Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for measuring forces and angles during knee surgery, transmitting data wirelessly to software for display. There is no mention of AI, ML, or any learning or adaptive algorithms. The performance metrics are based on accuracy of measurements, not on the performance of an AI/ML model.

Therapeutic

No.
The device is a tool to measure implant alignment and balance during Total Knee Arthroplasty (TKA), not to provide therapy itself. Its function is to guide the surgeon in aligning the implant, which is a diagnostic or procedural aid rather than a therapeutic intervention.

Diagnostic

Yes

The device is designed as a tool to measure implant alignment and dynamically balance the knee during Total Knee Arthroplasty (TKA), providing data on dynamic loads and static angular measurements to reduce instability from flexion gap asymmetry. This function of measurement and assessment for intraoperative use aligns with the definition of a diagnostic device, as it provides information crucial for guiding surgical decisions and ensuring proper implant placement.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (Electronic Module, Ultra-Thin Force Sensor, Multifunction Alignment Handle, Sensor Covers, Alignment Rod, Sterilization Tray) in addition to the software application. The software is part of a larger system that includes physical hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the TrueBalance™ Surgical System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
TrueBalance™ Function: The TrueBalance™ Surgical System is a surgical tool used during a Total Knee Arthroplasty (TKA) procedure. It measures forces and alignment within the knee joint during the surgery itself. It does not analyze biological specimens.
Intended Use: The intended use clearly states it's "For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry" during TKA. This is an intraoperative measurement tool, not a diagnostic test performed on a sample.

Therefore, the TrueBalance™ Surgical System falls under the category of a surgical instrument or device used to aid in a surgical procedure, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TrueBalance™ Surgical System 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. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.

Product codes (comma separated list FDA assigned to the subject device)

ONN

Device Description

TrueBalance™ Surgical System provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

TrueBalance™ Surgical System consists of seven components and one optional component:

Electronic Module, 1.
1. Ultra-Thin Force Sensor,
Multifunction Alignment Handle, 3.
1. Sensor Covers (8 sizes),
1. Alignment Rod,
Sterilization Tray, and 6.
1. TrueBalance™ Software Application (TSA) and Display (iPad)
1. (Optional) Off-the-shelf Tablet Floor Stand for iPad

The TrueBalance™ Surgical System Electronic Module and hardware components are steam sterilizable via autoclave and reusable via a Sterilization Tray. TrueBalance™ Surgical System Ultra-Thin Force Sensor is single use, packaged non-sterilizable via autoclaye. The TrueBalance™ Surgical System Electronic Module is steam sterilizable via autoclave in either the Sterilization Tray or standard autoclavable pouches.

TrueBalance™ Surgical System measures dynamic loads in the medial and lateral compartments of the knee and static angular measurements for the alignment functionality. The data from the Ultra-Thin Force Sensor and embedded accelerometer is wirelessly transmitted to the TrueBalance™ Software Application (TSA) and Display (iPad) which is located outside the sterile field in the operating room.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

TKA Procedures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon, Hospital (operating room)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

To establish substantial equivalence and a shelf-life period for the subject device, TrueBalance™ Surgical System, the tests performed in Table 5.2 were completed with results demonstrating that acceptance criteria were met and that the subject device is substantially equivalent in performance as compared to the cited predicate devices, VERASENSE For Zimmer Biomet Persona (K193580) and VERASENSE For Zimmer Biomet Persona (K180459).

Table 5.2 - The Subject Device, TrueBalance™ Surgical System, Safety and Performance Testing Summary

