The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.

Device Description

The ANT-X System is an automated needle positioning medical device that is used in conjunction with fluoroscopy to support percutaneous interventions (PCNL). There are 4 main components to the system - the ANT-X Device. ANT-X Controller Box. ANT- X Needle Holder, and ANT-X Software. It is intended to be used in an operating theatre equipped with standard surgical equipment which are generally found in operating rooms.

The ANT-X Device holds a sterile, disposable needle-guide kit, the ANT-X Needle Holder. The main bulk of ANT-X Device is made of biocompatible polyetheretherketone (PEEK) material. PEEK is preferred to build the robot because it is radiolucent and lightweight while being able to provide relatively high material strength. The Device has a fixed base made of three pairs of high stiffness parallel linkages allow millimetric planar needle adjustment. The targeted insertion point will act as a pivot point for the needle. The device will be mounted onto the operating table with a 6-DOF instrument holder (FISSO Articulated arm) such that it can be precisely oriented to the area of interest on the patient.

The ANT-X Controller Box powers the ANT-X Device and is the integrating point for the whole ANT-X System. Images from the C-arm fluoroscopy machine will be passed into the ANT-X Controller Box and then to the ANT-X Software, in real-time. The user will then use the ANT-X Software to command the ANT-X Device to commence needle alignment between the chosen insertion point on the skin surface, and the desired target point within the body. Validation of the puncture trajectory and the final needle insertion will be performed by the surgeon.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance data presented, aiming to demonstrate safety and effectiveness comparable to predicate and reference devices, and adherence to relevant standards. Specific numerical acceptance criteria are not explicitly listed in a "criteria" column, but rather the performance values obtained are reported and deemed to meet "specifications" or be "within acceptable limit."

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device components (ANT-X Needle Holder) contacting the patient are biocompatible for indirect contact (≤ 24h).	Passed: Tested in accordance with ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity). Considered biologically safe and biocompatible.
Sterility: ANT-X Needle Holder achieves a Sterility Assurance Level (SAL) of 10⁻⁶.	Passed: Validated in accordance with ISO 11135, achieving SAL of 10⁻⁶. ETO and ECH residual levels within acceptable limits.
Shelf Life: ANT-X Needle Holder maintains sterility and quality for one year.	Passed: Real-time studies confirmed sterility and quality maintained at 1 year.
Electrical Safety: System complies with relevant electrical safety standards.	Passed: Complies with IEC 60601-1.
Electromagnetic Compatibility (EMC): System complies with relevant EMC standards.	Passed: Complies with IEC 60601-1-2.
Software Verification & Validation: Software meets design specifications and FDA guidance.	Passed: Verification and validation testing conducted; deemed "moderate" level of concern.
Software Tracking Accuracy: ANT-X System software provides accurate tracking of individual points.	Passed: Tracking accuracy met design acceptance criteria.
Positional Repeatability: Robot achieves consistent positional accuracy.	Passed: System met specifications, repeatability accuracy within acceptable limit.
Bullseye Alignment Accuracy: ANT-X System provides accurate alignment between user-selected points.	Passed: ANT-X System met specifications.
Puncture Accuracy: ANT-X System achieves successful puncture of target size.	Passed: ANT-X System met specifications.
Animal Study Performance: Functionality and performance demonstrated in animal model.	Successful: Performance concluded to be consistent and safe for fluoroscopy-guided procedures.
Clinical Study - Safety: Comparable complication rates to standard of care (US-guided PCNL).	Comparable Safety: No significant differences in overall complication rates (p=0.396) or 1-month complication rates (p=0.88) between RAFG and USG groups. Complications not related to ANT-X device use.
Clinical Study - Efficacy (Non-inferiority for SFR): Stone-Free Rate (SFR) non-inferior to US-guided PCNL.	Comparable Efficacy: SFR at 3 months: USG 70.6%, RAFG 83.3% (p=0.26). Overall results comparable.
Clinical Study - Efficacy (Secondary outcomes): Improved puncture efficiency (e.g., fewer attempts, shorter time).	Improved Efficiency: Significantly fewer needle punctures (RAFG: 1.83 vs. USG: 2.51, p=0.025). Significantly shorter median needle puncture duration (RAFG: 5.5 min vs. USG: 8.0 min, p=0.049).
Image Registration Error: Comparable to reference device (0.38 ± 0.18 mm).	0.01 - 0.45 mm: Similar to reference device error.
Alignment Accuracy Range (Target Error): Within range of reference device (0.1-4mm).	0.14 - 0.97 mm: Within range of reference device.

