The LAP LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. LAP LUNA 3D may also be used to guide patients through breath-holds. The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and radiosurgery treatments and CT simulation for radiation therapy planning.

Device Description

The LUNA 3D optical camera system captures the current 3D patient skin surface with one or multiple camera pods. The software calculates the spacial deviations between the captured live surface and a reference surface within a selected region of interest using a registration algorithm. Reference surfaces may be generated with the optical camera system or may be imported using data received from Treatment Planning Systems (TPS). Based on the registration results the user can adjust the patient position for reproducible patient positioning relative to the treatment isocenter. During the imaging (simulation) and treatment delivery process, the system continuously calculates the deviations between live- and reference surface for patient motion monitoring to ensure that the patient position remains within pre-defined tolerances.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the LUNA 3D device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provides limited detailed acceptance criteria and mostly focuses on comparison to a predicate device. The performance claims primarily relate to accuracy.

Acceptance Criteria / Performance Metric	Reported Device Performance (LUNA 3D)
Positioning Accuracy	Target registration errors (as measured using calibration phantom) < 0.5mm for all couch angles.
Respiratory Tracking (RMS Errors)	Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles.
Electrical Safety	IEC 60601-1 compliant.
EMC Standard	IEC 60601-1-2 compliant.
Photobiological Safety	Compliant with IEC 60601-2-57 and IEC 62471.
Warm-up Drift	Tested (compliance to established technical specifications).
Latency	Tested (compliance to established technical specifications).
Multi-camera Accuracies	Tested (compliance to established technical specifications).

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not specify a sample size for any clinical test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is "non-clinical performance testing" which typically refers to bench testing rather than studies involving human subjects or clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided summary does not mention any test set requiring expert ground truth or the involvement of experts for this purpose. The performance testing relies on a "calibration phantom."

4. Adjudication Method for the Test Set

As no expert-derived ground truth or clinical test set is described, no adjudication method is mentioned or applicable in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or described in the provided summary. The summary focuses on the device's standalone performance and comparison of technical characteristics to a predicate device, not on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance assessment was conducted. The "non-clinical performance testing in terms of warm-up drift, latency, and multi-camera accuracies of the camera pods" and the reported "positioning accuracy" and "respiratory tracking" metrics (using a calibration phantom) reflect the algorithm's performance without direct human interaction during the measurement process. The device's function is to provide information for humans to use, but the core measurements are automated.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing was established using a calibration phantom. This is a physical object with known dimensions and properties used to assess the accuracy of the imaging system.

8. Sample Size for the Training Set

The provided summary does not specify a sample size for any training set. Given that this is a 510(k) for a medical charged-particle radiation therapy system accessory and not a purely AI/ML enabled diagnostic device, details on training data are often less emphasized in the summary unless substantial AI model development is a primary feature. The LUNA 3D is described as an "optical camera system" with "software calculates the spacial deviations... using a registration algorithm," which implies algorithms but not necessarily deep learning that would require a large training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, no information on how its ground truth was established is provided.

Summary

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March 29, 2024

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

LAP GmbH Laser Applikationen % Sebastian Boldhaus Regulatory Affairs Manager Zeppelinstraße 23 Lüneburg, 21337 GERMANY

Re: K232031

Trade/Device Name: Luna 3D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: July 6, 2023 Received: July 7, 2023

Dear Sebastian Boldhaus:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Loca Werther

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232031

Device Name

LUNA 3D

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, LAP GmbH Laser Applikationen herewith submits a Summary of Safety and Effectiveness. This 510(k) summary for the LUNA 3D meets the requirements of 21 CFR 807.92.

Submitter information:	LAP GmbH Laser ApplikationenZeppelinstrasse 2321337 LueneburgPhone: +49 4131 951167Fax: +49 4131 951196
	Establishment Registration Number: 9681134Owner/Operator Number: 9019434
Official Correspondent:	Sebastian BoldhausZeppelinstrasse 2321337 LueneburgGermanyPhone: +49 4131 9511357Email: s.boldhaus@lap-laser.com
US Agent (Contact):	Trent Van ArkelLAP of America Laser Applications, L.C.161 Commerce Rd Ste 3Boynton Beach, FL 33426Phone: 561 4169250Fax: 561 4169263Email: Tava@Lap-Laser.com
Date Prepared:	28th of March 2024

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Device(s) Identification:

Device trade name:	LUNA 3D
Common name:	Surface Guided Radio Therapy System (PatientPositioning System – accessory to a linear accelerator)

Classification of the device:

Device Classification Name: Product Code: C.F.R. Section .: Classification Panel: Device Class:

Medical charged-particle radiation therapy system IYE 892.5050 Radiology devices Class II

Device Description:

Indications for use:

The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and CT simulation for radiation therapy planning.