Test: Software Lifecycle, Standards: IEC 62304, Test Description: Software Development and V&V, Result: Pass
Test: Electrical Safety, Standards: IEC 60601-1, Test Description: Safety Testing, Result: Pass
Test: Electromagnetic Compatibility, Standards: IEC 60601-1-2, Test Description: EMC Testing, Result: Pass
Test: EMC Testing, Standards: EN 301 489-1 v2.2.3, EN 301 489-17 v3.2.2, Test Description: EMC Testing, Result: Pass
Test: Radio Frequency, Standards: 47 CFR Part 15.247, Test Description: FCC Testing, Result: Pass
Test: Reprocessing, Standards: AAMI TIR 30, AAMI TIR 12, ISO 17664, Test Description: Manual cleaning and automated wash, Result: Pass
Test: Sterilization, Standards: ISO 17665-1, ISO 17665-2, ISO 17664, ISO 11737-2, ISO 11138-7, Test Description: Autoclave steam sterilization, Result: Pass
Test: Biocompatibility, Standards: ISO 10993-1 and Family, Test Description: Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Material mediated pyrogenicity, Result: Pass
Test: Shelf Life, Standards: Real Time, Test Description: Tox, FT-IR and TOC, Result: Pass
Test: Packaging, Standards: ASTM D4169-16, Test Description: Drop, Vibration, Environmental Condition, Result: Pass
Test: Stability Studies, Standards: ISO 10993-5, Test Description: Cytotoxicity, FT-IR & TOC, Result: Pass
Test: Usability Engineering / Cadaver Labs, Standards: IEC 62366-1 & IEC 60601-1-6, Internal Protocol, Test Description: Usability Testing Cadaver Labs, Result: Pass
Test: Load / Force Performance Testing, Standards: Internal Protocol, Test Description: Load/Force Testing, Result: Pass
Test: Alignment Performance Testing, Standards: Internal Protocol, Test Description: Alignment Testing, Result: Pass
Test: Water Ingress Rating, Standards: IEC 60529, Test Description: IPX7 Water Ingress Test (electronic Module Only), Result: Pass
Test: Shelf Life, Standards: ASTM F1980, Test Description: Accelerated Aging studies, Result: Pass
Test: Performance Testing - Animal, Standards: N/A, Test Description: Animal performance testing was not required to demonstrate substantial equivalence, Result: N/A
Test: Performance Testing - Clinical, Standards: N/A, Test Description: Clinical performance testing was not required to demonstrate substantial equivalence, Result: N/A

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Load Balancing:

Operating Range: 0 - 160 LBF
Load Accuracy: ± 3.0 LB For ± 7.5% (whichever is greater)
Load Values Displayed: >160 LBF for Reference only
Maximum Safe Load: 160 LBF (per condyle)
A-P Condylar Position & M-L Distribution Accuracies: Equal to or better than ± 25%

Alignment:

Tibia Varus/Valgus: ± 0.9 degrees 95% Confidence
Femur Varus/Valgus: ± 1.2 degrees 95% Confidence
Posterior Slope: ± 1.0 degrees 95% Confidence
Mechanical Axis: ± 1.5 degrees 95% Confidence

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K193580, K180459

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

September 15, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

These Three Medical, LLC Moj Eram Regulatory Affairs Correspondent 20860 N. Tatum Blvd.. Suite 300 Phoenix, Arizona 85050

Re: K220830

Trade/Device Name: TrueBalance™ Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: August 15, 2022 Received: August 16, 2022

Dear Moj Eram:

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.

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

1

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 (OS) 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 mediation-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,

For: 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 Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K220830

Device Name TrueBalance™ Surgical System

Indications for Use (Describe)

TrueBalance™ Surgical System 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. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single 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 These Three Medical, LLC. The logo features a blue circle with three curved lines emanating from it, resembling a signal or sound wave. To the right of the symbol, the words "THESE THREE" are written in a bold, sans-serif font, with "MEDICAL, LLC" written in a smaller font below.

510(k) Summary

21 CFR 807.92(a)

1 General Provisions

Submitter Name:	These Three Medical, LLC
Address:	20860 N. Tatum Blvd., Suite 300
Phoenix, AZ 85050
Contact Person:	Jay Pierce
Telephone Number:	480.771.4133
Date of Preparation:	15 August 2022

Principle and Regulatory Contacts 2

Submitted By/Principal Contact:

Contact Name:	Jay Pierce
Title:	President/CEO
These Three Medical, LLC
Address:	20860 N. Tatum Blvd., Suite 300
Phoenix, AZ 85050
Phone Number:	480.771.4133
Email:	huan@generalvibronics.com

Regulatory Affairs Correspondance:

Name:	Moj Eram, PhD
Title:	Regulatory Affairs Representative
	Sage BioPartners, LLC
Phone Number:	801.230.8611 (Mobile)
Email:	moj.eram@sagebiopartners.com

