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.

Novation® press-fit femoral stems are intended for press-fit fixation.

Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Device Description

The proposed Exactech Novation 12/14 Press-Fit Femoral Components are a modification of the AcuMatch P-Series Plasma Press-Fit Femoral Stems cleared through premarket notifications #K041906.

The predicate and proposed products have the same intended use and the same basic fundamental scientific technology.

The modified Novation femoral stems share the following similarities to the predicate AcuMatch femoral stems:

the same indications for use, .
similar design features (e.g. neck angle, femoral head taper design (12/14), neck . flat geometry (angled), offsets - standard and extended).
the same materials (titanium alloy, commercially pure titanium plasma spray and . hydroxyapatite coating)
the same shelf life (5 years), and .
are packaged and sterilized using the same materials and processes (gamma . radiation sterilization to a sterility assurance level (SAL) of 10").

This Special 510k application supports the following design changes:

The trapezoidal cross-sectional area was modified to a circulo-trapezoidal . geometry.
A change to the sizing range and differential. .
A distally "splined" model was added to the product line. .
Change in plasma coating application area. .

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech Novation 12/14 Press-Fit Femoral Stems:

The provided document is a 510(k) summary for a Special 510(k) submission, meaning it's for a modification of an already cleared device. As such, the "acceptance criteria" here are generally focused on demonstrating that the modified device remains substantially equivalent to its predicate device, rather than proving performance against novel, independently established clinical endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance (Exactech Novation 12/14 Press-Fit Femoral Stems)
Primary Goal: Substantial Equivalence to predicate device (#K041906 AcuMatch P-Series Plasma Press-Fit Femoral Stems)	Concluded: "We propose that they are substantially equivalent to the Exactech AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems cleared through premarket notification #K041906."
Indications for Use (Same as predicate)	"the same indications for use"
Basic Fundamental Scientific Technology (Same as predicate)	"the same basic fundamental scientific technology"
Design Features (Similar to predicate: neck angle, taper, flat geometry, offsets)	"similar design features (e.g. neck angle, femoral head taper design (12/14), neck flat geometry (angled), offsets - standard and extended)"
Materials (Same as predicate: titanium alloy, Ti plasma spray, HA coating)	"the same materials (titanium alloy, commercially pure titanium plasma spray and hydroxyapatite coating)"
Shelf Life (Same as predicate)	"the same shelf life (5 years)"
Packaging & Sterilization (Same as predicate: gamma radiation to SAL 10^-6)	"are packaged and sterilized using the same materials and processes (gamma radiation sterilization to a sterility assurance level (SAL) of 10^-6)"
Risk Analysis (Impact of modifications on safety)	"A risk analysis was performed to assess the impact of the modifications on the safety of the Novation femoral stem design." (Implied successful completion and favorable outcome)
Mechanical Performance (Fatigue testing)	"Supporting verification activities include ISO 7206-8 empirical fatigue testing"
Engineering Analyses	"and engineering analyses."

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

Sample Size: The document does not specify a "test set" in the context of human clinical data or images. The testing mentioned is ISO 7206-8 empirical fatigue testing on the device itself.
Data Provenance: The data comes from laboratory testing (empirical fatigue testing) and engineering analyses performed on the manufactured device. It is not derived from human subjects or retrospective/prospective clinical data for this specific submission.

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

This information is not applicable to this 510(k) submission. The "ground truth" here is based on engineering standards (ISO 7206-8) and risk analysis, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable. No clinical adjudication method is mentioned or required for this type of engineering-focused Special 510(k) submission.

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 device is a passive orthopedic implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm, so this concept is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is primarily based on:
- Engineering standards: Specifically, ISO 7206-8 for empirical fatigue testing.
- Risk analysis: To evaluate the impact of design modifications.
- Demonstrated equivalence: To the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device. The "training" for the device's design would be through established engineering principles and prior device iterations, but not in a machine learning sense.

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

This information is not applicable for the reasons stated in point 8. The "ground truth" for the predicate device (AcuMatch P-Series) would have been established through its own 510(k) clearance process, likely involving similar engineering and potentially earlier clinical data or references to existing standards for femoral stems. For this specific Special 510(k), the ground truth for comparison is the predicate device's already cleared status.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Exactech" in a bold, sans-serif font. To the left of the word is a stylized "C" symbol. A registered trademark symbol is located to the right of the word.

