(177 days)
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.
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.
-
- Ultra-Thin Force Sensor,
- Multifunction Alignment Handle, 3.
-
- Sensor Covers (8 sizes),
-
- Alignment Rod,
- Sterilization Tray, and 6.
-
- TrueBalance™ Software Application (TSA) and Display (iPad)
-
- (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.
Here's a breakdown of the acceptance criteria and study information for the TrueBalance™ Surgical System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides specific performance specifications for Load/Force and Alignment, comparing them to previous predicate devices (K193580 and K180459). The acceptance criteria are implicit in these reported performance specifications, as stated "with results demonstrating that acceptance criteria were met."
| Performance Metric | Acceptance Criteria (Subject Device, TrueBalance™ Surgical System) | Reported Device Performance (Subject Device, TrueBalance™ Surgical System) | Predicate Device (K193580) Performance | Predicate Device (K180459) Performance |
|---|---|---|---|---|
| Load/Force Balancing | ||||
| Operating Range | 0 - 160 LBF (per condyle) | 0 - 160 LBF | 0 - 160 LBF | 5 - 40 LBF (reported as operating range) |
| Load Accuracy | ± 3.0 LBF or ± 7.5% (whichever is greater) | ± 3.0 LBF or ± 7.5% (whichever is greater) | ± 3.5 LBF | ± 3.5 LBF |
| Load Values Displayed for Reference | >160 LBF | >160 LBF | >160 LBF | 41-70 LBF (reported for reference) |
| Maximum Safe Load | 160 LBF (per condyle) | 160 LBF (per condyle) | 70 LBF | |
| A-P Condylar Position & M-L Distribution Accuracies | Equal to or better than ± 25% | Equal to or better than ± 25% | COL for Reference Only | COL for Reference Only |
| Alignment | ||||
| Tibia Varus/Valgus | ± 0.9° (95% Confidence) | ± 0.9° (95% Confidence) | Range ± 7°, accuracy ± 3° | N/A (this predicate doesn't specify alignment directly) |
| Femur Varus/Valgus | ± 1.2° (95% Confidence) | ± 1.2° (95% Confidence) | N/A | N/A |
| Posterior Slope | ± 1.0° (95% Confidence) | ± 1.0° (95% Confidence) | N/A | N/A |
| Mechanical Axis | ± 1.5° (95% Confidence) | ± 1.5° (95% Confidence) | N/A | N/A |
2. Sample Size for the Test Set and Data Provenance
The document states that "Load/Force Performance Testing" and "Alignment Performance Testing" were conducted using "Internal Protocol." However, specific sample sizes for the test sets are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not explicitly stated beyond being "Internal Protocol." Given the nature of the device (surgical system), it is likely that these tests were conducted in a laboratory setting or on cadaver models, but this is not explicitly detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions "Usability Engineering / Cadaver Labs" as a safety and performance test. While this implies involvement of surgical experts, the number of experts and their qualifications (e.g., radiologist with 10 years of experience) are not specified.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set results. The internal protocols for Load/Force and Alignment performance testing would typically detail how results are evaluated and confirmed, but these details are not provided in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned. The document explicitly states:
- "Performance Testing - Animal: N/A (Animal performance testing was not required to demonstrate substantial equivalence)"
- "Performance Testing - Clinical: N/A (Clinical performance testing was not required to demonstrate substantial equivalence)"
Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document as it's not an AI-assisted diagnostic device in the traditional sense, but a measurement tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as a "measurement tool to provide the surgeon with quantifiable data." It relies on "Electronics and sensors to measure load/force pressure" and an "accelerometer to measure coronal plane alignment." The "TrueBalance™ Software Application (TSA)" processes this data and "displays both numerically and pictorially load data along with angular measurements (alignment data)."
This indicates that the algorithm operates in a standalone capacity to process sensor input and generate measurements, which are then presented to the human user (surgeon). The performance specifications listed in the table (Load Accuracy, Tibia Varus/Valgus, etc.) are a direct measure of this standalone algorithmic performance.
