The Excia Hip System is intended to replace a hip joint. The device is intended for: 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 for cemented fixation. The other femoral stem is for uncemented from Ti with Plasmapore with or with or without yCaP®.

Device Description

Excia T femoral stem is manufactured from Titanium (Ti) with a Plasmapore coating. The femoral stem will be offered in a 12/14 taper in stem sizes 8 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 uncemented use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Excia T femoral stem, a component of the Aesculap Implant Systems Excia Total Hip System. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices, not to establish novel performance criteria for a new device type through extensive clinical trials or complex AI model validation. Therefore, many of the requested categories for acceptance criteria and study details are not fully applicable or explicitly stated in the context of a Class II medical device 510(k) submission focused on a line extension.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a hip implant component:

The acceptance criteria and study that proves the device meets the acceptance criteria are as follows:

The core acceptance criterion for a 510(k) submission, especially for a line extension like the Excia T femoral stem, is demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the new device must be as safe and effective as the predicate device(s) and does not raise different questions of safety and effectiveness.

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

Acceptance Criteria	Reported Device Performance
Substantial Equivalence: The device must be as safe and effective as the predicate devices and not raise different questions of safety and effectiveness. This is assessed by comparing: - Indications for Use - Design - Materials of Construction - Manufacturing Process - Range of Sizes Offered	The Excia T femoral stem was found to be "substantially equivalent" to the predicate devices (Aesculap Implant Systems Excia Total Hip System (K092143 and K060918) and Smith & Nephew Synergy Hip System) based on: - Indications for Use - Design - Materials of Construction - Manufacturing Process - Range of Sizes Offered
Mechanical/Endurance Properties: The device's mechanical performance (e.g., fatigue strength) must meet established standards for femoral prostheses to demonstrate safety and integrity under physiological loading.	Testing demonstrated that the subject device is "substantially equivalent" to the predicate devices. Specific standards followed include: - Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007 - ASTM F2068-09 - ISO 7206-4 - ISO 7206-6

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

Sample Size for Test Set: Not explicitly stated as a number of devices. Non-clinical testing typically involves a set number of test articles (e.g., typically 6-12 samples per test condition for fatigue testing), but the exact count is not provided. The data would be generated from new test articles manufactured for the purpose of this submission.
Data Provenance: The data is likely prospective, generated specifically for this 510(k) submission through laboratory testing performed by or for the manufacturer (Aesculap Implant Systems, LLC, located in Center Valley, PA). The country of origin for the data generation would be the USA (or wherever the testing laboratory is located).

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)

This question is not applicable in the context of this 510(k) submission. "Ground truth" as applied to clinical data or AI systems with human expert consensus is not part of a non-clinical, mechanical testing report for a hip implant component. The "ground truth" here is adherence to engineering standards and comparison to predicate device specifications. The "experts" involved are likely biomechanical engineers and material scientists conducting and interpreting the tests.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms. For mechanical testing, the results are quantitative measures against established standards or predicate device performance. There is no "adjudication" in this sense. The test results are typically reviewed and approved by internal engineering and regulatory teams along with notified bodies/FDA.

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

This question is not applicable. MRMC studies are used for evaluating diagnostic devices, particularly those involving medical imaging interpreted by human readers, often comparing AI-assisted performance to unassisted human performance. The Excia T femoral stem is a surgical implant, not a diagnostic device or an AI system.

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

This question is not applicable. The Excia T femoral stem is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" in this context is established by:

Engineering Standards: Adherence to recognized national and international standards for hip prostheses (e.g., ASTM F2068-09, ISO 7206-4, ISO 7206-6). These standards specify test methods and acceptance criteria for mechanical properties.
Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices, against which the new device's technological characteristics and performance are compared to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a 510(k) for a mechanical implant. This concept is relevant for machine learning algorithms.

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

This question is not applicable for the same reason as point 8.

Summary

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Aesculap Implant Systems Excia Total Hip System - Excia T

JUL 2 1 2014

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

Excia Total Hip System Excia T Femoral Stem

April 08, 2014

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 tomwing@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 PRODUCT CODE(S): LZO

SUBSEQUENT PRODUCT CODE(S): LWJ; KWY

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the addition of Excia T femoral stems to Excia Total Hip System is substantially equivalent to Aesculap Implant Systems Excia Total Hip System (510(K)s K092143 and K060918) and Smith & Nephew Synergy Hip System.

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DEVICE DESCRIPTION

Excia T femoral stem is intended for uncemented use.

PURPOSE FOR PREMARKET NOTIFICATION

The purpose of this premarket notification is to gain clearance of Excia T 12/14 femoral stems, a line extension which complements the full product range of Aesculap Implant Systems Excia Hip System (510(K)s 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

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 µCaP®

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TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)}

The addition of 12/14 Excia T femoral hip stems to Aesculap Excia Hip System is substantially equivalent to the predicates, Excia Hip System and Smith & Nephew Synergy Hip System, all previously cleared by FDA. The subject device has the same technological characteristics through comparison of the predicate devices' indications for use, design, materials of construction, manufacturing process, and range of sizes offered.

PERFORMANCE DATA

Endurance properties of the Excia T 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

July 21, 2014

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

Re: K140915

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: July 2, 2014 Received: July 3, 2014

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

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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Page 2 - Ms. Julie Tom Wing

(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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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.

Lori A. Wiggins

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K140915

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 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

· Paticats with congenital hip dysplasia, protrusion acctabuli, 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 for cemented fixation. The other femoral stem is for uncemented from Ti with Plasmapore with or with or without yCaP®.

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)

Elizabeth L. Frank -S

Division of Orthopedic 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.