Predicate device:

Device Name:	AlignRT Plus
510k number:	K212583
Device Classification Name:	Medical charged-particle radiation therapy system
Product Code:	IYE
C.F.R. Section.:	892.5050
Classification Panel:	Radiology devices
Device Class:	Class II

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Comparison to predicate device:

The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate device and the proposed device.

	Vision RT AlignRTPlus	LAP LUNA 3D	Comment
Indications foruse	The AlignRT Plussystem is indicated foruse to position andmonitor patientsrelative to theprescribed treatmentisocenter, and towithhold the beamautomatically duringradiation delivery. Forcranial treatments, amanual head adjusteris included which canbe used in concert withAlignRT Plus toprovide finecorrections for pitch,roll and yaw rotations.AlignRT Plus is alsoused to track thepatient's respiratorypattern for respiratorysynchronized imageacquisition, andradiation therapytreatment. Patientcontour data can beextracted and exportedfrom the data acquiredfor the purpose oftreatment planning.AlignRT Plus can becalibrated directly tothe treatment beamisocenter and in turnassists in performingquality assurance onMV, kV imagers, roomlasers and the	The LAP LUNA 3Dsystem is used tosupport reproduciblepatient positioning andmonitor patient surfacemotion duringradiotherapy andradiosurgery treatmentsand during CTsimulation for radiationtherapy planning. LAPLUNA 3D may also beused to guide patientsthrough breath-holds.The LAP LUNA 3Dsystem can be used forall patients, undergoingradiotherapy andradiosurgery treatmentsand CT simulation forradiation therapyplanning.	SimilarEven though theIndication for use of thepredicate device is moredetailed, the corefunctions remain thesame.Both devices are usedfor positioning thepatients and monitoringthe patients positionduring radiotherapytreatment. Both devicescan be used to monitorthe respiratory pattern ofthe patients. Bothdevices can be used toacquire a referencesurface or import data tobe used as a reference(e.g. DICOM).The LAP LUNA 3Ddevice cannot be used towithhold the beamautomatically duringradiotherapy.Furthermore, the LAPdevice comes not withhead adjuster for cranialtreatment.
	Vision RT AlignRTPlus	LAP LUNA 3D	Comment
	treatment couch.AlignRT Plus may beused duringsimulation, setup andstereotacticradiosurgery andprecision radiotherapyfor lesions, tumors andconditions anywhere inthe body whereradiation is indicated.
Principle ofoperation	Video based imagingof 3D skin surface datausing surfacematching software.	3D imaging of thepatients surfaces andcomparison withreference surfaces.	Identical
Targetpopulation	Any individual (adult orchild) undergoingradiotherapy.	Any individual of any ageundergoing radiotherapy.	Identical
Components	PC workstation,cables, video cameras.Block Polystyrene(calibration phantom),carbon fibre laminatematerial (headadjuster).	PC workstation, cables,camera pods (videocameras and a projectorunit).Calibration phantom,made of plastic.	SimilarThe LAP LUNA 3Ddevice does not containa head adjuster
Systemperformanceand accuracy	Positioning accuracy:Target registrationerrors (as measuredusing calibrationphantom) < 1mm(0.5mm) for all couchangles. Respiratorytracking: Tracksrespiratory signal fromimaged surface dataand sends to CT (4DCT) or to Linac orimaging device(gating). Surfacedisplacements can betracked with RMSerrors < 0.5mm over10 or more breathing	Planned Positioningaccuracy: Targetregistration errors (asmeasured usingcalibration phantom) <0.5mm for all couchangles. Respiratorytracking: Tracksrespiratory signal fromimaged surface data.Surface displacementscan be tracked with RMSerrors < 0.5mm over 10or more breathingcycles.	SimilarThe LAP LUNA 3D doesnot have a gatingfunction.
	Vision RT AlignRTPlus	LAP LUNA 3D	Comment
	cycles.
omp	The AlignRT Plusproduct requires nodirect contact with thepatient.	The LUNA 3D devicedoes not come intocontact with patientsduring its intended use.	SimilarThe LAP LUNA 3Ddevice does not containa head adjuster.
