NeuroLF is a positron emission tomography system that is used to detect and display the distribution of positron-emitting radionuclides within parts of the human body to assist in diagnosis, therapeutic planning, and therapeutic outcome assessment. The NeuroLF seat is intended to properly position the patient for PET imaging of the neck or head with the NeuroLF.

Device Description

The NeuroLF is a small aperture Positron Emission Tomography (PET) scanner that produces images of the distribution of positron-emitting isotopes from parts of a subject that are put into the aperture for medical diagnostic purposes. The NeuroLF System comprises the Scanning Unit and the Patient Positioning System (NeuroLF Seat). The circular opening in the scanner head has an effective inner diameter of 260mm and is designed such that the entire brain fits within the scanner's field of view (FoV). With a length of an axial FoV of 163mm, the NeuroLF is designed to capture a single image. The NeuroLF scanner head consists of an octagonal detector, which is composed of 8 detector module contains a total of 384 Lutetium Yttrium Orthosilicate (LYSO) Crystals. The software of the NeuroLF System integrates the equipment, allows acquisition, reconstruction and export of tomographic images. It also allows the user to detect the current state of the running system. The device shall only be used with patients whose weight is lower than 200kg (440lb). There are three different versions of the NeuroLF; 10 mm (NeuroLF Basic), 15 mm (NeuroLF Pro) and 20 mm (NeuroLF Advanced). The number corresponds to the length of the LYSO crystals in the detector modules. The absorption probability of gamma radiation is proportional to the volume of scintillating material in the scanner and therefore the highest absorption probability is to be expected from the 20 mm detectors. The longer the LYSO crystals the higher the sensitivity of the device, therefore in clinical use the acquisition time or the activity in the field of view could be reduced.

AI/ML Overview

The NeuroLF system, a positron emission tomography (PET) scanner, has been cleared for marketing based on its substantial equivalence to a legally marketed predicate device (BBX-PET Scanner, K210450). The clearance is supported by various performance tests demonstrating its compliance with predetermined specifications and applicable standards.

Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly lay out quantitative acceptance criteria for all aspects in a consolidated table, but rather compares specific performance metrics between the subject device (NeuroLF) and the predicate device, or states compliance with general requirements. However, based on the "Performance Data Specifications" section and the NEMA NU-2:2018 standard for PET systems, we can infer some criteria and reported performance.

Attribute	Acceptance Criteria (Inferred from NEMA NU-2:2018 or Predicate)	NeuroLF Reported Performance (NeuroLF Basic/Advanced)
Spatial Resolution (FWHM)	At center: 2.2mm (Predicate)	At 1 cm: 2.7 mm (Basic), 3.1 mm (Advanced)
	At 10 cm: Not published for predicate, but expected to be within acceptable range for PET for brain imaging.	At 10 cm: 3.5 mm (Basic), 3.7 mm (Advanced)
Energy Resolution	Not published for predicate	17-25% FHWM
System Sensitivity	1.1% (Predicate)	3.1% (Basic)
Coincidence Timing Window	Not published for predicate	3ns-5ns
Scatter Fraction	Not published for predicate	38% (Basic)
Scatter Correction Method	Not published for predicate	SSS - single scatter simulation
Slice Thickness	Depends on reconstruction (2mm/4mm) (Predicate)	1.66 mm
Count Rate Sensitivity	10 cps/kBq (Predicate)	4.8 cps/kBq (center), 6.8 cps/kBq (100mm) (Basic)
Electrical Safety (IEC 60601-1)	Compliance with IEC 60601-1:2005/A1:2012/A2:2020	Complies with IEC 60601-1:2005/A1:2012/A2:2020
EMC (IEC 60601-1-2)	Compliance with IEC 60601-1-2:2014	Complies with IEC 60601-1-2:2014
Software V&V	Compliance with FDA's "Content of premarket submission for Device Software Functions" guidance.	Conducted, documentation provided, classified as basic.
Clinical Effectiveness	Ability to produce clinically useful images for diagnosis, therapeutic planning, and outcome assessment.	Sample images from 4 clinical cases provided.

