AcuMatch M-Series Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis, and/or post-traumatic degenerative problems. M-Series components are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.

AcuMatch M-Series components are intended to be used in press-fit and cemented applications.

Device Description

The Exactech Modular Stem is a four-piece system consisting of a proximal neck segment, metaphyseal segment, diaphyseal segment and a locking screw. All of the components are interchangeable, therefore allowing for many sizing combinations to meet varying anatomical situations. The components are composed of titanium alloy. Design changes were made to the original neck segments cleared through premarket notification #K993736:

A. High Offset Neck Segments
- Material was added to the lateral radius of all neck segments. 1.
- 1. A new "-5 Neck Segment" model was added.

B. Low Offset Neck Segments

A new "Low Offset" Neck version of neck is proposed. These models represent a reduction in horizontal offset of 5mm as compared to the predicate design (#K993736):

Low Offset -- 5 Neck Segment 1.
Low Offset Standard (+0) Neck Segment 2.
1. Low Offset +10 Neck Segment

AI/ML Overview

The provided document is a 510(k) summary for the Exactech AcuMatch Integrated Hip System M-Series Femoral Stem Component, focusing on high and low off-set neck segments. It does not describe a study involving device performance for diagnostic purposes, or any human-in-the-loop or standalone AI performance. Instead, it describes a Finite Element Analysis to demonstrate substantial equivalence for a medical implant. Therefore, most of the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, and expert involvement for a diagnostic device is not applicable to this submission.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance adequate for anticipated in-vivo loading.	Finite Element Analysis (FEA) showed the proposed devices have "performance characteristics similar to or better than Exactech's predicate M-Series neck design."

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

Not applicable. The study was a Finite Element Analysis (FEA), which is a computational simulation, not a clinical study with a test set of human subjects or patient data.

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

Not applicable. FEA is a computational method; it does not involve expert readers establishing ground truth in the same way a diagnostic image interpretation study would. The 'ground truth' in FEA is based on engineering principles and material properties.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in the context of human readers.

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

No, an MRMC comparative effectiveness study was not done. The submission relies on a computational analysis (FEA) to demonstrate substantial equivalence.

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

Not applicable. This is not a diagnostic algorithm; it's a structural component for a hip implant. The "standalone performance" was evaluated through FEA, which is a simulation of the device's mechanical behavior.

7. The Type of Ground Truth Used

The "ground truth" for the Finite Element Analysis (FEA) would be the established engineering principles, material properties (e.g., titanium alloy characteristics), and biomechanical loading conditions used in the simulation, as compared to the predicate device. The goal was to show that the new designs performed similarly or better under these simulated conditions.

8. The Sample Size for the Training Set

Not applicable. As FEA is a simulation, there isn't a "training set" in the sense of machine learning algorithms. The FEA model is built based on the design specifications of the device.

9. How the Ground Truth for the Training Set was Established

Not applicable. The FEA model's "ground truth" (i.e., its accuracy in predicting real-world behavior) is established through validation against physical testing data or established engineering benchmarks for the materials and design principles used. This document references the predicate device's performance as a benchmark.

Summary

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lo120

2320 NW 66TH COUR1 GAINESVILLE, FL 3265.

352-377-1140 FAX 352-378-2617

FEB - 9 2001

Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

510(k) Summary of Safety and Effectiveness

Sponsor:

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

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

FDA Establishment Number 1038671

Gary J. Miller, Ph.D. Contact: Executive V.P. of Research and Development

Date:

January 10, 2001

Section 4 Page 1 of 4

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Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

510(k) Summary of Safety and Effectiveness

Trade Name:	Exactech® AcuMatch M-SeriesHigh Off-Set NeckLow Off-Set Neck
Common Name:	Total Hip Prosthesis Femoral Component
Classification Name:	Prothesis, Hip, Semi-Constrained, Metal/Polymer,Porous, Uncemented (Femoral Component)
Product Code:	LPH
Device Class:	II
Classification Panel:	Orthopedic

Legally Marketed Devices for Substantial Equivalence Comparison:

Model	Manufacturer	510(k)
M-Series	Exactech Inc.	#K993736
S-Rom	Joint MedicalProducts
Impact	Biomet
Mallory Head	Biomet
Link	Link America

The AcuMatch M-Series high and low off-set neck segments are made of similar materials and are of a similar design to other legally marketed modular femoral components. Most notably, the proposed neck segments are equivalent in materials and design to the Exactech's predicate M-Series neck segments. M-Series components are also similar to the "S-ROM" by Joint Medical Products Corporation, the Biomet "Impact", and "Mallory-Head" and the "Link MP" by Link America.

Section 4 Page 2 of 4

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Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

510(k) Summary of Safety and Effectiveness

Description:

A. High Offset Neck Segments
- Material was added to the lateral radius of all neck segments. 1.
- 1. A new "-5 Neck Segment" model was added.

B. Low Offset Neck Segments

A new "Low Offset" Neck version of neck is proposed. These models represent a reduction in horizontal offset of 5mm as compared to the predicate design (#K993736):

Low Offset -- 5 Neck Segment 1.
Low Offset Standard (+0) Neck Segment 2.
1. Low Offset +10 Neck Segment

Intended Use:

AcuMatch M-Series components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 the M-Series are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

The AcuMatch M-Series components are indicated for press-fit and cemented applications.

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Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

510(k) Summary of Safety and Effectiveness

Contraindications:

AcuMatch M-Series components are contraindicated in patients with active infection, Aculviation M-36Ttes components are to allow appropriate insertion and fixation of the patients without surficient bolle stock of the mot allow control of the hip joint, and in prosulchis, in nedromascural enetivity level would cause the surgeon to expect early failure of the system.

Performance Data Summary:

Finite Element Analysis was conducted to verify that the performance of the proposed I high and low off-set neck segments would be adequate for anticipated in-vivo loading. The results showed that the proposed devices have performance characteristics I he results blowed than Exactech's predicate M-Series neck design.

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Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

FEB = 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Simpson Regulatory Representative Exactech 2320 NW 66" Court Gainesville, Florida 32653

Re: K010120

Trade Name: Exactech® Integrated Hip System

AcuMatch™ M-series Femoral Stem Component High and Low Offset Neck Segments Regulatory Class: II Product Code: LPH Dated: January 10, 2001

Received: January 16, 2001

Dear Ms. Simpson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Lisa Simpson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Mulkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component

Indications for Use

510(k) Number:

K0/0/20

Device Name:

Exactech Integrated Hip System AcuMatch M-Series Femoral Stem Component High Off-Set Neck Segment Low Off-Set Neck Segment

Indications for use:

AcuMatch M-Series components are intended to be used in press-fit and cemented applications.

Contraindications:

AcuMatch M-Series components are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.

Mark N Melkerson

Division Sign-Off) Division of General, R rative and Neurological Devi

< 010120

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

510(k) Number

time - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use

Counter Use No

Section 3 Page 1 of 1

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.