The Metha® Short Stem 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, 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 to previous fusion; patients with acute femoral neck fractures.

Device Description

The Metha® Short Stem Hip System XL Femoral Head is manufactured CoCrMo and conforms to ISO 5832. The XL femoral head is offered in two diameters (28mm and 32mm). The CoCrMo head allows the surgeon a further option to meet the patient's needs.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the "Metha® Short Stem Hip System XL Femoral Head." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria in the manner typical for AI/ML-based medical devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document primarily highlights mechanical and material testing to ensure safety and functionality compared to existing devices.

Here's an attempt to address the request based only on the provided information, noting where information is not present:

Acceptance Criteria and Study for Metha® Short Stem Hip System XL Femoral Head

This 510(k) submission primarily demonstrates substantial equivalence to existing predicate devices, K080584 (Metha® Short Stem Hip System) and K040191 (BiContact Hip System and Femoral Head), by showing similar technological characteristics and materials. The performance data presented is focused on meeting existing orthopedic implant testing standards rather than a clinical study with specific performance metrics against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (if stated)	Reported Device Performance	Comments/Source
Material Conformance	Conforms to ISO 5832	Manufactured CoCrMo and conforms to ISO 5832	Device Description
Mechanical Performance	Meets requirements of various orthopedic implant testing guidance documents (see "Performance Data" section below)	"All required testing... were done where applicable."	Performance Data section lists various guidance documents; specific pass/fail results are not detailed in this summary document.
Dimensions/Shapes	Similar shapes and sizes as predicate devices	"Similar shapes and sizes as the predicate devices."	Technological Characteristics comparison
Indications for Use	Aligns with predicate devices and established medical necessity for hip replacement.	Device is intended for specific patient populations and conditions (listed in "Indications for Use").	Indications for Use statement

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

Sample Size: Not explicitly stated in terms of the number of tested devices. The document implies testing was performed on representative samples or prototypes.
Data Provenance: Not explicitly stated, but testing would typically be performed in a laboratory setting by the manufacturer or a contracted testing facility. No patient data (retrospective or prospective) is mentioned for this type of performance evaluation.

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

Not Applicable. This submission does not involve expert-established clinical ground truth for a test set in the context of device performance, as it is not an AI/ML device or a device requiring clinical adjudication. The "ground truth" here is adherence to engineering standards and material specifications, which are assessed through standardized laboratory tests.

4. Adjudication Method for the Test Set

Not Applicable. No human adjudication method is described. Performance is evaluated against objective engineering standards and material specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI-assisted diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone (Algorithm Only) Performance

No. This is a physical orthopedic implant. The concept of an "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established engineering standards, material specifications (e.g., ISO 5832), and recognized guidance documents for orthopedic implant testing. It is not clinical expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not Applicable. As no training set is relevant, this question does not apply.

Summary of Performance Data (from the document):

The performance data for the Metha® Short Stem Hip System XL Femoral Head relies on demonstrating compliance with various existing guidance documents for orthopedic implant testing:

"Draft Guidance for the 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 Polyethylene (UHMWPE) Used in Orthopedic Devices" (where applicable)

The statement "All required testing per... were done where applicable" indicates that the device underwent the necessary mechanical and material characterization tests outlined in these documents to support its safety and effectiveness for its intended use, by demonstrating substantial equivalence to predicate devices. Specific quantitative results are not included in this summary but would have been part of the full 510(k) submission.

Summary

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K082146

Metha@ Short Stem Hip System XL Femoral Head

Page 1 of 2

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

SEP 0 9 2008

Metha® Short Stem Hip Sytem (Metha® XL Femoral Head)

July 29, 2008

Aesculap Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
CONTACT: Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) kathy.racosky@aesculap.com (email)
Metha® Short Stem Hip System XL Femoral Head TRADE NAME:
Femoral Head COMMON NAME:
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented
888.3360, 888.3353, 888.3390 REGULATION NUMBER:
PRODUCT CODE: LWJ, MEH, KWY

SUBSTANTIAL EQUIVALENCE

Aesculab Implant Systems. Inc. believes that the XL Femoral Head is a line extension of Aesculap Implant Systems, Inc. Metha@ Short Stem Hip System that was cleared (KO80584). It is also substantially equivalent to the BiContact Hip System and Femoral Head (K040191).

DEVICE DESCRIPTION

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JUL 3 0 2003

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K082146

SPECIAL 510(k) Premarket Notification

Methard Short Stern Hip System XL Fernoral Head

Page 2 of 2

INDICATIONS FOR USE

The Metha® Short Stem 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, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
patients with congenital hip dvsplasia, 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 new XL femoral CoCrMo heads of the Metha® Short Stem Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Asseculap Implant Systems device is the same as that used to manufacture the predicate devices.

PERFORMANCE DATA

All required testing per "Draft Guidance for the Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. 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 방 Orthopedic Devices" was completed where applicable.

MANUFACTURING FACILITY

Aesculap AG Am Aesculad-Platz Tuttlingen Germany

004

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.

SEP 0 9 2008

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K082146 Trade/Device Name: Metha® Short Stem Hip System XL Femoral Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LWJ, MEH, KWY Dated: August 27, 2008 Received: August 28, 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 (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); 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 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 CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems 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 N Mullerson

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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K082/46

SPECIAL 510(k) Premarket Notification

Metha@ Short Stern Hip System XL Femoral Mead

Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

SEP 0 9 2008

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Metha® Short Stem Hip System XL Femoral Head

Indications for Use:

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

The device is intended for:

skeletally mature individuals undergoing primary surgery for total hip replacement ﻮ
patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the temoral 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 #

X and/or Over-the-Counter Use _ 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)

Concurrence of CDRH, O

Mark A. Millerson

(Division Sign-C Division of General, Restorative, and Neurological

002

Neurological Devices

510(k) Number K082146

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.