(144 days)
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.
OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior and anterior slope positioning, etc.) after insertion into the space between the tibia and the femur.
The provided text is a 510(k) summary for the OrthoSensor VERASENSE™ Knee System, which describes a modification to an existing device. It focuses on regulatory approval for labeling changes and physical modifications to allow compatibility with another knee system.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its performance or effectiveness in the way an AI/ML device would be evaluated (e.g., accuracy, sensitivity, specificity).
The document states:
"The modifications to the Orthosensor VERASENSE™ Knee System were evaluated under design controls, and met the same performance criteria as the predicate device."
This indicates that the modified device was tested against the same performance criteria as the original predicate device, not that a new study was conducted to establish new acceptance criteria or to prove clinical effectiveness of the device's intended use (reducing instability from flexion gap asymmetry). The changes are primarily related to mechanical compatibility and labeling.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert involvement, or MRMC studies for this specific submission, because that information is not present in the provided text.
The document discusses:
- Intended Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry.
- Device Description: An instrumented trial tibial insert with load sensors and angular positional information.
- Changes: Modification to package label to reflect use with Biomet Vanguard Knee System, changes to device surface contours and dimensions specific to the Biomet Vanguard Knee System, and addition of a new color of Polycarbonate.
- Design Control Activities: The modifications were evaluated under design controls and "met the same performance criteria as the predicate device."
- Substantial Equivalence: The submission claims substantial equivalence to the predicate device, stating it has the same intended use and technological characteristics that do not raise different questions of safety and effectiveness.
In summary, the provided text does not contain the specific information required to answer the prompt regarding acceptance criteria and performance study details for an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is composed of three curved lines converging towards the center, forming a triangular shape. The text "ORTHOSENSOR" is written in a serif font below the symbol.
1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343
Special 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
Submitter:
OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343 mgaray@orthosensor.com
Establishment Registration 3008592715 Number:
Contact:
Martha Garay Regulatory Affairs & Quality Assurance Manager OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343 mgaray@orthosensor.com
Date of Summary: October 14, 2013
Predicate 510(k) Number: K130380 - OrthoSensor Knee Balancer
Special 510(k) Number: K131767
Trade/Proprietary:OrthoSensor Knee Balancer (Trade / Proprietary names = OrthoSensor VERASENSE™ Knee System).
Classification Name: Intraoperative Orthopedic Joint Assessment Aid
Product Code: ONN
Device Classification: Class II (21 CFR 882.4560)
Intended Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.
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Image /page/1/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized triangle shape above the word "ORTHOSENSOR". The triangle shape is made up of three curved lines that meet at a point at the top. The text is in all caps and in a simple sans-serif font.
1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343
Device Description: OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior and anterior slope positioning, etc.) after insertion into the space between the tibia and the femur.
Description of Changes to the Device: The reason for this proposed special 510(k) submission is to include a modification to the package label (specifically the outer label) to reflect the use of the OrthoSensor VERASENSE™ Knee System with the Biomet Vanguard Knee System (K113550). In addition to this change on labeling, this submission also covers the changes to the device surface contours and dimensions (specific to the condylar surface of the Biomet Vanguard Knee System), as well as the addition of a new color of Polycarbonate (for Makrolon Rx 1851).
Completion of Design Control Activities:
The modifications to the Orthosensor VERASENSE™ Knee System were evaluated under design controls, and met the same performance criteria as the predicate device. Dimensional changes were implemented to meet customer needs (BIOMET), with new sizes and catalog numbers. The design control process was followed and the risk analysis method used to determine assess risks associated with these changes was Failure Mode Effects Analysis (FMEA), which has been updated appropriately.
Substantial Equivalence:
The proposed updated submission has the same intended use as the predicate and same technological characteristics that do not raise different types of questions of safety and effectiveness. The proposed updated submission is therefore substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2014
OrthoSensor, Incorporated Ms. Martha Garay Regulatory Affairs & Quality Assurance Manager 1855 Griffin Road, Suite A-310 Dania Beach, Florida 33004
Re: K131767
Trade/Device Name: OrthoSensor VERASENSETM Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONN Dated: September 6, 2013 Received: September 9, 2013
Dear Ms. Garay:
This letter corrects our substantially equivalent letter of September 6, 2013.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Martha Garay
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Orthosensor. The logo consists of the word "ORTHOSENSOR" in a light gray, sans-serif font. Above the word is a stylized symbol that looks like three curved lines converging at a point, also in light gray. The overall impression is clean and modern.
K131767
Indications for Use Statement
Device Name: OrthoSensor Knee Balancer (Proprietary name=VERASENSE™ Knee System).
Indications for Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D
Division of Orthopedic Devices
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§ 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).