3 Subject Device

Trade Name:	TrueBalance™ Surgical System
Classification Name:	Stereotaxic Instrument
Classification:	Class II
Product Code:	ONN
Regulation Number:	21 CFR 822.4560
Regulation Medical Specialty:	Neurology
Review Panel:	Orthopedic

4

Predicate Devices ব

1. 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 (hereafter VERASENSE For Zimmer Biomet Persona)

Manufacturer:	OrthoSensor, Inc.
510(k) Number:	K193580
Classification:	Class II
FDA Product Code:	ONN (Subsequent OLO)
Regulation Number:	21 CFR 882.4560
Regulation Medical Specialty:	Neurology
Review Panel:	Orthopedic
Device Classification Name:	Intraoperative Orthopedic Joint Assessment Aid

VERASENSE For Zimmer Biomet Persona 2.

Manufacturer:	OrthoSensor, Inc.
510(k) Number:	K180459
Classification:	Class II
FDA Product Code:	ONN
Regulation Number:	21 CFR 882.4560
Regulation Medical Specialty:	Neurology
Review Panel:	Orthopedic
Device Classification Name: Intraoperative Orthopedic Joint Assessment Aid

5 Device Description

TrueBalance™ Surgical System provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

TrueBalance™ Surgical System consists of seven components and one optional component:

Electronic Module, 1.
1. Ultra-Thin Force Sensor,
Multifunction Alignment Handle, 3.
1. Sensor Covers (8 sizes),
1. Alignment Rod,
Sterilization Tray, and 6.
1. TrueBalance™ Software Application (TSA) and Display (iPad)
1. (Optional) Off-the-shelf Tablet Floor Stand for iPad

The TrueBalance™ Surgical System Electronic Module and hardware components are steam sterilizable via autoclave and reusable via a Sterilization Tray. TrueBalance™ Surgical System

5

Ultra-Thin Force Sensor is single use, packaged non-sterilizable via autoclaye. The TrueBalance™ Surgical System Electronic Module is steam sterilizable via autoclave in either the Sterilization Tray or standard autoclavable pouches.

TrueBalance™ Surgical System measures dynamic loads in the medial and lateral compartments of the knee and static angular measurements for the alignment functionality. The data from the Ultra-Thin Force Sensor and embedded accelerometer is wirelessly transmitted to the TrueBalance™ Software Application (TSA) and Display (iPad) which is located outside the sterile field in the operating room.

Indications for Use 6

TrueBalance™ Surgical System 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. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.

7 Comparison of Technological Characteristics with the Predicate Devices

A comparison of the subject device. TrueBalance™ Surgical System and predicate devices. VERASENSE For Zimmer Biomet Persona (K193580) & VERASENSE For Zimmer Biomet Persona (K180459), is based on the following same technologies:

. Electronics and sensors to measure load/force pressure between the femur and tibia in TKA procedures.
. Electronics and accelerometer to measure coronal plane alignment of the tibial resection relative to the patient specific tibia reference axis defined by the system registered landmarks, and numerical value of the varus/valgus tibial mechanical axis.
Required components to support the system includes a device that communicates via Bluetooth communications and a software application.
Algorithms to calculate medial and lateral load pressures and present to a user interface. ●
Sensor covers (shims) for thickness. ●

In addition to the similarities stated above, the following technological differences exist between the subject device, TrueBalance™ Surgical System and Predicate devices, VERASENSE For Zimmer Biomet Persona (K193580) & (K180459):

. The Predicate device measures condylar load/force only when the trial hardware components are placed while the TrueBalance™ Surgical System measures condylar loading during gap balancing and trialling phase.
TrueBalance Surgical System utilizes a Multifunctional Alignment Handle to measure ● load/force in the medial and lateral compartments, along with load positions in the anterior and posterior compartments.
In addition to measuring the resected the tibia, TrueBalance Surgical System utilizes an accelerometer and 21inch Alignment Rod to measure coronal plane alignment of the femoral resection relative to the patient specific femur reference axis defined by the

6

system registered landmarks, and numerical value of the varus/valgus femoral mechanical axis. Note that most conventional instrumentation for TKA procedures includes a spacer block and alignment rod in order to provide the surgeon a tool for visual interpretation of post cut limb alignment, albeit without quantifiable data.

