The TSolution One™ w/ACG Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physicial planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under 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™ w/ACG Surgical System 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™ w/ACG Surgical System 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™ w/ACG Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.

Device Description

The TSolution One™ w/ACG Surgical System 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. TPLANTM 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 text describes a 510(k) premarket notification for the TSolution One™ w/ACG Surgical System, a robotic surgical system for total hip arthroplasty (THA). The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance testing.

However, the document does not contain the level of detail required to fulfill all aspects of your request, particularly regarding specific acceptance criteria values, sample sizes for test sets where performance metrics are quantified, the number and qualifications of experts, adjudication methods, details of MRMC studies, or the provenance of detailed data. The "Performance Data" section lists "Benchtop Accuracy Testing" as verifying overall system accuracy against specified requirements, but it does not provide the specific numerical acceptance criteria or the reported device performance against those criteria. It only states "PASS".

Based on the provided text, here's what can be extracted and what cannot:

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

Test/Activity	Acceptance Criteria	Reported Device Performance
Software Testing	Function as intended to successfully complete THA procedure including Acetabular Cup Guidance	PASS
Usability Testing	User interface functions as intended to successfully complete THA procedure including Acetabular Cup Guidance and meet user needs	PASS
Benchtop Accuracy Testing	Meet specified requirements for overall system accuracy	PASS
Cadaver Testing	Workflow functions as intended to successfully complete a THA procedure including Acetabular Cup Guidance and meet customer requirements in a simulated use environment	PASS

Important Note: The document states "Benchtop Accuracy Testing" verifies accuracy in "meeting specified requirements" but does not explicitly state what those numerical requirements are (e.g., a specific tolerance in mm or degrees) or the measured accuracy. It only indicates "PASS."

2. Sample sizes used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for any of the listed tests (Software, Usability, Benchtop Accuracy, Cadaver).
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The cadaver testing is a simulated use environment, which is a type of prospective lab-based testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified. Given the nature of these tests (software functionality, usability, benchtop accuracy, cadaver workflow), it's likely that a predefined protocol and objective measurements were used for "PASS/FAIL" rather than expert adjudication in the sense of consensus reading of medical images.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This type of study is typical for AI-assisted diagnostic devices to measure improvement in human reader performance. This device is a robotic surgical system, not a diagnostic AI.

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

Standalone Performance: The "Benchtop Accuracy Testing" would be the closest to a standalone performance evaluation, as it aims to verify the "overall system (TPLAN presurgical planning, and TCAT surgical system) accuracy." However, the exact metrics and whether this is "algorithm only" are not detailed. The system, by its description, always involves a human surgeon "under the direction of the surgeon" and implementing a "presurgical software plan." Thus, a purely standalone algorithm evaluation in the sense of a diagnostic AI is not applicable.

7. The type of ground truth used

Ground Truth Type:
- For "Software Testing" and "Usability Testing": Implied ground truth is the predefined functional specifications and user requirements for the system.
- For "Benchtop Accuracy Testing": Implied ground truth would be precise measurements from a known reference standard (e.g., phantom, jig) against which the system's output is compared. The "specified requirements" define this ground truth.
- For "Cadaver Testing": Implied ground truth would be successful completion of the THA procedure workflow as per established surgical protocols and meeting "customer requirements" in a simulated environment.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document describes a robotic surgical system, not a machine learning model that requires a distinct training set. The "software" mentioned refers to the system's control software and planning software, which are developed through traditional software engineering processes, not trained on a data set in the AI sense.

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

Training Set Ground Truth: Not applicable, as it's not a machine learning model that undergoes training on a data set with established ground truth.

Summary

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

October 22, 2015

THINK Surgical Incorporated % Mr. Glen Emelock Senior Partner The CRO Group, Incorporated 32 Harrison Street Melrose. Massachusetts 02176

Re: K150741

Trade/Device Name: TSolution One™ w/ACG Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OJP, OLO Dated: October 1, 2015 Received: October 2, 2015

Dear Mr. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Glen Emelock

forth in the quality systems (QS) 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" (21CFR 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 yours.

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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Indications for Use

510(k) Number (if known)

K150741

Device Name

TSolution One™ w/ACG Surgical System

Indications for Use (Describe)

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.

