The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures.

Device Description

During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

The EPIONE device consists in the following components:
Robot cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the patient. The cart carries a robotic arm including a force sensor assembly allowing handguiding of the robotic arm by the user. The robotic arm movements are enabled by the user using a footswitch. The robot cart also embeds the electronic systems required to power and operate the robot arm.
Display cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the operator. The cart carries a touchscreen to operate the system.
Navigation cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the table. The cart carries a navigation camera.
EPIONET software: A software provides the step-by-step workflow assistance for intervention planning and intraoperative positioning of the robotic arm for instruments placement and post-operative assessment.
EPIONE instruments: Needle guide, Patient reference, Navigation probe

AI/ML Overview

The provided document describes the Quantum Surgical EPIONE device and its FDA 510(k) summary, which includes non-clinical and clinical performance data to demonstrate substantial equivalence to a predicate device. This information will be used to answer your questions about acceptance criteria and the study proving the device meets them.

1. Table of acceptance criteria and the reported device performance

Based on the "Summary of Non-Clinical Performance Data" and "Clinical study" sections, the primary acceptance criteria revolve around the device's accuracy, safety, and effectiveness. A specific quantitative acceptance criterion for accuracy is hinted at by the mention of "average accuracy" being demonstrated as safe and effective, but the numerical value of this criterion is not explicitly stated. The performance is reported as meeting these general standards.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Accuracy	"The average accuracy of the system demonstrates that the EPIONE device is safe and effective for CT-guided needle placement in the liver."
Safety	"The study evaluated the accuracy, safety, and feasibility...The results of this study show that the EPIONE™ device is safe and effective... with no adverse events reported for any of the subjects."
Effectiveness	"The study evaluated the accuracy, safety, and feasibility...The results of this study show that the EPIONE™ device is safe and effective..."

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

Test set sample size:
- Non-clinical (Animal Study): 36 needle placements were performed in a preclinical animal study (porcine models).
- Clinical Study: 21 patients were enrolled in a multi-center, prospective, and interventional clinical study.
Data Provenance:
- Animal Study: The document states "preclinical animal study on the liver was conducted on porcine models". It does not specify the country of origin.
- Clinical Study: The document mentions a "multi-center, prospective and interventional clinical study." It does not specify the country of origin, but given the sponsor (Quantum Surgical SAS) is based in France, it is likely the study involved sites in France or other European countries. The study is described as "prospective," indicating data was collected specifically for this study.

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 used to establish ground truth or their qualifications for either the animal or clinical studies. The clinical study design focuses on the device's safety and effectiveness in guiding procedures performed by trained physicians, but it does not detail an independent ground truth establishment process by experts for, e.g., diagnostic accuracy or outcome evaluation separate from the performing physicians.

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

The document does not describe an adjudication method for the test set. Given that the clinical study focuses on the device's use in procedures and observed outcomes (safety and effectiveness of the procedure itself), rather than an image-based diagnostic evaluation requiring consensus reads, an adjudication process as typically understood for diagnostic AI might not have been applied in the same way.

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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not reported. The studies described are focused on the device's performance in assisting physicians with CT-guided percutaneous procedures, rather than on improving human reader performance in image interpretation. The EPIONE is a surgical assistance system, not primarily an image interpretation AI.

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

The EPIONE device is explicitly described as a "user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures." It involves a robotic arm, software, and instruments that are operated by a human. Therefore, a standalone (algorithm only without human-in-the-loop) performance study was not applicable or performed, as the device's function inherently requires human interaction.

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

Animal Study: The "accuracy" and "feasibility" were evaluated by observing the results of the 36 needle placements in porcine livers. The ground truth for accuracy would likely be the actual vs. planned needle tip position, measured perhaps by post-procedure imaging or dissection, though the specific measurement method is not detailed.
Clinical Study: The ground truth for the clinical study was primarily outcomes data regarding the safety and performance of the liver ablation procedures. Safety was assessed by the absence of adverse events, and effectiveness (performance) was confirmed by the successful execution of the CT-guided percutaneous procedures for liver ablations using the device.