Justification of Equivalence: The document states that the NeuroLF's detectors and fields of view are similar to the predicate, with a longer axial FoV for NeuroLF. While its crystal pitch is larger, the use of a single layer of scintillators is noted to facilitate correct gamma absorption location. These differences are deemed to "not affect the indications, only the performance," suggesting that the performance differences are within acceptable clinical variability or represent improvements. Specifically, the clinical effectiveness section concludes with "Same or better as predicate."

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

Sample Size for Test Set:
- Bench Performance Testing: The document does not specify a "sample size" in terms of number of units tested. Performance was tested on the NeuroLF System. The testing was performed according to NEMA NU-2:2018 standard, which dictates specific phantoms and procedures.
- Clinical Effectiveness: "Sample images from four clinical cases using the NeuroLF System were provided."
Data Provenance: The document does not explicitly state the country of origin for the clinical cases or whether they were retrospective or prospective. It only mentions that Positrigo AG provided the images. Given that Positrigo AG is based in Switzerland, it's plausible the data originated there, but this is not confirmed.

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

The document mentions "Sample images from four clinical cases" for clinical effectiveness and that this "supported the clinical effectiveness of the NeuroLF system." However, it does not specify the number of experts used to establish ground truth or their qualifications for these four clinical cases. The ground truth for these cases is implicitly the clinical images themselves being representative of appropriate PET imaging for the stated indications for use.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical images used in the clinical effectiveness assessment.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on showing the device's performance against NEMA standards and the predicate device's general capabilities, and provides a small number of clinical images as anecdotal evidence of clinical effectiveness. It does not assess the improvement of human readers with or without AI assistance, as AI assistance in image interpretation is not an explicit claim or feature described in the provided text.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm (the PET system itself). This is described under "Performance Testing - Bench," where "The performance of the NeuroLF System has been tested by Positrigo AG according to NEMA NU-2:2018." This involved objective physical performance measurements of the device without human interpretation studies to assess its imaging capabilities.

7. Type of Ground Truth Used

Bench Performance Testing: The ground truth for bench testing (e.g., spatial resolution, sensitivity) is established by the NEMA NU-2:2018 standard, which dictates the use of specific phantoms and measurement techniques to determine objective physical performance parameters.
Clinical Effectiveness: The ground truth for the four clinical cases is implicitly the clinical images themselves, which are presented as demonstrating the device's capability to produce images for diagnostic assistance, therapeutic planning, and outcome assessment. There is no mention of pathology, outcomes data, or expert consensus being explicitly used to establish ground truth for these specific cases beyond the images' clinical utility.

8. Sample Size for the Training Set

The document does not mention a training set in the context of device performance or software development. The NeuroLF is a PET scanner, and its primary function is image acquisition and reconstruction based on physical principles, not a machine learning model that requires a "training set" in the conventional sense of AI/ML. The software itself undergoes verification and validation, but not typically with a separate "training set" like an AI algorithm would.

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

As no training set is mentioned or applicable in the context of this device description (which is a physical PET scanner with image reconstruction software, not an AI/ML diagnostic tool), this information is not provided.

Summary

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July 15, 2024

Positrigo AG % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K241751

Trade/Device Name: NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: June 20, 2024 Received: June 21, 2024

Dear Dave Yungvirt:

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,

FDA

Daniel M. Krainak, Ph.D. Assistant Director 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

510(k) Number (if known) K241751

Device Name

NeuroLF (Basic);NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat

Indications for Use (Describe)

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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1. Contact Details:

Company Name:	Positrigo AG
Address:	Technoparkstrasse 1, 8005 Zürich, Switzerland
Contact Name:	Mr. Jannis Fischer
Phone:	0041 44 515 53 30
Email:	jannis.fischer@positrigo.com

2. Device Name:

Device trade name:

Common name: Classification name: Regulation number: Product code:

NeuroLF Basic NeuroLF Pro NeuroLF Advanced NeuroLF Seat

PET Scanner Emission computed tomography system 892.1200 KPS

3. Legally Marketed Predicate Device:

Predicate device application number: Predicate trade name: Predicate product code:

K210450 BBX-PET Scanner KBS

4. Device description summary:

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It also allows the user to detect the current state of the running system. The device shall only be used with patients whose weight is lower than 200kg (440lb).

