only difference is that the subject devices feature a distal recess that allows for optional use of the predicate Howmedica Osteonics Universal Distal Spacers and Howmedica Osteonics Universal Distal Hole Plugs.

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.

Testing Summary

Analysis of stresses in the subject hip stems was performed to ensure that the incorporation of a distal recess does not adversely affect the integrity of the subject devices.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular pattern. The eagle-like symbol is composed of three curved lines, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

AUG 2 6 2002

Debra Bing

Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route 17 Allendale. NJ 07401-1677

Re: K022555

Trade/Device Name: Accolade™ C Femoral Stems 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: LZO Dated: August 1, 2002

Received: August 2, 2002

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. Ilsting 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 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" (21 CFR 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 vours.

Mark A. Mulhausen

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: Accolade™ C Femoral Stems

The subject devices are single-use devices intended for use with any currently available Howmedica Osteonics acetabular component, unipolar component, or bipolar component. They may be used with any Howmedica Osteonics cobalt chromium alloy femoral head that can be mated with a 5°40' BG Taper. They may also be used with the Howmedica Osteenics Alumina C-Taper Heads when used with the Adapter Sleeve for V40 to C-Taper Ceramic Heads. The femoral stem is intended for cemented fixation.

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.

(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)

Mark N Millhenser

eral. Restorative and Neurologi

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.