· 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 ephiphysis

· Patients suffering from disability due to previous fusion
· Patients with acute femoral neck fractures

The Excia Hip System is available with two (2) femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without uCaP®.

Device Description

Excia T cemented femoral stem is manufactured from CoCrMo. The femoral stem will be offered in a 12/14 taper in stem sizes 10 to 20. The stems are designed without a trochanter wing and features a shorter stem length with an asymmetrical distal tip.

Excia T femoral stem is intended for cemented use.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically the Excia Total Hip System. This type of document is a regulatory submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/CADe device.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of document. The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and pre-clinical performance data (e.g., endurance testing), rather than clinical performance measured against acceptance criteria with patient outcomes.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not Applicable / Not Provided in this format. This document is a 510(k) for a medical implant (total hip system), not an AI/CADe device. The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through material, design, and mechanical testing, rather than clinical performance metrics (like sensitivity, specificity, AUC) for an AI algorithm.
The performance data mentioned are related to mechanical endurance properties, not clinical outcomes or diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. No "test set" in the context of an AI algorithm is mentioned. The testing described is mechanical (endurance properties) on physical device samples, not on patient data.

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 / Not Provided. There is no mention of experts establishing a "ground truth" related to patient data, as this is a hip implant, not a diagnostic device.

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

Not Applicable / Not Provided. No adjudication method is mentioned for any "test set."

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 / Not Provided. This is not an AI-assisted device. No MRMC study was done, nor is there any mention of human readers or AI assistance.

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

Not Applicable / Not Provided. This is not an algorithm.

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

Not Applicable / Not Provided. The "performance data" refers to "Endurance properties" of the medical device itself, evaluated against mechanical standards (ASTM, ISO). The "ground truth" for these tests would be the physical properties predicted by the standards, not clinical outcomes or expert consensus.

8. The sample size for the training set

Not Applicable / Not Provided. There is no "training set" for an AI algorithm mentioned.

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

Not Applicable / Not Provided. There is no "training set" for an AI algorithm mentioned.

Summary regarding the provided document:

The provided document is a 510(k) premarket notification for a hip implant system. It focuses on demonstrating substantial equivalence to previously cleared devices based on:

Technological Characteristics: Indications for Use, design, materials of construction, manufacturing process, and range of sizes.
Performance Data (Pre-clinical): Endurance properties of the stem, head, and neck evaluated according to industry standards (ASTM F2068-09; ISO 7206-4 and ISO 7206-6). The document states: "Testing demonstrated that the subject device is substantially equivalent to the predicate devices."

This document does not contain information about acceptance criteria or studies related to AI/CADe device performance, clinical trials with patient outcomes, or expert reviews for establishing ground truth, as it is a regulatory filing for a different type of medical device (a mechanical implant).

Summary

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Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

February 9, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Aesculap Implant Systems, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K150062 Trade/Device Name: Excia Total Hip System 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, LWJ, KWY Dated: January 12, 2015 Received: January 13, 2015

Dear Ms. Wing:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150062

Device Name Excia Total Hip System

Indications for Use (Describe) The Excia Hip System is intended to replace a hip joint.

The device is intended for:

· Patients suffering from disability due to previous fusion
· Patients with acute femoral neck fractures

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Page 1 of 3

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

Excia Total Hip System Excia T Cemented Femoral Stem

January 12, 2015

COMPANY:

Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034

Establishment Registration Number: 3005673311

CONTACT:

Julie Tom Wing 610-984-9147 (phone) 610-791-6882 (fax) julie.tomwinq@aesculap.com

TRADE NAME:

Excia Total Hip System

COMMON NAME:

Femoral Hip Stem

CLASSIFICATION NAME(s):

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Hip joint femoral (hemi-hip) metal polymer cemented or uncemented prosthesis

REGULATION NUMBER(S): 888.3353; 888.3360; 888.3390

CLASSIFICATION LZO PRODUCT CODE(S):

SUBSEQUENT PRODUCT CODE(S): LWJ: KWY

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the addition of cemented Excia T femoral stems to Excia Total Hip System is substantially equivalent to Aesculap Implant Systems Excia Total Hip System (510(K)s K140915 and K060918).

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Page 2 of 3

DEVICE DESCRIPTION

Excia T femoral stem is intended for cemented use.

PURPOSE FOR PREMARKET NOTIFICATION

The purpose of this premarket notification is to qain clearance of Excia T 12/14 cemented femoral stems, a line extension which complements the full product range of offered stems in Aesculap Implant Systems Excia Hip System (510(K)s K140915, K042344, K060437, K060918, and K061344, and K092143).

INDICATIONS FOR USE

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

The device is intended for:

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, protrusion acetabuli, or slipped capital femoral ● ephiphysis
Patients suffering from disability due to previous fusion ●
Patients with acute femoral neck fractures ●

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Page 3 of 3

TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s))

The addition of 12/14 Excia T cemented femoral hip stems to Aesculap Excia Hip System is substantially equivalent to the Excia Total Hip System. The subject device has the same technoloqical characteristics through comparison of the currently marketed stem indications for use, design, materials of construction, manufacturing process, and range of sizes offered.

PERFORMANCE DATA

Endurance properties of the Excia T cemented stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-09; ISO 7206-4 and ISO 7206-6. Testing demonstrated that the subject device is substantially equivalent to the predicate devices.

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.