Study Details

Sample Size and Data Provenance:
- Test Set (Clinical Study): Total of 71 patients. 35 in the Ultrasound-guided (USG) group and 36 in the Robotic Assisted Fluoroscopy (RAFG) group.
- Data Provenance: Japan (randomized, single-blind clinical trial). Prospective in nature.
Number of Experts and Qualifications for Ground Truth (Test Set):
- The document implies that traditional clinical outcomes (stone-free rate at 3 months, complication rates) were the primary ground truth. While radiologists/clinicians are involved in the procedures and assessments, the "ground truth establishment" isn't described as an expert consensus reading of images purely for validation purposes like in an AI image analysis tool. It's more about objective clinical endpoints.
- The study involved "fellowship-trained surgeons" for the animal study and clinicians/surgeons for the clinical trial.
Adjudication Method for Test Set:
- Not explicitly described in terms of a multi-reader adjudication process for image interpretation (e.g., 2+1 or 3+1). The primary outcomes are clinical, based on objective measurements (e.g., KUB radiography, CT scans for SFR, Clavien-Dindo classification for complications) rather than subjective image reads requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a formal MRMC study as typically understood for diagnostic AI (where human readers interpret images with and without AI assistance to measure improvement in diagnostic accuracy) was not performed.
- The clinical study was a comparative effectiveness study between two different procedural guidance methods (AI-assisted fluoroscopy vs. ultrasound guidance). It showed the effects of the AI-assisted system on procedural outcomes (e.g., fewer punctures, shorter puncture time), indicating how human proceduralists (not image readers) improve when using the ANT-X System compared to ultrasound guidance.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable in the context of an MRMC study measuring diagnostic performance. However, for procedural efficiency, the study did show improvement with the ANT-X:
  - Mean number of needle punctures: 1.83 (RAFG) vs. 2.51 (USG), a reduction of 0.68 punctures (p=0.025).
  - Median needle puncture duration: 5.5 minutes (RAFG) vs. 8.0 minutes (USG), a reduction of 2.5 minutes (p=0.049).
Standalone Performance (Algorithm Only):
- Yes, the "Bench Testing" section describes tests of the algorithm's performance in isolation or in a controlled environment, disconnected from live patient interaction where a human decision-maker is involved:
  - Software Tracking Accuracy (including marker detection)
  - Positional Repeatability (of the robot)
  - Bullseye Alignment Accuracy
  - Puncture Accuracy
- Image Registration Error (0.01-0.45mm) and Alignment Accuracy (0.14-0.97mm) are specific quantitative measures of standalone performance.
Type of Ground Truth Used:
- Bench Testing: Engineering measurements, possibly phantom-based. For example, "Puncture Accuracy" would likely be measured against a known target in a phantom. Image Registration Error and Alignment Accuracy are direct measurements against a reference.
- Clinical Study: Clinical outcomes data (Stone-Free Rate, complication rates, procedural metrics like puncture time and number of punctures), which are objective and generally established by clinical follow-up and imaging.
Sample Size for Training Set:
- Not specified in the provided text. The document focuses on the validation and testing of the device, not its development or training phase.
How Ground Truth for Training Set was Established:
- Not specified. This information would typically be proprietary to the manufacturer's development process and is not usually detailed in a 510(k) summary, which focuses on validation data for marketing clearance.

