The XACT Robotic System, ACE Model is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.

Device Description

The XACT Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning based on CT images and is intended to assist the physician in positioning of an instrument, such as a needle, and reviewing instrument position during advancement to the target. The system guides (i.e., positions and steers) the instrument according to a predefined trajectory. The physician controls advancement of the instrument along the trajectory using a foot pedal. The system also allows for monitoring of motion associated with respiration during the procedure.

The XACT Robotic System, ACE Model comprises the following main components:

. XACT Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
. XACT Console which includes a Control Unit, central computer (in the Control Unit) and monitor workstation for user trajectory planning, user interface and review of instrument position

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request fully. The document is an FDA 510(k) clearance letter and a summary of the device's characteristics and performance tests.

Here's what I can provide based on the given text, and what is missing:

Information available from the text:

Device Name: XACT Robotic System, ACE Model
Predicate Device: XACT Robotic System (K191332)
Performance Tests Conducted: Mechanical Accuracy, Registration Precision, CT Phantom Accuracy, Robot Rigidity, Axes Mapping, Complete SW STD, Electrical safety (IEC 60601-1), Electromagnetic compatibility (IEC 60601-1-2).

Missing Information:

The text does not provide the following crucial details needed for your request:

A table of acceptance criteria and reported device performance: While performance tests are listed, the specific acceptance criteria for each test and the quantitative results showing the device met those criteria are not provided.
Sample sizes used for the test set and data provenance: The document mentions tests but not the number of cases or samples used, nor the origin (country, retrospective/prospective) of any data if clinical studies were performed.
Number of experts and their qualifications for establishing ground truth: This information is not present.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: The text indicates performance and safety tests, but not comparative effectiveness studies with human readers.
If a standalone study (algorithm only) was done: The device is a "user-controlled positioning system intended to assist in the planning and advancement of an instrument." This suggests it's a human-in-the-loop system, and a standalone algorithm performance without human interaction isn't directly relevant or discussed.
The type of ground truth used: Not specified.
Sample size for the training set: The document describes performance tests and comparisons to a predicate device, but not a "training set" in the context of an algorithm's development. This device is a robotic system, not an AI diagnostic algorithm in the typical sense that would have a training set of data.
How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is mentioned.

Conclusion based on the provided text:

The document describes a robotic system that assists in CT-guided procedures. It outlines several engineering and safety performance tests that were conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide the specific quantitative acceptance criteria or results from these tests, nor does it delve into the details of clinical study design that would involve ground truth establishment, expert adjudication, or reader studies. It primarily focuses on the device's technological characteristics and safety and effectiveness from an engineering standpoint, rather than a diagnostic algorithm's performance.

Summary

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July 9, 2020

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XACT Robotics Ltd. % Mr. Jonathan S. Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K201586

Trade/Device Name: XACT Robotic System, ACE Model Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 11, 2020 Received: June 11, 2020

Dear Mr. Kahan:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K201586

Device Name XACT Robotic System, ACE Model

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 XACT Robotic System, ACE Model K201586

Submitter

XACT Robotics Ltd. 8 Hatochen Street POB 3097 Industrial Park North Caesarea 3079861 lsrael Phone: 972 (0)4 770 0153 Facsimile: +972 (0)4 770 0161

Contact Person: Chen Levin, CEO

Date Prepared

June 11, 2020

Name of Device

XACT Robotic System, ACE Model

Common or Usual Name

CT Stereotactic Accessory

Classification Name

21 CFR 892.1750; Computed tomography X-ray system

Regulatory Class

Class II

Product Code

JAK

Predicate Devices

XACT Robotics Ltd., XACT Robotic System (K191332)

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Device Description

The XACT Robotic System, ACE Model comprises the following main components:

. XACT Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
. XACT Console which includes a Control Unit, central computer (in the Control Unit) and monitor workstation for user trajectory planning, user interface and review of instrument position

Intended Use / Indications for Use

The XACT Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.

Summary of Technological Characteristics

The XACT Robotic System, ACE Model allows for planning of percutaneous CT-guided procedures and tracking and positioning of the instrument during the procedure.

Both the XACT Robotic System, ACE Model and its predicate, the XACT Robotic System, are designed and intended for planning and positioning of instruments for percutaneous intervention under imaging guidance of CT scanners. The systems position the instrument according to a predefined trajectory following a registration process between the device's coordinate system and real-time CT images. The user advances the instrument through a foot pedal.

Both systems are comprised of the same components and accessories, though the ACE Model incorporates minor modifications. XACT Robotic System, ACE Model, incorporates a refined aesthetic with new covers, along with minor updates to the electronics and cabling to address the more compact designed. The Console is also redesigned such that a laptop is no longer provided for the user interface as the ACE Model incorporates a central computer, and a monitor + mouse are used for user interface for ease of use and improved appearance. The system software for the ACE Model does not introduce any new features or significant changes to existing features.

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Performance Data

The following performance/safety tests were conducted with the XACT Robotic System, ACE Model:

. Mechanical Accuracy
Registration Precision
CT Phantom Accuracy
Robot Rigidity ●
Axes Mapping ●
Complete SW STD ●
Electrical safety in accordance with IEC 60601-1 .
Electromagnetic compatibility in accordance with IEC 60601-1-2

Conclusions

The XACT Robotic System, ACE Model has the same intended uses and indications for use, technological characteristics and principles of operation as its predicate device. The limited differences in the structural characteristics of the components do not affect its safety and effectiveness when used as labeled. In addition, the minor differences between the XACT Robotic System, ACE Model and its predicate do not raise different issues of safety or effectiveness. Performance data demonstrate that the XACT Robotic System, ACE Model is as safe and effective as the predicate device. Thus, the XACT Robotic System, ACE Model is substantially equivalent.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.