TrueBalance™ Software Application (TSA) and Display (iPad) presents tibia slope and . mechanical axis of the limb.
. The Predicate devices enclose all electronics and sensors in a plastic, hermetically sealed, single use component. The TrueBalance Surgical System electronics module is decoupled from the sensor and the multifunction alignment handle. The system requires assembly in the operating room.
. The Ultra-Thin Force Sensor fits directly between the Multifunction Alignment Handle and numerous size Sensor Covers and is placed between the Femur and resected Tibia with or without trial hardware.
. The entire TrueBalance Surgical System (excluding TSA) is autoclavable.
TrueBalance Surgical System is reusable. (Exception is the Ultra-thin Force Sensor which . single use)
The TrueBalance™ Surgical System is implant company agnostic system and not dependent on the dimensions of OEM implant components.
. The Predicate devices provide a separate computer (link station) that houses the Software Application. TrueBalance™ Software Application (TSA) and Display (iPad) is provided to the hospital as part of a complete system.

Table 5.1 - Subject and Predicate devices Comparison
	Subject Device
TrueBalance™ Surgical System	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580)	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459)
Sponsor / Owner	These Three Medical, LLC	OrthoSensor, Inc.	OrthoSensor, Inc.
Regulation
Number	21 CFR 882.4560	21 CFR 882.4560	21 CFR 882.4560
Product Code	ONN	ONN
Subsequent OLO	ONN
Environment for
Use	Hospital (operating room)	Hospital (operating room)	Hospital (operating room)
Intended User	Surgeon	Surgeon	Surgeon
General Device
Description	A measurement tool to provide the
surgeon with quantifiable data
relative to load and angular
measurements.	A measurement tool to
provide the surgeon with
quantifiable data relative to
load and angular
measurements.	A measurement tool to
provide the surgeon with
quantifiable data relative to
load measurements.
Table 5.1 – Subject and Predicate devices Comparison
	Subject Device
TrueBalance™ Surgical System	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580)	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459)
Principle of
Operation	A measurement system used to
collect quantifiable data that is
useful to the surgeon performing
Total Knee Arthroplasty (TKA)
procedures.
Capacitive sensors on the device
measure the pressure exerted by the
femoral component of the implant
on the sensor.
The components include an
Electronic Module, Ultra-Thin
Force Sensor, Sensor Covers
(various thicknesses), Multifunction
Alignment Handle, Alignment Rod,
and an iPad with a Software
Application. The load sensors on the
device, measure the pressures
exerted between the cut femur and
tibia and between the femoral
component of the implant on the
sensor. The embedded
accelerometer works in conjunction
with the Alignment Rod and is
placed in specified procedural
positions, in order to measure angles
associated with bone cuts.
The Electronic Module is connected
via Bluetooth to an iPad hosting the
TrueBalance™ Software
Application (TSA). The TSA
displays both numerically and
pictorially load data along with
angular measurements (alignment
data), according to the description
and specifications.	A measurement system used
to collect quantifiable data
that is useful to the surgeon
performing Total Knee
Arthroplasty (TKA)
procedures.
Capacitive sensors on the
device measure the pressure
exerted by the femoral
component of the implant on
the sensor.
The VERASENSE Software
Application calculates force
vectors and positional data,
display both numerically and
pictorially load data versus
position, according to the
description and
specifications.
Transceiver is connected to
LinkStation via a USB cable.
Data from the VERASENSE
is wirelessly received by the
transceiver at a frequency of
401.05-405.55 MHz. The
transceiver processes
Gaussian Frequency-Shift
Keying (GFSK) modulated
data.	A measurement system used
to collect quantifiable data
that is useful to the surgeon
performing Total Knee
Arthroplasty (TKA)
procedures.
Capacitive sensors on the
device measure the pressure
exerted by the femoral
component of the implant on
the sensor.
The VERASENSE Software
Application calculates force
vectors and positional data,
display both numerically and
pictorially load data versus
position, according to the
description and
specifications.
Transceiver is connected to
LinkStation via a USB cable.
Data from the VERASENSE
is wirelessly received by the
transceiver at a frequency of
401.05-405.55 MHz. The
transceiver processes
Gaussian Frequency-Shift
Keying (GFSK) modulated
data.
Control
Mechanism	Microelectronics, sensors and
accelerometer to measure the
femoral component load and angles
of bone cuts.	Microelectronics, capacitive
sensors and accelerometer to
measure the femoral
component load and angles
of bone cuts.	Microelectronics, capacitive
sensors and accelerometer to
measure the femoral
component load.
Table 5.1 - Subject and Predicate devices Comparison
	Subject Device
TrueBalance™ Surgical System	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580)	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459)
		Materials
Electronic Module
Top Housing	VICTREX450G Natural PEEK -
Material Polyetheretherketone
(Electronic Module)	Colored Polycarbonate Resin	Colored Polycarbonate Resin
Electronic Module
Bottom Housing	VICTREX450G Natural PEEK -
Material Polyetheretherketone
(Electronic Module)	Colored Polycarbonate Resin	Colored Polycarbonate Resin
Electronic Module
Seal Between Top
and Bottom
Housing	Silicone Gasket	Loctite	Loctite
Sensor Covers	VICTREX450G Natural PEEK -
Material Polyetheretherketone	Shims - Colored
Polycarbonate Resin	Shims - Colored
Polycarbonate Resin
Sensor	Flex PCB	N/A	N/A
Multifunction
Alignment Handle	VICTREX450G Natural PEEK -
Material Polyetheretherketone	N/A	N/A
		Operation
Ligament
Balancing	TrueBalance™ Surgical System has
2 load transducers per compartment
that are used to calculate a
composite joint load per
compartment. Load transfer is
derived from the measured loads.
The microelectronics are decoupled
from the Ultra-Thin Force Sensor.
The Electronic Module is reusable
and autoclavable. The Ultra-Thin
Force Sensor connects with the
electronic module and works in
conjunction with the Multifunction
Alignment Handle and Sensor
Covers (various thickness).	It has 3 load transducers per
compartment that are used to
calculate a composite joint
load per compartment. Load
transfer is derived from the
measured loads.	It has 3 load transducers per
compartment that are used to
calculate a composite joint
load per compartment. Load
transfer is derived from the
measured loads.
Alignment
Function	Surgical workflow – The surgeon
follows standard instrumented
surgical technique and makes the
distal femur and proximal tibia cuts.
The system is inserted into the gap
that has been created.	The varus/valgus angle of the
resected tibia in the coronal
plane is calculated using the
established tibia reference
frame and the patient tibial
length measured by the
surgeon and entered into the	N/A
Table 5.1 – Subject and Predicate devices Comparison
	Subject Device
TrueBalance™ Surgical System	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580)	Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459)
	The alignment measurement tool is
used to assist the surgeon in
confirming the cut varus/valgus
angles of the tibia and femur,
posterior slope of tibia and
mechanical axis of limb.

