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.

· 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 Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Alteon Monobloc Revision Stem implants are made from titanium alloy and offer multiple stem lengths, offsets, and diameters to accommodate an array of patient anatomies.

AI/ML Overview

This document describes a medical device called the Exactech Alteon Monobloc Revision Stem, which is a hip implant. The provided text is a 510(k) summary, a regulatory submission to the FDA, and it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with performance metrics.

Therefore, the requested information points regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment are not explicitly available in the provided document in the context of demonstrating specific performance outcomes.

The document discusses non-clinical testing performed, but it doesn't present a table of acceptance criteria versus reported device performance in a measurable way that would typically be associated with AI or diagnostic device studies.

Here's an analysis based on the information provided, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document.
The document mentions "non-clinical testing" like fatigue testing, range of motion analysis, cadaveric implantation and surgeon assessment, and biocompatibility assessment. However, it does not specify quantitative acceptance criteria for these tests (e.g., "fatigue strength shall be X MPa") nor does it report specific performance values against such criteria. The conclusion simply states that "Results of engineering studies and comparison of key features... demonstrate the proposed Alteon Monobloc Revision Stem devices are substantially equivalent."

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

Not explicitly provided.
The document mentions "cadaveric implantation and surgeon assessment" but does not specify the number of cadavers used or the number of surgeons involved.
Data provenance (country of origin, retrospective/prospective) is not mentioned.

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

Not explicitly provided.
The "cadaveric implantation and surgeon assessment" implies expert involvement (surgeons), but the number and specific qualifications (e.g., years of experience) are not stated. The term "ground truth" as typically used in AI/diagnostic studies is not applicable here, as it's a mechanical device assessment.

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

Not applicable/Not provided.
Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving multiple readers. This document describes testing for a mechanical implant, not a diagnostic device.

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 mechanical hip implant, not an AI or diagnostic device. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant or performed for this type of device.

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

Not applicable.
This is a mechanical hip implant; there is no algorithm or standalone performance in the context of AI or diagnostics.

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

Not explicitly defined in the context of "ground truth" for a diagnostic study.
For mechanical devices like this, "ground truth" might refer to engineering standards, material properties, biomechanical test results, or successful implantations. The document mentions "fatigue testing," "range of motion analysis," and "cadaveric implantation and surgeon assessment," which serve as forms of objective and expert-driven evaluation, but not "ground truth" in the AI/diagnostic sense.

8. The sample size for the training set

Not applicable.
This is a mechanical device, not an AI model that requires a training set.

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

Not applicable.
As there is no training set for an AI model, this question is not relevant.

Summary of what the document does provide:

Device Name: Exactech Alteon Monobloc Revision Stem
Predicate Device: Zimmer Wagner SL Revision Stem (K043356)
Purpose of Submission: To demonstrate substantial equivalence to the predicate device.
Non-Clinical Testing Mentioned:
- Fatigue testing
- Range of motion analysis
- Cadaveric implantation and surgeon assessment
- Biocompatibility assessment
Conclusion: "Results of engineering studies and comparison of key features included in this submission demonstrate the proposed Alteon Monobloc Revision Stem devices are substantially equivalent to cleared predicate Zimmer Wagner SL Revision Stem devices."

The provided text is a regulatory filing focused on substantial equivalence, which primarily involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically include the detailed performance metrics or study structures (like those for AI/diagnostic devices) that would answer the specific questions posed.

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 is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.

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

July 20, 2015

Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 North West 66th Court Gainesville, Florida 32653

Re: K150066 Trade/Device Name: Exactech Alteon Monobloc Revision Stem 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 Dated: May 28, 2015 Received: May 29, 2015

Dear Mr. Patrick Hughes:

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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(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 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/Resourcesfor You/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150066

Device Name Exactech Alteon Monobloc Revision Stem

Indications for Use (Describe)

· 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Exactech® Alteon™ Monobloc Revision Stem Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

Sponsor:	Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653
	Phone: (352) 327-4762Fax: (352) 378-2617
	FDA Establishment Number 1038671
Contact:	Patrick HughesSenior Regulatory Affairs Specialist
Date:	January 12, 2015

Trade of Proprietary or Model Name(s):

Exactech® Alteon™ Monobloc Revision Stem

Common Name:

Total Hip Arthroplasty – Femoral Components

Classification Name:

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (CFR 888.3353, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, Class II, Product Code LZO)

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K043356	Wagner SL Revision Stem	Zimmer

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Exactech® Alteon™ Monobloc Revision Stem Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

Indications for Use:

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:

Testing:

This submission includes results for the following non-clinical testing:

Fatigue testing ●
Range of motion analysis
Cadaveric implantation and surgeon assessment ●
Biocompatibility assessment ●

Substantial Equivalence Conclusion:

Results of engineering studies and comparison of key features included in this submission demonstrate the proposed Alteon Monobloc Revision Stem devices are substantially equivalent to cleared predicate Zimmer Wagner SL Revision Stem devices.

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.