7. The Type of Ground Truth Used
For the Load/Force and Alignment Performance Testing, the ground truth would have been established through highly precise mechanical measurement systems and/or calibrated physical models/phantoms designed to simulate the knee joint under various loading and alignment conditions. This is implied by the nature of the reported accuracy metrics (e.g., LBF, degrees). For the Usability Testing Cadaver Labs, the ground truth would likely be established by observing surgical procedures, expert assessment of outcomes, and possibly comparative measurements against established surgical references.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This is common for devices that rely on established physical principles and calibrated sensors for measurement, rather than machine learning models that require extensive training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned for a machine learning model, this information is not applicable/provided. The device operates based on sensor readings and algorithms derived from engineering principles.
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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
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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
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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 300Phoenix, 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/CEOThese Three Medical, LLC |
| Address: | 20860 N. Tatum Blvd., Suite 300Phoenix, 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 |
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Predicate Devices ব
-
- 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.
-
- Ultra-Thin Force Sensor,
- Multifunction Alignment Handle, 3.
-
- Sensor Covers (8 sizes),
-
- Alignment Rod,
- Sterilization Tray, and 6.
-
- TrueBalance™ Software Application (TSA) and Display (iPad)
-
- (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 DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| Sponsor / Owner | These Three Medical, LLC | OrthoSensor, Inc. | OrthoSensor, Inc. | |
| RegulationNumber | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 | |
| Product Code | ONN | ONNSubsequent OLO | ONN | |
| Environment forUse | Hospital (operating room) | Hospital (operating room) | Hospital (operating room) | |
| Intended User | Surgeon | Surgeon | Surgeon | |
| General DeviceDescription | A measurement tool to provide thesurgeon with quantifiable datarelative to load and angularmeasurements. | A measurement tool toprovide the surgeon withquantifiable data relative toload and angularmeasurements. | A measurement tool toprovide the surgeon withquantifiable data relative toload measurements. | |
| Table 5.1 – Subject and Predicate devices Comparison | ||||
| Subject DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| Principle ofOperation | A measurement system used tocollect quantifiable data that isuseful to the surgeon performingTotal Knee Arthroplasty (TKA)procedures.Capacitive sensors on the devicemeasure the pressure exerted by thefemoral component of the implanton the sensor.The components include anElectronic Module, Ultra-ThinForce Sensor, Sensor Covers(various thicknesses), MultifunctionAlignment Handle, Alignment Rod,and an iPad with a SoftwareApplication. The load sensors on thedevice, measure the pressuresexerted between the cut femur andtibia and between the femoralcomponent of the implant on thesensor. The embeddedaccelerometer works in conjunctionwith the Alignment Rod and isplaced in specified proceduralpositions, in order to measure anglesassociated with bone cuts.The Electronic Module is connectedvia Bluetooth to an iPad hosting theTrueBalance™ SoftwareApplication (TSA). The TSAdisplays both numerically andpictorially load data along withangular measurements (alignmentdata), according to the descriptionand specifications. | A measurement system usedto collect quantifiable datathat is useful to the surgeonperforming Total KneeArthroplasty (TKA)procedures.Capacitive sensors on thedevice measure the pressureexerted by the femoralcomponent of the implant onthe sensor.The VERASENSE SoftwareApplication calculates forcevectors and positional data,display both numerically andpictorially load data versusposition, according to thedescription andspecifications.Transceiver