The Ortho Development Balanced Knee™ System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis. primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.

The Balanced Knee™ System is intended for single use in primary total knee replacement only. Indications include:

Loss of joint configuration and joint function: ●
Osteoarthritis of the knee joint;
Rheumatoid arthritis of the knee joint; .
Post-traumatic arthritis of the knee joint; .
. Moderate valgus, varus, or flexion deformities.

Device Description

The Ortho Development Balanced Knee™ System is a semi-constrained total knee replacement system, consisting of femoral, tibial and patellar components.

The devices are manufactured from CoCr alloy (cast or Wrought), Ti-6Al-4V alloy Materials: and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards,
The system functions to provide restoration of function as a replacement for Function: diseased and arthritic knees.

AI/ML Overview

This document is a 510(k) premarket notification for the Ortho Development Balanced Knee™ System. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a de novo study with acceptance criteria and test results. Therefore, much of the requested information about device performance against acceptance criteria and study details is not present in this document.

Here's an analysis of the provided text in relation to your questions:

1. Table of acceptance criteria and the reported device performance:

This document does not report specific acceptance criteria or quantitative device performance metrics. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and performs as safely and effectively as the predicate. It does not typically involve setting novel performance acceptance criteria or conducting de novo clinical studies to prove these. Instead, it relies on comparison to existing devices.

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

Not applicable. This document does not describe a "test set" in the context of performance testing with human subjects or a dataset for AI. It's a regulatory submission for a medical device.

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

Not applicable. This document does not pertain to establishing ground truth for a test set, as no such test set (in the AI/clinical study sense) is described.

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

Not applicable. No test set or adjudication method 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:

Not applicable. This document describes a knee replacement system, not an AI or imaging diagnostic device that would typically undergo MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. No ground truth is established in this document, as it is a regulatory submission for substantial equivalence.

8. The sample size for the training set:

Not applicable. This document does not describe an AI device or a training set for an algorithm.

9. How the ground truth for the training set was established:
Not applicable. As above, no training set is described.

Summary of Relevant Information from the Document:

Device Type: Ortho Development Balanced Knee™ System (semi-constrained total knee replacement system).
Purpose of Submission: 510(k) premarket notification to demonstrate substantial equivalence to legally marketed predicate devices.
Predicate Devices: Performance Total Knee System (Kirschner), NexGen Total Knee System (Zimmer), PCA Modular Total Knee System (Howmedica), Natural Knee System (Intermedics), AGC Modular Total Knee System (Biomet), Foundation Total Knee System (Encore).
Basis of Equivalence: The document states, "There are no significant differences between the Ortho Development Balanced Knee™ System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." This comparison of design, function, materials, and intended use is the "testing" or "proof" presented in a 510(k) submission, rather than de novo performance metrics.
Intended Use/Indications: For patients suffering from severe knee pain and disability, including various forms of arthritis and complications from previous prostheses. Intended for cemented use only and for single use in primary total knee replacement.
Materials: CoCr alloy (cast or Wrought), Ti-6Al-4V alloy, and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards.

In conclusion, this document is a regulatory submission focused on demonstrating substantial equivalence, not a study reporting specific performance data against a set of acceptance criteria. Therefore, most of your questions, which are geared towards performance studies and AI evaluation, do not directly apply to the content provided.

Summary

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MAR 2 4 2 100

SUMMARY OF SAFETY AND EFFECTIVENESS:

This safety and effectiveness summary for the Ortho Development Balanced Knee™ System is provided as required per Section 513(i)(3) of the Food, Drug, and Cosmetic Act.

1. Submitter: Ortho Development Corporation 106 West 12200 South Draper, Utah 84020
1. Contact Person: Carol Freasier Telephone: (801) 553-9991 Fax: (801) 553-9993
Ortho Development Balanced Knee™ System 3. Trade Name: Balanced Knee™ System Common Name: Classification Name: Prosthesis, Knee patellofemorotibial, Semi-constrained, Cemented, Polymer/Metal/Polymer (888.3560)

4. Predicate or legally marketed devices which are substantially equivalent:

Performance Total Knee System (Kirschner) ●
NexGen Total Knee System (Zimmer) .
PCA Modular Total Knee System (Howmedica) ●
Natural Knee System (Intermedics) .
AGC Modular Total Knee System (Biomet) .
Foundation Total Knee System (Encore) .

5. Description of the device:

The Ortho Development Balanced Knee™ System is a semi-constrained total knee replacement system, consisting of femoral, tibial and patellar components.

The devices are manufactured from CoCr alloy (cast or Wrought), Ti-6Al-4V alloy Materials: and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards,
The system functions to provide restoration of function as a replacement for Function: diseased and arthritic knees.

6. Intended Use:

1. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
  There are no significant differences between the Ortho Development Balanced Knee™ System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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Image /page/1/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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing left and has three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2000

Ms. Carol Freasier Regulatory Affairs / Quality Assurance Ortho Development Corporation 106 West 12200 South Draper. Utah 84020

Re: K994370

Trade Name: Ortho Development Balanced KneerM System Regulatory Class: II Product Code: JWH Dated: December 23, 1999 Received: December 27, 1999

Dear Ms. Freasier:

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.

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Page 2 - Ms. Carol Freasier

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Styph Ruoch

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

Enclosure

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Device Name: Balanced Knee™ System

Indications for Use

The Balanced Knee™ System is intended for single use in primary total knee replacement only. Indications include:

Loss of joint configuration and joint function: ●
Osteoarthritis of the knee joint;
Rheumatoid arthritis of the knee joint; .
Post-traumatic arthritis of the knee joint; .
. Moderate valgus, varus, or flexion deformities.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) · livision of General Restorative 994370 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

Over-The Courter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.