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.

Device Description

VERASENSE provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

The VERASENSE consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE parent device. The LinkStation MINI / LinkStation MINI Evaluation Kit is capable of running the VSA and communicating wirelessly with the VERASENSE from outside the sterile field in the operating room. Individual VERASENSE 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.

The VERASENSE device is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI or LinkStation MINI Evaluation Kit. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. The VSA also provides location of the center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments for reference only.

VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the following implant systems:

VERASENSE for Biomet Vanguard
VERASENSE for Stryker Triathlon
VERASENSE for Zimmer NexGen
VERASENSE for Smith & Nephew Legion
VERASENSE for Smith & Nephew Journey II
VERASENSE for Zimmer Biomet Persona

AI/ML Overview

The provided text describes the VERASENSE for Zimmer Biomet Persona device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Operating Range	5 - 40 lbf (as per predicate device)
Load Accuracy	± 3.5 lbf (as per predicate device)
Load Values Displayed for Reference only	41-70 lbf (as per predicate device)
Maximum Safe Load	70 lbf (as per predicate device)
Electrical Safety	Complies with AAMI ANSI ES60601-1:2005
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2007AC:2010
Biocompatibility	Meets requirements outlined in EN ISO 10993-1:2009/AC:2010
Software Verification & Validation	Documentation provided as per FDA guidance, "minor" level of concern
Usability	Verified according to OrthoSensor, Inc.'s procedures
Sterilization	Verified according to OrthoSensor, Inc.'s procedures
Packaging Integrity	Verified according to OrthoSensor, Inc.'s procedures
Shelf Life	Verified according to OrthoSensor, Inc.'s procedures
Design Verification & Validation	Verified

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The text primarily focuses on bench testing and software verification. There are no specific "test set" sample sizes mentioned for clinical or animal studies, as they were not deemed necessary for this submission. The performance data is derived from:

Bench Performance Testing: The specific sample sizes for these tests (e.g., number of devices tested for load accuracy or operating range) are not explicitly stated in the document.
Biocompatibility Testing: Conducted on the final VERASENSE for Zimmer Biomet Persona and its raw materials. The sample size for these tests is not specified.
Electrical Safety and EMC Testing: Conducted on the VERASENSE for Zimmer Biomet Persona and required accessories. The sample size for these tests is not specified.
Software Verification and Validation Testing: Documentation provided.

The provenance (country of origin, retrospective/prospective) of this data is not explicitly stated, but it would have been generated internally by OrthoSensor, Inc. through their product design and development procedures.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert review for ground truth. The acceptance criteria relate to physical performance, electrical safety, biocompatibility, and software functionality, which are typically assessed through objective measurements and established standards, rather than expert consensus on diagnostic interpretations.

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

Not applicable, as this is not an AI/ML diagnostic tool requiring human adjudication for ground truth.

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. The VERASENSE is an intraoperative orthopedic joint assessment aid that measures dynamic loads; it is not an AI-assisted diagnostic tool that would involve human readers.

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

This refers to the performance of the device itself (the VERASENSE sensor and its software application) without direct human intervention in its measurement process, though it is a tool for human use in surgery. All performance testing (bench, biocompatibility, electrical safety, software) described can be considered "standalone" in this context, in that it assesses the device's inherent characteristics and compliance with standards. The device is intended to provide real-time data to a surgeon, who then uses that information for adjustment during TKA.

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

The "ground truth" for this device's performance is based on:

Physical measurements and established engineering standards: For operating range, load accuracy, maximum safe load, usability, sterilization, packaging integrity, and shelf life, the ground truth is determined by precise measurements and adherence to predefined engineering specifications and internal procedures.
International standards and guidance documents: For electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1), the ground truth is compliance with these recognized standards.
Software verification and validation documentation: For software, the ground truth is adherence to the documented requirements and design specifications as per FDA guidance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

June 7, 2018

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

Re: K180459

Trade/Device Name: VERASENSE for Zimmer Biomet Persona Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: May 16, 2018 Received: May 17, 2018

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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Katherine D. Kavlock -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K180459

Device Name VERASENSE for Zimmer Biomet Persona

Indications for Use (Describe)

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 implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.

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, one in dark blue, one in light blue, and one in gray. The company name is written in a simple, sans-serif font, with the "ORTHO" portion in gray and the "SENSOR" portion in blue.

