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.

AcuMatch Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.

Device Description

AcuMatch P-Series Porous Femoral Stems are composed of titanium alloy (Ti-6A1-4V) conforming to ASTM F1472-99. The stems have a trapezoidal cross-sectional geometry, distal taper, and calcar collar option. There are two offset options available. The porous bead coating on the proximal portion of the stem is composed of titanium beads meeting the specifications of ASTM F67-95, Grade 2. An optional hydroxyapatite (HA) coating is also available. The products are provided as sterile, single use only with a sterility assurance level (SAL) of 10-0.

AI/ML Overview

This 510(k) summary describes a premarket notification for a new femoral component for hip replacement, not an AI/ML device, therefore, the requested information elements related to AI/ML device performance and study design are not applicable.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document for the Exactech AcuMatch Integrated Hip System P-Series Porous Femoral Components is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and reporting performance in the same way an AI/ML device might.

For this medical device, the "acceptance criteria" are implied by the demonstration of substantial equivalence through:

Common Design Features: The new device shares design attributes with predicate devices.
Material Properties: The new device uses materials consistent with predicate devices (titanium alloy (Ti-6Al-4V) conforming to ASTM F1472-99, titanium beads conforming to ASTM F67-95).
Fatigue Testing: Performed to verify adequate implant performance for anticipated in vivo loading. This is the closest equivalent to a performance metric, though specific numerical criteria and results are not detailed in this summary.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Common design features with predicate devices	"The predicate and proposed devices share common design features."
Consistent material properties with predicate devices	Composed of titanium alloy (Ti-6Al-4V) conforming to ASTM F1472-99. Porous bead coating composed of titanium beads meeting ASTM F67-95, Grade 2. (Matches industry standards for these materials).
Adequate performance for in vivo loading	"Fatigue testing was performed to verify that the implant performance would be adequate for anticipated in vivo loading." (Specific quantitative results or thresholds not provided in this summary)

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

Not applicable. This is a physical medical device (femoral component for hip replacement), not a software or AI/ML device that uses test sets or data. The "testing" referred to is mechanical fatigue testing of the physical implant.

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

Not applicable. Ground truth, in the context of expert review, is not relevant for this type of physical device's substantial equivalence determination.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically for evaluating subjective expert opinions on data, which isn't the case for a physical implant's mechanical testing.

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

Not applicable. MRMC studies are for evaluating human performance, often with or without AI assistance, which is not relevant for this physical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used:

For a physical orthopedic implant, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness typically involves:

Engineering Standards and Specifications: Adherence to established ASTM standards for materials (F1472-99 for titanium alloy, F67-95 for titanium beads).
Mechanical Testing Results: Data from fatigue testing that demonstrates the device can withstand anticipated physiological loads and cycles. While the summary states testing was done, the specific results or definition of "adequate" are not provided.
Historical Performance of Predicate Devices: The long-term clinical success and safety profile of the legally marketed predicate devices serve as the "ground truth" for the new device's expected performance, given its substantial equivalence in design and materials.

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. There is no "training set" for this physical medical device.

Summary

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Exactech®

K030236

2320 NW 66TH COUF GAINESVILLE, FL 3265

352-377-1140 FAX 352-378-2617

Exactech® AcuMatch™ Integrated Hip System P-Series Porous Femoral Components

510(k) Summary of Safety and Effectiveness Special 510(k)

FEB 2 0 2003

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

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

FDA Establishment Number 1038671

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

Date: January 20, 2003

Section 4 Page 1 of 3

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Exactech® AcuMatch™ Integrated Hip System P-Series Porous Femoral Components

510(k) Summary of Safety and Effectiveness Special 510(k)

Classifications / Proprietary Names:

Classification Names:	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous, Uncemented (Femoral Component)
Product Code:	LPH
Trade / Proprietary Model Names:	AcuMatch P-Series Porous Press-Fit Femoral Component
C.F.R. Section:	888.3358
Device Class:	II
Classification Panel:	Orthopedic

Legally Marketed Devices for Substantial Equivalence Comparison:

Model	Manufacturer	510(k) Number
AcuMatch P-Series PlasmaFemoral Stem	Exactech	K002141
MCS PorousFemoral Stem	Exactech	K921113 K990197
AML Porous	Depuy	K003800 K012364
Synergy Porous	Smith & Nephew	K991485 K002996

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Exactech® AcuMatch™ Integrated Hip System P-Series Porous Femoral Components

510(k) Summary of Safety and Effectiveness Special 510(k)

Device Description:

Indications for Use

AcuMatch Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.

Contraindications

Exactech Hip Systems 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.

Design Features

Substantial Equivalency

AcuMatch P-Series Porous stems are substantially equivalent to other femoral components, most notably the Exactech MCS and P-Series Plasma stems. The predicate and proposed devices share common design features and material properties. Fatigue testing was performed to verify that the implant performance would be adequate for anticipated in vivo loading.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three arms or wing-like extensions. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. The text is in a simple, sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

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

Re: K030236

Trade/Device Name: AcuMatch P-Series Porous Press-Fit Femoral Component Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: January 20, 2003

Received: January 23, 2003

Dear Ms. Simpson:

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. Iisting 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 mav 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 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.

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Page 2 – Ms. Lisa Simpson

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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark n Milleson

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

Enclosure

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Exactech® AcuMatch™ Integrated Hip System P-Series Porous Press-Fit Femoral Components

Indications for Use

510(k) Number:

K030436

Device Name:

AcuMatch P-Series Porous Press-Fit Femoral Stem

Indications for Use:

AcuMatch Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.

Contraindications:

system

Division Sign Off

of General, Restorative ological Devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use $\mu_s$

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.