The subject femoral head is a single-use device intended for use in total hip replacement. It is intended for use with any currently available Howmedica Osteonics acetabular component. It is intended for use with any currently available Howmedica Osteonics hip stem featuring the V40™ trunnion and manufactured from a titanium alloy or Orthinox™ Stainless Steel. It is not intended for use with any stem manufactured from cobalt chromium alloy.

Indications:

Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative . arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
. Rheumatoid arthritis;
Correction of functional deformity; .
Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum;
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable uing other techniques;
Revision procedures where other treatments or devices have failed. .

Device Description

The subject Alumina V40™ Femoral Heads and the predicate Alumina V40™ Femoral Heads (#K003413) are manufactured from the same materials using the same manufacturing processes. They share the same indications for use and are of nearly identical design. The subject Alumina V40™ Femoral Heads differ from the predicate Alumina V40™ Femoral Heads as follows:

1. An improved taper grinding technique provides a smoother taper surface finish. This smoother taper surface finish yields stronger ball heads that can now be used with Orthinox™ stainless steel stems (in addition to the titanium alloy stems previously cleared for use with the predicate femoral heads).

AI/ML Overview

This document is an FDA 510(k) premarket notification for a medical device: Alumina V40™ Femoral Heads. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics as might be seen for novel high-risk devices.

Therefore, the information requested regarding acceptance criteria, study data, sample sizes, expert involvement, and reader studies is largely not applicable or not present in this type of regulatory document.

Here's an explanation based on the provided text:

This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is typically done by showing similar indications for use, technological characteristics, and performance. It does not generally require new clinical studies proving safety and efficacy against predefined acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Focus on Technological Comparison: The document explicitly states the basis of the submission: "The subject Alumina V40™ Femoral Heads and the predicate Alumina V40™ Femoral Heads (#K003413) are manufactured from the same materials using the same manufacturing processes. They share the same indications for use and are of nearly identical design." The key difference is "an improved taper grinding technique provides a smoother taper surface finish," leading to "stronger ball heads that can now be used with Orthinox™ stainless steel stems."

Therefore, many of the specific questions about acceptance criteria, study design, and performance metrics are not addressed in this document because the regulatory pathway (510(k)) does not typically require them in this format.

However, I can extract the relevant information that is present:

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

Not Applicable in this context. This 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through material and manufacturing process similarity, and an improved mechanical aspect. No specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy for a diagnostic device) or device performance against a predefined threshold are stated. The "performance" mentioned is an improved taper surface finish leading to "stronger ball heads" and expanded compatibility.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
None explicitly outlined as quantitative acceptance criteria for clinical or specific device performance beyond equivalence.	Improved taper grinding technique yields a smoother taper surface finish, resulting in stronger ball heads.
	Expanded compatibility with Orthinox™ stainless steel stems (in addition to previously cleared titanium alloy stems).

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

Not provided. No clinical or performance test set data, sample sizes, or data provenance are mentioned in this 510(k) summary. The "test" here refers to the comparison against the predicate and the mechanical improvement, which would typically involve engineering testing rather than patient data.

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 type of information is generally relevant for diagnostic devices or those requiring expert review of outcomes. For a femoral head component with a technological improvement, this is not a consideration in a 510(k) submission.

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

Not Applicable. As no clinical or expert-reviewed test set is described, there's no adjudication method.

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 an artificial hip component, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical medical device, not a software algorithm.

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

Not Applicable in the traditional sense of clinical "ground truth." The "ground truth" for this submission is based on the technological characteristics and performance of the predicate device, against which the new device is compared to establish substantial equivalence, and mechanical testing results to support the "stronger ball heads" claim.

8. The sample size for the training set

Not Applicable. No training set for an algorithm or a clinical trial is mentioned.

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

Not Applicable. As no training set is mentioned, this question is not relevant.

Summary

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JAN 2 8 2003

Alumina V40™ Femoral Heads

023901
510(k) Premarket Notification

page 1 of 1

510(k) Summary

Alumina V40TM Femoral Heads

Proprietary Name:	Alumina V40TM Femoral Heads
Common Name:	Artificial Hip Component
Classification Name and Reference:	Hip Joint,Metal/Ceramic/Polymer, Semi-Constrained,Cemented or Nonporous Uncemented Prosthesis,21 CFR §888.3353
Proposed Regulatory Class:	Class II
Device Product Code:	87 LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic /Polymer, Cemented or Non-Porous,Uncemented
Predicate Proprietary Name:	Alumina V40TM Femoral Heads
Predicate Regulatory Class:	Class II
Predicate Product Code:	87 LZO
For Information contact:	Debra BingHowmedica Osteonics Corp.59 Route 17Allendale, New Jersey 07401-1677Phone: (201) 831-5413Fax: (201) 831-6038

Description/Technological Comparison

1. An improved taper grinding technique provides a smoother taper surface finish. This smoother taper surface finish yields stronger ball heads that can now be used with Orthinox™ stainless steel stems (in addition to the titanium alloy stems previously cleared for use with the predicate femoral heads).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's head and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2003

Ms. Debra Bing Regulatory Affairs Manager Stryker Homedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K023901

Trade Name: Alumina V40™ Femoral Heads 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: LZO Dated: November 21, 2002 Received: November 22, 2002

Dear Ms. Bing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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,

Mark n Mllkerson

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): KO2390 /

Device Name: Alumina V40™ Femoral Heads

Indications:

Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative . arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
. Rheumatoid arthritis;
Correction of functional deformity; .
Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum;
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable uing 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

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark A. Milken

estorative .

K023901

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.