Registration of anatomy includes
capturing the center of the femoral
head and center of the ankle.

The mechanical alignment is
calculated and defined as the axis
from the center of the femoral head
to the intercondylar notch and
extends further down from the
center of the proximal tibia to the
center of the ankle.

Posterior slope is in the sagittal
plane of the tibia.

Differences:
The TrueBalance™ Surgical System
uses a static measurement system
w/accelerometer versus IMU, a
unique algorithm, along with the
utilization of a standard TKA
alignment rod to facilitate data
collection. This is a real-time
measurement system versus a
navigation system that directs bone
cuts. | software application. The
tibial mechanical alignment
range is varus/valgus ±7°
with an accuracy of ±3°.

The VERASENSE for
Zimmer Biomet Persona
includes an accelerometer
and gyroscope that make up
the inertial measurement unit
(IMU). The IMU is calibrated
to removed fixed biases,
scale errors, and
misalignment errors in both
the accelerometer, and
gyroscope. The
accelerometer provides the
linear acceleration, while
gyroscope provides the
angular velocity, which are
used to determine the frame
of reference for the IMU. The
VERASENSE for Zimmer
Biomet Persona registers the
first anatomical landmark,
the center of the tibia, based
on the placement of the
VERASENSE for Zimmer
Biomet device in the tibial
tray implant. The IMU within
the VERASENSE for
Zimmer Biomet Persona is
centered with respect to the
implant tibial tray, with a
specific offset value for each
size and side of the device.
The second anatomical
landmark, the lateral center
of the heel's calcaneus, is
registered when the surgeon
takes the leg through a pivot
motion with the heel
stabilized, while the hip and
the pelvis are stable through
the patient position. | | |
| | Table 5.1 - Subject and Predicate devices Comparison | | | |
| | Subject Device
TrueBalance™ Surgical System | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580) | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459) | |
| Communication
& Display | TrueBalance™ Electronics
Module: Bluetooth 4.2

