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 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 Zimmer Persona™ Knee System.

Device Description

The TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planner 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 surqical procedures.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: TSolution One® Total Knee Application

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Primary Safety Endpoint	Composite safety endpoint (7 relevant adverse events as defined by the Knee Society, each with expected incidence ≤2.7%, sum = 7.6%)	None of the seven adverse events identified were observed. 100% (115/115) of patients successfully completed the primary safety endpoint.
Primary Effectiveness Endpoint	Demonstrate a reduction in malalignment rate (coronal mechanical axis > ±3° from preoperative plan) by 50% compared to a historical 32% malalignment rate (i.e., achieve ≤ 16% malalignment).	ITT: 13.0% malalignment rate, a 59.2% reduction. PP: 11.2% malalignment rate, a 65.0% reduction.

2. Sample Sizes and Data Provenance

Test Set (Clinical Trial): 115 patients were enrolled in the study (Intent-to-Treat group). 107 patients were in the Per-Protocol group for the effectiveness endpoint.
Data Provenance: Multi-center, prospective, non-randomized clinical trial carried out at six investigational sites in the US.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth for the test set beyond the involvement of "eight clinical investigators" in the study. Their specific qualifications (e.g., years of experience) are not detailed, but their role as clinical investigators implies medical expertise.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like "2+1" or "3+1" for assessing the primary endpoints. The outcomes (adverse events, malalignment rates) appear to be directly measured based on predefined criteria, rather than requiring expert consensus or adjudication of individual cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted to evaluate how human readers improve with AI vs. without AI assistance. This device is a robotic surgical tool, not an AI-assisted diagnostic imaging tool that human readers would interpret. The comparative effectiveness was against historical conventional manual TKA.

6. Standalone (Algorithm Only) Performance

The device is a robotic surgical tool that assists the surgeon, not a standalone algorithm for diagnosis or treatment decision-making without human intervention. Its performance is evaluated in the context of its use by a surgeon. The "cutting accuracy" and "software testing" results (table on page 6) refer to technical performance aspects of the system itself, which are a form of standalone testing for the specific functions of the device (e.g., how accurate are the cuts, does the software function as intended).

7. Type of Ground Truth Used

For Safety: Clinical observation and reporting of predefined adverse events (composite safety endpoint).
For Effectiveness: Direct measurement of coronal mechanical axis alignment from postoperative imaging at 3 months, compared to the preoperative plan and historical malalignment rates.

8. Sample Size for the Training Set

The document does not provide details on the sample size of any specific "training set" for the device's development or internal validation. It mentions the "library of FDA cleared components used to develop optimal implant size and location" for planning but doesn't quantify data used for algorithm training.

9. How Ground Truth for the Training Set Was Established

The document does not specify how ground truth for any potential training set was established. Given the nature of a surgical robotic system, its "training" might involve rigorous engineering validation, testing against known physical standards, and simulated surgical scenarios, rather than a traditional medical image dataset with expert-labeled ground truth like an AI diagnostic algorithm. The text focuses on the device's functionality rather than a machine learning model's training data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. The logo is clean and professional, reflecting the FDA's role in regulating food and drugs in the United States.

October 8, 2019

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

Re: K191369

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: September 6, 2019 Received: September 9, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191369

Device Name TSolution One® Total Knee Application

Indications for Use (Describe)

The TSolution One® Total Knee Application is compatible with the Zimmer Persona™ 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, sans-serif letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in smaller, blue, sans-serif letters.

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:	May 20, 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 the following legally marketed device in commercial distribution: THINK Surgical, Inc's TSolution One® Surgical System Model 210 cleared under K170430. The difference between the new device and the predicate is that the new device introduces a new indication for use for total knee arthroplasty and provides the tools and modified software for the preparation of the bone for this indication.

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters, with a blue square above the "T". Below "THINK" is the word "SURGICAL" in smaller, blue letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.

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 surqical procedures.

Intended Use / Indications for Use:

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 compatible with the Zimmer Persona™ Total Knee System.

Substantial Equivalence:

Both the TSolution One® Total Knee Application, and the predicate device, the TSolution One Surgical System Model 210 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 presurqical 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 are that the new device introduces a new indication for use for TKA and provides the tools and modified software for the preparation of the bone for this indication.