8. The sample size for the training set

The document does not mention the sample size used for the training set for the EPIONE software or system. This information is typically found in details about the AI/algorithm development, which may not be fully disclosed in a 510(k) summary focused on substantial equivalence.

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

The document does not provide details on how the ground truth for the training set (if any specific training data was used for AI/ML components within the software) was established. The software development and validation were conducted in compliance with FDA guidance and IEC standards, which would cover verification and validation methods, but not necessarily the detailed ground truth establishment for a training dataset.

Summary

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February 24, 2022

Quantum Surgical SAS % Elise Lagacherie Ouality Assurance and Regulatory Affairs Director ZAC Eureka 1000 rue du Mas de Verchant Montpellier, 34000 FRANCE

Re: K211645

Trade/Device Name: Epione Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: January 19, 2022 Received: January 21, 2022

Dear Elise Lagacherie:

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,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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) K211645

Device Name EPIONE

Indications for Use (Describe)

During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Quantum Surgical. The logo consists of an orange geometric shape on the left, resembling a stylized letter "Q". To the right of the shape, the words "QUANTUM" and "surgical" are written in gray, with "QUANTUM" on top of "surgical". The logo appears to be for a medical or technology company.

K211645 510(k) SUMMARY

Date prepared: 23, February 2022

Submitter

Quantum Surgical SAS

1000 rue du mas de Verchant 34000 Montpellier France

Contact Person:

Elise Lagacherie, Quality & Requlatory Affairs Director e.lagacherie@quantumsurgical.com

Device:

Name of Device: EPIONE™ Common or Usual Name: Computer assisted Surgical System. Classification Name: Computed tomography X-ray system (21 CFR 892.1750) Requlatory Class: II Product Code: JAK

Predicate Device

MAXIO (JAK, K132108), Perfint Healthcare Pvt. Ltd.,

Reference Device:

CAS-One IR (JAK, K152473), CAScination AG

Device Description

During the planning phase, the desired instrument placement and performance is defined relative to the tarqet anatomy. During the quidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

The EPIONE device consists in the following components:

Robot cart	This mobile equipment can be moved in and out of the intervention room and is positioned next to the patient. The cart carries a robotic arm including a force sensor assembly allowing handguiding of the robotic arm by the user. The robotic arm movements are enabled by the user using a footswitch. The robot cart also embeds the electronic systems required to power and operate the robot arm.
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Image /page/4/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange geometric shape on the left and the words "QUANTUM surgical" on the right. The word "QUANTUM" is in orange, and the word "surgical" is in gray.

Display cart	This mobile equipment can be moved in and out of the intervention room and is positioned next to the operator. The cart carries a touchscreen to operate the system.
Navigation cart	This mobile equipment can be moved in and out of the intervention room and is positioned next to the table. The cart carries a navigation camera.
EPIONET™ software	A software provides the step-by-step workflow assistance for intervention planning and intraoperative positioning of the robotic arm for instruments placement and post-operative assessment.
EPIONE instruments	Needle guidePatient referenceNavigation probe

