The Durcaon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or devices have failed,
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
Irreparable fracture of the knee
These products are intended to achieve fixation with and without the use of bone cement.

Device Description

This submission is a line extension to the Duracon® Total Knee System for a tibial insert. Tibial inserts will be identical in design to the predicate tibial inserts of the Duracon® Total Knee System and manufactured from the same material as the Triathlon® and Scorpio® X3TM Tibial Inserts.

AI/ML Overview

This document pertains to the 510(k) submission for the Duracon® X3™ CS Tibial Insert. The information provided focuses on demonstrating substantial equivalence to predicate devices through engineering analysis, rather than presenting a study with specific acceptance criteria for device performance in a clinical setting.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully provided from the given text. The submission relies on an engineering analysis to demonstrate equivalence in strength, implying that if the new device is structurally comparable to existing, approved devices, it should meet an equivalent safety and effectiveness profile.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics in the way one would typically find for a clinical study (e.g., sensitivity, specificity, accuracy). The acceptance criterion implicitly seems to be "substantial equivalence" in terms of design, materials, and strength to predicate devices.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence in Strength to Predicate Devices (Duracon® Total Knee System, Triathlon® X3™, and Scorpio® X3TM Tibial Inserts)	"The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components."

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable to this type of submission. There is no "test set" of clinical data described. The evaluation is based on engineering analysis of the device itself and comparison to predicate devices.
Data provenance: Not applicable. The "data" here refers to the engineering analysis.

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

Not applicable. There is no mention of experts establishing ground truth for a clinical test set. The "ground truth" for the engineering analysis would be the established material properties and mechanical performance standards for such devices, likely evaluated by internal engineers and potentially external consultants if needed.

4. Adjudication method for the test set:

Not applicable. There is no test set or adjudication process described for clinical performance.

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 a medical device (tibial insert) submission, not an AI-powered diagnostic or assistive tool.

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:

For the substantial equivalence claim, the "ground truth" is largely based on:
- Engineering analysis results: Demonstrating comparable physical and mechanical properties (specifically strength) to predicate devices.
- Regulatory precedent: The substantial equivalence of the predicate devices themselves to other legally marketed devices.
This is not a clinical "ground truth" (e.g., pathology, clinical outcomes).

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/algorithm. For the engineering analysis, the "data" would be the specifications and testing of the materials and designs.

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

Not applicable. See point 8.

Summary of the Study (Engineering Analysis) that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is an engineering analysis. The purpose of this analysis was to demonstrate that the Duracon® X3™ CS Tibial Insert is substantially equivalent to existing predicate devices already on the market (Duracon® Total Knee System, Triathlon® X3™, and Scorpio® X3TM Tibial Inserts).

The specific finding from this analysis is: "The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components."

This implies that through various engineering calculations, simulations, and/or physical testing (though the specific methods are not detailed in this summary), the new tibial insert was shown to meet the same structural integrity and mechanical performance characteristics as the already approved devices. This equivalence in strength is the primary basis for the FDA's substantial equivalence determination for this particular 510(k) submission.

Summary

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Duracon® X3TM CS Tibial Insert			MAY 11 2007
Proprietary Name:	Duracon® X3TM CS Tibial Insert
Common Name:	Knee Prosthesis
Classification Name/Reference:	Knee joint patellofemorotibialpolymer/metal/polymer semi constrainedcemented prosthesis. 21 CFR §888.3560Knee joint patellofemorotibial metal/polymerporous coated uncemented prosthesis.21 CFR §888.3565
Device Product Code:	87 JWH, 87 MBH
Proposed Regulatory Class:	Class II
For Information contact:	Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (201) 831-6038
Date Summary Prepared:	March 29, 2007

510(k) Summary of Safety and Effectiveness

Description:

Indications:

The Durcaon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic . arthritis or avascular necrosis,
. Rheumatoid arthritis,
. Correction of functional deformity,
Revision procedures where other treatments or devices have failed, .

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Post-traumatic loss of joint anatomy, particularly when there is patello-femoral . erosion, dysfunction or prior patellectomy; and,
Irreparable fracture of the knee ●

These products are intended to achieve fixation with and without the use of bone cement.

Substantial Equivalence:

The Duracon® X3™ CS Tibial Inserts are substantially equivalent to the Duracon® Total Knee System, Triathlon® X3™, and Scorpio® X3TM Tibial Inserts in regards to intended use, design, materials, and operational principles as tibia components. The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY I 1 2007

Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K070883

Trade/Device Name: Duracon® X3TM CS Tibial Insert Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: March 29, 2007 Received: March 30, 2007

Dear Mr. Haro:

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

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Page 2 - Mr. Francisco Haro

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 procced 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 (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Bucher
for

Mark N. Melkerson 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 (if known): K070883

Device Name: Duracon® X3TM CS Tibial Insert

Indications for Use:

The Durcaon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
Rheumatoid arthritis, ●
Correction of functional deformity, ●
Revision procedures where other treatments or devices have failed, .
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral . erosion, dysfunction or prior patellectomy; and,
� Irreparable fracture of the knee

These products are intended to achieve fixation with and without the use of bone cement.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrenge of CPRH, Office of Device Evaluation (ODE) envere mann

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(Division Sign Off) Division of General, Restorative. and Neurological Devices

510(k) Number K070583

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.