AcuMatch Press-Fit Femoral 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 AcuMatch Integrated Hip System.are.also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

AcuMatch Press-Fitt Femoral Components are intended to be used in press fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.

Device Description

AcuMatch Press-Fit Stems are made of similar materials and are of a similar design to other legally marketed femoral components, most notably the Exactech MCS femoral components. The proposed AcuMatch models are composed of titanium alloy (Ti-6Al-4V), have a trapezoidal crosssectional geometry, secondary distal tapers, optional calcar collars and optional hydroxyapatite (HA) coatings. The HA coating available on the AcuMatch models is identical to the one used for the predicate MCS component.

AI/ML Overview

The Exactech AcuMatch™ Integrated Hip System Press-Fit Femoral Components underwent performance testing to establish substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the performance results of the AcuMatch Press-Fit stems to those of the predicate Exactech MCS design, which has a positive clinical history. The acceptance criterion is that the AcuMatch results must "exceed those of the predicate MCS design."

Acceptance Criteria	Reported Device Performance
Adequate for anticipated in vivo loading	AcuMatch results exceeded those of the predicate MCS design.
No reported stem failures (reference MCS)	Predicate MCS design has a clinical history in excess of 7 years with no reported stem failures.
Material specifications met	Vendor material certifications were part of the performance data.
Design considerations met

2. Sample Size and Data Provenance for Test Set:

Sample Size: The document mentions "production quality parts" were used for fatigue testing, but a specific number is not provided.
Data Provenance: The tests appear to be prospective in nature, conducted specifically for the AcuMatch device. The country of origin of the data is implied to be within the United States, given the sponsor (Exactech Inc., Florida, USA).

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable as the study focuses on mechanical performance testing, not human expert interpretation for establishing ground truth.

4. Adjudication Method for Test Set:

This information is not applicable as the study focuses on mechanical performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not performed/applicable. This study is for a medical device (hip implant) and involves mechanical performance testing, not a diagnostic imaging study that would typically utilize an MRMC design.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

Not applicable. This device is a physical implant, not a software algorithm with or without human-in-the-loop performance. The "performance" here refers to the mechanical integrity of the implant itself.

7. Type of Ground Truth Used:

The ground truth for the performance claims appears to be:

Mechanical Testing Results: This includes fatigue testing of the device and material properties.
Predicate Device Clinical History: The successful 7-year clinical history of the similar MCS design without reported stem failures serves as a form of "ground truth" to establish the safety and effectiveness of the design principles.

8. Sample Size for Training Set:

Not applicable. This study does not involve machine learning or a "training set" in the conventional sense.

9. How Ground Truth for Training Set was Established:

Not applicable. As there is no training set for a machine learning model, this question is irrelevant to the provided document.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Exactech" in white letters on a black background. The word is in a bold, sans-serif font. To the left of the word is a white circle with a gap in the upper right quadrant. The image is simple and clean, with a focus on the company name.

Koo214/

2320 NW 66TH COURT GAINESVILLE, FL 32653

352-377-1140 FAX 352-378-2617

AUG 1 6 2000

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

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

Sponsor:

Exactech® Inc. 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. V.P. of Research and Development

Date:

July 14, 2000

Section 4 Page 1 of 5

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

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

LWJ

not specified

Classifications / Proprietary Names:

Classification Name:

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (Femoral Component)

Trade / Proprietary Model Names:

AcuMatch P-Series Press-Fit Plasma AcuMatch P-Series Press-Fit AcuMatch L-Series Press-Fit

Product Code:

C.F.R. Section:

Device Class:

Classification Panel: Orthopedic

Classification Name:

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (Femoral Component)

Trade / Proprietary Model Names:

AcuMatch P-Series Press-Fit Plasma / HA AcuMatch P-Series Press-Fit / HA AcuMatch L-Series Press-Fit / HA

Product Code:

not specified

Device Class:

C.F.R. Section:

MEH

Classification Panel: Orthopedic

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

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

Legally Marketed Devices for Substantial Equivalence Comparison:

The Exactech AcuMatch Press-Fit Stems are made of similar materials and are of a similar design to other legally marketed femoral components, most notably the Exactech MCS femoral components:

Model	Manufacturer	510(k) Number	Product Code
MCS	Exactech	921113	LPH
MCS/HA	Exactech	990197	MEH

Perfecta	Wright MedicalTechnology	----------	----------
Synergy HA	Smith & Nephew	----------	----------
Synergy Press-Fit	Smith & Nephew	----------	----------
Secur-Fit HA	Osteonics	----------	----------
APR FullyTextured	Sulzer	----------	----------

Device Description

Indications for Use:

AcuMatch Press-Fit Stems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, dhenmatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-taunatio degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred tratment. Components of AcuMatch Integrated Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is prased ond to restore mobility resulting from previous fusion.

