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
United U2 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

The provided document, a 510(k) Premarket Notification for the THINK Surgical TSolution One Total Knee Application, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way requested by the user.

Here's a breakdown of why and what information is missing:

The document primarily focuses on establishing "substantial equivalence" of a modified device (adding a new compatible knee implant system) to previously cleared predicate devices. It states that performance testing, specifically "cutting accuracy verification" and "cadaver lab validation testing," was conducted and "passed" following "similar test methods and acceptance criteria to those used for the predicate device." However, it does not provide the specific numerical acceptance criteria or the detailed results of these studies.

Therefore, I cannot provide a comprehensive answer to most of your questions based solely on the provided text.

Here's what I can extract and what's missing, aligning with your numbered questions:

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

Acceptance Criteria: Not explicitly stated in numerical form. The document only mentions that testing was done with "similar test methods and acceptance criteria to those used for the predicate device" and that the device "met all test criteria and specifications."
Reported Device Performance: Only reported as "Passed" for "Cutting Accuracy Verification" and "Cadaver Lab Validation Testing." No specific data (e.g., accuracy values, precision, failure rates) is provided.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Cutting Accuracy Verification:	Passed
Specific metric 1: (e.g., +/- X mm)	Not provided
Specific metric 2: (e.g., % within spec)	Not provided
Cadaver Lab Validation Testing:	Passed
Specific metric 1: (e.g., post-cut accuracy)	Not provided
Specific metric 2: (e.g., ease of use ratings)	Not provided

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing involved "simulated surgical testing in a cadaver model," implying a laboratory setting, but details are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document refers to the surgeon's role in the "preoperative planning software" and "robotic surgical tool" but does not detail expert involvement in establishing ground truth for testing.

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

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a robotic surgical tool, not an image interpretation AI tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood for AI image analysis performance is not relevant here. The device assists the surgeon in implementing a surgical plan.

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

The document implies that the "cutting accuracy verification" and parts of the "cadaver lab validation testing" would be representative of "algorithm only" performance (i.e., how accurately the robot cuts based on the plan). However, the results are only stated as "Passed" without numerical data. The system is described as operating "under the direction of the surgeon," so it's inherently a human-in-the-loop system for clinical use, but the underlying robotic precision can be tested standalone.

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

For the "cutting accuracy verification," the ground truth would likely be the pre-surgical plan (the intended cut), measured against the actual cut made by the robotic arm. This would be a form of objective physical measurement.
For the "cadaver lab validation testing," the ground truth would also be related to the planned vs. executed surgical steps and the resulting bone preparation accuracy, again measured objectively.
The document does not detail how this ground truth was established or measured (e.g., through metrology, post-cut imaging comparisons).

8. The sample size for the training set

Not applicable. This document describes a robotic surgical system, not a machine learning or AI model that requires a "training set" in the context of data-driven learning. While the robot's control algorithms are developed, they are based on engineering principles and precise physical models, not on being "trained" on a dataset in the way a diagnostic AI would be.

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

Not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) document confirms that performance testing was performed and met acceptance criteria, but it does not disclose the specific numerical criteria, the detailed quantitative results, or the methodological specifics (like sample size, expert involvement, or ground truth establishment details) of these tests. This level of detail is typically found in the full submission, which is not publicly available in this FDA clearance letter.

Summary

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June 10, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K201255

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: May 8, 2020 Received: May 11, 2020

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

Shumaya Ali, MPH 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) K201255

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
United U2 Knee System

Type or 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 vertical line in place of 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 line adds a touch of color and visual interest.

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:	10 June 2020

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 (primary predicate) and K193135.

Device Modification:

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

. Compatible implants - Addition of the United U2 Knee System.
Labeling - Implant compatibility has been modified in the Indications for Use.

Device Description:

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

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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 large, bold, sans-serif letters, with the "I" in "THINK" being a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in smaller, sans-serif letters. A registered trademark symbol is located to the right of the letter "K".

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

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.

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
United U2 Knee System .

Substantial Equivalence:

Both the TSolution One® Total Knee Application, and the predicate devices have the same intended use. Both are intended for use as devices that use 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 surqical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The difference between the new device and the predicates is that the new device provides an additional compatible total knee implant system to those previously cleared.

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Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in a sans-serif font, with a blue vertical line in the middle of the "I". Below the word "THINK" is the word "SURGICAL" in a smaller font.

