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 M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.

Device Description

Exactech 12/14 Alumina Femoral Heads: Design changes to the proposed BIOLOX® forte 12/14 Ceramic Femoral Heads relative to Exactech's predicate Zirconia Ceramic Femoral Heads (#K914574, #K931617). The modifications include a change in the ceramic material composition from zirconia to alumina and a change in the taper geometry from a proprietary 11/13 design to a European 12/14 design. The proposed Ceramic Femoral Heads are composed of CeramTec BIOLOX® forte alumina material and have a European 12/14 bore design.

AcuMatch M-Series 12/14 Neck Segments: Modification of the AcuMatch M-Series neck segments (#K993736, #K010120). Modifications were made to the femoral stem cone design, neck geometry and through-hole diameter. The material composition, surface finish, neck angle, neck length and metaphyseal taper connection are unchanged.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for orthopedic implants (Exactech® Alumina Femoral Heads and M-Series Neck Segments). It describes design changes to existing, legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of a typical medical device performance study (e.g., diagnostic accuracy, clinical endpoint achievement).

Instead, it focuses on demonstrating substantial equivalence to predicate devices through design considerations and laboratory-based engineering evaluations. The "conclusion" section states:

"Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 alumina heads and the 12/14 neck segments would be adequate for anticipated in vivo loading. Based on successful results we conclude that the proposed devices are substantially equivalent Exactech's predicate devices."

This implies that the "acceptance criteria" were met if the new designs performed adequately in engineering tests simulating in vivo loading, demonstrating equivalence to the predicate devices. However, the specific quantitative acceptance criteria and detailed results of these tests are not provided in this summary.

Therefore, most of the requested information cannot be extracted from the provided text. Below, I will answer the questions based on the type of information presented in the document, highlighting what is missing.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Performance adequate for anticipated in vivo loading, demonstrating substantial equivalence to predicate devices.	"Successful results" from "testing and engineering evaluations" confirming adequacy for anticipated in vivo loading.

Details not available in the document: Specific quantitative acceptance criteria (e.g., load limits, fatigue cycles) and the exact performance metrics achieved by the device in these "testing and engineering evaluations."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document refers to "testing and engineering evaluations," which typically involve a limited number of physical samples for mechanical testing, not a "test set" of patient data.
Data Provenance: Not applicable in the context of this type of submission. The "evaluations" would be laboratory-based rather than from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert-established ground truth for a diagnostic or clinical outcome. The "ground truth" for mechanical performance would be established by engineering standards and validated testing protocols.

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

Not applicable. No clinical test set or adjudication process is described.

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. This submission is for orthopedic implants, not an AI or diagnostic imaging 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 AI device.

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

The "ground truth" for this type of device (orthopedic implant) is typically established by engineering and mechanical standards, simulating biomechanical forces and wear. These evaluations were used to demonstrate that the device is "adequate for anticipated in vivo loading" and "substantially equivalent" to predicate devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in this context.

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

Not applicable.

Summary

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

NOV 1 3 2003

2320 NW 661H COUF : GAINESVILLE, FL 32653

352-377-1140 FAX 352-378-2617

K032964

Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

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

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

FDA Establishment Number 1038671

Gary J. Miller Contact: Exec. V.P. of Research & Development

October 22, 2003 Date:

rev. 10/22/03

EXACTECH exist to inque the quility of included by munitive ad integendere. Ne to this through inovative ideos, high-quothy moves education and comminsent to serve.

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

Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

Trade / Proprietary Name:	Exactech
Model Name:	12/14 Alumina Femoral Head
Classification Name:	Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cementedor Non-Porous, Uncemented
Product Code:	LZO
C.F.R. Section:	not specified
Device Class:	II
Classification Panel:	Orthopedic

Trade / Proprietary Name:	Exactech AcuMatch
Model Name:	M-Series 12/14 Neck Segment
Name:	Prosthesis, Hip, Semi-Constrained, Metal/Polymer,Porous, Uncemented
Product Code:	LPH
C.F.R. Section:	888.3358

Legally Marketed Devices for Substantial Equivalence Comparison:

Exactech Zirconia Ceramic Femoral Head	#K914574
	#K931617
Exactech AcuMatch M-Series Femoral Stems
(Neck Segments)	#K010120

Section 4 Page 2 of 4

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

Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

Device Description:

INDICATIONS

AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.

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. The L-Series unipolar and bipolar endoprostheses are also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.

Exactech 12/14 Alumina Femoral Heads

This Special 510(k) application supports design changes to the proposed BIOLOX® forte 12/14 Ceramic Femoral Heads relative to Exactech's predicate Zirconia Ceramic Femoral Heads (#K914574, #K931617). The modifications include a change in the ceramic material composition from zirconia to alumina and a change in the taper geometry from a proprietary 11/13 design to a European 12/14 design.

The proposed Ceramic Femoral Heads are composed of CeramTec BIOLOX® forte alumina material and have a European 12/14 bore design. The material properties of BIOLOX® forte are described in FDA Master Files MAF-197, MAF-746, and MAF-747.

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

Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

AcuMatch M-Series 12/14 Neck Segments

This Spccial 510(k) application supports modification of the AcuMatch M-Series neck segments (#K993736, #K010120). Modifications were made to the femoral stem cone design, neck geometry and through-hole diameter. The material composition, surface finish, neck angle, neck length and metaphyseal taper connection are unchanged.

Conclusion:

Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 alumina heads and the 12/14 neck segments would be adequate for anticipated in vivo loading. Based on successful results we conclude that the proposed devices are substantially equivalent Exactech's predicate devices.

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

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

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

Re: K032964 Trade/Device Name: Exactech 12/14 Alumina Femoral Head, Exactech AcuMatch M-Series 12/14 Neck Segment Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO Dated: October 22, 2003 Received: October 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, 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 (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 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

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

Page 2 - Ms. Lisa Simpson

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.

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) 594-4659. 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 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,

for Mark A. Mellema

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

Enclosure

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

Exactech®, Inc.

Image /page/6/Picture/1 description: The image contains a hand-drawn circle with the text '#4' inside. The number 4 is written in a simple, slightly tilted style. The circle appears to be drawn with a pen or marker, and the overall image has a casual, informal look.

Exactech 12/14 Alumina Femoral Head Exactech AcuMatch M-Series 12/14 Neck Segment

Indications for Use

510(k) Number:

K032964

INDICATIONS

AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Fcmoral Heads are intended to be used in press-fit and cemented applications.

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion 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)

Prescription Use

Al or N Over the Counter Use
Division Sign Off

Estorative

spinal Neurological Devices

rev. 10/22/03

(k) Number

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.