For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.

Device Description

Orthosensor Intra-Operative Load Sensor (IOLS) system provides a means to dynamically balance the knee during knee replacement surgery intraoperatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface after insertion into the space between the tibia and the femur.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OrthoRex Intra-Operative Load Sensor, based on the provided document:

This 510(k) summary does not provide detailed acceptance criteria or extensive study data typical of a clinical trial. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific quantitative acceptance criteria are not provided in this document. The document broadly states the device should "perform in accordance with internal and customer requirements."	"The results of the testing have shown the device to perform in accordance with internal and customer requirements and the device performance has not shown any negative impact on the safety and effectiveness of the proposed device when compared to the predicate device."

Study Information

Sample size used for the test set and the data provenance:
- The document mentions "a series of bench testing which includes mechanical, engineering, and comparison studies." However, specific sample sizes (e.g., number of units tested, number of measurements taken) for these bench tests are not provided.
- Data Provenance: The nature of "bench testing" implies the data was generated in a controlled laboratory environment, not from human subjects. The country of origin is not explicitly stated, but the company is based in Sunrise, FL, USA. The testing would be considered prospective for the device's development and regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was bench testing, there was no "ground truth" established by human experts in the way clinical studies requiring image interpretation or diagnosis would. The "ground truth" would be the known physical properties and performance of the test setups (e.g., applied forces, mechanical loads).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for clinical studies involving multiple human readers and is not applicable to mechanical bench testing.
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 device is an intra-operative load sensor, not an AI-based diagnostic imaging tool. It does not involve human readers interpreting data, nor does it involve AI assistance in that context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the typical AI sense. The device is a sensor and measurement system designed to provide real-time data during surgery for direct human interpretation and action. Its performance is inherent in its ability to accurately measure forces, which is what the bench testing would have evaluated. There isn't an "algorithm only" performance separate from its function as a measurement tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" would have been established by precisely calibrated measurement instruments (e.g., load cells, force gauges) used in the mechanical and engineering studies. This would represent physical measurements under controlled conditions.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" would be the engineering design, calibration, and manufacturing process.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

Summary

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K090474

510(k) SUMMARY (as required by 807.92(e))

OCT 1 9 2009

Regulatory Correspondent: Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572 Jon Ward Phone: 813-645-2855 Fax: 813-645-2856 wardjp@ajwtech.com

Submitter of 510(k):

Orthosensor, Inc. 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise, FL 33323 Mark Stein Phone: 954-577-7770 Fax: 954-577-7343

Date of Summary:

Trade/Proprietary Name:

Classification Name:

Product Code:

Intended Use:

Device Description:

Intraoperative orthopedic joint assessment aid

OrthoRex Intra-Operative Load Sensor

September 27, 2009

ONN

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.

Predicate Device:

Elibra Dynamic Knee Balancer - K070108

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Substantial Equivalence:

The Orthosensor, Inc. claims the proposed device to be substantially equivalent to the device previously cleared by FDA in K070108. Orthosensor, Inc. claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational specifications as compared to the predicate devices.

The similarities and differences between the proposed and predicate devices have been identified and explained in the Substantial Equivalence Discussion which has been included in Section 10 of this submission. These differences identified have no impact on safety or effectiveness.

Performance Testing:

The proposed device has undergone a series of bench testing which includes mcchanical, engineering, and comparison studies The results of the testing have shown the device to perform in accordance with internal and customer requirements and the device performance has not shown any negative impact on the safety and effectiveness of the proposed device when compared to the predicate device.

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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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of three curved lines representing wings and a tail. The overall design is simple and recognizable, representing the department's role in public health and human services.

Orthosensor, Inc. % Mr. Jon Ward Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, Florida 33572

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

OCT 1 9 2009

Re: K090474

Trade/Device Name: OrthoRex Intra-Operative Load Sensor Regulation Number: 21 CFR 882,4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONN Dated: August 9, 2009 Received: August 13, 2009

Dear Mr. Ward;

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Jon Ward

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Milhurn

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

no osure

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Indications for Use

510(k) Number (if known):

Device Name: OrthoRex Intra-Operative Load Sensor

Indications for Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use

-1

Prescription Use Yes (Part 21 CFR 801 Subpart D)

10 - 2014/01/20 11:10:10 - 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/0

AND/OR

ショットではないと思ったけど、このコミニックにしたことになっています。ここには、ここには、このことに、このことに、このことになったときになるということです。この

Over-The-Counter Use No (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omtu for mkm

Page 1 of 1

(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090474

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).