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 LPB 12/14 Femoral Stems are intended to be used in press-fit and cemented applications.

Device Description

The Exactech M-Series LPB 12/14 Femoral Stem is a modular four-piece system consisting of a proximal neck segment, metaphyseal segment, diaphyseal segment and metaphyseal assembly screw. All of the components are interchangeable, therefore allowing for many sizing combinations to meet varying anatomical situations. The neck segments are machined from titanium alloy bar stock or forgings (ASTM F-1472), the metaphyseal segments are machined from titanium alloy forgings (ASTM F-1472), and the distal segments are machined from titanium alloy bar stock (ASTM F-1472). The metaphyseal screws are machined from titanium alloy (ASTM F 136). The LPB system is a modification to the Exactech M-Series 12/14 Femoral Stem system cleared through premarket notifications #K993736, #K011081 and #K032964. Changes to the device relative to the predicates include minor geometry modifications, raw material manufacturing changes and application of a low-plasticity burnishing (LPB) process to the distal taper of the neck segments.

AI/ML Overview

The provided text describes a Special 510(k) Summary of Safety and Effectiveness for the Exactech® AcuMatch M-Series LPB 12/14 Femoral Stems. This type of submission is used when a device is significantly equivalent to a previously cleared device (predicate device) and involves minor modifications.

Crucially, this document does not contain an independent clinical study with acceptance criteria and reported device performance metrics in the way one would typically describe for a new diagnostic AI device. Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on design modifications and associated verification activities.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not present in this type of regulatory submission.

Here's an attempt to address the request based on the available information:

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

This document does not present quantitative acceptance criteria or performance metrics in the form of a table. The "acceptance criteria" for this Special 510(k) are met by demonstrating that the modified device, through risk assessment of design changes and successful completion of associated verification activities, remains substantially equivalent to the predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the predicate devices.

2. Sample sized used for the test set and the data provenance

Not applicable. This document describes mechanical/material modifications to an existing device, not a study involving a "test set" of patient data.

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

Not applicable.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This is not an AI device or a diagnostic device where MRMC studies would be conducted.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable in the typical sense of a diagnostic study. The "ground truth" here relates to engineering and material science principles, ensuring the modified materials and geometry meet established safety and performance standards for orthopedic implants.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "study" in this context is the risk assessment of design changes and associated verification activities. The "acceptance criteria" are implied by demonstrating that these activities confirm the device's continued substantial equivalence to the predicate devices.

Device Changes: The changes to the device (relative to predicates K993736, K011081, K032964) include:
- Minor geometry modifications.
- Raw material manufacturing changes.
- Application of a low-plasticity burnishing (LPB) process to the distal taper of the neck segments.
Verification Activities: The document states that the conclusion of substantial equivalence is "Based on a risk assessment of the design changes and successful completion of the associated verification activities". While the details of these verification activities are not provided in this summary, they would typically involve:
- Mechanical testing (e.g., fatigue, static strength, wear) to ensure the modified components meet or exceed the performance of the predicate device.
- Biocompatibility testing (if new materials or significant processing changes affecting biocompatibility were introduced).
- Material characterization (e.g., to confirm the properties of the raw materials and the effect of the LPB process).
Conclusion: The regulatory acceptance, indicated by the FDA's 510(k) clearance letter (K051858), signifies that the FDA agreed with Exactech's conclusion of substantial equivalence to legally marketed predicate devices, meaning the device's safety and effectiveness were demonstrated through engineering verification, not a clinical trial with patient outcome data.

Summary

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长051858 2005 DEC 1 Exactech®

AcuMatch M-Series LPB 12/14 Femoral Stems

Special 510(k) Summary of Safety and Effectiveness

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

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

FDA Establishment Number 1038671

Contact: Michael S. Simpson Vice President, Regulatory and Clinical Affairs

November 30, 2005 Date:

Section 4 Page 1 of 3

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K051858

p. 2/3

ن لالك . لبادا

ات بيالوا

Exactech® AcuMatch M-Series LPB 12/14 Femoral Stems

Special 510(k) Summary of Safety and Effectiveness

Trade or proprietary or model name(s):
AcuMatch M-Series LPB 12/14 Femoral Stem:
• M-Series LPB 12/14 Neck Segment
• M-Series Plasma Metaphyseal Segment
• M-Series Plasma Calcar Segment
• M-Series Distal Segments (Straight, Curved)

ProductClassification:	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
Product Code:	LWJ	C.F.R.Section	Not specified
ClassificationPanel:	Orthopedic	DeviceClass:	II

ProductClassification:	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented non-porous, uncemented
Product Code:	LZO	C.F.R.Section	888.3353
ClassificationPanel:	Orthopedic	DeviceClass:	II
ProductClassification:	Prosthesis, hip, semi-constrained, metal/polymer, cemented
Product Code:	JDI	C.F.R.Section	888.3350
ClassificationPanel:	Orthopedic	DeviceClass:	II

	Information on devices to which substantial equivalence is claimed.
510(k)Number	Trade or Proprietary or Model Name	Manufacturer
#K993736	AcuMatch M-Series Femoral Stem(S, M, L metaphyseal, calcar & distal segments)	Exactech, Inc.
#K011081	AcuMatch M-Series Femoral Stem(XS metaphyseal segments)	Exactech, Inc.
#K032964	AcuMatch M-Series Femoral Stem(12/14 neck segments)	Exactech, Inc.

rev. 11/30/05

Section 4
Page 2 of 3

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K051858

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Exactech® AcuMatch M-Series LPB 12/14 Femoral Stems

Special S10(k) Summary of Safety and Effectiveness

INDICATIONS

AcuMatch M-Series LPB 12/14 Femoral Stems 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.

DEVICE DESCRIPTION

CONCLUSION

Based on a risk assessment of the design changes and successful completion of the associated verification activities, we conclude that the AcuMatch M-Series LPB 12/14 Femoral Stems are substantially equivalent to the predicate AcuMatch M-Series 12/14 Femoral Stem components cleared through premarket notifications #K993736, #K011081 and #K032964.

rev. 11/30/05

Section 4 Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 DEC 1

Michael S. Simpson Vice President, Regulatory & Clinical Affairs Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K051858 Trade/Device Name: AcuMatch M-Series LPB 12/14 Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, JDI, LWJ Dated: November 1, 2005 Received: November 3, 2005

Dear Mr. 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 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- Michael S. Simpson

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally premailed.org. The Presults 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 if you desire specific at notially 3 at (240) 276-0120. 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 other general intermational and Consumer Assistance at its toll-free number (800) 638-2041 or 14.01) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark Melkerson رمن Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech®, Inc.

AcuMatch M-Series LPB 12/14 Femoral Stem

Indications for Use

510(k) Number:

K051858

INDICATIONS

AcuMatch M-Series LPB 12/14 Femoral Stems are intended to be used in press-fit and cemented applications.

CONTRAINDICATIONS

Prescription Use	X	or	Over the Counter Use
------------------	---	----	----------------------	--

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K051858
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rev. 06/27/05	Section 3
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rev. 06/27/05

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.