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. ● Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.

Device Description

The proposed Novation Cemented Plus femoral stem is a modification to the existing Novation Cemented femoral stem devices previously cleared in K052787. The proposed stem has the same general design features (collar, cement groove, and "cobra" flange) as the predicate stem. but incorporates a more trapezoidal distal geometry. Additionally, the proposed device includes 5 additional sizes (standard offset Size 10, standard and extended offset Size 12 and 14) to the scope. The proposed stems mate with previously cleared 12/14 CoCr (#K041906), Zirconia ceramic (#K060107), and Alumina ceramic (#K032964 and #K051682) femoral heads.

AI/ML Overview

The provided text describes a 510(k) submission for the Exactech® Novation® Cemented Plus Femoral Stems, focusing on its substantial equivalence to a predicate device. This type of submission is for medical devices and does not involve AI or machine learning. Therefore, the concepts of "acceptance criteria," "study proving the device meets acceptance criteria," "sample sizes," "ground truth," "MRMC studies," or "standalone performance" as they relate to AI/ML device evaluation are not applicable to this document.

The document primarily demonstrates that the modified femoral stem (the new device) is substantially equivalent to a previously cleared device (the predicate device) based on design features, indications for use, materials, shelf life, packaging, and sterilization processes.

Here's how the information provided aligns with what would be in an AI/ML context, if it were applicable, but noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable for this type of device. For a traditional medical device like a femoral stem, "acceptance criteria" relate to engineering performance (e.g., strength, fatigue life, biocompatibility) rather than diagnostic accuracy or sensitivity/specificity of an algorithm. The reported "performance" is that it demonstrates substantial equivalence to the predicate device through "engineering studies."

Acceptance Criteria (Not explicitly stated as such for AI/ML)	Reported Device Performance (Focus on Substantial Equivalence)
(Hypothetical: Device meets specific engineering benchmarks)	Results of engineering studies demonstrate substantial equivalence to the cleared predicate device. The device has the same indications for use, design features, materials, shelf life, and sterilization processes as the predicate.

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

Not applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The evaluation relies on "engineering studies" of the physical implant. The document does not specify the sample size of these engineering studies or their provenance.

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

Not applicable. No "ground truth" establishment in the AI/ML sense is needed for this type of device. The evaluation of a femoral stem is based on engineering principles and regulatory compliance, not expert consensus on image interpretation or similar tasks.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is used as there is no "test set" of AI/ML outputs to adjudicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, not applicable. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a physical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

No, not applicable. This concept belongs to AI/ML device evaluation. The "device" here is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable in the AI/ML context. For this device, the "ground truth" (if analogies must be drawn) would be established engineering standards, material science principles, and clinical safety/efficacy data from the predicate device that inform the modified device's design and testing. The document states "Results of engineering studies" as the basis for substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. Again, no AI/ML training set is involved.

In summary, the provided text pertains to a regulatory submission for a physical medical device (a femoral stem) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The criteria and study types relevant to evaluating AI/ML models are not found or necessary in this document.

Summary

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Exactech® Novation® Cemented Plus Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness

Sponsor:

Exactech® Inc. 2320 N.W. 66th Court Gainesville, FL 32653

DEC 1 7 2008

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

FDA Establishment Number 1038671

Contact: Graham L. Cuthbert Regulatory Affairs Specialist

Date: November 14, 2008

Trade or Proprietary or Model Name(s): Exactech® Novation® Cemented Plus Femoral Stems

Common Name: Cemented Femoral Hip Prosthesis

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Information on devices to which Substantial equivalence is claimed:

510(k) Number Trade or Proprietary or Model Name Manufacturer K052787 Novation® 12/14 Cemented Femoral Stems Exactech, Inc.

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Indications for Use:

. . 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. ● Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.

Device Description:

The predicate and proposed devices have intended use and basic fundamental scientific technology and share the following similarities:

· the same indications for use
· the same design features
· incorporate the same materials
· the same shelf life
· are packaged and sterilized using the same materials and processes.

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate that the proposed Novation Cemented Plus femoral stem is substantially equivalent to the cleared predicate devices.

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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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Exactech, Inc. % Mr. Graham L. Cuthbert Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

DEC 1 7 2008

Re: K083392

Trade/Device Name: Exactech® Novation® Cemented Plus Femoral Stems 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, JDI Dated: November 14, 2008 Received: November 17, 2008

Dear Mr. Cuthbert:

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 - Mr. Graham L. Cuthbert

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.

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. Milliman

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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Exactech® Novation® Cemented Plus Femoral Stems Special 510(k) - Indications for Use

510(k) Number:

K083392

Device Name: Exactech® Novation® Cemented Plus Femoral Stems

INDICATIONS

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, theumatoid 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. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
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)

Mark N. Milken

(Division Sign-Off) (Division Sign-Old)
Division of General, Restorative,
Division of General, Devices Division of General Devices

510(k) Number __

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.