The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and re numeratured from Ti with Plasmapore with or without u-CaP®. The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement . patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of provious fractures of the femur. patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis . patients suffering from disability due to previous fusion ◆ ◆ patients with acute femoral neck fractures

Device Description

The Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System consist of a ceramic head manufactured from an alumina matrix composite available in diameters of 28, 32, and 36 mm and a titanium adapter for the femoral stem cone with a range of neck lengths. The BIOLOX® OPTION Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty. Two Metha® XL Heads are available. The CoCrMo head is offered in two diameters (28mm and 32mm). The BIOLOX® delta ceramic head is composed of an alumina matrix composite and is available in two diameters (32mm and 36mm).

AI/ML Overview

The provided text describes a medical device submission (K090299) for the BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads. It outlines the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or other statistical measures typically found in clinical studies or performance evaluations for AI/ML devices.

Instead, the "Performance Data" section lists various guidance documents from the FDA that were followed for testing. This suggests that the "acceptance criteria" for this device are related to compliance with these established standards and guidelines for orthopedic implants, rather than statistical performance thresholds from a specific study.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for a clinical or AI/ML study cannot be extracted from this document.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"	"All required testing... were done where applicable."
Compliance with "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"	Testing completed where applicable.
Compliance with "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"	Testing completed where applicable.
Compliance with "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"	Testing completed where applicable.
Compliance with "Draft Guidance Document for Testing Acetabular Cup Prostheses"	Testing completed where applicable.
Compliance with "Points to Consider for Femoral Stem Prostheses"	Testing completed where applicable.
Compliance with "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"	Testing completed where applicable.
Compliance with "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices"	Testing completed where applicable.
Substantial Equivalence to Predicate Devices (K042344, K060918, K062684, K071916, K080584, K082146, K082991, K071535)	Device is claimed to be substantially equivalent to listed predicates. Material used is the same, and offered in similar shapes and sizes.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. The document refers to engineering and material testing standards, not a clinical "test set" with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. Ground truth in this context would refer to material science and mechanical engineering standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable/Not provided. This concept is for clinical studies with human review of data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The document focuses on regulatory compliance for mechanical and material properties of an implant, not clinical effectiveness studies comparing human readers with and without AI assistance.

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

Not applicable/Not provided. This device is a physical orthopedic implant, not an algorithm or software.

7. The type of ground truth used:

The "ground truth" for this device's performance would be established through material property testing, mechanical performance testing, and biocompatibility assessments based on the referenced FDA guidance documents and recognized international standards (e.g., ISO standards for implants, not specified in detail here but implied by "where applicable"). This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI/ML evaluation.

8. The sample size for the training set:

Not applicable/Not provided. There is no "training set" in the context of an AI/ML algorithm for this physical device.

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

Not applicable/Not provided. There is no "training set" or corresponding ground truth for an AI/ML algorithm for this physical device.

Summary

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h090299 (pg 1/2)

SPECIAL 510(k) Premarket Notification

Page 1 of 2

B. 510(k) SUMMARY (as required by 21 CFR 807.92)

APR 24 2009

BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads

and Metha® XL Heads

February 5, 2009

COMPANY:	Aesculap Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com (email)
TRADE NAME:	BIOLOX® OPTION Ceramic Femoral Head System andMetha® XL Heads
COMMON NAME:	Total Hip System
	CLASSIFICATION NAME: Hip joint Metal/Ceramic/Polymer Semi-Constrained Cemented orNon-Porous Uncemented ProsthesisProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer,Non-Porous, Calcium-PhosphateProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented orUncemented
REGULATION NUMBER:	888.3353, 888.3360, 888.3353, 888.3390

PRODUCT CODE: LZO. LWJ, MEH, KWY

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, Inc. believes that the BIOLOX® OPTION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aescular Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082991). It is also substantially equivalent to the Zimmer BIOLOX® OPTION Ceramic Femoral Head System (K071535).

DEVICE DESCRIPTION

Two Metha® XL Heads are available. The CoCrMo head is offered in two diameters (28mm and 32mm). The BIOLOX® delta ceramic head is composed of an alumina matrix composite and is available in two diameters (32mm and 36mm).

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SPECIAL 510(k) Premarket Notification

Page 2 of 2

BIOLOX® OPTION Ceramic Fernoral Head Syste and Metha® XL Heads

INDICATIONS FOR USE

The Excia Hip System is intended to replace a hip joint.

The device is intended for:
- Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral hims, tradination of the femur.
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
Patients suffering from disability due previous fusion
Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and re numeratured from Ti with Plasmapore with or without u-CaP®.

The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.

The device is intended for:

skeletally mature individuals undergoing primary surgery for total hip replacement
. patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of provious fractures of the femur.
patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis .
patients suffering from disability due to previous fusion ◆
◆ patients with acute femoral neck fractures

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}

The Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads are offered in similar shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;

"Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces . Apposing Bone or Bone Cement".
"Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements".
"Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components".
"Draft Guidance Document for Testing Acetabular Cup Prostheses", .
"Points to Consider for Femoral Stem Prostheses". .
"Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball . Hip Systems" and
"Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in . Orthopedic Devices" was completed where applicable.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized manner.

APR 2 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K090299 Trade/Device Name: Novation Biolox® Option Ceramic Femoral Head and Metha XL 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, LWJ, MEH, KWY Dated: March 26, 2009 Received: March 27, 2009

Dear Ms. Racosky:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Kathy A. Racosky

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 Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Oshm Def D.K

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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SPECIAL 510(k) Premarket Notification

BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads

Page 1 of 1

A. INDICATIONS FOR USE STATEMENT

510(k) Number: K090299 (pg 1/1)

BIOLOX® OPTION Ceramic Femoral Head System Device Name: For use with the Aesculap Implant Systems Excia and Metha® Hip Systems

Indications for Use:

The Excia Hip System is intended to replace a hip joint.

The device is intended for:

Patients suffering from severe hip and disability due to rheumatoid anhritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.

Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
Patients suffering from disability due previous fusion .
Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.

The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.

The device is intended for:

skeletally mature individuals undergoing primary surgery for total hip replacement
patients suffering from severe hip pain and disablity due to meumatoid arthritis, traumatic arthrits, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
patients suffering from disability due to previous fusion
patients with acute femoral neck fractures

Prescription Use × and/or Over-the-Counter Use (per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Chamage Brill

Division of General, Restorative. and Neurological Devices

002

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.