Software Application (TSA) and
Display: 9th Generation Apple iPad
with 10.2" Display, Bluetooth 4.2
Compatible, WIFI | Sensor: Bluetooth 4.2
compatible

LinkStation
MINI/LinkStation MINI
Evaluation Kit: Bluetooth
4.2 compatible, WIFI | Sensor: Bluetooth 4.2
compatible

LinkStation
MINI/LinkStation MINI
Evaluation Kit: Bluetooth
4.2 compatible, WIFI | |
| Electrical Details
(power, outlets,
voltage, etc.) | TrueBalance™ Electronic
Module: Internally powered high
temp lithium battery (3.6V 2/3AA)

iPad: AC power | Sensor: Internally powered
(3.1V DC)

LinkStation MINI
/LinkStation MINI
Evaluation Kit: AC Power | Sensor: Internally powered
(3.1V DC)

LinkStation MINI
/LinkStation MINI
Evaluation Kit: AC Power | |
| | Protection against electrical
Shock: Type BF Applied

Electromagnetic Interference
(EMI):
will tolerate typical levels of
electromagnetic interface

Electrostatic Discharge (EDS)
will tolerate exposure to 8kV
contact discharge and 8 kV air
discharge.

The TrueBalance™ Software
Application (TSA) and Display
(iPad) runs on a 9th generation iPad. | Protection against electrical
Shock:
Type BF Applied

Electromagnetic
Interference (EMI):
will tolerate typical levels of
electromagnetic interface

Electrostatic Discharge
(EDS)
will tolerate exposure to 8kV
contact discharge and 8 kV
air discharge. | Protection against electrical
Shock:
Type BF Applied

Electromagnetic
Interference (EMI):
will tolerate typical levels of
electromagnetic interface

