The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).

The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes.

The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:

· Zimmer Persona™ Knee System
· Corin Unity Knee System
Aesculap Columbus Knee System
· DJO Surgical® EMPOWR 3D Knee® System

Device Description

The TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

The TSolution One® Total Knee Application consists of TPLAN and TCAT. TPLAN is a three-dimensional (3D) preoperative planning workstation that aids a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy. TCAT consists of an electromechanical arm, an arm base including control electronics and computer, a display monitor, operating software, pendant control, and tools and accessories, for the implementation of the preoperative plan. TCAT and TPLAN when used according to the instructions for use, make submillimeter precision bone preparation possible before and during TKA surgical procedures.

AI/ML Overview

This document describes a 510(k) premarket notification for the TSolution One® Total Knee Application by Think Surgical, Inc. The submission is a "Special 510(k)" because it concerns modifications to a previously cleared device (K191369). The primary modifications are the addition of compatibility with three new knee implant systems (Corin Unity Knee System, Aesculap Columbus Knee System, and DJO Surgical® EMPOWR 3D Knee® System) and corresponding labeling changes.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria. Instead, it refers to prior testing and states that the current device met all test criteria and specifications and passed various tests. The claim of equivalence is based on the new device performing similarly to the predicate device, which had already met specified criteria.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Cutting Accuracy Verification	"similar test methods and acceptance criteria to those used for the predicate device"	"Passed"
Cadaver Lab Validation Testing	"methods and acceptance criteria similar to that used for the predicate device"	"Passed"
Software Testing	(Implied to be sufficient for proper function)	"Passed"

2. Sample Size Used for the Test Set and Data Provenance

The document states:

Cutting Accuracy Verification: "Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device." No specific sample size (e.g., number of tests, number of bone samples) is provided for this testing.
Cadaver Lab Validation Testing: "Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met." No specific sample size (e.g., number of cadavers, number of procedures) is provided.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective in nature, as new testing was conducted specifically for this submission to verify the modifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions "simulated surgical testing in a cadaver model" and that the robotic surgical tool operates "under the direction of the surgeon." While this implies clinical involvement, it does not specify the number of experts, their qualifications, or their role in establishing ground truth for the test set used for regulatory submission. The focus is on the device's ability to precisely implement a presurgical plan, rather than on expert interpretation of outcomes for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The testing described (cutting accuracy, cadaver lab validation, software testing) suggests objective, quantifiable measurements against engineering specifications or predetermined surgical plans, rather than a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned in this document. The submission is a Special 510(k) for modifications to an existing device, focusing on demonstrating that the changes do not negatively impact safety or effectiveness. There's no comparative study presented on human reader performance with or without AI assistance. The device is an AI/robotic system assisting surgeons, but its comparative effectiveness against unaided human surgeons is not described here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes the TSolution One® Total Knee Application as consisting of:

TPLAN: "a three-dimensional (3D) preoperative planning workstation that aids a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy."
TCAT: "an electromechanical arm... for the implementation of the preoperative plan."
The core function is a "robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan." This clearly indicates a "human-in-the-loop" system.

However, the "Cutting Accuracy Verification" and "Software Testing" could be considered "standalone" tests of the algorithm's and robotic arm's mechanical precision and software functionality in a controlled environment, even if the overall system is always used with a surgeon. The cadaver lab testing also evaluates the system's performance, but still within the context of a simulated surgical procedure involving a human operator.

7. The Type of Ground Truth Used

Based on the description of performance testing:

Cutting Accuracy Verification: The ground truth would likely be engineering specifications or predefined geometric targets. The robotic arm's actual cut surfaces or trajectory would be compared against these targets.
Cadaver Lab Validation Testing: The ground truth for this would likely be the preoperative plan generated by TPLAN. The actual resections performed by the TCAT robotic arm on cadaver bone would be measured and compared against the planned resections (e.g., bone resection depth, angle, implant position). This would be an objective, quantifiable ground truth based on the software's plan.
Software Testing: Ground truth for software testing generally involves verifying that the software functions according to its design specifications and requirements, producing expected outputs for given inputs.

8. The Sample Size for the Training Set

This document describes a device modification and substantial equivalence comparison, not the development of a novel machine learning algorithm from scratch. Therefore, information about a "training set" for an AI model is not provided. The TSolution One system uses CT images to create 3D models and a "library of FDA cleared components" for planning, but this is not described as a traditional machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is mentioned or implied for a machine learning model, information on how its ground truth was established is not applicable to this document. The system's functionality relies on engineering principles, image processing, and pre-defined surgical planning rules.

Summary

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December 11, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

Think Surgical, Inc. Meliha Mulalic Director, Regulatory Affairs and Quality Assurance 47201 Lakeview Blvd Fremont, California 94538

Re: K193135

Trade/Device Name: TSolution One Total Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 11, 2019 Received: November 12, 2019

Dear Meliha Mulalic:

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,

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) K193135

Device Name TSolution One® Total Knee Application

Indications for Use (Describe)

The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:

· Zimmer Persona™ Knee System
· Corin Unity Knee System
Aesculap Columbus Knee System
· DJO Surgical® EMPOWR 3D Knee® System

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/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with a blue triangle replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest.

