The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE for Zimmer Biomet Persona is sterile, for single patient use.

Device Description

VERASENSE for Zimmer Biomet Persona provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

The VERASENSE for Zimmer Biomet Persona consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE for Zimmer Biomet Persona parent device. Individual VERASENSE for Zimmer Biomet Persona devices are packaged sterile, for single patient use with a shim set for thickness adjustments. The required accessories are not packaged sterile and are reusable.

VERASENSE for Zimmer Biomet Persona devices are implant system specific due to variations in implant design and is compatible with the Zimmer Biomet Persona Knee System.

The VERASENSE for Zimmer Biomet Persona is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and angular velocity and acceleration for the alignment functionality. The data from the sensor is wirelessly transmitted to the LinkStation MINI or LinkStation MINI Evaluation Kit which runs the VSA and is located outside the sterile field in the operating room. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee, center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only, static measurement of the coronal alignment of the tibial resection relative to the patient specific tibial reference axis defined by the system registered anatomical landmarks, and numerical value of the varus/valgus tibial mechanical alignment.

AI/ML Overview

The provided text describes the VERASENSE for Zimmer Biomet Persona device, an intraoperative tool for Total Knee Arthroplasty (TKA), and specifically focuses on a 510(k) submission (K193580) for a modified version of the device. This modification primarily involves an updated firmware and software application to enable and utilize an IMU (inertial measurement unit) chip for measuring tibial implant coronal alignment.

The document states that performance studies were conducted to demonstrate that the product meets established acceptance criteria. However, it does not provide a detailed table of acceptance criteria and reported device performance for the alignment functionality. Instead, it broadly states that "Performance studies demonstrated the product meets established acceptance criteria."

Based on the information provided, here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table listing specific numerical acceptance criteria alongside
corresponding reported device performance for the alignment function. The only specific performance metric mentioned for the alignment function is:

Tibial Mechanical Alignment Range: varus/valgus ± 7°
Accuracy: ± 3°

However, it does not state the actual measured performance against this accuracy or range in a reportable format beyond "performance studies demonstrated the product meets established acceptance criteria."

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "Performance Testing Bench" including "Benchtop Design, Cadaver Design, Benchtop Sensitivity analysis, Usability, Software Verification." It also states, "The method for calculating alignment was verified through sensitivity analysis and a mathematical simulation." While these imply testing, the sample sizes (e.g., number of cadavers, number of benchtop tests) are not provided.
Data Provenance: The studies appear to be benchtop and cadaver-based. The country of origin is not specified, but the device manufacturer is OrthoSensor, Inc., located in Dania Beach, Florida, USA. The studies seem to be retrospective or laboratory-based, as it explicitly states, "This submission does not include any clinical testing."

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Role of Experts: Given the nature of a medical device submission without clinical trials for the specific modification, it's highly likely that engineering or testing personnel established the "ground truth" for the benchtop and cadaver studies. However, this is not detailed.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Given that no clinical studies with human readers or experts are described for the performance evaluation of the alignment function, an adjudication method for a test set is not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states: "This submission does not include any clinical testing. We determined that no such testing was required to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with AI assistance vs. without AI assistance can be reported. The device is a measurement tool, not an AI-assisted diagnostic tool for image interpretation by clinicians.

6. Standalone Performance (Algorithm Only)

Yes, standalone performance was assessed. The "Performance Testing Bench" section describes how the "Alignment function calculation" was tested and verified through "sensitivity analysis and a mathematical simulation." This implies testing of the algorithm's performance in a controlled, non-human-in-the-loop environment. The device itself (VERASENSE for Zimmer Biomet Persona) with its integrated IMU and associated software (VSA) acts as the "algorithm only" system in the context of this specific regulatory submission for its alignment measurement capability.

7. Type of Ground Truth Used

The ground truth used for the benchtop and cadaver studies was established through:

Experimental/Physical Measurement: For benchtop design and cadaver studies, the ground truth for alignment would have been established using highly accurate physical measurement tools (e.g., optical tracking systems, precise goniometers, or reference jigs) against which the device's measurements were compared.
Mathematical/Simulated Ground Truth: For the "sensitivity analysis and a mathematical simulation," the ground truth would have been derived from theoretical models or known inputs within the simulation environment.

The document does not explicitly state these methods but they are implied by the nature of benchtop and simulation testing.

8. Sample Size for the Training Set

Not applicable/Not mentioned. The document describes a "510(k) premarket notification" for a hardware/firmware/software modification to an existing device. It does not describe the development or training of a de novo AI/ML model for which a training set would typically be referenced. The "software accessory" is stated as a "minor" level of concern and primarily reports calculated values, not predictions from a data-driven learning model.

9. How Ground Truth for Training Set was Established

Not applicable, as a training set for an AI/ML model is not described as being part of this submission for this specific modification. The "Software Verification and Validation Testing" section refers to standard software testing procedures, not AI model training.

Summary

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April 1, 2020

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side-by-side.