There are three different versions of the NeuroLF; 10 mm (NeuroLF Basic), 15 mm (NeuroLF Pro) and 20 mm (NeuroLF Advanced). The number corresponds to the length of the LYSO crystals in the detector modules. The absorption probability of gamma radiation is proportional to the volume of scintillating material in the scanner and therefore the highest absorption probability is to be expected from the 20 mm detectors. The longer the LYSO crystals the higher the sensitivity of the device, therefore in clinical use the acquisition time or the activity in the field of view could be reduced.

Intended Use/Specification for Use: 5.

6. Indications for Use Comparison:

Both the subject and predicate device have the same intended use for obtaining positron emission tomography (PET) images of parts of the human body that fit in its patient aperture.

7. Technological Comparison:

NeuroLF and the predicate device are both Positron Emission Tomography systems used to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings. Main technological elements of NeuroLF and predicate device are the same:

PET detectors are arranged in a cylindrical shape.
Detectors are composed of scintillator crystals and Silicon photomultipliers, that detect gamma rays emitted by radioactivity located inside the cylinder.
Single and coincidence events are captured on detector electronics and acquired and processed by software that generates images using iterative reconstruction methods.
Attenuation correction method is in both cases Calculated Attenuation Correction. ●
Main differences between predicate device and NeuroLF are: ●
Patient is in a seated/reclined position in NeuroLF, while the predicate device is lying on ● a bed.
Cylinder diameter is 26 cm in NeuroLF, while in predicate device is 29cm.

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· Crystals are Lutetium Yttrium OrthoSilicate (LYSO) in NeuroLF, while in predicate lutetium fine-silicate (LFS) crystals are used.