K180459

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

I. 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, Senior Manager Regulatory Affairs

Date Prepared: May 15, 2018

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

VERASENSE Knee System, K150372

IV. DEVICE DESCRIPTION

VERASENSE provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

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Image /page/4/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the word "ORTHOSENSOR". The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The word "ORTHOSENSOR" is written in a simple, sans-serif font, with the letters in gray.

for single patient use with a Shim Set for thickness adjustments. The required accessories are not packaged sterile and are reusable.

VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the following implant systems:

VERASENSE for Biomet Vanguard ●
VERASENSE for Stryker Triathlon ●
VERASENSE for Zimmer NexGen ●
VERASENSE for Smith & Nephew Legion ●
VERASENSE for Smith & Nephew Journey II ●
. VERASENSE for Zimmer Biomet Persona

INDICATIONS FOR USE V.

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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

At a high level, the subject and predicate devices are based on the following same technological elements:

Capacitive sensors on the device measure the pressure exerted by the ● femoral component of the implant on the sensor.
Required accessories intended to support the performance of the VERASENSE parent device are the LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA)
Patient contacting material of the top and bottom housings

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Image /page/5/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the word "ORTHOSENSOR". The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The word "ORTHOSENSOR" is written in a simple, sans-serif font, with each letter in gray.

The following technological differences exist between the subject and predicate devices:

the geometry / dimensions of the Zimmer Biomet Persona implant . system
Articular surface is on shims, detached from the electronics ●
Electronics module is reversible ●
Patient contacting shim material changed to PolyEtherEtherKetone ● (PEEK) and stainless steel
. Sensor wireless communication frequency changed to 2402 – 2480 MHz Bluetooth
. New wireless connection mode for the LinkStation MINI / LinkStation MINI Evaluation Kit via tablet component integrated Bluetooth
New version of the VSA with the addition of the VERASENSE for Zimmer Biomet Persona to the scope of the software application
. Updated labeling to include compatibility with VERASENSE for Zimmer Biomet Persona variant and instructions for new wireless connection mode

	Predicate Device K150372	Subject Device
Classification	21 CFR 882.4560	21 CFR 882.4560
Product Code	ONN	ONN
Indications for Use	The VERASENSE is indicated for anymedical condition in which primary orrevision Total Knee Arthroplasty (TKA)would be indicated.For use as a tool for adjustment of thefemoral knee implant to reduceinstability from flexion gap asymmetry.The VERASENSE is sterile, for singlepatient use.	The VERASENSE is indicated for anymedical condition in which primary orrevision Total Knee Arthroplasty (TKA)would be indicated.For use as a tool for adjustment of thefemoral knee implant to reduceinstability from flexion gap asymmetry.The VERASENSE is sterile, for singlepatient use.
Environment	Hospital	Hospital
VERASENSE (sensor)
Operating Principle	Capacitive sensors on the devicemeasure the pressure exerted by thefemoral component of the implanton the sensor.	Capacitive sensors on the devicemeasure the pressure exerted by thefemoral component of the implanton the sensor.
Power Requirements	Internally poweredTwo 1.55V, 27mAh Silver Oxidebatteries (in series)	Internally poweredTwo 3V, 30mAh Lithium batteries(in parallel)
	Predicate Device K150372	Subject Device
Form of Wireless technology	Radio Frequency	Radio Frequency
RFFrequencies	VERASENSEfor StrykerTriathlon402.0 – 405.0 MHz	2402 – 2480 MHzBluetooth
	VERASENSEfor BiometVanguard
	VERASENSEfor ZimmerNexGen
	VERASENSEfor Smith &NephewLegion404.3 MHz
	VERASENSEfor Smith &NephewJourney II
	VERASENSEfor ZimmerBiometPersona

Range	2 m	2 m
Packaging	Sterile, Double Tyvek /Film pouches,chipboard box	Sterile, Double Tyvek /Film pouches,chipboard box
Sterilization Method(sensor only)	Ethylene Oxide 10-6 SAL	Ethylene Oxide 10-6 SAL
Materials(patientcontacting)	TophousingColored Polycarbonate Resin	Colorless Polycarbonate Resin
	BottomhousingColorless Polycarbonate Resin	Colorless Polycarbonate Resin
	Adhesivebetweentop andbottomhousingLoctite	Loctite
	ShimsColored Polycarbonate Resin	10, 11, 12, 13 mmVITREX PolyEtherEtherKetone (PEEK)381G & stainless steel metal plates14 and 16 mmVITREX PolyEtherEtherKetone (PEEK)381G
Shelf Life	24 months	3 months

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Image /page/6/Picture/0 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 serif font, with the "S" in "SENSOR" being slightly larger and a different shade of blue than the rest of the letters.

