The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

Device Description

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40 mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "BIOLOX® delta* Ceramic Femoral Head." This document outlines the device's summary of safety and effectiveness to gain market clearance via substantial equivalence to predicate devices, rather than a study typically associated with AI/ML-based diagnostic devices. Therefore, many of the requested categories related to AI/ML study design (e.g., test set, training set, ground truth, expert adjudication, MRMC studies) are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence to Predicate Devices)	Reported Device Performance
Mechanical Equivalence: Capable of withstanding in vivo loading similar to predicate devices.	Non-Clinical Performance: "Mechanical testing was performed and results indicate that the BIOLOX delta Ceramic Femoral Heads are equivalent to devices currently on the market and capable of withstanding in vivo loading." This indicates the device passed mechanical performance tests, demonstrating its ability to endure forces encountered in the human body, similar to already approved devices. The specific acceptance criteria (e.g., force thresholds, cycles) for these mechanical tests are not detailed in this summary, but the conclusion states equivalence to currently marketed devices.
Material Equivalence: Manufactured from the same materials as predicate devices.	Comparison to Predicate Device(s): "Both the proposed and predicate designs are intended to function as a modular femoral head component in total hip arthroplasty and are manufactured from the same materials." Specifically, it states the device is "fabricated from an alumina matrix composite." This confirms material equivalence.
Intended Use Equivalence: Same indications for use as predicate devices.	Intended Use: The provided indications for use are comprehensive and consistent with typical indications for ceramic femoral heads in total hip arthroplasty, and the submission states the device is "substantially equivalent to the femoral heads listed above as predicate devices."

Explanation of the "Study" (510(k) Equivalence):

For this type of device (a Class II orthopedic implant), the "study" is a demonstration of substantial equivalence to legally marketed predicate devices. This is a regulatory pathway where the new device does not need to prove efficacy and safety from scratch in a de novo clinical trial if it can show it is as safe and effective as a device already on the market.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable (N/A): This is not an AI/ML diagnostic device with a "test set" in the traditional sense. The equivalence was primarily demonstrated through non-clinical mechanical testing and comparison of design, materials, and intended use to predicate devices.
The "data" for equivalence is derived from:
- Non-clinical mechanical testing: Performed on the BIOLOX delta Ceramic Femoral Head. Details on the number of samples tested are not provided, but it would typically involve a sufficient number to meet testing standards for orthopedic implants (e.g., ISO standards).
- Comparison to predicate devices: This involves reviewing the design, materials, manufacturing processes, and indications for use of previously cleared devices (Biomet K061312, DePuy K062748, Howmedica Osteonics K052718).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable (N/A): No "ground truth" was established by experts in the context of interpreting medical images or clinical outcomes for this device. The assessment for substantial equivalence is performed by FDA reviewers based on the submitted technical documentation and regulatory guidelines.

4. Adjudication Method for the Test Set

Not Applicable (N/A): There was no "test set" requiring adjudication in the context of an AI/ML study.

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 (N/A): No MRMC study was conducted. This device is a passive implant, not an AI-assisted diagnostic tool.

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

Not Applicable (N/A): This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this submission is based on established engineering and material science standards for orthopedic implants, and the regulatory acceptance of existing predicate devices. The device's performance (primarily mechanical in this case) is compared against these benchmarks and the performance of devices already deemed safe and effective by the FDA.

8. The Sample Size for the Training Set

Not Applicable (N/A): There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not Applicable (N/A): There is no "training set" or corresponding ground truth establishment process in this context.

Summary

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Қ071535

Summary of Safety and Effectiveness

NOV 1 9 2007

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Patricia JenksSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8354Fax: (574) 372-4605
Date:	June 4, 2007
Trade Name:	BIOLOX ® delta* Ceramic Femoral Head
Common Name:	Ceramic Femoral Head Prosthesis
Classification Name andReference:	Hip joint metal/ceramic/polymer semiconstrainedcemented or nonporous uncemented prosthesis21 CFR § 888.3353
Predicate Device(s):	36mm Biolox delta Ceramic Heads, manufacturedby Biomet, K061312, cleared June 6, 2006DePuy Delta Ceramic Femoral Head, manufacturedby DePuy, K062748, cleared November 30, 2006V40 TM Biolox delta Ceramic Femoral Heads,manufactured by Howmedica Osteonics, K052718,cleared October 27, 2005
Device Description:	The BIOLOX delta Ceramic Femoral Heads arefabricated from an alumina matrix composite andare available in diameters of 28, 32, 36, and 40 mmwith a range of offsets to accommodate variouspatient anatomies. They serve as an alternative toboth metal and alumina ceramic femoral heads foruse in total hip arthroplasty.

Trademark of CeramTec: AG

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Intended Use:	The BIOLOX delta Ceramic Femoral Heads aremodular components used in total hip arthroplastyand indicated for the following:
	Patients suffering from severe hip pain anddisability due to rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis, collagen disorders,avascular necrosis of the femoral head, andnonunion of previous fractures of the femur;patients with congenital hip dysplasia, protrusioacetabuli, or slipped capital femoral epiphysis;patients suffering from disability due to previousfusion; patients with previously failedendoprostheses and/or total hip components in theoperative extremity; and patients with acute neckfractures.
Comparison to Predicate Device(s):	The BIOLOX delta Ceramic Femoral Heads aresubstantially equivalent to the femoral heads listedabove as predicate devices. Both the proposed andpredicate designs are intended to function as amodular femoral head component in total hiparthroplasty and are manufactured from the samematerials.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Mechanical testing was performed and resultsindicate that the BIOLOX delta Ceramic FemoralHeads are equivalent to devices currently on themarket and capable of withstanding in vivo loading.
	Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed forthis device.

and the comments of the comments of

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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 features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

NOV 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. c/o Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

K071535 Trade/Device Name: Biolox® delta Ceramic Femoral Head 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: October 25, 2007 Received: October 26, 2007

Dear Ms. Jenks:

Re:

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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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 logally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliario at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsiblities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Wilkerson

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

Enclosure

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K071535

Indications for Use

510(k) Number (if known):

Device Name:

BIOLOX® delta* Ceramic Femoral Head

Indications for Use:

The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed?

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sabara Cuchup

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K071535

*Trademark of CentuaTes AG

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.