Summary

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June 1, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

NDR Medical Technology Pte. Ltd. % Ainoa Forteza Vice Director of Regulatory Affairs Alira Health Avinguda Josep Tarradellas, 123 (7th Floor) Barcelona 08029 SPAIN

Re: K230185

Trade/Device Name: ANT-X System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: May 5, 2023 Received: May 5, 2023

Dear Ainoa Forteza:

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

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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 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 medical devices and radiation-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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known) K230185

Device Name ANT-X System

Indications for Use (Describe)

The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.

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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K230185

510(k) Summary for the ANT-X System (per 21CFR 807.92)

Date: May 5, 2023

1. 510K Applicant / Submitter:

NDR Medical Technology Pte Ltd 75 Ayer Rajah Crescent, #02-19 Singapore 139953 Tel: +65 6908 5497 CTO: Jason Ng Ka Wei Email: jason(@ndrmedical.com

2. Submission Contact Person

Ainoa Forteza Vice President of Regulatory Affairs Alira Health Avinguda Josep Tarradellas, 123 (7th Floor) 08029 Barcelona, Spain Email: ainoa.forteza@alirahealth.com

3. Subject Device

Name of Device: ANT-X System Common or Usual Name: Robotic Needle Positioning Unit Classification Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1650 Regulatory Class: II Product Code: OWB

4. Predicate and Reference Device

Predicate Device: Device Name: Nuvasive LessRay with Enhanced Tracking 510(k) Number: K170800 Classification Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1650 Regulatory Class: II Product Code: OWB

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Reference Device: Device Name: iSYS 1 510(k) Number: K131433 Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Regulatory Class: II Product Code: JAK

5. Device Description:

Accessorv:

The FISSO Articulated Arm is used as an accessory to the ANT-X System. It functions to hold or position the ANT-X Device over the patient's body to allow for needle positioning and alignment during the surgical procedure. The base of the articulated arm is mounted onto the operating bed while the head component is attached to the ANT-X Device. The joints of the articulated arm can be maneuvered to any desired position and comes with a mechanical central locking mechanism, a knob, which can be tightened to lock the arm in place. The FISSO Articulated Arm is delivered non-sterile and must be cleaned, disinfected and sterilized before each use as per manufacturer's Instructions for Use.

The FISSO Articulated Arm device is exempt from Premarket Submission.

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6. Indications for Use

The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.

7. Substantial Equivalence Discussion:

The ANT-X System is designed to assist interventional radiologists and clinicians in the manual advancement of interventional trocar needles, during fluoroscopic image guided percutaneous nephrolithotomy (PCNL). The ANT-X has the same intended use as its predicate device NuVasive LessRay with Enhanced Tracking, and the reference device iSYS 1. The devices are designed to assist interventional radiologists and clinicians in the positioning of instruments, such as needles in the case of the ANT-X System, for percutaneous procedures that are fluoroscopy-guided. All the three devices require the physician to execute the final gesture, that is, to advance the needle by physically pushing the instrument into the patient.

The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process, while the NuVasive LessRay with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated. The indications of the ANT-X are the same as the indications of the predicate device, in that fluoroscopy-guided PCNL procedures are a subset of any fluoroscopy-guided treatment applications in which the predicate device is intended for use.

The ANT-X System subject of this submission, the predicate device NuVasive LessRay with Enhanced Tracking, and the reference device iSYS 1 are all powered, computer controlled devices that provide the position of the instrument for the procedure in real time.

The ANT-X System subject of this submission and the NuVasive LessRay with Enhanced Tracking predicate device not only use the image acquired from interventional fluoroscopic Xray system (2D X-Ray video input), as the intraoperative guidance, but they are both passive devices to the fluoroscope and they do not perform instrument advancement into the patient, which is left as manual task to the clinician.

The ANT-X System differs from the predicate NuVasive LessRay with Enhanced Tracking in the locations of marker placement that is on the robotic system in the ANT-X, as opposed to the markers placed on the fluoroscope and the tracking clip in the predicate device. Moreover, the type of markers used as reference points during image registration represent another difference between the ANT-X System and the predicate device. The ANT-X System uses fiducial markers which differ from the optical gray markers in the NuVasive LessRay with Enhanced Tracking device. Instead, the ANT-X System and the reference device iSYS 1 both use fiducial markers as reference points. their software duplicates 2D fluoroscopy images onto the software UI to provide navigational assistance and monitoring of device deployment during procedure without performing tracking.