OrthoSensor, Inc. Deborah Johnson Director of Regulatory Affairs 1855 Griffin Road Suite A-310 Dania Beach, Florida 33004

Re: K193580

Trade/Device Name: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: December 20, 2019 Received: December 23, 2019

Dear Deborah Johnson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193580

Device Name VERASENSE for Zimmer Biomet Persona

Indications for Use (Describe)

The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The company name, "ORTHOSENSOR," is written in a simple, sans-serif font, with "ORTHO" in gray and "SENSOR" in blue.

Traditional 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92

l. SUBMITTER

OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Establishment Registration Number: 3008592715

Phone: (954) 577-7770 Fax: (954) 337-9222

Contact Person: Deborah Johnson, Director of Regulatory Affairs

Date Prepared: March 31, 2020

II. DEVICE

Name of Device: VERASENSE for Zimmer Biomet Persona Common or Usual Name: Intraoperative Orthopedic Joint Assessment Aid Classification Name: Stereotaxic instrument Regulatory Class: II Regulation Number: 21 CFR 882.4560 Product Code: ONN

III. PREDICATE DEVICE

Predicate Device - OrthAlign Plus System, K172462 Reference Device - VERASENSE for Zimmer Biomet Persona, K180459

IV. DEVICE DESCRIPTION

VERASENSE for Zimmer Biomet Persona provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

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Image /page/4/Picture/2 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The company name, "ORTHOSENSOR," is written in a serif font, with "ORTHO" in gray and "SENSOR" in blue.

accessories are intended to support the performance of the VERASENSE for Zimmer Biomet Persona parent device. Individual VERASENSE for Zimmer Biomet Persona devices are packaged sterile, for single patient use with a shim set for thickness adjustments. The required accessories are not packaged sterile and are reusable.

VERASENSE for Zimmer Biomet Persona devices are implant system specific due to variations in implant design and is compatible with the Zimmer Biomet Persona Knee System.

V. INDICATIONS FOR USE

The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool to measure implant alignment and for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE for Zimmer Biomet Persona is sterile, for single patient use.

VI. PRODUCT DESIGN CHANGES

The subject device is a modification to the previously cleared VERASENSE for Zimmer Biomet Persona (K180459). Changes from the reference device to the subject device:

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Image /page/5/Picture/1 description: The image shows the text "VERASENSE for Zimmer Biomet Persona Traditional 510(k)". The text is centered and in a bold, sans-serif font. The first line is larger than the second line, and the second line is larger than the third line.

Image /page/5/Picture/2 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 shapes, two in blue and one in gray, arranged in a triangular formation. The text "ORTHOSENSOR" is written in a simple, sans-serif font, with the letters in gray.

1. Firmware version was updated to enable the functionality of the IMU chip. This change allows the VERASENSE Software Application VSA (Version 7) to process alignment information from the IMU chip.
1. Firmware version was updated to change the power output of the existing VERASENSE for Zimmer Biomet Persona device.
1. VERASENSE Software Application VSA (Version 7) accessory algorithm was updated to include calculations for the tibial mechanical alignment.
1. Labeling change Indications for use changed from:

The VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

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

to the following:

The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool to measure tibial implant coronal alignment and for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE for Zimmer Biomet Persona is sterile, for single patient use.

Instructions for Use and the User Guide were updated to include a. instructions for the alignment functionality.
1. There were no changes to hardware and the manufacturing process was equivalent to the reference device.

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Image /page/6/Picture/1 description: The image contains the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is composed of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The text "ORTHOSENSOR" is written in a serif font, with the letters in a dark blue color.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