Indications for Use

	EPIONE	MAXIOpredicate device
Intended use /Indication for Use	The EPIONE device is a user controlled,stereotactic accessory intended to assist in theplanning and manual advancement of one ormore instruments, as well as in verification ofinstrument position during ComputedTomography (CT) guided percutaneousprocedures.During the planning phase, the desiredinstrument placement and performance isdefined relative to the target anatomy. Duringthe guidance phase, the device enables tomonitor respiratory levels and verify patientposition prior to instrument advancement.During the assessment phase, the achievedinstrument placement and performance aredisplayed relative to the previously defined planthrough an overlay of the pre- and post-treatment image data.The device is indicated for use in liver ablationprocedures under general anesthesia with rigidstraight instruments such as needles and probesof diameters ranging from 11G to 19G byphysicians trained for CT procedures.	MAXIO is a user controlled, stereotacticaccessory intended to assist in the planning andmanual advancement of one or moreinstruments during Computed Tomography (CT)guided percutaneous procedures.MAXIO permits physician verification of patientposition prior to needle advancement andmonitoring of respiratory levels during theprocedure.Image registration and overlay tools available inMAXIO are intended to provide guidance to theuser during planning and instrument placement.MAXIO is indicated for use with rigid straightinstruments such as needles and probes used inComputed Tomography (CT) guidedpercutaneous interventional proceduresperformed by physicians trained for CTprocedures on organs and anatomical structuresin the thorax, abdomen and pelvis.
Patient AnesthesiaConditions	For use under general anesthesia conditions	For use under local to general anesthesiaconditions
	EPIONE	MAXIO
		predicate device
Intra-interventionalPlanning	Physician defines trajectory per an entry pointand a target point on CT images.	Physician defines trajectory per an entry pointand a target point on CT images.
Interventionalinstruments	Rigid straight interventional instruments such asneedles and probes for ablation from 11G to19G.	Rigid straight interventional instruments such asneedles, probes for biopsy, ablation anddrainage from 11G to 21G.
Needleconfiguration andperformance	• Needle selection among a list of predefinedneedles• Manufacturer defined performances (e.g.ablation zones).	• Needle selection among a list of predefinedneedles• Manufacturer defined performances (e.g.ablation zones).• User-defined performances (e.g. ablationzones).
Needle guidance	• Robotic arm with needle guide is positionedon the desired trajectory as was planned onthe intra-interventional CT images.• Instrument (e.g. needle) is then manuallyadvanced through the guide on the plannedtrajectory.	• Robotic arm with needle guide instrument ispositioned on the desired trajectory as wasplanned on the intra-interventional CT images.• Instrument (e.g. needle) is then manuallyadvanced through the guide on the plannedtrajectory.
Patient registration	Automatic patient location to image registrationper array of markers on a patient referenceinstrument placed on the patient's skin andincluded in the CT-scan images and which arelocated using an optical tracking system.	The location of the robotic workstation is locatedto a fixed established reference position relativeto the C-arm and bed per the use of a dockingmat and calibration process performed duringthe initial workstation installation.
PatientRegistrationverification	The navigation probe is pointed to pre-identifiedpoints on the patient (skin markers) to verifytheir relative locations.	Skin markers are placed on the patient andincluded in the CT-scan and located whenplanning. Then before needle placement, it isverified using a laser system that the patient hasnot moved by verifying that the locations of theskin markers are still in the same location aswhen scanned. In addition, table markers on theC-arm are also used to verify also per a lasercross-hairs that the relative locations of the C-arm and robot workstation have not changedfrom the original installation.
Respiratory MotionManagement	Respiratory motion control using breath-holdMeasurement of apnea reference level duringthe intra-interventional planning CT imaging.Live display of respiratory level using the markers/ patient reference placed on the patient andvisual comparison with the reference levelduring needle guidance.	Respiratory motion control using breath-hold.Measurement of apnea reference level duringthe intra-interventional planning CT imaging.Live display of respiratory level using arespiratory belt mounted on the patient(Medspira Breath-Hold for InterventionalRadiology) and visual comparison with thereference level during needle guidance.
Intra-interventionalverification	Verification CT Image registration with planningCT to compare achieved needle position toplanned needle trajectory.	Verification CT Image registration with planningCT to compare achieved needle position toplanned needle trajectory.
Post-procedureverification	Register intra-interventional CT series with postprocedure CT series to display planned targetposition on Post-procedure CT image.	Register intra-interventional CT series with postprocedure CT series to display planned targetposition on Post-procedure CT image.

Comparison of Technological Characteristics with the predicate device

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Image /page/5/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange hexagon with a stylized "Q" shape on the left side. To the right of the hexagon is the text "QUANTUM" in a larger, bolder font, stacked above the word "surgical" in a smaller font.

The comparisons between the EPIONE and the predicate determined that:

The EPIONE device has the same general intended use as the predicate. The indications for use of the EPIONE is for liver ablations as in the predicate except that the predicate has a wider indication to also include other procedures and anatomical areas. The EPIONE is therefore equivalent to the predicate in this respect within its indications for use in liver ablations.
The EPIONE device is limited for use for patients under general anesthesia as in the predicate except that the predicate allows also for local anesthesia conditions. The EPIONE device is therefore equivalent to the predicate within its use under general anesthesia conditions.