K042842

. Paper Water Ke (GAINI 5 (H) Fire 31%)

招聘, 房日报 FAX 357 376 17617

Exactech® Novation 12/14 Press-Fit Femoral Stems

NOV - 9 2004

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

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

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

FDA Establishment Number 1038671

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

October 7, 2004 Date:

Rev. 10/07/ 04

Section 4 Page 1 of 3

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K042842

Exactech® Novation 12/14 Press-Fit Femoral Stems

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

Trade or proprietary or model name(s):

Novation 12/14 Press-Fit Plasma Femoral Stems

Information on devices to which substantial equivalence is claimed:

510(k)Number	Trade or Proprietary or Model Name	Manufacturer
#K041906	AcuMatch P-Series Plasma Press-Fit Femoral Stems	Exactech, Inc.

INDICATIONS FOR USE:

Novation® press-fit femoral stems are intended for press-fit fixation.

Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Device Description:

The proposed Exactech Novation 12/14 Press-Fit Femoral Components are a modification of the AcuMatch P-Series Plasma Press-Fit Femoral Stems cleared through premarket notifications #K041906.

The predicate and proposed products have the same intended use and the same basic fundamental scientific technology.

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

042842

Exactech® Novation 12/14 Press-Fit Femoral Stems

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

The modified Novation femoral stems share the following similarities to the predicate AcuMatch femoral stems:

the same indications for use, .
similar design features (e.g. neck angle, femoral head taper design (12/14), neck . flat geometry (angled), offsets - standard and extended).
the same materials (titanium alloy, commercially pure titanium plasma spray and . hydroxyapatite coating)
the same shelf life (5 years), and .
are packaged and sterilized using the same materials and processes (gamma . radiation sterilization to a sterility assurance level (SAL) of 10").

This Special 510(k) application supports the following design changes:

The trapezoidal cross-sectional area was modified to a circulo-trapezoidal . geometry.
A change to the sizing range and differential. .
A distally "splined" model was added to the product line. .
Change in plasma coating application area. .

Substantial Equivalency Conclusion:

A risk analysis was performed to assess the impact of the modifications on the safety of the Novation femoral stem design. Based on successful completion of design control activities for the Exactech Novation 12/14 Press-Fit Plasma Femoral Stems, we propose that they are substantially equivalent to the Exactech AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems cleared through premarket notification #K041906. Supporting verification activities include ISO 7206-8 empirical fatigue testing and engineering analyses.

Rev. 10/07/ 04

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its body or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

Gary J. Miller, Ph.D. Executive Vice President of Research & Development Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K042842

Trade/Device Name: Novation 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353, 888.3350 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis, Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II

Product Code: LZO, MEH, LWJ, JDI Dated: October 8, 2004 Received: October 14, 2004

Dear Dr. Miller:

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 for associated in the 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 r ou may, aron's reversions 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 If your de rise 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 - Gary J. Miller, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse of substantial equivalence of your device to a legally promance hoticated on "ceresults 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 arrivance 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 golleral milermational 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 A. Mellman

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

2320 NW 6611 1 OUt GAINI:SVILLE, FL 326

52 377 1140 FAX 352 378-26 7

Exactech®, Inc.

Indications for Use

510(k) Number (if known):

0428y_

Device Name:

Novation 12/14 Press-Fit Femoral Stems

INDICATIONS FOR USE:

All Exactech Hip Systems are indicated for use in skeletally mature individuals i the Endiven in the 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 notentially 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.

Novation® press-fit femoral stems are intended for press-fit fixation.

Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Prescription Use (Part 21 CFR 801 Subpart D)	X	and/or	Over-The-Counter Use (21 CFR 807 Subpart C)
----------------------------------------------	---	--------	---------------------------------------------	--

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

Rev. 10/04/04	510(k) Number	K042842 K042842	Section 3 Page 1 of 1
---------------	---------------	--------------------	-----------------------

EXACECH exist to inqrowe the quility of the activity ond integentent. We to this through incordive ieess, ligh-quolity coduction and commitment to server

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.