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

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

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

Contraindications:

AcuMatch Press-Fit Femoral 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.

The indications/contraindications for use for the proposed AcuMatch Press-Fit Femoral Components are identical to those of our predicate Exactech MCS and MCS/HA Femoral Components (#K921113,#K990197).

Material	Composition
Inner / Outer Trays	PETG - 0.040" thickness
Tray Lids	Spun-Bonded Olefin - Tyvek®
Inserts	Medium grade LD45 Foam
Box	Heavy weight cardboard
Outer Shrink-Wrap	Clear, Light-Weight Plastic
Shipping Cartons	Heavy-weight Corrugated Cardboard

Packaging Materials:

Utilization and implantation instructions are included in the package insert provided with each product. The name, size, dimension, material, lot, serial number and sterility status are indicated on the labeling.

Sterilization Specifications:

Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 100

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

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

Substantial Equivalency Comparison:

Like the Exactech MCS models (ref. #K921113 and #K990197), the proposed AcuMatch models are composed of titanium alloy (Ti-6Al-4V), have a trapezoidal crosssectional geometry, secondary distal tapers, optional calcar collars and optional hydroxyapatite (HA) coatings. The HA coating available on the AcuMatch models is identical to the one used for the predicate MCS component.

The differences in design features between the proposed AcuMatch and predicate MCS models include changes in the manufacturing technique, dimensional modifications to the neck region, a new sizing differential and changes to the surface presentations.

These design changes for the proposed AcuMatch models do not affect the intended use of the device and do not alter the fundamental scientific technology of the device.

In addition, the AcuMatch Press-Fit Stems have basic design features in common with femoral components designed by other orthopedic companies. These include but are not limited to Wright Medical's "Perfecta", Osteonic's "Secur-Fit HA", Sulzer's "APR Fully Textured" and Smith & Nephew's "Synergy" press-fit designs.

Performance Information:

Functional tests were conducted to verify that the performance of the AcuMatch Press-Fit stems would be adequate for anticipated in vivo loading. This performance data included fatigue testing of production quality parts, rotating beam fatigue tests of the wrought and forged materials, and vendor material certifications. The AcuMatch results exceeded those of the predicate MCS design which has a clinical history in excess of 7 years with no reported stem failures.

Based on the fatigue performance data, material specifications and design considerations, it is felt that the Exactech AcuMatch Press-Fit femoral components are substantially equivalent to the Exactech MCS femoral components (#K921113, #K990197).

Section 4 Page 5 of 5

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and below the eagle are three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

AUG 1 6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K002141

Trade Name: AcuMatch P-Series Press-Fit, Plasma and HA Coated Femoral Components AcuMatch L-Series Press-Fit and HA Coated Femoral Components Regulatory Class: II Product Code: LWJ and MEH Dated: July 14, 2000 Received: July 17,2000

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 control provisions of the Act. The general control 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.

{6}------------------------------------------------

Page 2 - Ms. Lisa Simpson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in Thio diagnostions on the promotion and advertising of your device, (301) 594-4037. Additionally, for quest 21 (1) 594-4639. Also, please note the regulation prease connect the Office or Compilance en premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on Jour responsibility the number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

e R. lochner

M 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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Indications for Use

510(k) Number:

1002141

Device Name:

AcuMatch P-Series Press-Fit Plasma AcuMatch P-Series Press-Fit AcuMatch L-Series Press-Fit

AcuMatch P-Series Press-Fit Plasma/HA AcuMatch P-Series Press-Fit/HA AcuMatch L-Series Press-Fit/HA

Intended Use / Indications:

AcuMatch Press-Fitt Femoral Components are intended to be used in press fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.

Contraindications:

AcuMatch Press-Fit Femoral Stem 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.

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

			Concurrence of CDRH, Office of Device Evaluation (ODE) Vochines.
			(Division Sign-Off)
			Division of General Restorative Devices
			510(k) Number K002141
Prescription Use	yes	or	Over the Counter Use No

Section 3Page 1 of 1

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.