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.

. Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Description

The proposed Novation Crown Cup devices represent a modification to the predicate Novation Crown Cup cleared in K070479 and K100269. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only difference between the predicate and the proposed devices is the process by which the titanium plasma spray coating is applied.

AI/ML Overview

The provided text does not describe a study involving acceptance criteria for a medical device's performance that can be presented in the requested table format.

This document is a 510(k) premarket notification for a medical device, the Exactech® Novation® Crown Cup®. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving that the device meets specific performance acceptance criteria for a clinical or diagnostic task.

Here's a breakdown of why the requested information cannot be fully provided from the text:

No specific acceptance criteria for "device performance" (as in clinical/diagnostic outcomes): The document describes a change in the manufacturing process (plasma spray coating) for an existing hip implant. The "testing" mentioned (stereological evaluation, tensile and shear testing, abrasion resistance) are engineering tests designed to ensure the physical properties and functionality of the modified coating are equivalent to the original, not to measure clinical performance metrics like sensitivity, specificity, accuracy, or other patient-centric outcomes.
No "study" in the clinical sense: The document refers to "engineering analyses" and "engineering studies," not clinical trials or diagnostic performance studies that would involve a test set, ground truth experts, or MRMC studies.
No AI or algorithm present: This device is a physical hip implant, not an AI/ML powered diagnostic or therapeutic device. Therefore, questions 5, 6, 8, and 9 are not applicable.

However, I can extract the information relevant to the engineering tests that were performed to support substantial equivalence:

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

Note: The document only states that "Results of engineering studies... demonstrate the proposed Novation Crown Cup are substantially equivalent to cleared Novation Crown Cup devices." It does not provide specific numerical acceptance criteria or reported values for the engineering tests. It implies that the test results were within acceptable limits or comparable to the predicate device, thereby demonstrating substantial equivalence. The document lists the types of tests conducted, but not their specific quantitative outcomes or the thresholds for acceptance.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated in document, inferred as "comparable to predicate")	Reported Device Performance (Not explicitly stated in document, inferred as "met criteria")
Porous Coating	Stereological parameters (e.g., porosity, pore size, layer thickness) comparable to predicate	Results demonstrated substantial equivalence to predicate
Mechanical Strength	Tensile strength comparable to predicate	Results demonstrated substantial equivalence to predicate
Mechanical Strength	Shear strength comparable to predicate	Results demonstrated substantial equivalence to predicate
Durability	Abrasion resistance comparable to predicate	Results demonstrated substantial equivalence to predicate

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document. Engineering tests typically use a small number of samples (e.g., 5-10 per test) for mechanical property evaluations.
Data Provenance: Not specified, but assumed to be from Exactech's internal testing labs, likely in the USA (where Exactech Inc. is located). The studies are retrospective in the sense that they are laboratory tests performed on manufactured samples, not prospective clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This involves engineering tests, not clinical diagnosis where human experts establish ground truth. Engineers/technicians would perform the tests according to standardized protocols and analyze the data.

4. Adjudication method for the test set

Not applicable. This refers to clinical/diagnostic interpretation, not engineering test results.

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 device is a physical hip implant, not an AI-powered medical device.

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

Not applicable. This device is a physical hip implant, not an algorithm.

7. The type of ground truth used

Engineering Standards/Material Properties: The "ground truth" for these engineering tests would be established through industry standards for material properties, specified design requirements, and comparison to the previously cleared predicate device's measured properties.

8. The sample size for the training set

Not applicable. This device is a physical hip implant. No "training set" in the context of AI/ML or statistical modeling is involved.

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

Not applicable. No training set exists for this type of device.

Summary

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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.

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

September 3, 2015

Exactech Incorporated Mr. Thomas McNamara Regulatory Affairs Specialist 2320 North West 66th Court Gainesville, Florida 32653

Re: K141960 Trade/Device Name: Exactech® Novation® Crown Cup® Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, JDI, LWJ, MBL Dated: July 22, 2015 Received: July 27, 2015

Dear Mr. McNamara:

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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Page 2 - Mr. Thomas McNamara

(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 (OS) 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" (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

K141960 510(k) Number:

Device Name: Exactech® Novation® Crown Cup®

INDICATIONS

. Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Prescription Use_ x (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Exactech® Novation® Crown Cup® Plasma Spray Coating Manufacturing Change Traditional 510(k)

510(k) Summary

Sponsor:	Exactech®, Inc2320 NW 66th CourtGainesville FL, 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Date:	August 27, 2015
Contact Person:	Thomas McNamaraRegulatory Affairs SpecialistTelephone: (352) 377-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Novation® Crown Cup®

Common Name: Acetabular Component

Classification Name:

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or ● Non-Porous, Uncemented, 21 CFR 888.3353, Class II, Product Code LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 21 CFR ● 888.3350 Class II, Product Code JDI
Prosthesis, Hip, Semi-constrained, Meta/Polymer, Porous Uncemented, 21 ● CFR 888.3358, Class II, Product Code LPH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, 21 CFR 888.3360, Class II, Product Code LWJ
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, 21 ● CFR 888.3358, Class II, Product Code MBL

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Name	Manufacturer	510(k) Number
Exactech Novation Crown Cup andLiners	Exactech, Inc	K070479, K100269

Indication for Use:

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Exactech® Novation® Crown Cup® Plasma Spray Coating Manufacturing Change Traditional 510(k)

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.

Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
Femoral heads and endoprostheses are intended for use in cemented and pressfit applications.

Device Description

Testing:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Novation Crown Cup devices to the predicate Novation Crown Cups:

. Stereological Evaluation of Porous Coating
Tensile and Shear Testing of Porous Coating
Abrasion Resistance Testing .

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Novation Crown Cup are substantially equivalent to cleared Novation Crown Cup devices.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.