Submitter Name:	THINK Surgical, Inc.
Submitter Address :	47320 Mission Falls Court Fremont, CA 94539
Contact Person:	Glen Emelock
Phone Number:	(510) 249-2300
Fax Number:	(510) 249-2396
Date Prepared:	March, 2015
Device Trade Name:	TSolution One™ w/ACG Surgical System
Device Common Name:	Stereotaxic Instrument
Classification Name:	Orthopedic Computer Controlled Surgical System, OJP, OLC
Regulation Number:	21 CFR 882.4560
Predicate device:	TCAT™/TPLAN™ Surgical System, K140585
Reason for submission:	Not previously marketed in the USA

Device Description:

Intended Use:

The TSolution One™ w/ACG Surgical System is intended for use as a device that uses 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 TSolution One w/ACG Surgical System 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.

Predicate Device:

The TSolution One™ w/ACG Surgical System is substantially equivalent to the TCAT™/TPLANTM Surgical System, K140585 and the OrthAlign OrthAlign Plus® System, K140331.

Comparison of Technological Characteristics and Principles of Operation:

The TSolution One™ w/ACG Surgical System is similar to the legally marketed devices listed previously in that they share the same intended use and indications, technological characteristics, principles of operation and performance data as the predicate devices.

Table 1 provides a comparison of technological characteristics and principles of operation between the TSolution One™ w/ACG Surgical System and its predicate devices.

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Device	Patient Image Data	PresurgicalPlan	SurgicalPlan Data	MachineInstructions	Patient/DeviceRegistrationRequirement	RobotElectromechanicalArm
TCAT™/TPLAN™Surgical System	Yes, CT Scan	Yes,Presurgery	Yes, highleveloperativeplan	Yes, RoboticArm drivenby validatedcontrolsoftware andhardware	Yes, point tosurfaceregistration	Yes, robot withsingleelectromechanicalarm and endeffector implementcontrol fileinstructions
TSolution One™w/ACG SurgicalSystem	Yes, CT Scan	Yes,Presurgery	Yes, highleveloperativeplan	Yes, RoboticArm drivenby validatedcontrolsoftware andhardware	Yes, point tosurfaceregistration	Yes, robot withsingleelectromechanicalarm and endeffector implementcontrol fileinstructions
OrthAlign OrthAlignPlus® System	Not specified	Yes,Presurgery	Yes, highleveloperativeplan	N/A,surgeonmanipulatesbased oncomputermodule info	Yes, point tosurfaceregistration	No

Any minor differences between the TSolution One™ w/ACG Surgical System and its predicate devices 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™ w/ACG Surgical System has been evaluated with non-clinical performance testing as per Table 2 below for the following modifications and or improvements:

TPLAN Acetabular Cup Module prepares surgeon for acetabular cup reaming and impacting .
TCAT Acetabular Cup Module guides surgeon during acetabular cup reaming and impacting ●
. Irrigation Pump Modification - results in improved irrigation of surgical site during bone cutting
Acetabular Cup Bone Motion Recovery Markers permits continuation of procedure in event of acetabular ● cup motion during surgery
. Acetabular Cup Tools – provides reusable surgical instruments facilitating acetabular cup reaming and impacting
Cutter Motor Controller provides additional cutter motor control capabilities for future surgical systems .
Direct Drive Z-axis provides more responsive Z-axis positioning during robot movement ●
Load Cell Change for RoHS compliance .
BMM Cable Change for improved BMM signal quality ●

Table 2: Verification / Validation Activities

Verification / Validation Activity	Purpose	Results
Software Testing	Verify TPLAN presurgical planning and TCATsurgical system software function as intended tosuccessfully complete THA procedure includingAcetabular Cup Guidance	PASS
Usability Testing	Verify TPLAN presurgical planning and TCAT userinterface functions as intended to successfullycomplete THA procedure including AcetabularCup Guidance and meet user needs.	PASS
Benchtop Accuracy Testing	Verify overall system (TPLAN presurgicalplanning, and TCAT surgical system) accuracy inmeeting specified requirements.	PASS

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Cadaver Testing	Validate that the workflow of the TSolution One™ wACG Surgical System including THA software aswell as tools and accessories in a simulated useenvironment functions as intended to successfullycomplete a THA procedure including AcetabularGup Guidance and meets customer requirements.	PASS
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Conclusions

The results of performance testing indicated the device performed within the intended use and the differences between the predicate and the TSolution One™ w/ACG Surgical System do not raise any new safety or efficacy
issues. Supporting information included in this premarket submissi Surgical System is adequate for the intended use and is substantially equivalent to 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).