The TSolution One® Surgical System Model 210 is 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 preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/ reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.

The TSolution One® Surgical System Model 210 is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Surgical System Model 210 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® Surgical System Model 210 facilitates accurate positioning of THA implants, relative to these alignment axes.

Device Description

The TSolution One® Surgical System Model 210 is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary THA procedure. The system consists of the TPLAN® Preoperative Planning Workstation and TCAT®, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN® and TCAT® when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.

AI/ML Overview

The provided document is about a 510(k) premarket notification for the TSolution One® Surgical System Model 210, a robotic surgical system for total hip arthroplasty (THA). The document primarily focuses on demonstrating substantial equivalence to a predicate device (TSolution One® Cup1 Surgical System, K162195) rather than providing detailed acceptance criteria and a study dedicated to proving the device meets those criteria with specific performance metrics as typically expected for complex AI/ML devices.

However, based on the information provided, I can infer the acceptance criteria within the context of this 510(k) submission as the successful completion of verification and validation activities demonstrating the device functions as intended and does not raise new safety or efficacy issues compared to its predicate.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

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

Acceptance Criteria (Inferred from Validation Activities)	Reported Device Performance
TPLAN® presurgical planning and TCAT® surgical system software function as intended to successfully complete THA procedure including Acetabular Cup Guidance.	PASS
TCAT® surgical support instruments function as intended to successfully complete THA procedure including Acetabular Cup Guidance and meet user needs.	PASS
No new safety or efficacy issues raised by modifications/improvements compared to the predicate device.	Confirmed (Implicit in "PASS" and "no new safety or efficacy issues")
Device performs within its intended use.	Confirmed (Implicit in "PASS")

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

The document does not specify a sample size for any test set or the data provenance. The verification and validation activities are described broadly as "Software Testing" and "Support Surgical Instrument Testing," implying internal testing rather than a clinical study with real patient data.

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)

The document does not mention the use of experts to establish ground truth for a test set. This type of information is typically not included in a 510(k) summary focused on substantial equivalence for a surgical robotic system unless a specific clinical study with expert reviews was conducted to prove a clinical endpoint.

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

The document does not mention any adjudication method.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. The device is a robotic system for performing surgery based on a presurgical plan, not an AI-assisted diagnostic tool that helps human readers.

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

The document implies that the "Software Testing" and "Support Surgical Instrument Testing" evaluate the system's performance in a standalone capacity (as an algorithm and robotic system functioning as intended) without explicit human-in-the-loop performance described in the context of effectiveness evaluation. However, the device itself is "under the direction of the surgeon," indicating a human-in-the-loop for actual surgical procedures. The testing described focuses on the proper functioning of the software and instruments.

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

The document does not explicitly state the type of ground truth used for its internal verification and validation activities. Given the nature of a surgical robotic system, it's likely based on engineering specifications, kinematic accuracy, planned surgical outcomes (e.g., bone preparation dimensions) against actual robotic execution, and functional tests.

8. The sample size for the training set

The document does not describe any "training set." This device is a robotic system with software for planning and execution, not an AI/ML system that undergoes a training phase with a dataset in the way a diagnostic algorithm would.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 6, 2017

Think Surgical Inc. % Glen Emelock Senior Partner The Cro Group, Inc. 32 Harrison St. Melrose, Massachusetts 02176

Re: K170430

Trade/Device Name: Tsolution One Surgical System Model 210 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 13, 2017 Received: February 13, 2017

Dear Glen Emelock:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
See PRA Statement below.

510(k) Number ( if known )	K170430
Device Name	TSolution One® Surgical System Model 210

Indications for Use (Describe)

The TSolution One® Surgical System Model 210 is 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 preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/
reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip
arthroplasty (THA) using a posterior approach.

The TSolution One® Surgical System Model 210 is indicated for orthopedic procedures in which the broaching, reaming
and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be
considered to be safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Surgical System Model 210 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® Surgical System Model 210 facilitates accurate positioning of THA implants, relative to these alignment
axes.

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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510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

THINK Surgical. Inc.

Submitter Name: Submitter Address : Contact Person: Phone Number: Fax Number: Date Prepared: Device Trade Name: Device Common Name: Classification Name: Product Code: Predicate device: Reason for submission:

47201 Lakeview Blvd.. Fremont, CA 94538 Glen Emelock (510) 249-2300 (510) 249-2396 January 26, 2017 TSolution One® Surgical System Model 210 Orthopedic Stereotaxic Instrument 21 CFR 882.4560, Stereotaxic Instrument OLO TSolution One™ Cup1 Surgical System, K162195 Not previously marketed in the USA

Device Description:

Indications for Use:

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.

Predicate Device:

The TSolution One® Surgical System Model 210 is substantially equivalent to the TSolution One® Cup1 Surgical System, K162195.

Comparison of Technological Characteristics and Principles of Operation:

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The TSolution One® Surgical System Model 210 is very similar to the legally marketed predicate in that they share the same intended use and indications, same fundamental scientific technology, same principles of operation and similar technological characteristics and performance data as the predicate device.

Table 1 provides a comparison of technological characteristics and principles of operation between the The TSolution One® Cup1 Surgical System and its predicate devices.

Device	Patient Image Data	PresurgicalPlan	SurgicalPlan Data	MachineInstructions	Patient/DeviceRegistrationRequirement	RobotElectromechanicalArm
TSolution One®Cup1 SurgicalSystem	Yes, CT Scan	Yes,Presurgery	Yes, highleveloperativeplan	Yes, RoboticArm drivenby validatedcontrolsoftware andhardware	Yes, point tosurfaceregistration	Yes, robot withsingleelectromechanicalarm and endeffector implementcontrol fileinstructions
TSolution One®Surgical SystemModel 210	Yes, CT Scan	Yes,Presurgery	Yes, highleveloperativeplan	Yes, RoboticArm drivenby validatedcontrolsoftware andhardware	Yes, point tosurfaceregistration	Yes, robot withsingleelectromechanicalarm and endeffector implementcontrol fileinstructions

Table 1: Comparison of Technological Characteristics and Principles of Operation

Any minor differences between the TSolution One® Surgical System Model 210 and its predicate device raise no new questions of safety or effectiveness nor change the device's intended therapeutic effect in comparison to its predicate.

Performance Data:

The TSolution One® Surgical System Model 210 has been evaluated with non-clinical performance testing for the following modifications and or improvements:

TPLAN Bug Fixes
TCAT Bug Fixes
TCAT Instrument Changes .
TPLAN Operating System Upgrade .
System User Manuals Changes .

Table 2: Verification / Validation Activities

Verification / Validation Activity	Purpose	Results
Software Testing	Verify TPLAN® presurgical planning and TCAT®surgical system software function as intended tosuccessfully complete THA procedure includingAcetabular Cup Guidance	PASS
Support Surgical Instrument Testing	Verify TCAT® surgical support instrumentsfunction as intended to successfully complete THAprocedure including Acetabular Cup Guidance andmeet user needs.	PASS

In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of modifications to the predicate instruments. Design validation testing were conducted on the subject instruments to confirm that the design input requirements and that each instrument is safe and effective for its intended use.

Conclusions

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The results of performance testing indicated the device performed within the intended use and the differences between the predicate and the TSolution One® Surgical System Model 210 do not raise any new safety or efficacy issues. Supporting included in this premarket submission confirms that the TSolution
One® Surgical System Model 210 is safe and effective for the intended use and i the predicate device.

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).