TechnologicalCharacteristic	Subject Device	Predicate Device
LigamentBalancing	It has 3 load transducers per compartmentthat are used to calculate a composite jointload per compartment. Load transfer arederived from the measured loads.	K172462Ligament balancing is achieved bymeasuring the angle and gap distancesbetween the femur and proximal tibiaand establishing a reference line to assistin setting the rotation of the femoralimplant in primary or revisionprocedures.
AlignmentFunction	The varus/valgus angle of the resected tibia inthe coronal plane is calculated using theestablished tibia reference frame and thepatient tibial length measured by the surgeonand entered into the software application. Thetibial mechanical alignment range isvarus/valgus $\pm$ 7° with an accuracy of $\pm$ 3°.The VERASENSE for Zimmer Biomet Personaincludes an accelerometer and gyroscope thatmake up the inertial measurement unit (IMU).The IMU is calibrated to removed fixed biases,scale errors, and misalignment errors in boththe accelerometer, and gyroscope. Theaccelerometer provides the linearacceleration, while gyroscope provides theangular velocity, which are used to determinethe frame of reference for the IMU. TheVERASENSE for Zimmer Biomet Personaregisters the first anatomical landmark, thecenter of the tibia, based on the placement ofthe VERASENSE for Zimmer Biomet device inthe tibial tray implant. The IMU within theVERASENSE for Zimmer Biomet Persona iscentered with respect to the implant tibialtray, with a specific offset value for each sizeand side of the device. The second anatomicallandmark, the lateral center of the heel'scalcaneus, is registered when the surgeontakes the leg through a pivot motion with theheel stabilized, while the hip and the pelvisare stable through the patient position.	The mechanical alignment is defined asthe axis from the center of the femoralhead to the intercondylar notch. This axisextends further down from the center ofthe proximal tibia to the center of theankle.The main observed difference is thealgorithm used by the software and themechanical measurements based on thesensor versus the femoral and tibial jigsused by OrthAlign. The OrthAlign also canbe used for hip and knee arthroplasty,while VERASENSE for Zimmer BiometPersona is only used for kneearthroplasty.
TechnologicalCharacteristic	Subject Device	Predicate Device
		K172462
Communication	Sensor: Bluetooth 4.2 compatibleLinkStation MINI/LinkStation MINI EvaluationKit: Bluetooth 4.2 compatible, WIFI	Bluetooth
	Sensor: Internally powered (3.1V DC)LinkStation MINI /LinkStation MINI EvaluationKit: AC Power	Navigation unit, reference, sensor, andlaser module: DC battery powered
Electrical details(power, outlets,voltage etc.)	Protection against electrical Shock:Type BF Applied	Protection against electrical Shock:Type BF Applied.
	Electromagnetic Interference (EMI):will tolerate typical levels of electromagneticinterface	Electromagnetic Interference (EMI):Unknown
	Electrostatic Discharge (EDS)will tolerate exposure to 8kV contactdischarge and 8 kV air discharge.	Electrostatic Discharge (EDS)Unknown
	Display Unit Protection AgainstElectrical ShockClass I (65W universal 3-pin jack, 100-240V,1.5A, 50-60Hz)
	Transceiver Unit Protection Against ElectricalShockClass II USB powered and intended to beconnected to the USB port of the LinkStationMINI display unit (5 V dc)
Software	The VERASENSE Software Application calculatesforce vectors and positional data, display bothnumerically and pictorially load data versusposition, according to the description andspecifications. For alignment, the VSA displaysthe tibial varus/valgus alignment anglenumerically using tibial length, positional data,angular velocity.
	User Interface:Accessory with tablet computer with agraphical user interface	User Interface:Integrated graphical user interface, on anelectronic unit that attaches to
	Operating System Compatibility (display Unit):Microsoft Windows 10	instrumentation.Operating system: unknown
TechnologicalCharacteristic	Subject Device	Predicate DeviceK172462
Packaging	Sensor: double pouched, sterileAccessories: LinkStation MINI - Wood boxLinkStation MINI Evaluation Kit – Waterproof plastic case	Sensor and accessories are packaged sterile
	Ingress ofLiquids	Sensor:Rated IPX4Display Unit:Rated IP54	unknown
		Sterilization	Sensor: Ethylene Oxide 10-6 SALLinkStation MINI/LinkStation MINI Evaluation Kit: Non-Sterile

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Image /page/7/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The company name, "ORTHOSENSOR," is written in a simple, sans-serif font, with "ORTHO" in gray and "SENSOR" in blue.

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Image /page/8/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The company name "ORTHOSENSOR" is written in a serif font, with "ORTHO" in gray and "SENSOR" in blue.

The technological characteristics are the same with the exception of alignment and ligament balancing calculation methods.

VIII. PERFORMANCE DATA

In order to review the different characteristics and support of the substantial equivalence determination the following performance verification studies were performed:

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The software accessory for this device was considered as a "minor" level of concern, since the VERASENSE Software Application reports real time the amount of applied force, COL location (for reference only), and tibial varus/valgus angle from the VERASENSE for Zimmer Biomet Persona. The VERASENSE Software Application does not directly drive a decision regarding treatment or therapy.

Performance Testing Bench

In order to test the Alignment function calculation (technological difference and new design change), the following studies were performed:

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Image /page/9/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 shapes, two in blue and one in gray, arranged in a triangular formation. The company name, "ORTHOSENSOR," is written in a serif font, with "ORTHO" in gray and "SENSOR" in blue.

Benchtop Design, Cadaver Design, Benchtop Sensitivity analysis, Usability, Software Verification. The method for calculating alignment was verified through sensitivity analysis and a mathematical simulation.
Ligament balancing calculation method was previously cleared per ● VERASENSE for Zimmer Biomet persona (K180459) reference device

Performance Testing Clinical

This submission does not include any clinical testing. We determined that no such testing was required to demonstrate substantial equivalence.

Performance Testing Animal

This submission does not include any animal performance testing. We determined that no such testing was required to demonstrate substantial equivalence.

IX. CONCLUSIONS

Performance studies demonstrated the product meets established acceptance criteria. Failure mode and effects analysis also demonstrated that all risks related to the different characteristics have been reduced as far as possible. The different technological characteristics do not raise different questions in regard to safety and effectiveness of the product. Thus, the modifications are substantially equivalent to the predicate device.

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).