SECTION 6

K193135

510(k) SUMMARY

Applicant Information:

Owner Name:	THINK Surgical, Inc.
Address:	47201 Lakeview Blvd., Fremont, CA 94538
Phone number:	510-249-2337
Fax number:	510-249-2396
Establishment Registration Number:	3000719653
Contact Person:	Meliha Mulalic
Date Prepared:	11 November 2019

Device Information:

Device Classification:	Class II
Trade Name:	TSolution® One Total Knee Application
Common name:	Orthopedic Stereotaxic Instrument
Classification name:	Stereotaxic Instrument
Regulation number:	882.4560
Product Code:	OLO

Predicate Device:

The TSolution® One Total Knee Application is substantially equivalent in intended use, fundamental scientific technology and performance to TSolution One® Total Knee Application cleared via K191369.

Device Modification:

The following changes have been made to the TSolution® One Total Knee Application:

Compatible implants Addition of the Corin Unity Knee System, Aesculap . Columbus Knee System and DJO Surgical® EMPOWR 3D Knee® System.
. Labeling - Implant compatibility has been modified in the Indications for Use.

Device Description:

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Image /page/4/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with a blue triangle replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest.

TSolution One® Total Knee Application Special 510(k) Submission

Intended Use / Indications for Use:

The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:

Zimmer Persona™ Knee System
Corin Unity Knee System ●
Aesculap Columbus Knee System .
DJO Surgical® EMPOWR 3D Knee® System .

Substantial Equivalence:

Both the TSolution One® Total Knee Application, and the predicate device have the same intended use. Both are intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The difference between the new device and the predicate is that the new device provides additional compatible total knee implant systems to those previously cleared.

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Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in large, bold, gray letters, with a blue triangle in place of the "I". Below the word "THINK" is the word "SURGICAL" in smaller, gray letters.

The indications for use of the new device adds three new total knee implant systems that are compatible with the TSolution One® Total Knee Application.

Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TSolution One® Total Knee Application met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.

Substantial equivalence in technological characteristic and performance of the TSolution One® Total Knee Application to the predicate device is outlined in the table below:

Product	TSolution One Total KneeApplication	TSolution One Total KneeApplication	Conclusion
510(k) number	Subject Device	K191369
Manufacturer	THINK Surgical Inc	THINK Surgical Inc	SAME
TechnologicalCharacteristics
-Patient Imaging	CT Scan	CT Scan	SAME
-User Controls	Keyboard, mouse, Pendantwith mechanically latchedStop Button	Keyboard, mouse, Pendantwith mechanically latchedStop Button	SAME
-Preoperativeplanningworkstation	TPLAN three-dimensionalpreoperative planningworkstation	TPLAN three-dimensionalpreoperative planningworkstation	SAME
-Pre-surgical Plan	CT images used to createa 3D model of the bone,library of FDA clearedcomponents used todevelop optimal implantsize and location	CT images used to create a3D model of the bone,library of FDA clearedcomponents used todevelop optimal implantsize and location	SAME
-Surgical PlanData	High level operative planbased on preoperative planwith predetermined controlfile developed to control therobotic arm.	High level operative planbased on preoperative planwith predetermined controlfile developed to control therobotic arm.	SAME
-SurgicalExposure	Similar to traditionalsurgical exposure for theanatomic site	Similar to traditionalsurgical exposure for theanatomic site	SAME
Electromechanicalarm to implementpre-surgical plan	TCAT electromechanicalarm system implementspre-surgical plan	TCAT electromechanicalarm system implementspre-surgical plan	SAME
-Patient/RobotRegistration	Pinless point to surfaceregistration withmechanical tracking.Percutaneous probe thinenough to make contact viadirect puncture throughskin	Pinless point to surfaceregistration withmechanical tracking.Percutaneous probe thinenough to make contact viadirect puncture throughskin	SAME

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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.

TSolution One® Total Knee Application Special 510(k) Submission

Product	TSolution One Total KneeApplication	TSolution One Total KneeApplication	Conclusion
510(k) number	Subject Device	K191369
Manufacturer	THINK Surgical Inc	THINK Surgical Inc
-Bone MotionRecovery	Two bone motion recoverymarkers are used torecover registration afterbone motion.	Two bone motion recoverymarkers are used torecover registration afterbone motion.	SAME
PerformanceTesting
-Cutting AccuracyVerification	Passed	Passed	SAME
-Cadaver LabValidation Testing	Passed	Passed	SAME
-Software Testing	Passed	Passed	SAME

Conclusion

The TSolution One® Total Knee Application is equivalent to the predicate, TSolution One® Total Knee Application, in the following ways: it has the same intended use, the same technological characteristics and operating principles, incorporates the same design and materials. Performance testing has demonstrated that the characteristics of the TSolution One® Total Knee Application are equivalent to the predicate device, and that the device is as safe and effective as the predicate device and does not raise any new questions of safety and effectiveness; therefore, a determination of Substantial Equivalence is supported.

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).