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Image /page/7/Picture/0 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 lines, with the top line being blue, the middle line being gray, and the bottom line being blue. The company name is written in a sans-serif font, with the letters being gray.

Predicate Device K150372		Subject Device
Required Accessories (intended to support the performance of the VERASENSE parent device)
	VERASENSE Software Application (VSA)
	VSA for MacOX	VSA for MicrosoftWindows	VSA for Microsoft Windows
Operating Principle	The VERASENSESoftwareApplicationcalculates forcevectors andpositional data,display bothnumerically andpictorially loaddata versusposition,according to thedescription andspecifications.	The VERASENSE SoftwareApplication calculates forcevectors and positional data,display both numerically andpictorially load data versusposition, according to thedescription andspecifications.	The VERASENSE Software Application calculatesforce vectors and positional data, display bothnumerically and pictorially load data versusposition, according to the description andspecifications.
Operating SystemCompatibility	Mac OSX	Microsoft Windows	Microsoft Windows
VSA version number(s)	3.7 - 3.9.4.2	4.0.31.0 - 5.0.0.0	5.1.0.17
		LinkStation
		LinkStation	LinkStationMINI	LinkStation MINIEvaluation Kit
Operating Principle	Transceiver is connected toLinkStation via a USB cable. Datafrom the VERASENSE is wirelesslyreceived by the transceiver at afrequency of 401.05-405.55 MHz.The transceiver processes GaussianFrequency-Shift Keying (GFSK)modulated data		The transceivercomponent of theLinkStationMINI/LinkStation MINIEvaluation Kit canreceive and processsimultaneously 2channels and thecarrier frequency bandfor the wirelesscommunication is401.05 - 405.55 MHz.The integratedBluetooth transceiverin the tablet computercomponent of theLinkStationMINI/LinkStation MINIEvaluation Kit carrierfrequency band for thewirelesscommunication is 2402– 2480 MHz Bluetooth4.0 compatible. Thetransceivers processesGaussian Frequency-Shift Keying (GFSK)modulated data.	The transceivercomponent of theLinkStationMINI/LinkStation MINIEvaluation Kit canreceive and processsimultaneously 2channels and the carrierfrequency band for thewireless communicationis 401.05 - 405.55 MHz.The integrated Bluetoothtransceiver in the tabletcomputer component ofthe LinkStationMINI/LinkStation MINIEvaluation Kit carrierfrequency band for thewireless communicationis 2402 — 2480 MHzBluetooth 4.0compatible. Thetransceivers processesGaussian Frequency-ShiftKeying (GFSK) modulateddata.
		Predicate Device K150372	Subject Device
Sensor Compatibility		VERASENSE for Stryker Triathlon	VERASENSE for Stryker Triathlon	VERASENSE for Stryker Triathlon
		VERASENSE for Biomet Vanguard	VERASENSE for Biomet Vanguard	VERASENSE for Biomet Vanguard
		VERASENSE for Zimmer NexGen	VERASENSE for Zimmer NexGen	VERASENSE for Zimmer NexGen
		VERASENSE for Smith & Nephew Legion	VERASENSE for Smith & Nephew Legion	VERASENSE for Smith & Nephew Legion
		VERASENSE for Smith & Nephew Journey II	VERASENSE for Smith & Nephew Journey II	VERASENSE for Smith & Nephew Journey II
Display Unit		Apple iMac 27"	Tablet PC 12.5"	VERASENSE for Zimmer Biomet PersonaTablet PC 12.5"
	Display Unit Connection Modes	WIFI connectivity, Bluetooth connectivity, USB ports, Ethernet, Thunderbolt, and FireWire	WIFI connectivity, Bluetooth connectivity, and a USB port	WIFI connectivity, Bluetooth connectivity, and a USB port
	Display Unit Power Requirements	310W universal 3-pin jack, 100-240V, 50-60Hz	65W universal 3-pin jack, 100-240V, 1.5A, 50-60Hz	65W universal 3-pin jack, 100-240V, 1.5A, 50-60Hz
	Display Unit Operating System	Mac OSX	Windows 10	Windows 10
Stand Component		Ergotron Neo-Flex Stand	Roll Stand	Tablet Kickstand
Magnet		Neodymium magnet with a magnet to steel disc pull of greater than 2.75 lbs	Neodymium magnet with a magnet to steel disc pull of greater than 2.75 lbs	Neodymium magnet with a magnet to steel disc pull of greater than 2.75 lbs
Mount		Mounted on roll stand	Mounted on roll stand	Mounted on tripod
Transceiver Component	Power requirements	USB powered and intended to be connected to the USB port of the LinkStation MINI display unit (5 V dc)	USB powered and intended to be connected to the USB port of the LinkStation MINI display unit (5 V dc)	USB powered and intended to be connected to the USB port of the LinkStation MINI display unit (5 V dc)
	Form of Wireless technology	Radio Frequency	Radio Frequency	Radio Frequency
	RF Frequencies	401.05 - 405.55MHz	401.05 – 405.55MHz	401.05 – 405.55MHz
	Range	2 m	2 m	2 m
Sterilization Method		N/A. Supplied non-sterile.	N/A. Supplied non-sterile.	N/A. Supplied non-sterile.
Patient Contacting Materials		None	None	None
Shelf Life		5 years	5 years	5 years