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Although there are other minor differences in technological characteristics between the ANT-X System and the predicate device, such as the instrumentation, the instrument fixation method, the calibration, the immobilization of the system between patient and device and whether the instrument positioning is done automatically or manually, these minor differences do not raise any additional safety and effectiveness concerns. As the reference device, the ANT-X System serves as a mechanical guide to ensure desired end-effector (needle) trajectory is fixed during puncture. Furthermore, performance tests were conducted on ANT-X to ensure that it is safe and effective for its intended use.

Table 5-1 below compares the intended uses, the indications for use and the technological characteristics of the ANT-X System with the predicate and reference devices.

Differences in technological characteristics between the ANT-X System and the NuVasive LessRay with Enhanced Tracking were evaluated through performance and safety tests (bench studies and animal studies). A feasibility clinical trial was conducted as a reference study for the use of ANT-X System. No new questions of safety and effectiveness was raised, and therefore, it can be concluded that the ANT-X System is substantially equivalent to the selected predicate NuVasive LessRay with Enhanced Tracking device.

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Characteristic	Automated Needle Targeting(ANT-X)	Predicate	Reference Device	Comparison
510(k) number	K230185	K170800	K131433
Primary Product Code	OWB	OWB	JAK
Manufacturer	NDR Medical Technology Pte. Ltd.	NuVasive, Incorporated	ISYS Medizintechnik GmbH
General Description	Computer controlled automatic needle alignment robot used during fluoroscopy guided percutaneous procedures.	Software based device used to provide computer display systems interfaced to fluoroscope through a video cable.	Computer controlled electromechanical multi-joined arm indicated for CT and fluoroscopy guided invasive procedures.
Intended Use	The ANT-X System assists interventional radiologists and clinicians in the manual advancement of trocar needles during image guided (C-arm fluoroscopy) percutaneous procedures (PCNL). It is a low-risk medical device that helps to create a keyhole access accurately by carrying out automated specific needle targeting while using image guiding with fluoroscopy system. Its primary aim is to carry out accurate needle positioning.	Intended for use with a standard C-arm or fluoroscope during a surgical or interventional procedure. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user may improve the quality (clarity, contrast, noise level and usability) of a noisy (low-quality) image. LessRay with Enhanced Tracking	The intended use of the iSYS1 device is to function as a remote- operated positioning and guidance system during interventional procedures. Positioning is done in remote control manner; planning of the position/ angulation is done based on 2D/3D patient data (CT, cone- beam CT, fluoroscopy) by external planning software for example using an external navigation system or planning software coming	Same Intended Use as the predicate and reference devices, in the sense that the devices are intended to use C-arm fluoroscopic images to aid the clinician in positioning the instrumentation for percutaneous procedures.
		EnhancedTracking hasadditionalcapability ofinstrumenttracking toaid the user inpositioningan instrumentusing priorbaseline x-rays.	with the usedimaging device.Also, verificationof the correctposition andorientation of thetool priorto/during/after theintervention isdone by means ofthese externaldevices. TheiSYS1- System isthen acting as aguideway duringthe manualinsertion of theinterventionaltool - usually aneedle typedevice, and thelike.
Indication for Use		The ANT-X System isindicated for use inconjunction withfluoroscopy imaging inpercutaneousnephrolithotomy (PCNL)procedures to aid inneedle positioning andalignment process.	Indicated foruse in anyapplicationwhere afluoroscopeisincorporatedto aid indiagnosis andtreatment ofdisease.	The iSYS 1device is a usercontrolledelectromechanicalarm with a needleguide. It isintended to assistthe surgeon in thepositioning of aneedle orelectrode whereboth computedtomography (CT)and fluoroscopicimaging can beused for targettrajectoryplanning andintraoperativetracking. Theneedle orelectrode is thenmanuallyadvanced by thesurgeon.Trajectoryplanning is madewith software thatis not part of theiSYS device.Applicationsinclude, but arenot limited to,interventions like	Same Indications foruse as the predicatedevice, as the PCNLprocedures where theANT-X is intended foruse are a subset of anyfluoroscopic guidedprocedure in which thepredicate device isintended to be used.