is connected toLinkStation via a USB cable.Data from the VERASENSEis wirelessly received by thetransceiver at a frequency of401.05-405.55 MHz. Thetransceiver processesGaussian Frequency-ShiftKeying (GFSK) modulateddata. | A measurement system usedto collect quantifiable datathat is useful to the surgeonperforming Total KneeArthroplasty (TKA)procedures.Capacitive sensors on thedevice measure the pressureexerted by the femoralcomponent of the implant onthe sensor.The VERASENSE SoftwareApplication calculates forcevectors and positional data,display both numerically andpictorially load data versusposition, according to thedescription andspecifications.Transceiver is connected toLinkStation via a USB cable.Data from the VERASENSEis wirelessly received by thetransceiver at a frequency of401.05-405.55 MHz. Thetransceiver processesGaussian Frequency-ShiftKeying (GFSK) modulateddata. | |
| ControlMechanism | Microelectronics, sensors andaccelerometer to measure thefemoral component load and anglesof bone cuts. | Microelectronics, capacitivesensors and accelerometer tomeasure the femoralcomponent load and anglesof bone cuts. | Microelectronics, capacitivesensors and accelerometer tomeasure the femoralcomponent load. | |
| Table 5.1 - Subject and Predicate devices Comparison | ||||
| Subject DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| Materials | ||||
| Electronic ModuleTop Housing | VICTREX450G Natural PEEK -Material Polyetheretherketone(Electronic Module) | Colored Polycarbonate Resin | Colored Polycarbonate Resin | |
| Electronic ModuleBottom Housing | VICTREX450G Natural PEEK -Material Polyetheretherketone(Electronic Module) | Colored Polycarbonate Resin | Colored Polycarbonate Resin | |
| Electronic ModuleSeal Between Topand BottomHousing | Silicone Gasket | Loctite | Loctite | |
| Sensor Covers | VICTREX450G Natural PEEK -Material Polyetheretherketone | Shims - ColoredPolycarbonate Resin | Shims - ColoredPolycarbonate Resin | |
| Sensor | Flex PCB | N/A | N/A | |
| MultifunctionAlignment Handle | VICTREX450G Natural PEEK -Material Polyetheretherketone | N/A | N/A | |
| Operation | ||||
| LigamentBalancing | TrueBalance™ Surgical System has2 load transducers per compartmentthat are used to calculate acomposite joint load percompartment. Load transfer isderived from the measured loads.The microelectronics are decoupledfrom the Ultra-Thin Force Sensor.The Electronic Module is reusableand autoclavable. The Ultra-ThinForce Sensor connects with theelectronic module and works inconjunction with the MultifunctionAlignment Handle and SensorCovers (various thickness). | It has 3 load transducers percompartment that are used tocalculate a composite jointload per compartment. Loadtransfer is derived from themeasured loads. | It has 3 load transducers percompartment that are used tocalculate a composite jointload per compartment. Loadtransfer is derived from themeasured loads. | |
| AlignmentFunction | Surgical workflow – The surgeonfollows standard instrumentedsurgical technique and makes thedistal femur and proximal tibia cuts.The system is inserted into the gapthat has been created. | The varus/valgus angle of theresected tibia in the coronalplane is calculated using theestablished tibia referenceframe and the patient tibiallength measured by thesurgeon and entered into the | N/A | |
| Table 5.1 – Subject and Predicate devices Comparison | ||||
| Subject DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| The alignment measurement tool isused to assist the surgeon inconfirming the cut varus/valgusangles of the tibia and femur,posterior slope of tibia andmechanical axis of limb.Registration of anatomy includescapturing the center of the femoralhead and center of the ankle.The mechanical alignment iscalculated and defined as the axisfrom the center of the femoral headto the intercondylar notch andextends further down from thecenter of the proximal tibia to thecenter of the ankle.Posterior slope is in the sagittalplane of the tibia.Differences:The TrueBalance™ Surgical Systemuses a static measurement systemw/accelerometer versus IMU, aunique algorithm, along with theutilization of a standard TKAalignment rod to facilitate datacollection. This is a real-timemeasurement system versus anavigation system that directs bonecuts. | software application. Thetibial mechanical alignmentrange is varus/valgus ±7°with an accuracy of ±3°.The VERASENSE forZimmer Biomet Personaincludes an accelerometerand gyroscope that make upthe inertial measurement unit(IMU). The IMU is calibratedto removed fixed biases,scale errors, andmisalignment errors in boththe accelerometer, andgyroscope. Theaccelerometer provides thelinear acceleration, whilegyroscope provides theangular velocity, which areused to determine the frameof reference for the IMU. TheVERASENSE for ZimmerBiomet Persona registers thefirst anatomical landmark,the center of the tibia, basedon the placement of theVERASENSE for ZimmerBiomet device in the tibialtray implant. The IMU withinthe VERASENSE forZimmer Biomet Persona iscentered with respect to theimplant tibial tray, with aspecific offset value for eachsize and side of the device.The second anatomicallandmark, the lateral centerof the heel's calcaneus, isregistered when the surgeontakes the leg through a pivotmotion with the heelstabilized, while the hip andthe pelvis are stable throughthe patient position. | |||
| Table 5.1 - Subject and Predicate devices Comparison | ||||
| Subject DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| Communication& Display | TrueBalance™ ElectronicsModule: Bluetooth 4.2Software Application (TSA) andDisplay: 9th Generation Apple iPadwith 10.2" Display, Bluetooth 4.2Compatible, WIFI | Sensor: Bluetooth 4.2compatibleLinkStationMINI/LinkStation MINIEvaluation Kit: Bluetooth4.2 compatible, WIFI | Sensor: Bluetooth 4.2compatibleLinkStationMINI/LinkStation MINIEvaluation Kit: Bluetooth4.2 compatible, WIFI | |
| Electrical Details(power, outlets,voltage, etc.) | TrueBalance™ ElectronicModule: Internally powered hightemp lithium battery (3.6V 2/3AA)iPad: AC power | Sensor: Internally powered(3.1V DC)LinkStation MINI/LinkStation MINIEvaluation Kit: AC Power | Sensor: Internally powered(3.1V DC)LinkStation MINI/LinkStation MINIEvaluation Kit: AC Power | |
| Protection against electricalShock: Type BF AppliedElectromagnetic Interference(EMI):will tolerate typical levels ofelectromagnetic interfaceElectrostatic Discharge (EDS)will tolerate exposure to 8kVcontact discharge and 8 kV airdischarge.The TrueBalance™ SoftwareApplication (TSA) and Display(iPad) runs on a 9th generation iPad. | Protection against electricalShock:Type BF AppliedElectromagneticInterference (EMI):will tolerate typical levels ofelectromagnetic interfaceElectrostatic Discharge(EDS)will tolerate exposure to 8kVcontact discharge and 8 kVair discharge. | Protection against electricalShock:Type BF AppliedElectromagneticInterference (EMI):will tolerate typical levels ofelectromagnetic interfaceElectrostatic Discharge(EDS)will tolerate exposure to 8kVcontact discharge and 8 kVair discharge. | ||
| Display Unit ProtectionAgainst Electrical ShockClass I (65W universal 3-pinjack, 100-240V, 1.5A, 50-60Hz) | Display Unit ProtectionAgainst Electrical ShockClass I (65W universal 3-pinjack, 100-240V, 1.5A, 50-60Hz) | |||
| Transceiver Unit ProtectionAgainst Electrical ShockClass II USB powered andintended to be connected tothe USB port of theLinkStation MINI displayunit (5 V dc) | Transceiver Unit ProtectionAgainst Electrical ShockClass II USB powered andintended to be connected tothe USB port of theLinkStation MINI displayunit (5 V dc) | |||
| Table 5.1 - Subject and Predicate devices Comparison | ||||
| Subject DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| Range (Meter) | 2m | 2m | 2m | |
| PerformanceSpecifications(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 | |
| PerformanceSpecifications(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 DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| tibial varus/valgus for the tibia,femur, slope and mechanicalalignment. | the VSA displays the tibialvarus/valgus alignment anglenumerically using tibiallength, positional data,angular velocity. | description andspecifications.Alignment N/A | ||
| User Interface:Component with iPad with agraphical user interfaceiPad Resolution: 10.2" screen,2160 x 1620 resolution at 264 ppiOperating System Compatibility(display Unit):iOS - iPad Version 15.6 or later | User Interface:Accessory with tabletcomputer with a graphicaluser interfaceOperating SystemCompatibility (displayUnit):Microsoft Windows 10 | User Interface:Accessory with tabletcomputer with a graphicaluser interfaceOperating SystemCompatibility (displayUnit):Microsoft Windows 10 | ||
