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 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 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 to previous fusion patients with acute femoral neck fractures.

Device Description

The Aesculap Implant Systems BIOLOX® delta Ceramic Femoral Heads are manufactured from an alumina matrix composite. The ceramic femoral head is offered in thee diameters of 28, 32, and 36 mm with a range of neck lengths. The BIOLOX® delta Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty.

AI/ML Overview

The provided text describes a 510(k) submission for a ceramic femoral head (BIOLOX® delta Ceramic Femoral Head), which is a medical device used in hip replacement surgery. The documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in the context of AI/algorithm performance.

Therefore, many of the requested categories in your prompt a.are not applicable or cannot be answered from the provided text, as the submission is for a physical orthopedic implant, not an AI or software-as-a-medical-device (SaMD) product.

Here's an analysis based on the provided text, highlighting what is applicable and what is not:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through material and technological characteristics comparisons, and references general performance testing guidance for orthopedic implants, rather than specific acceptance criteria for a new performance claim or a new algorithm.

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

Not applicable. This is a physical device, and the "test set" concept as used for AI/algorithm validation (e.g., images for classification) does not apply. The document mentions "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," along with other specific guidance documents for orthopedic implants (e.g., testing orthopedic implants with modified metallic surfaces, testing metallic plasma sprayed coatings, testing non-articulating modular implant components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, UHMWPE). These guidances typically entail mechanical, fatigue, wear, and biocompatibility testing of the physical implant components, not data-driven performance.

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

Not applicable. Ground truth, in the context of expert consensus for AI/algorithm training or validation, is not relevant for this physical device submission.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements in expert labeling for AI/algorithm ground truth, which is not relevant here.

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 not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

7. The type of ground truth used

Not applicable. Ground truth for AI/algorithm validation is not relevant. The "ground truth" for this device's performance would be established through physical testing and material characterization against established standards and predicate device performance.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

Summary of Device and Performance Information Provided:

Device Name: BIOLOX® delta Ceramic Femoral Head
Manufacturer: Aesculap Implant Systems, Inc.
Device Description: An alumina matrix composite ceramic femoral head, offered in 28, 32, and 36 mm diameters with a range of neck lengths for use in total hip arthroplasty.
Intended Use: To replace a hip joint for patients suffering from severe hip issues due to various conditions (rheumatoid arthritis, traumatic arthritis, avascular necrosis, fractures, congenital hip dysplasia, etc.)
Substantial Equivalence Claim: The device is claimed to be a line extension to previously cleared Aesculap Implant Systems Excia and Metha Hip Systems and substantially equivalent to the Zimmer BIOLOX® delta Ceramic Femoral Head (K071535).
Performance Data (General): The document states that all required testing per various guidance documents for orthopedic devices was completed where applicable. These guidances typically cover mechanical, material, and biocompatibility aspects relevant to physical implants. There are no specific performance metrics or acceptance criteria explicitly listed in this summary, as the focus is on compliance with general testing standards for similar orthopedic devices to demonstrate substantial equivalence.

Summary

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6082991 (pg112)

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

BIOLOX® delta Ceramic Femoral Head

NOV 20 20

October 6, 2008

Aesculap Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
Kathy A. Racosky CONTACT: 610-984-9291 (phone) 610-791-6882 (fax) kathy.racosky@aesculap.com (email)
BIOLOX® delta Ceramic Femoral Head TRADE NAME:
Ceramic Femoral Head COMMON NAME:
CLASSIFICATION NAME: Hip joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis. Hip. Hemi-. Femoral. Metal/Polymer. Cemented or Uncemented
REGULATION NUMBER: 888,3353,888,3360,888,3353,888,3390

PRODUCT CODE: LZO, LWJ. MEH, KWY

SUBSTANTIAL EQUIVALENCE

Aesculab Implant Systems, Inc. believes that the BIOLOX® delta Ceramic Femoral Head is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) - Hip Systems and Metha Short Stem Hip System (K080584) that were previously cleared. It is also substantially equivalent to the Zimmer BIOLOX detta Ceramic Femoral Head (K071535).

DEVICE DESCRIPTION

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K082991 (pg 212)

Page 2 of 2

INDICATIONS FOR USE

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

The device is intended for:

o is intents suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, ● r alle of the really on 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 Tixation. The other femoral stern 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 disability due to meumatoid 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 to previous fusion .
. patients with acute femoral neck fractures

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}

The Aesculap Implant Systems BIOLOX® delta Ceramic Femoral 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 Polethevlene (UHMWPE) Used in . Orthopedic Devices" was completed where applicable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular pattern around the eagle, emphasizing the department's name and national affiliation. The eagle is depicted in a stylized manner, with flowing lines suggesting movement and dynamism.

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

NOV 20 2008

Re: K082991

Trade/Device Name: BIOLOX® DELTA Ccramic Fcmoral Head 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: November 7, 2008 Received: November 10, 2008

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. Iisting 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kathy A. Racosky

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 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 postmarket surveillance, please contact CDRII's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Syrems at (240) 276-3464. You may obtain other general information on your responsibilities 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 M. Millman

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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A. INDICATIONS FOR USE STATEMENT

510(k) Number: h08299) (pq ili)

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

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 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 (oint.

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 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

(Division Sign-Up)
Division of General, Restorative

and Neurologic

510(k) Number K082441

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 Evaluation (ODE)

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.