Patients suffering from severe hip and disability due to rheumatoid arthritis, osteoarthritis, . traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 ●

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

Device Description

The Excia lateral offset femoral stem is available in two designs and standard lengths. The stem is designed to provide an increased offset during total joint replacement. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Excia Total Hip System Lateral Offset. This is for a medical device (a hip implant), not a software or AI device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like accuracy, F1-score, sensitivity, specificity, etc.) and associated studies (like MRMC, standalone performance) does not directly apply here.

Instead, for a device like this, acceptance criteria are generally related to biocompatibility, mechanical performance, design specifications, and manufacturing quality, and the "study" demonstrating this involves various types of engineering and materials testing.

Based on the provided text, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide explicit "acceptance criteria" with numerical targets like a software evaluation would. Instead, it references adherence to established guidance documents and material properties. The "performance data" section indicates that the device met the requirements outlined in these guidance documents.

Acceptance Criteria (Implied by Guidance Documents)	Reported Device Performance (Implied)
Mechanical properties (fatigue, strength, wear, etc.) as per: - "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" - "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" - "Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in Orthopedic Devices"	"All required testing... were done where applicable." The device met the requirements of the referenced guidance documents for the specified tests. This implies that the device's mechanical, material, and design performance was found to be satisfactory according to these established standards.
Material equivalence to predicate devices (Ti with plasma spray coating / u-CaP, CoCrMo)	"The material used for the Aseculap device is the same as that used to manufacture the predicate devices."
Design and size similarity to predicate devices	"The new lateral offset femoral stems of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices."

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

Sample Size: Not applicable in the context of this device. The testing described is primarily mechanical and materials-based, not involving patient data or test sets in the AI sense.
Data Provenance: Not applicable. The "data" here refers to test results from laboratory experiments on the physical device and its materials, not collected patient information.

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

Number of Experts: Not applicable. The "ground truth" for a hip implant's mechanical and material performance is established by scientific and engineering principles, standardized testing protocols, and regulatory guidance, not by expert consensus on data interpretation.
Qualifications of Experts: Not applicable in the conventional sense of clinical experts interpreting data. The "experts" involved would be biomedical engineers, materials scientists, and regulatory specialists within the company and at the FDA, who define and evaluate the compliance with the testing guidance.

4. Adjudication Method:

Not applicable. This is a concept related to resolving discrepancies in human interpretation of data, which is not relevant for the described device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This device is a physical implant, not an AI software.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

No. This refers to AI algorithm performance. The device is a physical product.

7. The Type of Ground Truth Used:

Engineering and Material Standards/Specifications: The "ground truth" here is defined by industry standards, FDA guidance documents, and scientific principles governing the mechanical, chemical, and biological properties required for a safe and effective orthopedic implant. For example, a fatigue test will have a specified load and number of cycles that the implant must withstand without failure, based on established biomechanical understanding and regulatory requirements.

8. The Sample Size for the Training Set:

Not applicable. There is no AI training set for this physical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no AI training set for this physical device.

In summary, the provided document describes a 510(k) for a physical medical device (a hip implant). The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to predicate devices through adherence to established mechanical and material testing standards and regulatory guidance, rather than the performance metrics and study designs typically associated with AI/software devices.

Summary

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Excia Total Hip System Lateral Offset

SPECIAL 510(k) Premarket Notification

K061344 (pg 1 of 2)Page 1 of 2B. 510(k) SUMMARY (as required by 21 CFR 807.92)		AUG 02 2006
	Excia Total Hip System(Excia Lateral Offset)May 12, 2006
COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky800-258-1946 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com (email)
TRADE NAME:	Excia Total Hip System Lateral Offset
COMMON NAME:	Femoral Hip Stem
CLASSIFICATION NAME:	Prosthesis, hip, semi-constrained, metal/polymer,uncementedProsthesis, hip, semi-constrained, metal/polymer,cementedProsthesis, Hip, semi-constrained, uncemented,metal/polymer, non-porous, calcium-phosphateProsthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cemented or Non-Porous,Uncemented

REGULATION NUMBER: 888.3360, 888.3350, 888.3353, 888.3353

LWJ, JDI, MEH, LZO PRODUCT CODE:

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Lateral Offset Femoral Stem is a line extension of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the Excia Total Hip System with u-CaP® (K060437), BiContact Hip System (K040191), PERFECTA RS Lateralized Hip Stem (K991123) and Dual Offset PERFECTA IMC Hip Stem (K972641):

DEVICE DESCRIPTION

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<061344 (pg 2 of 2)

Page 2 of 2

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, . 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, 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 µ CaP®.

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The new lateral offset femoral stems of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Aseculap 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 stylized eagle with three lines representing its body and wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2006

Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K061344 Trade/Device Name: Excia Total Hip System Lateral Offset 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, JDI, LWJ, MEH Dated: July 20, 2006 Received: July 21, 2006

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

Sincerely yours,

Herbert Lehman

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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Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

510(k) Number:

Device Name: Excia Lateral Offset

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, osteoarthritis, . traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 ●

Herbert Leuner

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number /o61344

Prescription 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

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.