Electrostatic Discharge
(EDS)
will tolerate exposure to 8kV
contact discharge and 8 kV
air discharge. | |
| | | Display Unit Protection
Against Electrical Shock
Class I (65W universal 3-pin
jack, 100-240V, 1.5A, 50-
60Hz) | Display Unit Protection
Against Electrical Shock
Class I (65W universal 3-pin
jack, 100-240V, 1.5A, 50-
60Hz) | |
| | | Transceiver Unit Protection
Against Electrical Shock
Class II USB powered and
intended to be connected to
the USB port of the
LinkStation MINI display
unit (5 V dc) | Transceiver Unit Protection
Against Electrical Shock
Class II USB powered and
intended to be connected to
the USB port of the
LinkStation MINI display
unit (5 V dc) | |
| Table 5.1 - Subject and Predicate devices Comparison | | | | |
| | Subject Device
TrueBalance™ Surgical System | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580) | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459) | |
| Range (Meter) | 2m | 2m | 2m | |
| Performance
Specifications
(Load Balancing) | Operating Range | 0 - 160 LBF | N/A | 5 - 40 LBF |
| | Load Accuracy | $\pm$ 3.0 LB For $\pm$ 7.5%
(whichever is greater) | N/A | $\pm$ 3.5 LBF |
| | Load Values Displayed for Reference only | >160 LBF | N/A | 41-70 LBF |
| | Maximum Safe Load | 160 LBF
(per condyle) | N/A | 70 LBF |
| | A-P Condylar Position & M-L Distribution Accuracies | Equal to or better than $\pm$ 25% | N/A | COL for Reference Only |
| Performance
Specifications
(Alignment) | Tibia Varus/Valgus | $\pm$ 0.9 $^{\circ}$
95% Confidence | Range is varus/valgus $\pm$ 7 $^{\circ}$ with an accuracy of $\pm$ 3 $^{\circ}$ | N/A |
| | Femur Varus/Valgus | $\pm$ 1.2 $^{\circ}$
95% Confidence | N/A | N/A |
| | Posterior Slope | $\pm$ 1.0 $^{\circ}$
95% Confidence | N/A | N/A |
| | Mechanical Axis | $\pm$ 1.5 $^{\circ}$
95% Confidence | N/A | N/A |
| Software | The TrueBalance™ Software Application (TSA) and Display (iPad) calculates force vectors and positional data, displayed both numerically and pictorially load data versus position, according to the description and specifications. | The VERASENSE Software Application calculates force vectors and positional data, display both numerically and pictorially load data versus position, according to the description and specifications. For alignment, | The VERASENSE Software Application calculates force vectors and positional data, display both numerically and pictorially load data versus position, according to the | |
| Table 5.1 - Subject and Predicate devices Comparison | | | | |
| | Subject Device
TrueBalance™ Surgical System | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580) | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459) | |
| | tibial varus/valgus for the tibia,
femur, slope and mechanical
alignment. | the VSA displays the tibial
varus/valgus alignment angle
numerically using tibial
length, positional data,
angular velocity. | description and
specifications.
Alignment N/A | |
| | User Interface:
Component with iPad with a
graphical user interface
iPad Resolution: 10.2" screen,
2160 x 1620 resolution at 264 ppi
Operating System Compatibility
(display Unit):
iOS - iPad Version 15.6 or later | User Interface:
Accessory with tablet
computer with a graphical
user interface
Operating System
Compatibility (display
Unit):
Microsoft Windows 10 | User Interface:
Accessory with tablet
computer with a graphical
user interface
Operating System
Compatibility (display
Unit):
Microsoft Windows 10 | |
| Software LOC | Minor | Minor | Minor | |
| Sterilization
Method | Electronics Module:
Steam Sterilization via Autoclave
Ultra-Thin Force Sensor:
Steam Sterilization via Autoclave
Other components:
Steam Sterilization via Autoclave | Sensor: Ethylene Oxide 10-6
SAL
LinkStation
MINI/LinkStation MINI
Evaluation Kit: Non-Sterile | Sensor: Ethylene Oxide 10-6
SAL
LinkStation
MINI/LinkStation MINI
Evaluation Kit: Non-Sterile | |
| Shelf Life | Ultra-Thin Force Sensor: 17 months
PEEK Components: 24 months
prior to first reprocessing cycle | 3 Months | 3 Months | |
| Packaging | TrueBalance™ Surgical System is
not offered sterile.
Ultra-Thin Force Sensor: 50 sensors
are bagged and labelled (single Use)
Electronic Module: 5 per box and
labeled
Kitted Sterilization Tray: include,
Multifunction Alignment Handle,
Sensor Covers (8 sizes), Alignment
Rod, boxed and labeled | Sensor: double pouched,
sterile
Accessories: LinkStation
MINI - Wood box
LinkStation MINI Evaluation
Kit - Waterproof plastic case | Sensor: double pouched,
sterile
Accessories: LinkStation
MINI - Wood box
LinkStation MINI Evaluation
Kit – Waterproof plastic case | |
| Table 5.1 - Subject and Predicate devices Comparison | | | | |
| | Subject Device
TrueBalance™ Surgical System | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K193580) | Predicate Device
VERASENSE for Zimmer
Biomet Persona
(K180459) | |
| | All components are steam
sterilizable via autoclave with the
exception of the iPad. | | | |
| Ingress of Liquids | Electronic Module: IPX7
Display Unit: N/A, the iPad does
not come in contact with fluids
(outside of the sterile field). | Sensor: Rated IPX4
Display Unit: Rated IP54 | Sensor: Rated IPX4
Display Unit: Rated IP54 | |
| Electrical Safety | AAMI ANSI ES60601-
1:2005/A1:2012 | AAMI ANSI ES60601-
1:2005 | AAMI ANSI ES60601-
1:2005 | |
| Electromagnetic
Capability (EMC) | IEC 60601-1-2:2014 | IEC 60601-1-
2:2007/AC:2010 | IEC 60601-1-
2:2007/AC:2010 | |
| Sensor
Compatibility | Implant Company Agnostic | Zimmer Biomet: Persona | Zimmer Biomet: Persona | |
| Single Use /
Reusable | TrueBalance™ Surgical System is
reusable with the exception of the
Ultra-Thin Force Sensor component
which is single use only. | Single Use | Single Use | |
| Anatomical Site
Use | TKA Procedures | TKA Procedures | TKA Procedures | |
| Patient
Contacting | Yes - Sensor Covers, Multifunction
Alignment Handle, and Ultra-Thin
Force Sensor are direct patient
contacting components.
Evaluated according to ISO 10993-
1:2018 | None | None | |
| Prescription or
Over-the-Counter | Prescription Only | Prescription Only | Prescription Only | |