	The only interactionsbetween the user andthe system are with:• the PC (in the controlroom) or remoteworkstation (in thevault),• the Remote Control(in the vault),• the Real Time Coach(RTC) (in the vault), or• the Head Adjuster (inthe vault).• Calibration plate (inthe vault)• Calibration cube (inthe vault)• Calibration levellingplate (in the vault)The materials of thedevices (which arecommonly used inlight-industrial,commercial and homeuse) and that theapplication onlyinvolves intermittentexternal contact with	The User does come intocontact withcommercially availableuser interfaces such askeyboards ortouchscreens of mobiledevices. Furthermore,during calibration theuser does come intocontact with thecalibration cube.
	Vision RT AlignRTPlus	LAP LUNA 3D	Comment
	adjuster is clamped tothe treatment couchthrough universal baseplate.	environment.
Optical Pattern	Optical (near infra-red)pattern is projected topatient.	Optical visible bluepattern is projected onthe patient's bodysurface.	SimilarOptical pattern isprojected on the patient'sbody surface.
ElectricalStandard	IEC 60601-1compliant.	IEC 60601-1 compliant.	Identical
EMC Standard	IEC 60601-1-2compliant.	IEC 60601-1-2compliant.	Identical
Size andWeight	The camera (key partof the system) has thefollowing dimensions:HD Cameras (each) –470 x 220 x 70 – 4.5kgHorizon cameras(each) – 480 x 140 x127 – 2.75kg InBoreoptional cameraaccessory - Ring499mm diameter (plus1mm protrusions) x177mm wide (max) –3.2kg	The camera pods havethe following dimensions:540mm x 240mm x95mm and a weight of6.4 kg	SimilarLAP LUNA 3D systemcameras have similardimensions and weighas the Align RT horizoncamera.
Packaging	The system ispackaged in a varietyof boxes and thenpackaged withinpalletised crate.	System components willbe packed separatelyand commissionedbased on the customersorder. All componentscould be send separatelyor shipped together.	SimilarBoth devices areprovided separatelypacked andcommissioned accordingto request.
Environmentalrange	AlignRT Plus isintended for use ataltitudes below 3000m(9,842ft). Theoperating temperatureis +16°C to +30°C(60.8° to 86°Fahrenheit). Theshipping and storageconditions are - 20°C	OperatingTemp: 15..30°CHumidity: 25-80%Altitude: <= 2000mStorageTemp: -10..+40°C	Similar:Both devices havealmost identicaloperating conditions.However the Align RTDevice has a broaderstorage temperaturerange.
	Vision RT AlignRTPlus	LAP LUNA 3D	Comment
	to +50°C (-4° to 122°Fahrenheit).
WorkstationOperatingSystem	Windows 10	Windows 10 IOT,Windows Server 2022	Similar:Both devices useWindows OS.
Powerrequirements	110-230V 50/60Hz	110-240V 50/60Hz	Similar:The maximum voltagerange of the LAP LUNA3D is slightly higher, butnot relevant for the USmarket.
Networkrequirements	10BaseT internetconnection behind alocal firewall.	100 Mbit/s connected tolocal hospital network	Similar:LAP LUNA 3D devicehas a secured 100 Mbit/snetwork connection tothe local hospitalnetwork.

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Biocor

Mechanical

safety

Cameras are ceiling

mounted and do not contact patient or user.

The InBore camera

inside of the bore-

based linac. Head

solution is fixed to the

LAP LUNA 3D camera

mounted. Display device

The breath hold device is

clamped to the treatment

is rigidly wall mounted.

pods are ceiling

couch in patient

Similar

couch.

All components are

either rigidly mounted or

clamped to the treatment

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Summary of performance testing:

The proposed device has been tested in respect to electrical and mechanical safety in accordance with IEC 60601-1, EMC in accordance with IEC 60601-1-2 and photobiological safety according to IEC 60601-2-57 and IEC 62471 respectively. Non-clinical performance testing in terms of warm-up drift, latency, and multi-camera accuracies of the camera pods has been conducted. The conducted tests verify the compliance to the established technical specifications and support the substantial equivalence to the predicate device.

Conclusion:

LAP GmbH Laser Applikationen believes that the LUNA 3D is substantially equivalent to currently legally marketed devices. The device does not indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.