			biopsyprocedures, tumorablation, nerveblocking,electrodeplacement, etc
Intended User(s)	Trained physicians	Trained physicians	Trained physicians	Same to the predicateand reference devices
Used with imagingGuidance	Yes	Yes	Yes	Same to the predicateand reference devices.
Powered	Yes	Yes	Yes	Same.
Computercontrolled	Yes	Yes	Yes	Same
Real-timeInstrument Position	Yes	Yes	Yes	Same.
Imaging Modality	Fluoroscopy	Fluoroscopy	Fluoroscopy andcomputedtomography	Same to the predicateand reference devices.
Video Input Image	2D X-ray	2D X-ray	N.A. iSYS 1 usesan external third-party softwarethat is not part ofthe system.	Same to the predicatedevice. Different to thereference device.
Localization means	Fiducialmarkers onrobotic device	Opticmarkers onthe trackingclip fitted ontheinstrumentand thefluoroscope.	Fiducial markerson tool holder	Different Locations ofMarkersplacementfrom both thepredicate and thereference device.
Registration Method	Fiducial Markers	OpticalMarkers	Fiducial Markers	Same to the referencedevice, as the sametype of marker(fiducial) are used..Different from thepredicate device.
Planningandnavigation software	Directly duplicates 2Dfluoroscopy images ontosoftware UI to providenavigationalassistanceand monitoring of devicedeploymentduringprocedure.	N.A.NuvasiveLessRay usesan off-the-shelf trackingsystem toguide the userin positioningtheinstrument	N.A. iSYS 1 usesan external third-party software forplanningandmonitoringofdevicedeploymentduring procedure.	Different tobothpredicate andreference device.
Instrumentation	ANT-X Device	ComputerScreenCamera	RoboticPositioning Unit	Differentinstrumentationtoboth the predicate andreference devices.
	ANT-X Needle HolderANT-X SoftwareANT-X Controller BoxFISSO Instrument Holder(Model 3840.40)	Table arraysC-arm collararrays C-armcollarTrackingSnaps	Instrument GuideControl UnitHandheld ControlUnitTable AdapterGross PositioningArm
Instrument Fixation	Robot is mountedtooperating table using aFISSOInstrumentHolder, Model 3840.40(US FDA Class IExempt). It does not havedirect contact with thepatient's body	C-arm collararrays andtable arraysare used inorder tomount theoff-the-shelftrackinghardware tothe C-armand to theoperatingtable. It doesnot havedirect contactwith thepatient'sbody.	Robot is mountedto operating tableusing a grosspositioning armand table adapter.It does not havedirect contactwith the patient'sbody	Differentmountinginstruments tobothpredicate andreference device.
Systemimmobilization	Yes	No	Yes	Same to the referencedevice. Different fromthe predicate device.
DeviceInstrumentCalibration	Intraoperative	Not required	Intraoperative	Same to the reference device. Different from the predicate device.
Device end effectortrajectory alignment	Auto alignment to desired trajectory	Manual alignment to desired trajectory via manual freehand technique	Manual alignment to desired trajectory using handheld control unit	Different to both predicate and reference device.
Execution of final gesture aftertrajectory alignment	Physician executes final gesture via manual advancement of device end effector	Physician executes final gesture via manual advancement of the instrument	Physician executes final gesture via manual advancement of device end effector	Same to both predicate and reference device.
MechanicalGuidance For DeviceEnd-effector	Yes, the device serves as a mechanical guide to ensure desired needle (end-effector) trajectory is fixed during puncture.	No, the instrument is manipulated via manual freehand technique	Yes, the device serves as a mechanical guide to ensure desired needle (end-effector) trajectory is fixed during puncture.	Same mechanical guidance principle as the reference device. Different from the predicate device.
Image RegistrationError	0.01-0.45mm	Unknown	$0.38 \pm 0.18$ mm	Similar. The ANT-X image registration error (mean) is comparable to the reference device's error.
Alignment AccuracyRange (Targeterror)	0.14-0.97mm	Unknown	0.1-4mm	Similar. The subject device alignment accuracy range is within the range of the reference device's target error.
Sterility AssuranceLevel	SAL 10-6	Unknown	SAL 10-6	Same as the reference device.
Biocompatibility	-Cytotoxicity-Sensitization-Irritation-Material-mediated-Pyrogenicity-Acute systemic toxicity	NA- no patient contacting components	NA- no patient contacting components	Different to both predicate and reference device, due to the presence of an indirect patient contacting component (Needle Holder) in the subject device.

