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.

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 quides (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 comprises the following main components:

. XACT Robot Positioning Unit & Insertion Module Assembly which is placed on the patient
XACT Control Unit (Central Computer) .
. XACT Computer Work Station which includes the user interface for trajectory planning and review of instrument position
XACT System Cart ●

AI/ML Overview

The provided text describes the XACT Robotic System, a user-controlled positioning system intended to assist in CT-guided percutaneous procedures. While the document outlines several performance tests and mentions preliminary clinical data, it does not explicitly define acceptance criteria as a table with numerical targets, nor does it detail a comparative effectiveness study (MRMC) or a standalone AI algorithm. It provides some performance figures from pre-clinical and preliminary clinical studies.

Here's an attempt to extract the information based on the provided text, acknowledging the limitations regarding the completeness of "acceptance criteria" as you might expect in a formal table with specific thresholds:

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

The document doesn't present "acceptance criteria" in a formal table with specific numerical thresholds for each test. Instead, it describes performance tests and their outcomes.

Performance Test Category	Reported Device Performance (Proxy for Acceptance)
Pre-clinical Animal Study (Porcine Model)	- Target Reach: System reached the target in all 40 interventional procedures.
	- Average Accuracy: 1.41mm ± 0.94mm (Distance from target).
	- Adverse Events: No adverse events reported specific to the system (implied by "demonstrate the safety and effectiveness").
Preliminary Clinical Data	- Target Reach/Success Rate: Device successfully reached the target in 27 out of 31 cases (87.1%).
	- Procedure Completion (Manual Intervention): In 4 out of 31 subjects, the procedure was completed successfully with manual insertion after initial system use.
	- Specifications Met: "The system met its predefined specifications for use to guide and advance an instrument during CT-guided interventional procedures." (Specific values not provided).
	- Serious Adverse Events: No serious adverse events reported for any of the subjects.
Bench/Laboratory Tests (General Statements)	- Mechanical Accuracy: In accordance with ASTM F2554-10 (standard met).
	- Registration Precision: Assessed in a simulated clinical environment.
	- CT Phantom Accuracy: Evaluated device performance and system accuracy.
	- Rigidity: Tested under different weight loads.
	- Axes Mapping: Evaluated performance specifications of each axis.
	- Needle Properties: Evaluated mechanical strength of compatible needles.
	- Body Contour & Movement/Respiration Synchronization: Evaluated compatibility and synchronization.
	- System Lifetime Testing: Conducted.
	- Electrical Safety: In accordance with IEC 60601-1 (standard met).
	- Electromagnetic Compatibility (EMC): In accordance with IEC 60601-1-2 (standard met).
	- Biocompatibility: In accordance with ISO 10993 (standard met).

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

Test Set (Pre-clinical animal study):
- Sample Size: 40 interventional procedures.
- Data Provenance: Porcine model (animal study). Specific country of origin is not mentioned, but it's a pre-clinical study.
Test Set (Preliminary clinical data):
- Sample Size: 31 cases (interim set of subjects).
- Data Provenance: Clinical data gathered in 2 clinical centers. Specific country of origin is not mentioned. It is prospective data collection since it's described as "preliminary clinical data, to supplement the bench and preclinical animal testing."

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

The document does not specify the number of experts for "ground truth" establishment in the context of the animal or clinical studies. The results from the animal study (target reach, accuracy) and clinical study (successful target reach, adverse events) are presented as direct measurements. For the clinical data, the procedures were performed by physicians, as indicated by "physician defined trajectory path" and "manual insertion according to routine clinical procedure," implying the usual clinical practice standards would serve as the "truth" for procedure success and safety. However, the exact process of establishing ground truth by a panel of experts is not described.

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

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating outcomes in either the pre-clinical or preliminary clinical studies. Outcomes appear to be directly measured (e.g., distance from target, successful reach, reported adverse events).

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 MRMC comparative effectiveness study is mentioned. The study focuses on the device's ability to assist in procedures, not on evaluating human reader performance with or without AI assistance, as the system is a robotic positioning system, not an AI-based diagnostic tool for image interpretation.

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

The device is a "user-controlled positioning system" and "intended to assist in the planning and advancement of an instrument." It is designed for human-in-the-loop operation, where the physician controls advancement and defines the trajectory. Therefore, a standalone (algorithm only) performance evaluation without human interaction would not be applicable or described for this type of device. The accuracy results (1.41mm ± 0.94mm) from the animal study could be considered a measure of the system's standalone (robotic execution) accuracy once a trajectory is defined.

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

Pre-clinical Animal Study: The ground truth for accuracy was based on direct measurement of the "distance from the target" following robotic insertion in animal models. Successful target reach was also a direct outcome. Safety was assessed through reporting of adverse events.
Preliminary Clinical Data: The ground truth for success appears to be whether the device "successfully reached the target" and whether the "procedure was completed successfully" (even if later by manual intervention). Safety was assessed by "no serious adverse events reported." These are outcomes-based or procedural success-based ground truths, likely determined by the operating physician and recorded.

8. The sample size for the training set

The document does not provide information about a "training set" for an AI algorithm because the XACT Robotic System is described as a "user-controlled positioning system," not explicitly an AI-driven image analysis or diagnostic tool that would typically undergo a separate training phase with a large dataset. While it has software for planning, the core function described is mechanical assistance and guidance.

