The TCAT™/TPLAN™ Surgical System is intended for use as a device which 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 techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The TCAT™/TPLAN™Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Device Description

The TCAT™ TPLAN™ 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, and reaming techniques for the preparation of bone for patients requiring a 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 bone preparation possible before and during THA surgical procedures.

AI/ML Overview

The provided document is a 510(k) summary for the TCAT™/TPLAN™ Surgical System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance statistics for the new device.

Therefore, the information requested cannot be fully extracted from this document as it does not contain a study specifically designed to establish acceptance criteria and prove the device meets them in the way a clinical trial or a detailed performance validation study would for a novel device. The document emphasizes comparison to a predicate device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing:

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

This information is not explicitly provided in the document. The document states that "The TCAT™ Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements" and lists various components. It also mentions "Bench and simulated use tests included functional software testing... and hardware, functional software, user interface, instrument/tool and sterile disposable accessory testing and simulated clinical use of new and changed instrument /tools for the TCAT™/TPLAN™ Surgical System." However, specific numerical acceptance criteria (e.g., accuracy, precision thresholds) and the corresponding reported performance values for the TCAT™/TPLAN™ Surgical System are not detailed.

Table: Acceptance Criteria and Reported Device Performance (Information Not Available in Document)

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

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

This information is not explicitly provided. The document mentions "non-clinical performance testing" and "Bench and simulated use tests" but does not detail the sample sizes (e.g., number of test cases, number of simulated surgeries) or the provenance of any data used for these tests. It is implied these are laboratory/bench tests, not patient data studies.

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)

This information is not explicitly provided. Since the document describes "non-clinical performance testing" and "simulated use tests," it's unlikely that experts were used in the context of establishing a clinical ground truth for a test set in the way a diagnostic AI would require. The ground truth for engineering or functional tests would typically be established by design specifications and measurement tools.

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

This information is not explicitly provided. Given the nature of the described tests (bench and simulated use for functional software and hardware), a clinical adjudication method is not relevant or would not be described in this context.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The TCAT™/TPLAN™ Surgical System is described as a robotic system that implements a presurgical plan, not an AI to assist human readers in, for instance, image interpretation. The comparison is between the robotic system and manual planning/broaching/reaming techniques, not between human readers with and without AI assistance for interpretation tasks.

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

This concept is partially applicable but not fully detailed. The device consists of a planning software (TPLAN™) and a robotic surgical tool (TCAT™). The "algorithm only" performance would relate to the precision and accuracy of the robotic arm's movements in executing the presurgical plan. The document states that "the robotic surgical tool... precisely implements the presurgical software plan" and mentions "functional software testing" and "hardware... testing." While this suggests standalone performance evaluation of the system's components, specific metrics and studies are not detailed. The system is still "under the direction of the surgeon," implying continued human involvement.

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

The document does not specify the type of ground truth used for performance validation. For a surgical robotic system, ground truth for bench tests would typically refer to highly accurate physical measurements of movement, accuracy, and precision against known targets or reference points. It would not typically involve expert consensus, pathology, or outcomes data in the context of this 510(k) submission's described testing.

8. The sample size for the training set

This information is not applicable or not provided. This document describes approval for a medical device (a surgical system), not an AI model trained on a dataset. Therefore, there is no "training set" in the context of machine learning. The term "training set" is generally used for machine learning algorithms, which is not the primary focus of this device's validation as presented in this 510(k).

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

This question is not applicable as there is no mention of a "training set" for a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

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

August 18, 2014

Curexo Technology Corporation % Mr. Glen Emelock 32 Harrison Street Melrose, Massachusetts 02176

Re: K140585

Trade/Device Name: TCAT™/TPLANTM Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OJP, HAW Dated: July 17, 2014 Received: July 21, 2014

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

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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/Resourcesfor You/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.

Lori A. Wiggins -S

for 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

K140585 510(k) Number:

Device Name: TCAT™/TPLAN™ Surgical System

Indications For Use:

The TCAT™/TPLANTMSurgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

AND/OR

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-C
(21 CFR §

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

TCAT™/TPLANTM

Page 1 of 1

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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: Submitter Address : Contact Person: Phone Number: Fax Number: Date Prepared: Device Trade Name: Device Common Name: Classification Name: Requlation Number: Predicate device: Reason for submission:
Curexo Technology Corp. 47320 Mission Falls Court Fremont. CA 94539 Glen Emelock (510) 249-2300 (510) 249-2396 March, 2014 TCAT™/TPLAN™ Surgical System Stereotaxic Instrument Orthopedic Computer Controlled Surgical System, OJP, HAW 21 CFR 882.4560 DigiMatch™ ROBODOC® Surgical System, K072629 Not previously marketed in the USA

Device Description:

Intended Use:

The TCAT™/TPLAN™ Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Predicate Device:

The TCAT™/TPLAN™ Surgical System is substantially equivalent to the DigiMatch™ ROBODOC® Surgical System, K072629.

Comparison of Technological Characteristics and Principles of Operation:

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

Table 1 provides a comparison of technological characteristics and principles of operation between the TCAT™/TPLAN™ Surgical System and its predicate device.

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	Table 1: Comparison of Technological Characteristics and Principles of Operation

Device	Patient Image Data	PresurgicalPlan	SurgicalPlan Data	MachineInstructions	Patient/RobotRegistrationRequirement	RobotElectromechanicalArm
DigiMatch™ROBODOC®Surgical System	Yes, CT Scan	Yes,Presurgery	Yes, highleveloperativeplan	Yes, RoboticArm drivenby validatedcontrolsoftware andhardware	Yes, point tosurfaceregistration	Yes, robot withsingleelectromechanicalarm and endeffector implementcontrol fileinstructions
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

Any minor differences between the TCAT™/TPLAN™Surgical System 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 TCAT™ Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements:

TPLAN™/TCAT™ host computer and operating system .
TPLAN™/TCAT™ Graphical User Interface .
TPLAN™/TCAT™ Software Architecture .
. TPLAN™ addition of CT file complete/size check
TPLAN™ CT Slice Region of Interest .
TCAT™ Electromechanical Arm .
TCAT™ Base Hardware .
TCAT™ Bearing Sleeve .
. TPLAN™/TCAT™ elimination of pin patient/robot registration
. TCAT™ Two-Pin Registration Recovery
TCAT™ Percutaneous Probe .
. Change of TCAT™ Irrigation Set Length and Manufacturer
TCAT™ Monitor Drape .

Bench and simulated use tests included functional software testing for the TPLAN™ Surgical Planning Workstation hardware, software, and user interface, and hardware, functional software, user interface, instrument/tool and sterile disposable accessory testing and simulated clinical use of new and changed instrument /tools for the TCAT™/TPLAN™ Surgical System.

Conclusions

In conclusion, based on the intended use, indications for use, technological characteristics and performance data the TCAT™TPLAN™ Surgical is substantially equivalent (SE) to the DigiMatch™ ROBODOC® Surgical System, K072629 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).