Table 5-1: Side by Side Comparison Table of ANT-X System with Nuvasive LessRay with Enhanced Tracking and iSYS 1

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8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

Biocompatibility tests in accordance with Annex A of ISO 10993-1:2018 was conducted to evaluate the potential biological risks arising from the use of the ANT-X Needle Holder. The battery of testing included the following tests:

Cytotoxicity
Sensitization
Irritation
· Material-mediated pyrogenicity
Acute systemic toxicity

The ANT-X Needle Holder is considered an externally communicating medical device which has indirect contact with the internal body tissues. The duration of contact, when used as intended, is ≤ 24 h. The ANT-X Needle Holder has been validated to be biologically safe for use in a surgical setting and is considered to be biocompatible.

Sterilization

The only component of the ANT-X System that is supplied sterile is the ANT-X Needle Holder, which is intended to be attached to the ANT-X Device during use. ANT-X Needle Holders are for single-use only and are sterilized using Ethylene Oxide sterilization. The sterilization method has been validated in accordance with ISO 11135 Sterilization of healthcare products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices to demonstrate a Sterility Assurance Level (SAL) of 106. The ETO and ECH sterilant residual levels are also found to be within acceptable levels.

Shelf Life

Real time studies were conducted to validate a one-year shelf life of the ANT-X Needle Holder. Sterility and packaging validation testing and functional testing demonstrated that the ANT-X Needle Holder sterility and quality are maintained at 1 year of real time storage conditions.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on ANT-X System consisting of the controller box, device, software and third-party instrument holder. The system complies with the IEC 60601-1 standard for Safety and the IEC 60601-1-2 for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this

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subject device was considered as a "moderate" level of concern.

Bench Testing

Software Tracking Accuracy including marker detection

The purpose of this testing was to verify that the ANT-X System software is able to provide accurate tracking of individual points in plane under C-arm fluoroscopy imaging. The test results showed that the tracking accuracy of ANT-X Software meet the design acceptance criteria.

Positional Repeatability

The purpose of this testing was to verify that the robot can achieve positional repeatability when instructed to move to specific locations from the home position repeatedly over multiple trials. The test demonstrated that the system met specifications and the repeatability accuracy is within the acceptable limit.

Bullseye Alignment Accuracy

The purpose of this testing was to verify that the ANT-X System is able to provide an accurate bullseye alignment between two points selected by the user under C-arm fluoroscopy. The testing demonstrated that ANT-X System met specifications.

Puncture Accuracy

The purpose of this testing was to verify that the ANT-X System can ultimately achieve a successful puncture of a specific target size. The test demonstrated that the ANT-X System met its specifications.

Animal Study

Pre-clinical animal testing was conducted on the ANT-X System to demonstrate the functionality and performance of the device. Percutaneous access to the target site, the kidneys (PAK), using the ANT-X System are compared to the conventional free-hand, unassisted procedure performed by fellowship-trained surgeons. Animal trials were successful and the performance of the ANT-X System were satisfactory. The performance of ANT-X System is concluded to be consistent and that it can be used in fluoroscopy guided procedure safely.