| Software LOC | Minor | Minor | Minor | |
| SterilizationMethod | Electronics Module:Steam Sterilization via AutoclaveUltra-Thin Force Sensor:Steam Sterilization via AutoclaveOther components:Steam Sterilization via Autoclave | Sensor: Ethylene Oxide 10-6SALLinkStationMINI/LinkStation MINIEvaluation Kit: Non-Sterile | Sensor: Ethylene Oxide 10-6SALLinkStationMINI/LinkStation MINIEvaluation Kit: Non-Sterile | |
| Shelf Life | Ultra-Thin Force Sensor: 17 monthsPEEK Components: 24 monthsprior to first reprocessing cycle | 3 Months | 3 Months | |
| Packaging | TrueBalance™ Surgical System isnot offered sterile.Ultra-Thin Force Sensor: 50 sensorsare bagged and labelled (single Use)Electronic Module: 5 per box andlabeledKitted Sterilization Tray: include,Multifunction Alignment Handle,Sensor Covers (8 sizes), AlignmentRod, boxed and labeled | Sensor: double pouched,sterileAccessories: LinkStationMINI - Wood boxLinkStation MINI EvaluationKit - Waterproof plastic case | Sensor: double pouched,sterileAccessories: LinkStationMINI - Wood boxLinkStation MINI EvaluationKit – Waterproof plastic case | |
| Table 5.1 - Subject and Predicate devices Comparison | ||||
| Subject DeviceTrueBalance™ Surgical System | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K193580) | Predicate DeviceVERASENSE for ZimmerBiomet Persona(K180459) | ||
| All components are steamsterilizable via autoclave with theexception of the iPad. | ||||
| Ingress of Liquids | Electronic Module: IPX7Display Unit: N/A, the iPad doesnot come in contact with fluids(outside of the sterile field). | Sensor: Rated IPX4Display Unit: Rated IP54 | Sensor: Rated IPX4Display Unit: Rated IP54 | |
| Electrical Safety | AAMI ANSI ES60601-1:2005/A1:2012 | AAMI ANSI ES60601-1:2005 | AAMI ANSI ES60601-1:2005 | |
| ElectromagneticCapability (EMC) | IEC 60601-1-2:2014 | IEC 60601-1-2:2007/AC:2010 | IEC 60601-1-2:2007/AC:2010 | |
| SensorCompatibility | Implant Company Agnostic | Zimmer Biomet: Persona | Zimmer Biomet: Persona | |
| Single Use /Reusable | TrueBalance™ Surgical System isreusable with the exception of theUltra-Thin Force Sensor componentwhich is single use only. | Single Use | Single Use | |
| Anatomical SiteUse | TKA Procedures | TKA Procedures | TKA Procedures | |
| PatientContacting | Yes - Sensor Covers, MultifunctionAlignment Handle, and Ultra-ThinForce Sensor are direct patientcontacting components.Evaluated according to ISO 10993-1:2018 | None | None | |
| Prescription orOver-the-Counter | Prescription Only | Prescription Only | Prescription Only |
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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).
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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 TestingSummary | |||
|---|---|---|---|
| Test | Standards | Test Description | Result |
| Software Lifecycle | IEC 62304 | Software Development and V&V | Pass |
| Electrical Safety | IEC 60601-1 | Safety Testing | Pass |
| ElectromagneticCompatibility | IEC 60601-1-2 | EMC Testing | Pass |
| EMC Testing | EN 301 489-1 v2.2.3EN 301 489-17 v3.2.2 | EMC Testing | Pass |
| Radio Frequency | 47 CFR Part 15.247 | FCC Testing | Pass |
| Reprocessing | AAMI TIR 30AAMI TIR 12ISO 17664 | Manual cleaning and automated wash | Pass |
| Sterilization | ISO 17665-1ISO 17665-2ISO 17664ISO 11737-2ISO 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, EnvironmentalCondition | Pass |
| Stability Studies | ISO 10993-5 | Cytotoxicity, FT-IR & TOC | Pass |
| Usability Engineering/ Cadaver Labs | IEC 62366-1 & IEC 60601-1-6Internal Protocol | Usability Testing Cadaver Labs | Pass |
| Load / ForcePerformance Testing | Internal Protocol | Load/Force Testing | Pass |
| AlignmentPerformance 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 TestingSummary | |||
| Test | Standards | Test Description | Result |
| Shelf Life | ASTM F1980 | Accelerated Aging studies | Pass |
| Performance Testing- Animal | N/A | Animal performance testing was notrequired to demonstrate substantialequivalence | N/A |
| Performance Testing- Clinical | N/A | Clinical performance testing was notrequired to demonstrate substantialequivalence | N/A |
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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).
§ 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).