7

8

9

10

11

12

13

Safety and Performance Tests 8

To establish substantial equivalence and a shelf-life period for the subject device, TrueBalance™ Surgical System, the tests performed in Table 5.2 were completed with results demonstrating that acceptance criteria were met and that the subject device is substantially equivalent in performance as compared to the cited predicate devices, VERASENSE For Zimmer Biomet Persona (K193580) and VERASENSE For Zimmer Biomet Persona (K180459).

14

Risk management, including a failure mode and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2019, Medical Devices – Application of risk management to medical devices.

| Table 5.2 - The Subject Device, TrueBalance™ Surgical System, Safety and Performance Testing

Summary
Test	Standards	Test Description	Result
Software Lifecycle	IEC 62304	Software Development and V&V	Pass
Electrical Safety	IEC 60601-1	Safety Testing	Pass
Electromagnetic
Compatibility	IEC 60601-1-2	EMC Testing	Pass
EMC Testing	EN 301 489-1 v2.2.3
EN 301 489-17 v3.2.2	EMC Testing	Pass
Radio Frequency	47 CFR Part 15.247	FCC Testing	Pass
Reprocessing	AAMI TIR 30
AAMI TIR 12
ISO 17664	Manual cleaning and automated wash	Pass
Sterilization	ISO 17665-1
ISO 17665-2
ISO 17664
ISO 11737-2
ISO 11138-7	Autoclave steam sterilization	Pass
Biocompatibility	ISO 10993-1 and Family	• Cytotoxicity
• Irritation
• Sensitization
• Acute systemic toxicity
• Material mediated pyrogenicity	Pass
Shelf Life	Real Time	Tox, FT-IR and TOC	Pass
Packaging	ASTM D4169-16	Drop, Vibration, Environmental
Condition	Pass
Stability Studies	ISO 10993-5	Cytotoxicity, FT-IR & TOC	Pass
Usability Engineering
/ Cadaver Labs	IEC 62366-1 & IEC 60601-
1-6
Internal Protocol	Usability Testing Cadaver Labs	Pass
Load / Force
Performance Testing	Internal Protocol	Load/Force Testing	Pass
Alignment
Performance Testing	Internal Protocol	Alignment Testing	Pass
Water Ingress Rating	IEC 60529	IPX7 Water Ingress Test
(electronic Module Only)	Pass
Table 5.2 - The Subject Device, TrueBalance™ Surgical System, Safety and Performance Testing
Summary
Test	Standards	Test Description	Result
Shelf Life	ASTM F1980	Accelerated Aging studies	Pass
Performance Testing

Animal | N/A | Animal performance testing was not
required to demonstrate substantial
equivalence | N/A |
| Performance Testing
Clinical | N/A | Clinical performance testing was not
required to demonstrate substantial
equivalence | N/A |

15

9 Summary of Substantial Equivalence

TrueBalance™ Surgical System has the same intended use as the predicate devices, VERASENSE For Zimmer Biomet Persona (K193580) and VERASENSE For Zimmer Biomet Persona (K180459), as well as substantially equivalent technological characteristics and is as safe and effective as the predicate device. The differences in the technological characteristics do not raise different questions of safety or efficacy. The subject device, TrueBalance™ Surgical System, is substantially equivalent to its predicate devices.

Based on the intended use, technological characteristics, and safety and performance testing, the subject device, TrueBalance™ Surgical System, met the requirements that are considered sufficient for its intended use and are as safe and as effective as the predicate devices, VERASENSE For Zimmer Biomet Persona (K193580) and VERASENSE For Zimmer Biomet Persona (K180459).