7.1. Comparison Table:

Attributes	Predicate deviceBBX-PET Scanner	Subject deviceNeuroLF	Justification ofequivalence
Device	Image: BBX-PET Scanner	Image: NeuroLF	n/a
Intended Use	Dedicated PositronEmission Tomography	Dedicated PositronEmission Tomography	Same aspredicate
Indication foruse	BBX-PET is scannerintended to obtain PositronEmission Tomography(PET) images of parts ofthe human body that fit inthe patient aperture (e.g.,head) to detect abnormalpattern of Distribution ofradioactivity after injectionof a positron emittingradiopharmaceutical. Thisinformation can assist inresearch, Diagnosis,therapeutic planning andtherapeutic outcomeassessment.	NeuroLF is a positronemission tomographysystem that is used to detectand display the distributionof positron-emittingradionuclides within parts ofthe human body to assist indiagnosis, therapeuticplanning, and therapeuticoutcome assessment.	Same aspredicate
Principle ofdetection	Positron EmissionTomography (PET) systemto image the distribution ofinjected positron emitting	NeuroLF is a smallaperture Positron EmissionTomography (PET) scannerto image the distribution of	Same aspredicate
	radiopharmaceuticals intolive humans or animals.The BBX-PET Scannerproduces images thatrepresent the internaldistribution of radioactivityin the head.	injected positron emittingradiopharmaceuticals in thehead of live humans, asdefined in 21 CFR 892.1200.NeuroLF generatestomographic images thatrepresent the internaldistribution of radioactivity inthe patient's brain.
Scintillatorconfiguration/ Scanner	Double-layer staggeredSilicate Lutetium Finepixelated crystals (13 x 13and 14 x 14 arrays,1.76-mm pitch) coupled tolight detector solid statesilicon photomultiplier. Onehundred twenty-eightblocks positioned in acircular shape make up thegantry, with bore diameterof 288mm, and 250mm and100mm transaxial and axialFoVs.	Pixelated lutetium-basedscintillator coupled inlight-sharing architecturewith silicon photomultipliers.A single crystal array iscomposed of 4x4scintillators. The pitch of thecrystals is 3.19 mm. Overall,12288 pixels disposed inoctagonal shape forms thedetection ring. The transaxialFoV is 268 mm, the axialFoV is 164 mm.	Detectorsdesign andfields of vieware similar.NeuroLF axialFoV is longer.While the pitchfor NeuroLF islarger, the useof a single layerof scintillatorsfacilitates thecorrectassignment ofthe gammaabsorptionlocation. Thesedifferences donot affect theindications, onlytheperformance.
TargetPopulation	Adults, young adults	Adults and adolescent	Same aspredicate
Anatomicalsite	Parts of the human bodythat fit in the patientaperture	Parts of the human body thatfit in the patient aperture	Same aspredicate
Where used	Hospital	Hospital	Same aspredicate
Energy usedand/or	Detects distribution ofradioactivity after injection	Detects distribution ofradioactivity after injection of	Same aspredicate
delivered	of a positron emittingradiopharmaceutical. Noenergy delivered.	a positron emittingradiopharmaceutical. Noenergy delivered.
Humanfactors	PET detection system in amovable cart. Its gantry canmove up to allow brainimaging while the patient isseated. It can also movedown to image the breastwithout compression, whilea patient is lying on abiopsy table or rotate andallow imaging the breast,hand, or leg in a seatedposition.	The PET detection system isfixed and includes a chair.Gantry can be manuallymoved up, down,horizontally and with tiltadjusted to properly fit theheight of the patient forimaging the brain while thepatient is seated.	Only brainimaging in aseated positionis possible. Thisposition is thesame as inpredicate. Maindifference isthat the chair ispart of thesystem, asexplained in thediscussionsection.Imaging in alying position isnot possible.
Design	The BBX-PET Scanner iscomprised of two parts; theGantry containing detectorsand electronics, and theUniversal Console that thecomputer containsworkstation. These twoparts are connected toeach other using opticalfiber and an USB cable.	NeuroLF has threeseparable parts. TheNeuroLF Seat is used toplace the subject's headprecisely in the DetectorRing. The Scanning Unitcontains the Detector Ringthat performs the dataacquisition with customelectronics, a ScanningComputer System located inthe gantry and theReconstruction ComputerSystem performingtomographic imagereconstruction. The NeuroLFsystem comes with two UserInterfaces.The first is locatedon the gantry of theScanning Unit and is usedfor monitoring, starting, andinterrupting scans directlynext to the patient. The	Same aspredicate, thatthe exceptconnection isstandardethernet cableinstead of afiber opticscable and USB
		second User interface is anapplication on a separateConsole Computer System.Scanning Unit and ConsoleComputer System areconnected by ethernet cablewith and through the hospitalnetwork. The system hasDICOM Worklist support andPACS connectivity.
PerformanceDataSpecifications	Spatial resolution in FWHMat the center: 2.2mm	Spatial resolution in FWHMat 1 cm:2.7 mm (NeuroLF Basic)3.1 mm (NeuroLF Advanced)
	Spatial resolution in FWHMat 10 cm: Not published	Spatial resolution in FWHMat 10 cm:3.5 mm (NeuroLF Basic)3.7 mm (NeuroLF Advanced)
	Energy resolution: NotPublished	Energy resolution: 17-25%FHWM
	System sensitivity: 1.1%	System sensitivity: 3.1%(NeuroLF Basic)(NEMA-NU4-2008)
	Coincidence timing window:Not published	Coincidence timing window:3ns-5ns
	Scatter fraction: Notpublished	Scatter fraction: 38%(NeuroLF Basic)(NEMA-NU2-2018)
	Scatter correction method:Not published	Scatter correction method:SSS - single scattersimulation
	Slice thickness: Dependson reconstruction	Slice thickness: 1.66 mm

	(2mm/4mm)Count rate sensitivity: 10cps/kBqIsolation of the detectorfrom background: Notapplicable for PETIntrinsic spatial resolution:Not applicable for PETAttenuation:Calculated methodComputer: GPU	Count rate sensitivity: 4.8cps/kBq (center), 6.8cps/kBq (100mm)(NeuroLF Basic)(NEMA-NU2-2018)Isolation of the detector frombackground: Not applicablefor PETIntrinsic spatial resolution:Not applicable for PETAttenuation:Calculated methodComputer: CPU
Materials andbio-compatibility	Standard electronics andmedical grade materials	Standard electronics andmedical grade materials	Same aspredicate
Compatibilitywith theenvironmentand otherdevices	Complies with standard IEC60601-1-2 ed 4.0 (2014-02)Medical equipmentelectrical Part 1-2: Generalrequirements for basicsafety and essentialperformance - CollateralStandard: Electromagnetic:disturbances -Requirements and tests forEMC.	Complies with standard IEC60601-1-2:2014 Medicalequipment electrical Part1-2: General requirementsfor basic safety andessential performance -Collateral Standard:Electromagneticcompatibility-requirementsand tests.	Same aspredicate
Sterility	The product is not sterileand has not to be sterilizedby the user. Cleaningprocedure devices.Cleaning of standardmedical devices	The product is not sterileand has not to be sterilizedby the user. Cleaningprocedure devices. Cleaningof standard medical devices	Same aspredicate
Mechanicaland electrical	Complies with standard IEC(Third 60601-1:2005 Edition)	Complies with standard IEC(Third 60601-1:2005 Edition)	Same aspredicate
safety	+ COOR.1:2006 +CORR.2:2007 + A1:2012Medical equipmentelectrical Part 1: Generalrequirements for basicsafety and essentialperformance for electricalsafety	+ COOR.1:2006 +CORR.2:2007 + A1:2012 +A2:2020 Medical equipmentelectrical Part 1: Generalrequirements for basic safetyand essential performancefor electrical safety
Clinicaleffectiveness	3 clinical images areprovided from PrescientBBX-PET to demonstratethe image capability andthe fulfillment with itspredeterminedspecification.	4 clinical images areprovided by Positrigo AGfrom NeuroLF todemonstrate the imagecapability and the fulfillmentwith its predeterminedspecification.	Same or betteras predicate