The new indication for use of the device for total knee arthroplasty does not raise any new types of safety and effectiveness questions. The types of questions for the changes made raise the same questions as for the cleared indication for total hip arthroplasty and are addressed by similarities in materials, technological characteristics, operational principles, and performance testing. Additionally, clinical testing of the new device consisted of a multicenter clinical study to demonstrate the safety and effectiveness of

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in large, gray block letters, with a small blue square above the "T". Below the word "THINK" is the word "SURGICAL" in smaller, blue letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.

the TSolution® One Total Knee Application for total knee arthroplasty. Furthermore, the Mako Surgical Corp. RIO for Total Knee Application (K143752) has the same intended use as the TSolution One® Total Knee Application, similar operational principles and has a cleared indication for use in total knee arthroplasty.

Substantial equivalence in technological characteristic and performance of the TSolution One® Total Knee Application to the predicate device, TSolution One Surgical System Model 210 is outlined in the table below:

Product	TSolution One TotalKnee Application	TSolution OneSurgical SystemModel 210
510(k) number	K191369(Subject Device)	K170430
Manufacturer	Think Surgical Inc	Think Surgical Inc	Conclusion
-Patient Imaging	CT Scan	CT Scan	SAME
-User Controls	Keyboard, mouse,Pendant withmechanically latchedStop Button	Keyboard, mouse,Pendant withmechanically latchedStop Button	SAME
-Preoperativeplanningworkstation	TPLAN three-dimensionalpreoperative planningworkstation	TPLAN three-dimensionalpreoperative planningworkstation	SAME
-Pre-surgical Plan	CT images used tocreate a 3D model ofthe bone, library ofFDA clearedcomponents used todevelop optimalimplant size andlocation	CT images used tocreate a 3D model ofthe bone, library of FDAcleared componentsused to develop optimalimplant size andlocation	SAME
-Surgical PlanData	High level operativeplan based onpreoperative plan withpredetermined controlfile developed tocontrol the roboticarm.	High level operativeplan based onpreoperative plan withpredetermined controlfile developed to controlthe robotic arm.	SAME
-SurgicalExposure	Similar to traditionalsurgical exposure forthe anatomic site	Similar to traditionalsurgical exposure forthe anatomic site	SAME
Electromechanicalarm to implementpre-surgical plan	TCATelectromechanical armsystem implementspre-surgical plan	TCATelectromechanical armsystem implements pre-surgical plan	SAME

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, sans-serif letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in smaller, blue, sans-serif letters. The logo is simple and modern, and the colors are clean and professional.

Product	TSolution One TotalKnee Application	TSolution One Surgical SystemModel 210	Conclusion
510(k) number	K191369(Subject Device)	K170430
Manufacturer	Think Surgical Inc	Think Surgical Inc	SAME
-Patient/RobotRegistration	Pinless point tosurface registrationwith mechanicaltracking.Percutaneous probethin enough to makecontact via directpuncture through skin.	Pinless point to surfaceregistration withmechanical tracking.Percutaneous probethin enough to makecontact via directpuncture through skin.
-Bone MotionRecovery	Two bone motionrecovery markers areused to recoverregistration after bonemotion.	Two bone motionrecovery markers andpercutaneously locateddistal band regionsused to recoverregistration after bonemotion.	SubstantiallyEquivalent(Distal band onlyrequired to track tip offemoral hipcomponent - notrequired for knee)
PerformanceTesting
-Biocompatibility	Passed	Passed	SAME
-Cutting Accuracy	Tested to Meets Userrequirements - PASSED	Tested to Meets UserRequirements - PASSED	SubstantiallyEquivalent
-Cadaver LabValidation Testing	Passed	Passed	SAME
-Software Testing	Verify TPLANpresurgical planningand TCAT SurgicalSystem Softwarefunction successfullyto completeprocedure- PASS	Verify TPLANpresurgical planningand TCAT SurgicalSystem Softwarefunction successfully tocomplete procedure -PASS	SAME
ElectromagneticCompatibility andElectrical Safety	Meets IECRequirements	Meets IECRequirements	SAME

Clinical Testing:

The TSolution One Total Knee Application clinical trial was designed as a multi-center, prospective, non-randomized clinical trial to evaluate the safety and effectiveness of TSolution One Total Knee Application compared to a historical control for orthopedic procedures of the knee requiring a primary unilateral total knee arthroplasty (TKA). Enrolled subjects had a confirmed Kellgren-Lawrence Grade of 3 or higher, had not undergone previous open knee surgery in the operative knee, and did not have a coronal deformity greater than 20 degrees, or a sagittal flexion contracture greater than 15 degrees.

