All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Device Description

Addition of 36 mm outside diameter size femoral head components in three different head lengths (-3.5, 0 +3.5 mm)

AI/ML Overview

The provided text describes a 510(k) Special Modification for the Exactech AcuMatch 12/14 Press-Fit Femoral Stems, specifically the addition of 36mm outside diameter size femoral head components. This is a submission for a medical device and not for a software or AI-driven device. Therefore, the traditional "acceptance criteria" and "study" framework as it applies to software performance (such as sensitivity, specificity, or reader studies) is not applicable here.

Instead, the "acceptance criteria" for this device modification are related to its mechanical performance and substantial equivalence to existing predicate devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Adequacy for In Vivo Use: The modified device (36mm femoral heads) must demonstrate performance adequate for its intended use in the human body.	"Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use."
Material Equivalence/Compatibility: The materials and design should maintain safety and effectiveness.	The device is an "Alumina Femoral Head," implying ceramic material, consistent with common hip prosthesis materials. The modification is an addition of a size, not a fundamental design change influencing material.
Substantial Equivalence: The modified device must be substantially equivalent to a legally marketed predicate device.	"Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems." Specifically claimed substantially equivalent to "Exactech 12/14 Alumina Femoral Heads" (K032964).

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

The document does not specify a "test set" in the context of clinical data or patient samples as it is not a clinical study of a diagnostic device. The "testing" refers to empirical (mechanical/engineering) testing and engineering analyses. The sample size for these tests (e.g., number of femoral heads tested for fatigue) is not provided. Similarly, no data provenance (country, retrospective/prospective) is relevant or mentioned, as this is pre-market device testing, not a clinical trial.

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

This concept is not applicable. "Ground truth" in this context would implicitly refer to the established engineering standards and biomechanical principles used to design and evaluate orthopedic implants. The "experts" involved would be the engineering team at Exactech, potentially external consultants, and regulatory reviewers at the FDA. Their specific number or qualifications for establishing biomechanical "ground truth" are not mentioned, but it's implicit that they possess relevant engineering and medical device expertise.

4. Adjudication Method for the Test Set

This concept is not applicable for mechanical testing. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. For device performance testing, the results are typically quantitative and objective measurements against predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical orthopedic implant modification.

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

No, a standalone algorithm performance study was not done. This concept is specific to AI/software performance.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on:

Engineering Analyses: Biomechanical principles, material science, and established orthopedic design standards.
Empirical Testing Data: Results from mechanical tests (e.g., fatigue, static strength, wear) designed to simulate in vivo conditions and evaluate the integrity and durability of the implant components.
Predicate Device Performance: The established safety and effectiveness of the existing Exactech 12/14 Alumina Femoral Heads (K032964) serves as a benchmark and "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This concept is not applicable. This is not an AI/machine learning device that requires a "training set."

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

This concept is not applicable.

Summary

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Exactech

JUL 1 9 2005

<051682
page 1 of
2324 NW 56TH COURT
GAINESVILLE, FL 32653
352-377-1140

350

Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

510(k) Summary of Safety and Effectiveness Special 510(k)

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

(352) - 377 - 1140 Phone: (352) - 378 - 2617 Fax:

FDA Establishment Number 1038671

Bennie Gladdish Contact: Hip Systems Manager/Principal Engineer

June 20, 2005 Date:

Rev. 06/20/05

Section 4 Page 1 of 2

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page of
2526 NW 66TH COURT
GAINESVILLE, FL 3265

Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

510(k) Summary of Safety and Effectiveness Special 510(k)

Trade or proprietary or model name(s):

Exactech 12/14 Alumina Femoral Heads

Information on devices to which substantial equivalence is claimed:

510(k)Number	Trade or Proprietary or Model Name	Manufacturer
#K032964	Exactech 12/14 Alumina Femoral Heads	Exactech, Inc.

INDICATIONS

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Special 510(k) Modifications

Addition of 36 mm outside diameter size femoral head components in three different . head lengths (-3.5, 0 +3.5 mm)

Conclusion:

Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.

Rev. 06/20/05

Section 4 Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.

Public Health Service

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maritza Elias Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K051682

Trade/Device Name: Exactech 12/14 Alumina Femoral Heads 36 mm Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZ0 Dated: June 20, 2005 Received: June 23, 2005

Dear Ms. Elias:

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

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Page 2 - Ms. Maritza Elias

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. ・。 ﺘﺸﺘﺮ ﺗﺤ

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Signature

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech®, Inc.

Exactech 12/14 Alumina Femoral Heads 36 mm

Indications for Use

1081682

510(k) Number:

INDICATIONS

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.

Prescription Use

X =

Over the Counter Use $\mu_2$

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental and Restorative
and Neurological Devices
	K051682
06/20/05		Section
		Page 1 of

Page 1 of 1

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.