skeletally mature individuals undergoing primary surgery for total hip replacement .
patients suffering from severe hip pain and disability due to rheumatoid arthritis, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise 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 Hip Systems are a short stem design with either a single piece stem or a The Metha Thip Systems are a short seem beag. These hip systems share common heads in either modular Stemmeck Option: Doll of the Step titanium alloy. The proximal area of Cool of Geranic. The stem to manufacturers with a secondary coating of the lemoral stem is plasma oplaysu (r lasinopolised for cementless use only. Galcium i nosphate (p Oal o). "This etsin a sestems is referred to as The acetabiliar Jup that is VIPE insert with a Titanium plasmaspray shell.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Metha Hip System, structured to address your specific points:

The provided text is a 510(k) summary for the Metha Hip System, focusing on demonstrating substantial equivalence to predicate devices. This type of submission relies heavily on non-clinical performance data (mechanical testing) rather than clinical studies with human subjects or AI-driven evaluation. Therefore, many of your requested fields related to AI, clinical trials, ground truth, and expert consensus are not applicable to this document.

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

Acceptance Criteria (What they aimed to demonstrate)	Reported Device Performance (How it met the criteria)
As safe, effective, and performs as well as predicate devices.	"Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices." (Implied by meeting or exceeding predicate device performance in the specific tests).

2. Sample sized 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 in the document for the fatigue testing. It refers to "testing" performed, but not the number of units tested.
Data Provenance: Not specified, but implied to be from laboratory testing and not human subject 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. Ground truth in this context refers to mechanical performance parameters established by industry standards (ISO, ASTM) and evaluated in a laboratory setting, not by clinical experts.

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

Not applicable. Adjudication methods are typically for clinical data and consensus building among human experts, which is not relevant for mechanical testing.

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 a medical device (hip implant), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (hip implant), not an algorithm.

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

The "ground truth" for the performance data is established industry standards and predicate device performance. The device's mechanical integrity and durability are compared against the performance requirements outlined in standards like ISO 7206-4 and ASTM F2068-03, and implicit performance of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for a medical implant like this.

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

Not applicable. There is no "training set" or corresponding ground truth establishment process relevant to this type of device submission.

Summary of Acceptance Criteria and Study:

The acceptance criteria for the Metha Hip System are demonstrating that its technological characteristics (design, intended use, material composition, function, and range of sizes) and performance data (specifically fatigue testing) are substantially equivalent to legally marketed predicate devices.

The study that proves the device meets these criteria is fatigue testing per ISO 7206-4 and ASTM F2068-03. This testing, a non-clinical evaluation, aims to show the mechanical durability and safety of the implant under simulated physiological loads, demonstrating that it performs "as safe, as effective, and performs as well as the predicate devices." The specific numerical results of this testing and the comparison points to predicate devices are not detailed in this summary but would have been part of the full 510(k) submission.

Summary

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K 112 682

MAR 1 9 2012

Page 1 of 2

510(k) SUMMARY (as required by 21 CFR 807.92) 8.

Metha Hip System

February 29, 2012

COMPANY:

Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311

CONTACT:

Kathv A. Racosky 610-984-9291 (phone) 610-791-6882 (fax)

Metha TRADE NAME:

Metha Hip System COMMON NAME:

CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis. Hip. Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented

888.3360, 888.3353, 888.3353 REGULATION NUMBER:

LWJ, MEH, LZO PRODUCT CODE:

SUBSTANTIAL EQUIVALENCE

SUBSTANTIAL EGON ALLING
Aesculap Implant Systems, LLC believes that the Metha Hip Systems are substantially equivalent to:

Metha Hip Systems (K080584 & K071916) .
MAYO Conservative Hip Prosthesis (K030733 & K061461) .
Profemur Hip System Modular Necks (K091423) .

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DEVICE DESCRIPTION

INDICATIONS FOR USE

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 i .
Skeletally mature individuals and disability due to rheumatoid arthritis, . patterits suitening from severe hip pain and city and disorders, avascular USteoathinis, "traumatio" antimal" poryious fractures of the femur.
heciosis of the 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))

As is established in this submission, the Aesculap Implant Systems Melna Hip Systems As is established in this Submission, the Acceanap stem or a modular stem or a modular stem on the subjection are a short stem design with cither a cingle process cleared by FDA. The subject that are substantially equivalent to other productions the same technological device is shown to be substantially equivalism in design, intended use, onaterial composition, function and range of sizes.

PERFORMANCE DATA

As recommended by the FDA Guidance for Industry and FDA Staff - Non-clinical As recommended by the PDA Guldance for Industry and to recomments that the Metha Information for Femoral Stem Prosmose that perceive devices. The following testing was performed to support substantial equivalence: -

Fatigue testing per ISO 7206-4 and ASTM F2068-03 .
Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human figure embracing or protecting something.

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

MAR 1 9 2012

Aesculap Implant Systems, LLC. % Ms. Kathy A. Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K112682

Trade/Device Name: Metha 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, MEH, LWJ Dated: March 9, 2012 Received: March 12, 2012

Dear Ms. Rocosky:

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 (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

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Page 2 - Ms. Kathy A. Racosky

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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.

Sincerely vours.

sincerely yours,

For

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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.

K112.682

510(k) Number:_

Device Name: Metha Hip System

Indications for Use:

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, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise 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 .

Prescription Use	X	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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices510(k) Number K112682

002

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.