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

As no training set for an AI algorithm is mentioned, the method for establishing its ground truth is also not applicable or described in the provided text.

Summary

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October 3, 2019

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

Re: K191332

Trade/Device Name: XACT Robotic System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: September 4, 2019 Received: September 4, 2019

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

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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 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 (OS) 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,

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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510(k) Number (if known)

K191332

Device Name

XACT Robotic System

Indications for Use (Describe)

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 positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

x 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 (K191332)

Submitter

XACT Robotics Ltd. 8 Hatochen Street POB 3097 Caesarea Industrial Park North Caesarea 3079861 Israel Phone: +972 (0)4 770 0153 Facsimile: +972 (0)4 770 0161
Contact Person: Chen Levin, CEO

Date Prepared:

September 4, 2019

Name of Device:

XACT Robotic System

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

iSYS Medizintechnik GmbH iSYS 1 (K131433) Perfint Healthcare Pvt. Ltd. Maxio (K132108)

Device Description

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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 comprises the following main components:

. XACT Robot Positioning Unit & Insertion Module Assembly which is placed on the patient
XACT Control Unit (Central Computer) .
. XACT Computer Work Station which includes the user interface for trajectory planning and review of instrument position
XACT System Cart ●

Intended Use / Indications for Use

Summary of Technological Characteristics

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

Both the XACT System and the cleared iSYS 1 predicate device are designed to provide positioning of instruments for percutaneous intervention under imaging guidance from 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. achieving this, both the XACT Robotic System and the iSYS 1 System comprise similar components, namely a control unit, a bed/table, floor or patient mount, a robotic positioning unit and tool guide adapter and insertion module.

The XACT Robotic System robot positioning unit is placed directly on the patient in the region of interest for the percutaneous procedure, whereas the iSYS 1 System is placed on the bed/table using various adapters.

While the iSYS 1 System is only used to initially position the instrument prior to insertion into the patient and the insertion of the instrument is completed manually by the physician holding the instrument, the XACT Robotic System Insertion Module Assembly includes a jig which holds the instrument. Advancement of the instrument is controlled by the physician depressing a foot pedal to move the needle forward with the XACT Robotic System with the robot positioning unit making adjustments to the positioning of the instrument to ensure that the instrument remains on the physician defined trajectory path.

The XACT Robotic System also includes software for planning the instrument trajectory overlaid on CT images. The iSYS 1 System is used with separately cleared planning software to perform this function, though the cleared Perfint Maxio device includes its own planning software.

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Performance Data

The following performance/safety tests were conducted with the XACT Robotics System:

. Mechanical Accuracy in accordance with the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
. Registration Precision in a simulated clinical environment under CT quidance
CT Phantom Accuracy to evaluate device performance and system accuracy under simulated clinical conditions under CT quidance.
. Rigidity of the system under different weight loads
. Axes Mapping to evaluate the performance specifications of each of the axes of movement when individually operated
. Needle Properties Testing to evaluate the mechanical strength of compatible needles under forces which may be applied by the XACT Robot during insertion
Body Contour & Movement/Respiration Synchronization to evaluate compatibility with different body contours and that the movement sensor is synchronized with patient breathing motions
System Lifetime Testing
Electrical safety in accordance with IEC 60601-1
. Electromagnetic compatibility in accordance with IEC 60601-1-2
. Biocompatibility in acordance with ISO 10993 for all patient-contacing componnets of the system

Pre-clinical animal testing was conducted on the XACT Robotic System to demonstrate the safety and effectiveness of the device. The study in a porcine model evaluated the accuracy of the XACT system as determined by the measurement of the distance from the target and reporting on adverse events. A total of 40 interventional procedures were performed in different body organs while animals were under general anesthesia. The XACT system reached the target in all of the 40 interventional procedures. The average accuracy of the system was 1.41mm ± 0.94mm.

The results of the testing demonstrate that the XACT System meets its specifications and that CT-quided interventional procedures can be performed safely and successfully consistent with the target accuracy specification.

Preliminary clinical data, to supplement the bench and preclinical animal testing and confirm the safety and performance of the system was gathered in 2 clinical centers, where the XACT Robotic System was used to plan an instrument trajectory and advance the instrument to the target in subjects undergoing CT-guided procedures in the abdominal area. Out of the 31 cases from an interim set of subjects where an instrument was inserted using the XACT Robotic System, the device successfully reached the target in 27 cases. In 4 out of the 31 subjects, the procedure was completed successfully with manual insertion according to routine clinical procedure. The system met its predefined specifications for use to guide and advance an instrument during CT-guided interventional procedures. There were no serious adverse events reported for any of the subjects.

Conclusions

The XACT Robotic System has the same intended uses and similar indications for use,

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technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the XACT Robotic System and its predicate devices do not raise different issues of safety or effectiveness. Preclinical performance data demonstrate that the XACT Robotic System meets its defined specifications and that it is as safe and effective as the predicate devices. Preclinical and clinical performance with the device further supports its substantial equivalence to the predicates, providing evidence that the XACT Robotic System can be used to assist in the planning and advancement of an instrument during CT-guided percutaneous procedures with no serious adverse events specific to use of the system. Thus, the XACT Robotic System 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.