The study was carried out at six investigational sites in the US with eight clinical investigators. A total of 115 patients were enrolled in the study and constitute the intent to treat group. Subject age ranged from 43.0 to 85.0 years old, with a mean age of

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in gray block letters, with a blue square above the "I". Below the word "THINK" is the word "SURGICAL" in blue, smaller block letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.

65.91. These results are reflective of the expected TKA patient population, which tends to be older. The mean BMI for subjects was 30.71. Subjects were 50.4% male and 49.6% female and the majority of patients had never smoked (72.2%). The most common comorbidity was cardiovascular conditions (71.2%), followed by musculoskeletal conditions (41.3%). Eleven subjects did not have any comorbidities and none of the comorbidities constituted an exclusion criteria or contraindication for surgery.

The primary endpoints include components that address safety and effectiveness. The primary safety endpoint was a composite safety endpoint that includes seven relevant adverse events that were defined and published by the Knee Society, each having an expected incidence ≤2.7%. The sum of these relatively rare complications is equal to 7.6%. The percentage of patients with TCAT-assisted implantation using the TSolution One Total Knee Application experiencing the composite safety event was compared to 7.6%. None of the seven adverse events identified were observed in the study. A total of 115 out of 115 patients (100%) successfully completed the primary safety endpoint.

The primary effectiveness endpoint was alignment of coronal mechanical axis at 3 months defined as achieving varus-valgus alignment after TKA that is less than ±3° from the preoperative plan in the frontal plane. A review of 1,376 patients undergoing conventional TKA with manual instrumentation showed a 32% malalignment rate for neutral mechanical axis deviation greater than 3°. The study was designed to demonstrate that the investigational device is capable of reducing the malalignment rate by 50%, i.e. to 16%.

With respect to the primary effectiveness endpoint, all 115 patients were evaluated at 3 months. The study population saw a low malalignment rate of 13.0% (15 out of 115 ITT patients) and 11.2% (12 out of 107 PP patients) which equates to a reduction of 59.2% (ITT) and 65.0% (PP) compare to 32% malalignment rate reported in literature. The study does provide significant data to demonstrate with a high probability (0.958) that the TSolution One Total Knee Application achieved a 37.2% (ITT) and a 43.1% (PP) reduction in the malalignment rate. The overall effectiveness results for the data presented demonstrate that the robotic-assisted TKA with TSolution One Total Knee Application is an effective treatment and helped to substantially reduce the overall malalignment rates in comparison to manual TKA.

Subsequent and supportive endpoints further demonstrate the effectiveness of the TSolution One Total Knee Application. The secondary radiographic outcomes (TJLA, FJLA, Tibial Slope) showed an ability of the system to match the pre-op plan. The KSS and SF-12 components showed a positive and comparable outcome in comparison to other TKA performed in the literature.

A review of adverse events further supported the safety of the device. There were 34 adverse events that were considered possibly, probably, or definitely related to the device or procedure. The most commonly occurring of these were: Pain. Excessive or Unexpected (6 subjects), Edema, Excessive or Unexpected (5 subjects), Fall (4 subjects) and Rash and Stiffness of the Joint (3 subjects each). There was a case in which two recovery markers (tacks) were left in the subject. However, the event did not require surgery and the patient showed good clinical outcomes out to 12 months. There were only five device related adverse events. Of those five, three were SAEs. These same three SAEs were also reported as Device or Procedure Related SAEs. All three

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters, with a blue square above the "T". Below "THINK" is the word "SURGICAL" in smaller, blue letters. The logo is simple and modern, and the colors are clean and professional.

events were classified as "Stiffness of the joint" and were resolved through manipulation under anesthesia (MUA). There were no serious adverse events (0%) classified as definitely related to the device. No subject required a surgical intervention related to the TKA.

In conclusion, the data from this clinical trial demonstrate that the TSolution One Total Knee Application in comparison to conventional manual surgical TKA has a positive riskbenefit profile and is both safe and effective for use in a TKA patient population.

Conclusion

The TSolution One® Total Knee Application is equivalent to the predicate, TSolution One Surgical System Model 210 in the following ways: it has the same intended use, the same technological characteristics and operating principles, incorporates the same basic design and incorporates the same or similar materials. The results of performance testing demonstrate that the TSolution One® Total Knee Application performed substantially equivalent to the predicate and did not raise any new questions of safety and effectiveness. Clinical data further supports the safety and effectiveness of the TSolution One® Total Knee Application and demonstrated a positive risk/benefit for the indication for use in total knee arthroplasty. The data presented supports a determination of Substantial Equivalence.

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).