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Image /page/6/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange geometric shape resembling a stylized "q" on the left, followed by the words "QUANTUM" in orange and "surgical" in gray on the right. The geometric shape is made up of connected lines and angles, creating a modern and abstract design.

The EPIONE device is compatible for use with interventional instruments with diameters ranging from 11G to 19G as compared to the predicate with a wider range of 11G to 21G. Given that the proposed EPIONE range is within that of the predicate, the EPIONE device is therefore equivalent to the predicate within its narrower range.
· The EPIONE device was shown to have equivalent technological characteristics to the predicate including a robotic arm to position the needle guide per the planned trajectory. An important difference is that the EPIONE additionally implements an optical tracking system to both register and track the patient location and instrumentation to ensure correct placement of the needle relative to the CT based planned trajectory. The predicate alternately utilizes a locating mat and location calibration process at installation to provide for a fixed known location of the C-arm, and a laser system to thereafter ensure that the patient location has not changed. However, this different technological approach in the EPIONE is, along with other related differences in instrumentation for use with the tracking system, is supported by an equivalent implementation of an optical tracking system in the reference device, the CAS-One IR, for the same purposes and the same intended use as the EPIONE. This should then not raise any new questions of safety or effectiveness.

Summary of Non-Clinical Performance Data:

The following nonclinical performance testing was conducted to establish substantial equivalence and to verify that the EPIONE device will perform safely and effectively per its intended use:

. Overall System Accuracy Tests
. Respiratory Monitoring Effectiveness Tests
. Needle Bending Test Study
Positional accuracy testing in accordance with the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
Electrical Safety Tests, in accordance with IEC 60601-1
. Electromagnetic Compatibility Tests, in accordance with IEC 60601-1-2
. Biocompatibility Tests, in accordance with standard ISO 10993 for patient contacting components
Cleaning and Sterilization Validation Tests, for the instrument reprocessing
. Usability Testing, in accordance with IEC 62366-1:2015 and the FDA quidance document Applying Human Factors and Usability Engineering to Medical Devices.

A preclinical animal study on the liver was conducted on porcine models using the EPIONE device to demonstrate safety and effectiveness of the device. The study evaluated the accuracy, safety, and feasibility of robotically assisted CT-guided needle placement in the liver of an in-vivo model (with breathing movements) with the EPIONE device. A total of 36 needle placements were performed in the liver. The average accuracy of the system demonstrates that the EPIONE device is safe and effective for CT-guided needle placement in the liver.

Additionally, Software design and velidation testing was completed in completed in compliance with the FDA guidance "Content of Premarket Submissions for Software Contained in Medical Devices", the IEC 62304 Standard "Medical Device Software - Life Cycle Process", as well as FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

The performance testing of the EPIONE device demonstrated that it should be as safe and as effective as the predicate device.

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Image /page/7/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange hexagon with a stylized "q" shape on the left side. To the right of the hexagon, the words "QUANTUM" are written in orange, and below that, the word "surgical" is written in gray.

Clinical study

A multi-center, prospective and interventional clinical study, was performed using the EPIONE™ device for liver ablations on 21 patients under general anesthesia to supplement the bench and preclinical animal testing and confirm the safety and performance of the results of this study show that the EPIONE™ device is safe and effective for CT-quided percutaneous procedures for liver ablations under general anesthesia conditions with no adverse events reported for any of the subjects.

Conclusions

Compared to the predicate, the EPIONE device has the same intended use, indications for use within that of the predicate, patient anesthesia condition within that of the predicate, and equivalent technological characteristics. The differences between the EPIONE device and the predicate do not raise different questions of safety and effectiveness. The testing including bench testing, animal, and clinical testing demonstrated that the device should be as safe and effective in achieving its intended use as in the predicate. The EPIONE™ device is therefore substantially equivalent to the identified predicate device.

Regulation Number and Section

N/A