The indications for use of the new device adds one new total knee implant systems that is 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 OneTotal KneeApplication	TSolution OneTotal KneeApplication	TSolution OneTotal KneeApplication
510(k) number	Subject Device	K191369	K193135
Manufacturer	THINK SurgicalInc.	THINK SurgicalInc.	THINK SurgicalInc.	Conclusion
TechnologicalCharacteristics
-Patient Imaging	CT Scan	CT Scan	CT Scan	SAME
-User Controls	Keyboard,mouse, Pendantwith mechanicallylatched StopButton	Keyboard,mouse, Pendantwith mechanicallylatched StopButton	Keyboard,mouse, Pendantwith mechanicallylatched StopButton	SAME
-Preoperativeplanningworkstation	TPLAN three-dimensionalpreoperativeplanningworkstation	TPLAN three-dimensionalpreoperativeplanningworkstation	TPLAN three-dimensionalpreoperativeplanningworkstation	SAME
-Pre-surgical Plan	CT images usedto create a 3Dmodel of thebone, library ofFDA clearedcomponents usedto developoptimal implantsize and location	CT images usedto create a 3Dmodel of thebone, library ofFDA clearedcomponents usedto developoptimal implantsize and location	CT images usedto create a 3Dmodel of thebone, library ofFDA clearedcomponents usedto developoptimal implantsize and location	SAME
-Surgical PlanData	High leveloperative planbased onpreoperative planwithpredeterminedcontrol filedeveloped tocontrol the roboticarm	High leveloperative planbased onpreoperative planwithpredeterminedcontrol filedeveloped tocontrol the roboticarm	High leveloperative planbased onpreoperative planwithpredeterminedcontrol filedeveloped tocontrol the roboticarm	SAME
Product	TSolution OneTotal KneeApplication	TSolution OneTotal KneeApplication	TSolution OneTotal KneeApplication
510(k) number	Subject Device	K191369	K193135
Manufacturer	THINK SurgicalInc.	THINK SurgicalInc.	THINK SurgicalInc.	Conclusion
-SurgicalExposure	Similar totraditional surgicalexposure for theanatomic site	Similar totraditional surgicalexposure for theanatomic site	Similar totraditional surgicalexposure for theanatomic site	SAME
Electromechanicalarm to implementpre-surgical plan	TCATelectromechanicalarm systemimplements pre-surgical plan	TCATelectromechanicalarm systemimplements pre-surgical plan	TCATelectromechanicalarm systemimplements pre-surgical plan	SAME
-Patient/RobotRegistration	Pinless point tosurfaceregistration withmechanicaltracking.Percutaneousprobe thinenough to makecontact via directpuncture throughskin.	Pinless point tosurfaceregistration withmechanicaltracking.Percutaneousprobe thinenough to makecontact via directpuncture throughskin.	Pinless point tosurfaceregistration withmechanicaltracking.Percutaneousprobe thinenough to makecontact via directpuncture throughskin.	SAME
-Bone MotionRecovery	Two bone motionrecovery markersare used torecoverregistration afterbone motion.	Two bone motionrecovery markersare used torecoverregistration afterbone motion.	Two bone motionrecovery markersare used torecoverregistration afterbone motion.	SAME
-Compatible KneeImplant Systems	-ZimmerPersona™ KneeSystem-Corin Unity KneeSystem-AesculapColumbus KneeSystem-DJO Surgical®EMPOWR 3DKnee® System-United U2 KneeSystem	-ZimmerPersona™ KneeSystem	-ZimmerPersona™ KneeSystem-Corin Unity KneeSystem-AesculapColumbus KneeSystem-DJO Surgical®EMPOWR 3DKnee® System	SubstantiallyEquivalent(AddsCompatibilitywith oneadditional totalknee implantsystem)
PerformanceTesting
-Cutting AccuracyVerification	Passed	Passed	Passed	SAME
Product	TSolution OneTotal KneeApplication	TSolution OneTotal KneeApplication	TSolution OneTotal KneeApplication
510(k) number	Subject Device	K191369	K193135
Manufacturer	THINK SurgicalInc.	THINK SurgicalInc.	THINK SurgicalInc.	Conclusion
-Cadaver LabValidation Testing	Passed	Passed	Passed	SAME
-Software Testing	Passed	Passed	Passed	SAME

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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in a bold, sans-serif font, with the "I" represented 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

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Image /page/7/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 the "I" represented 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

Conclusion

The TSolution One® Total Knee Application is equivalent to the predicates, TSolution One® Total Knee Application (K191369 and K193135), 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 devices, and that the device is as safe and effective as the predicate devices 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).