Clinical Study

A feasibility clinical study was conducted as a reference study for the safe use of the ANT-X System in PCNL procedures.

A randomized, single-blind clinical trial comparing the surgical outcomes of Robotic Assisted Fluoroscopy (RAF)- and Ultrasound (US)-guided renal access in mini-PCNL was conducted in Japan. The intention of the study was to prove the non-inferiority of ANT-X over US-guided Endoscopic combined intrarenal surgery (ECIRS), one of the most ideal methods currently utilized for PCNL. A total of 71 patients were randomized for the study, 35 in the USG group and 36 in the RAFG group. No significant differences were observed between the two groups in terms of other preoperative factors, including patient background, hydronephrosis and stone characteristics.

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Primary objective:

Stone-free rate (SFR) at 3 months after surgery. SFR is defined as following: no residual fragments larger than 4 mm detected in kidney ureter bladder (KUB) radiography at 1 month after surgery and no residual fragments larger than 2 mm detected by computed tomography (CT) 3 months after surgery.

Secondary objectives:

Overall complication rate and Clavien-Dindo classification complication rates.
Renal puncture time -
Total operation time -
Number of successful punctures -
Fluoroscopy time ।

Efficacy evaluation

The SFR at 3 months after surgery in the US and RAF groups was 70.6% and 83.3 %, respectively (p=0.26). Overall, the results were comparable for both ANT-X and ultrasoundguided access procedures.

The RAFG and US groups showed similar trends in the selection of renal calyces for percutaneous access. In the US group, 14.3% of patients had a puncture surgeon change, whereas puncture surgeon change during percutaneous renal access was not required in the RAF group (p=0.025). The mean number of needle punctures was significantly fewer in the RAF group than that in the USG group (1.83 times vs. 2.51 times, p=0.025). The median needle puncture duration was also significantly shorter in the RAF group than in the USG group (5.5 minutes vs. 8.0 minutes, p=0.049). Moreover, there were no statistical differences in other intraoperative parameters, such as percutaneous tract size, tubeless cases, and device set/ percutaneous access/ fragmentation/ surgery/ fluoroscopy durations. The ANT-X System resulted to be as easy to use as the ultrasound-guided PCNLs to resident doctors still in training and demonstrated to require less puncture surgeon changes, fewer punctures attempts and reduced puncturing time.

Safety evaluation

The study demonstrated that the robotic assisted fluoroscopy-guided PCNL procedure is as safe as the control ultrasound-guided PCNL, as no significant differences were observed between the RAFG and USG groups in overall complication rates, complications within the first month after the surgery, or between the complications within 1 and 3 months. The results of the regression analysis demonstrates that the complications in the study are not related to or caused by the use of the ANT-X device, as they are directly associated with the dilation of the renal tract after needle insertion is performed by the surgeon after the ANT-X System is used and removed from the operating area.

It is noted that the overall complication rates between the robotic-assisted fluoroscopic-guided procedures and ultrasound-guided procedures presented in this study are not statistically significant (p-value = 0.396) and also the rates of complications within one month are not statistically significant (p=0.88). Even if this study showed only that the use of the ANT-X device did not have effect on the adverse events for the entire PCNL procedure as opposed to

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use of the ANT-X system alone, it allowed to answer the basic question of the relationship between the occurring complications and the use of the ANT-X System, and to exclude that complications arise from the use of the ANT-X System. These results support the safety of the ANT-X System as adjunctive method to perform safe fluoroscopy-guided PCNL procedures.

Summary

The results of the study indicated that ANT-X is a feasible, safe, and comparable as the control ultrasound-guided PCNL method of percutaneous nephrolithotomy (PCNL) for kidney stone procedure. Its safety and efficacy evaluations are comparable to the control.

9. Conclusion:

Based on the information provided in this 510(k) premarket notification, NDR Medical Technology Pte Ltd. concludes that the ANT-X is substantially equivalent to the Nuvasive LessRay with Enhanced Tracking predicate device.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.