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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 simple, sans-serif font, with "ORTHO" in gray and "SENSOR" in blue.

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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.

	Predicate Device K150372	Subject Device
Sensor and Required Accessories
Electrical Safety*	AAMI ANSI ES60601-1:2005	AAMI ANSI ES60601-1:2005
Electromagnetic Compatibility (EMC)*	IEC 60601-1-2:2007AC:2010	IEC 60601-1-2:2007AC:2010
Performance Specifications	Operating Range	5 - 40 lbf
	Load Accuracy	$\pm$ 3.5 lbf
	Load Values Displayed for Reference only	41-70 lbf
	Maximum Safe Load	70 lbf

when VERASENSE and accessories tested together

PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the VERASENSE for Zimmer Biomet Persona was conducted in accordance with Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff, Issued 06-16-2016. The biocompatibility tests conducted were:

Cytotoxicity
Sensitization
Irritation
Acute systemic toxicity ●
Material mediated pyrogenicity ●

The VERASENSE for Zimmer Biomet Persona is an implant device with limited duration contact (<24 hours) with tissue/bone.

Based on the results of the biocompatibility testing performed on the final VERASENSE for Zimmer Biomet Persona, in addition to the biocompatibility

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Image /page/10/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the word "ORTHOSENSOR". The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The text "ORTHOSENSOR" is written in a sans-serif font, with the letters in gray.

testing results of the raw materials, the VERASENSE for Zimmer Biomet Persona meets the requirements outlined in EN ISO 10993-1:2009/AC:2010.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the VERASENSE for Zimmer Biomet Persona and required accessories. The subject device and required accessories comply with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.

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 and COL location (for reference only) from the VERASENSE device. The VERASENSE Software Application does not directly drive a decision regarding treatment or therapy.

Performance Testing Bench

The safety performance of the VERASENSE for Zimmer Biomet Persona has been verified according to OrthoSensor, Inc's procedures for product design and development to ensure that it meets its intended use, including:

Usability ●
Sterilization ●
Packaging Integrity ●
Shelf life ●
Biocompatibility ● Assessment
Electrical Safety Testing IEC 60601-1
Electromagnetic ● Compatibility (EMC) IEC 60601-1-2
. Design Verification and Validation
. Software Verification and Validation

Performance Testing Animal

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

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Image /page/11/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 that converge at a central point, resembling a stylized triangle or a three-leaf clover. The company name "ORTHOSENSOR" is written in a serif font, with "ORTHO" in a darker shade of gray and "SENSOR" in a lighter shade of gray.

Performance Testing Clinical

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

CONCLUSIONS VIII.

The subject device VERASE for Zimmer Biomet Persona and required accessories have the same intended use, indications for use, environment, sterilization method, operating principle, packaging, electrical safety, and electromagnetic compatibility as the predicate device VERASENSE and required accessories. The differences in dimensions, wireless communications, materials, and shelf life have been identified and we determined that they have no impact on safety and effectiveness. Thus, the modifications are substantially equivalent to the previously cleared VERASENSE and required accessories.

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).