The Empire Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The Empire Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with Empire Acetabular Augments. The assembled construct is intended for press-fit fixation. The construct may also be used with bone cement at the discretion of the surgeon.

Device Description

The proposed acetabular augments are manufactured by an additive manufacturing process from titanium alloy to create a porous structure designed to provide initial mechanical fixation in addition to the potential for long-term biological fixation. The augments feature holes that allow for the use of 4.5mm bone screws for adjunct fixation of the acetabular augment and the surrounding bone. The acetabular augments are available in 3 heights (8mm, 11mm, and 13mm) and cover acetabular shell outer diameter sizes 48-58mm.

The proposed augments mate with the following devices:

Novation Crown Cup acetabular shells (K070479) .
Exactech Bone Screws (K896601). .

AI/ML Overview

The provided text describes a medical device, the Exactech® Novation® Empire™ Acetabular Augments, and its 510(k) submission for substantial equivalence to a predicate device. This document is a regulatory submission, not a study report, and therefore does not contain the detailed information typically found in a study focused on establishing acceptance criteria and proving performance through rigorous testing and analysis as requested by the prompt.

Specifically, the document does not describe an AI/ML-based device, nor does it detail a study with acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence of a physical medical implant to a legally marketed predicate device through engineering analyses and mechanical/animal studies.

Therefore, many of the requested fields cannot be directly extracted or are not applicable to the provided text. I will fill in what can be inferred and explicitly state when information is not available or not applicable.

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

The document does not explicitly state acceptance criteria in terms of numerical thresholds for performance metrics for a diagnostic or AI device. Instead, it relies on demonstrating substantial equivalence to a predicate device (Zimmer Hedrocel Acetabular Augment) through material, design, sterilization, and, critically, performance specifications and mechanical tests, animal studies, simulated-use tests, and engineering analyses. The "reported device performance" is essentially that it conforms to recognized performance standards for total hip replacement devices and is substantially equivalent to the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Intended Use: Similar to predicate.	The Empire Acetabular Augments and predicate Zimmer Hedrocel Acetabular Augments have similar indications for use statements, intended for use as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
Materials: Composed of materials conforming to recognized industry standards for permanent implants.	Composed of titanium alloy, conforming to recognized industry standards. Demonstrated through a test summary and reports of the material based on FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement.
Sterilization Processes: Provided sterile, conform to recognized industry standards.	Provided sterile for single use and conform to recognized industry standards.
Design Features: Similar to predicate.	Incorporate similar design features to the predicate. Demonstrated through cadaver lab validation (outside geometry and overall scope).
Performance Specifications: Conform to recognized performance standards for total hip replacement devices.	Conforms to recognized performance standards. Demonstrated through mechanical tests, animal studies (comparing biological fixation characteristics of porous Ti-6Al-4V to historical data), simulated-use tests, and engineering analyses. The studies "demonstrate the proposed Empire Acetabular Augments are substantially equivalent." A clinical literature review of predicate acetabular augment devices was also performed to support this.

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

Test Set Sample Size: Not explicitly stated with a specific numerical value. The "test set" in this context refers to the samples used in mechanical tests, simulated-use tests, and animal studies. These types of studies often use a limited number of physical samples (e.g., a few augments for mechanical testing, a cohort of animals for an animal study), but the exact numbers are not provided.
Data Provenance: Not specified. The document is a 510(k) summary from Exactech®, Inc., located in Gainesville, FL, USA. The studies would likely have been conducted in a similar regulated environment, but specific countries of origin for the data are not mentioned. The studies can be considered prospective in the sense that they were conducted for the purpose of this submission (e.g., the animal study comparing biological fixation characteristics).

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. This device is a physical implant, not an AI/ML diagnostic tool requiring expert ground truth for interpretation of images or patient data. The "ground truth" here is based on objective measurements from mechanical tests, biological responses in animal models, and engineering analyses, rather than expert interpretation.

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

Not Applicable. As above, this is not a diagnostic study requiring inter-reader agreement or adjudication for ground truth establishment.

