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 Novation LPI Prime Femoral Stem is a titanium press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The proximal region of the stem is coated with porous titanium plasma spray for uncemented, biological fixation.

The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:

Exactech Cobalt Chromium Alloy Femoral Heads (K041906) .
Exactech Ziramic Zirconia Femoral Heads (K050398, K060107) .
Exactech BIOLOX®forte Alumina Femoral Heads (K032964, K051682) .
Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
AcuMatch L-series Unipolar endoprosthesis (K010081)

The proposed femoral stems are intended to mate with the following bipolar components:

AcuMatch L-Series Bipolar Endoprosthesis (K013211) .

AI/ML Overview

The provided document is a 510(k) summary for the Exactech® Novation® LPI Prime Femoral Stem, a medical device. It does not describe an AI/ML device or present a study comparing AI performance against acceptance criteria in the typical sense of a diagnostic or predictive algorithm.

Therefore, the requested information about acceptance criteria, device performance in terms of metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance is not applicable to this document.

Instead, this document describes the regulatory submission for a physical medical implant (a femoral stem for hip replacement) and establishes its substantial equivalence to previously marketed devices based on technological characteristics and mechanical testing.

Here's a breakdown of the relevant information from the document, rephrased to fit the context of a medical device submission, rather than an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Context)

Acceptance Criteria (based on standards/guidance)	Reported Device Performance (based on testing/analysis)
Materials conform to recognized industry standards for permanent implants.	Composed of materials conforming to recognized industry standards (e.g., titanium for the stem, porous plasma spray).
Sterilization processes conform to recognized industry standards.	Provided sterile for single use and conforms to recognized industry standards.
Design features are similar to predicate devices.	Incorporates similar design features to predicate devices.
Performance specifications conform to recognized performance standards for total hip replacement devices.	Demonstrates substantial equivalence through: - Clinical Literature Review of similar femoral prostheses. - Cadaver lab validation for design features. - Finite Element Analyses for worst-case size. - Range of Motion testing per EN ISO 21535. - Distally Fixed Fatigue Worst case Press-fit Fatigue Testing per FDA guidance. - Femoral Neck Fatigue Worst case Press-fit Fatigue Testing per FDA guidance. - Femoral Head Modular Junction Burst Testing and Axial pull-off Testing on the taper specification.
Intended Use is similar to predicate devices.	Similar indications for use as predicate devices (e.g., hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, fractures).

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

This is not applicable as it's not an AI/ML study. The "test set" here refers to mechanical and cadaveric testing.
Mechanical Testing: The document mentions "worst case size for testing" for fatigue tests, implying specific sample selections rather than a broad 'test set' in the data sense.
Cadaver Lab: Used for "validation demonstrating the design features," implying a limited number of cadavers for physical fit and design assessment.
Data Provenance: Not explicitly stated as "data provenance" but the clinical literature review would draw from existing medical literature, likely international. Cadaver labs and mechanical testing are typically conducted in-house or by contract labs.

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

Not applicable in the context of AI/ML. The "ground truth" for a medical device like this is established through engineering principles, adherence to recognized standards, and clinical experience of surgeons.
The "experts" involved would be biomechanical engineers, materials scientists, regulatory specialists, and orthopedic surgeons (for cadaver lab validation and clinical input) but their number or specific qualifications are not detailed in this summary.

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

Not applicable as it's not an AI/ML study involving expert consensus on data. The "adjudication" in this context would be regulatory review by the FDA.

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, as this is a physical medical device, not an AI/ML algorithm for image interpretation or diagnosis.

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

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

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

The closest equivalent to "ground truth" for this device would be established engineering principles, international performance standards for hip implants (e.g., EN ISO 21535), and clinical practice guidelines, validated through mechanical testing and cadaveric studies. The objective is to demonstrate safety and effectiveness for its intended use, primarily through mechanical integrity and functional fit.

8. The sample size for the training set:

Not applicable as this is a physical medical device, not an AI/ML algorithm. There is no "training set" in this context. The design of the device would be informed by biomechanical principles, prior device designs, and clinical experience.

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

Not applicable.

