The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylenc bearing surfaces.

Indications for Use as a Bipolar

Femoral head/neck fractures or non-unions, .
Aseptic necrosis of the femoral head, .
. Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Pathological conditions or age considerations that indicate a more conscrvative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum,
. Salvage of failed total hip arthroplasty.

Indications for Use as a Total Hip:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results,
Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.

Device Description

The subject Biolox® Delta Ceramic Femoral Heads mate with Howmedica Osteonics` C-Taper femoral stems fabricated from Titanium or CoCr alloys. The Biolox® Delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a line extension to the Biolox® Delta Ceramic Femoral Heads. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing. The information provided does not detail acceptance criteria or a study design in the way one would typically describe for AI/ML-based device performance. Instead, the study outlined is a mechanical testing study to demonstrate safety and effectiveness for a physical medical device.

Therefore, many of the requested fields are not applicable to the provided document.

Here's an analysis of the information, addressing your points where possible:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the performance of an AI/ML device. Instead, it refers to "mechanical testing" to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new components perform equivalently or better than the predicate devices under mechanical stress.

Acceptance Criteria	Reported Device Performance
Mechanical strength substantially equivalent to predicate devices	"Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength."

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: Not explicitly stated for the mechanical testing. For physical device testing, this typically refers to the number of units tested.
Data Provenance: Not applicable in the context of clinical data or patient data. The "data" here refers to mechanical test results, likely generated in a lab setting.

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 testing of a physical device, "ground truth" is established by engineering standards and measurement equipment, not clinical expert consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical expert review of data (e.g., medical images), not for mechanical testing of physical components.

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 physical medical device (femoral heads), not an AI/ML diagnostic or assistive device that would involve human readers.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for the mechanical testing would be based on established engineering standards and specifications for material properties and mechanical performance (e.g., fatigue strength, fracture toughness) relevant to implantable medical devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. No training set is involved.

Summary

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Line Extension to the Biolox® Delta Ceramic Femoral Heads

K05/588

1/3

JUL 1 2 2005 510(k) Summary of Safety and Effectiveness

Line Extension to the Biolox® Delta Ceramic Femoral Heads

Proprietary Name:	Biolox® Delta Ceramic Femoral Heads
Common Name:	Artificial femoral head component
Proposed Regulatory Class:	Class II
Classification:	Hip joint metal/ceramic/polymer semi-constrained cemented or
	nonporous uncemented prosthesis, 21 CFR §888.3353.
Device Product Code:	87 LZO: Prosthesis, Hip, Semi-Constrained,
	Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
For Information contact:	Karen Ariemma, Senior Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	325 Corporate Drive
	Mahwah, NJ 07430
	Telephone: (201) 831-5718
	Fax: (201) 831-6038
	Email: karen.ariemma@stryker.com
Date Summary Prepared:	June 13, 2005

Device Description

Device Modification

This submission adds additional femoral heads (36 mm diameter -5.0 mm offset heads and 36 mm diameter +7.5 mm offset heads) and allows for use of the Biolox® Delta Ceramic Femoral Heads with the Trident® X3™ Acetabular inserts.

{1}------------------------------------------------

Line Extension to the Biolox® Delta Ceramic Femoral Heads

Indications for Use

Indications for Use as a Bipolar

Femoral head/neck fractures or non-unions, .
Aseptic necrosis of the femoral head, .
. Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Pathological conditions or age considerations that indicate a more conscrvative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum,
. Salvage of failed total hip arthroplasty.

Indications for Use as a Total Hip:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results,
Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.

The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032.

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Substantial Equivalence

The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use, materials and design. Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.

JUL 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Senior Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430

Received: June 15, 2005

Re: K051588

Trode/Device Name: Line Extension to Biolox® Delta Ceramic Femoral Heads 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: June 13, 2005

Dear Ms. Ariemma:

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. Karen Ariemma

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Erle M

Miriam Provost, Ph.D. Acting 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: Biolox® Delta Ceramic Femoral Heads

The subject devices are single use devices. They are intended for mcchanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.

Indications for Use as a Bipolar

Femoral head/neck fractures or non-unions, ■
트 Aseptic necrosis of the femoral head,
트 Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
b Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
. Salvage of failed total hip arthroplasty.

Indications for Use as a Total Hip:

Painful disabling joint discase of the hip resulting from: degenerative arthritis, rheumatoid 미 arthritis, post-traumatic arthritis or late stage avascular necrosis,
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
i Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
.. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acctabulum.

The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032

Prescription Use X - -AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Ola

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page - 1 - of - - low

Civision Sin -Off Division of Conneral, Restorative and Neurolo, Joal Devices

051588

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.