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. This is not an AI/ML device, and no MRMC comparative effectiveness study was conducted or is applicable here.

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

No. This is not an AI/ML algorithm.

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

The "ground truth" in this context is established through scientific and engineering methods:

Mechanical Test Data: Objective measurements of mechanical properties (e.g., strength, durability, fixation).
Animal Study Data: Biological responses (e.g., bone ingrowth, inflammation) in animal models, compared against historical data.
Engineering Analyses: Calculations and simulations based on design specifications and material properties.
Cadaver Lab Validation: Demonstrating design features and fit.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device requiring a training set.

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

Not Applicable. This is not an AI/ML device requiring a training set.

Summary

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Exactech® Novation® Empire™ Acetabular Augments Traditional 510(k) – 510(k) Summary

510(k) Summary

Company:	Exactech®, Inc2320 NW 66th CourtGainesville FL, 32653	SEP 21, 2010
Date:	September 17, 2010
Contact Person:	Darrell KassnerDirector, Regulatory AffairsTelephone: (352) 377-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Novation® Empire™ Acetabular Augmentswith InteGrip™
Common Name:	Acetabular Augment
Classification Name:	21 CFR 888.3358 - Hip joint metal/polymer/metalsemi-constrained porous-coated uncemented prosthesis.Device Class: II, Classification Panel: Orthopedic,Product Code: LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncemented

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

Zimmer Hedrocel Acetabular Augment, 510(k) K001471 .

Device Description

The proposed augments mate with the following devices:

Novation Crown Cup acetabular shells (K070479) .
Exactech Bone Screws (K896601). .

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Exactech® Novation® Empire™ Acetabular Augments Traditional 510(k) - 510(k) Summarv

Indications for Use

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

. Intended Use. The proposed Empire Acetabular Augments and predicate Zimmer Hedrocel Acetabular Augments are intended for use as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies and have similar indications for use statements.
. Materials. The proposed Empire Acetabular Augments and predicate Zimmer Hedrocel Acetabular Augments are composed of materials conforming to recognized industry standards for permanent implants.
Sterilization processes. The proposed Empire Acetabular Augments and . predicate Zimmer Hedrocel Acetabular Augments are provided sterile for single use and conform to recognized industry standards.
Design Features. The proposed Empire Acetabular Augments and predicate . Zimmer Hedrocel Acetabular Augments incorporate similar design features.
Performance specifications. The proposed Empire Acetabular Augments and . predicate Zimmer Hedrocel Acetabular Augments conform to recognized performance standards for total hip replacement devices.

Substantial Equivalence Conclusion

Results from mechanical tests, animal studies, simulated-use tests, and engineering analyses demonstrate the proposed Empire Acetabular Augments are substantially equivalent to the predicate Zimmer Hedrocel Acetabular Augments. A summary of these tests and analyses are as follows:

Cadaver lab validation demonstrating the design features (including outside . geometry and overall scope).
Test summary and reports of the material based on FDA Guidance Document for . Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement.
Animal study report comparing the biological fixation characteristics of the . porous Ti-6Al-4V to historical data.
Clinical literature review of predicate acetabular augment 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 stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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

Exactech, Inc. % Mr. Darrell J. Kassner Director, Regulatory Affairs 2320 N.W. 66th Court Gainesville, Florida 32653

EP 2 1 2010

Re: K101761

Trade/Device Name: Exactech® Novation® Empire™ Acetabular Augments with InteGrip™ Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: LPH, JDI, LWJ, LZO Dated: June 21, 2010 Received: June 23, 2010

Dear Mr. Kassner:

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

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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 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 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 yours.

Ваввадвник

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech® Novation® Empire™ Acetabular Augments Traditional 510(k) - Indications for Use Statement

Indications for Use Statement

510(k) Number:

K101761

Device Name: Exactech® Novation® Empire™ Acetabular Augments with InteGrip™

INDICATIONS FOR USE:

Prescription Use_ and/or X (Part 21 CFR 801 Subpart D)

Over-T
(21 CFR

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)

Souther
(Division Sign-Off)
for mxm

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K101761

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.