Summary

{0}------------------------------------------------

121684 Exactech® Novation® LPI Prime Femoral Stem Traditional 510(k)

510(k) Summary

Company:	Exactech®, Inc2320 NW 66th CourtGainesville FL, 32653
Date:	September 24, 2012
Contact Person:	Vladislava Zaitseva

Vladislava Zaitseva Contact Person: Regulatory Affairs Specialist II Telephone: (352) 327-4674 Fax: (352) 378-2617

Exactech® Novation® LPI Prime Femoral Stem Proprietary Name:

Femoral Hip Stem Common Name:

Classification Name:

A - France

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (21 CFR Section 888.3353, Class II, Product Code LZO)

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (21 CFR Section 888.3390, Class II, Product Code KWY)

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358, Device Class: II, Product Code: LPH)

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Name	Manufacturer	510(k) Number
Metha Short Stem Hip System	Aesculap	K080584 and K112682

Device Description

The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:

Exactech Cobalt Chromium Alloy Femoral Heads (K041906) .
Exactech Ziramic Zirconia Femoral Heads (K050398, K060107) .
Exactech BIOLOX®forte Alumina Femoral Heads (K032964, K051682) .
Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
AcuMatch L-series Unipolar endoprosthesis (K010081)

Ocr

1 2012

{1}------------------------------------------------

The proposed femoral stems are intended to mate with the following bipolar components:

AcuMatch L-Series Bipolar Endoprosthesis (K013211) .

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. .
Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.

Summary of Technological Characteristics

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

Intended Use. The proposed Novation LPI Prime Femoral Stems and . predicate devices have similar indications for use.
Materials. The proposed Novation LPI Prime Femoral Stems and predicate . devices are composed of materials conforming to recognized industry standards for permanent implants.
Sterilization processes. The proposed Novation LPI Prime Femoral Stems ● and predicate devices are provided sterile for single use and conform to recognized industry standards.
Design Features. The proposed Novation LPI Prime Femoral Stems and . predicate devices incorporate similar design features.
Performance specifications. The proposed Novation LPI Prime Femoral . Stems and predicate devices conform to recognized performance standards for total hip replacement devices.

Substantial Equivalence Conclusion

Results from mechanical testing, engineering analyses, simulated surgical implantations and literature reviews demonstrate the proposed Novation LPI Prime Femoral Stems are substantially equivalent to the predicate devices. A summary of these tests and analyses are as follows:

Clinical Literature Review of similar femoral prostheses .
Cadaver lab validation demonstrating the design features (including outside . geometry and overall scope).
Finite Element Analyses for determination of worst case size for testing. t

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the text "K121684" at the top. Below that, the text "Exactech® Novation® LPI Prime Femoral Stem" is displayed. The last line of text says "Traditional 510(k)". The image appears to be a label or identifier for a medical device, specifically a femoral stem.

Range of Motion testing per EN ISO 21535, Non-active surgical implants --. Joint replacement implants -- Specific requirements for hip-joint replacement implants
Distally Fixed Fatigue Worst case Press-fit Fatigue Testing per FDA guidance .
Femoral Neck Fatigue Worst case Press-fit Fatigue Testing per FDA guidance .
Femoral Head Modular Junction Burst Testing and Axial pull-off Testing on . the taper specification

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three lines forming a stylized staff with a serpent entwined around it. The text is in a simple, sans-serif font.

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

Exactech, Incorporated % Ms. Vladislava Zaitseva Regulatory Affairs Specialist II 2320 NW 66th Court Gainesville, Florida 32653

OCT
1 2012

Re: K121684

Trade/Device Name: Exactech® Novation® LPI Prime Femoral Stem 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, KWY Dated: September 11, 2012 Received: September 12, 2012

Dear Ms. Zaitseva:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

Page 2 - Ms. Vladislava Zaitseva

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/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 vours.

Sincerely yours,

Mark A. Milliman

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

Enclosure

{5}------------------------------------------------

Exactech® Novation® LPI Prime Femoral Stem

Traditional 510(k)

Indications for Use

510(k) Number:

1/2/684

Device Name: Exactech® Novation® LPI Prime Femoral Stem

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. .
Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Over-The-Counter Use and/or X Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ast

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121684

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.