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Image /page/6/Picture/0 description: The image shows the logo for Positron Imaging. The logo consists of a blue atom-like symbol on the left, followed by the company name "POSITRIGO" in bold, black letters. Below the company name, in smaller, lighter font, is the tagline "IMAGING EVERYONE."

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Image /page/7/Picture/0 description: The image shows the logo for Positron Imaging. The logo consists of a stylized atom symbol on the left and the word "POSITRON" in bold, sans-serif font on the right. Below "POSITRON" is the phrase "IMAGING EVERYWHERE" in a smaller, lighter font. The atom symbol is light blue and appears to be made up of interconnected circles and lines.

510(k) Summary K241751

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Image /page/10/Picture/0 description: The image contains the logo for "Positrigo". The logo consists of a stylized, interconnected network of circles and lines, resembling a molecule or a network node, on the left side. To the right of the icon is the company name, "POSITRIGO", in bold, sans-serif font. Below the company name, in a smaller font size, is the tagline "IMAGING EVERYONE".

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Image /page/11/Picture/0 description: The image shows the logo for "Positrigo Imaging Everyone". The logo consists of a blue icon on the left and the company name on the right. The icon is a stylized representation of interconnected nodes, while the company name is written in a clean, sans-serif font, with "Positrigo" in a larger font size than "Imaging Everyone".

8. Performance Data:

8.1. Electrical safety and electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on the NeuroLF System and certified by the independent certification company TÜV SÜD Product Service GmbH. The system complies with:
IEC 60601-1:2005 / A1:2012 / A2:2020. Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance.
. IEC 60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
- 8.2. Software Verification and Validation testing:

Software verification and validation is conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of premarket submission for Device Software Functions (CDRH, 2023).

According to the referred FDA guidance, the software documentation level is classified as basic. A failure or latent flaw of the device software function(s) would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures.

8.3. Performance Testing - Bench:
Performance testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems" Section IX.C.2. (CDRH, 1998).

The performance of the NeuroLF System has been tested by Positrigo AG according to NEMA NU-2:2018 - Performance Measurements of Positron Emission Tomography. The testing performed include:

Spatial resolution ●
Scatter Fraction and count rate (NECR) .
Sensitivity
Accuracy: Corrections for count losses and randoms ●
Image quality, accuracy of corrections ●

Test results indicate that the NeuroLF System complies with its predetermined specifications and the applicable standards.

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Image /page/12/Picture/0 description: The image contains the logo for "Positrigo". To the left of the company name is a blue icon that looks like a molecule. Below the company name is the text "Imaging Everyone".

Performance Testing - Clinical Effectiveness 8.4.

Clinical effectiveness was conducted and documentation was provided as recommended by FDA's Guidance for industry and FDA staff, "Guidance for the submission of Premarket notification for Emission computed Tomography Devices and accessories (SPECT and PET) and nuclear Tomography Systems" Section IX.F: (CDRH, 1998).

Sample images from four clinical cases using the NeuroLF System were provided.

9. Conclusion:

The data support the safety of the device and the hardware and software verification and validation demonstrate that the NeuroLF System should perform as intended in the specified use conditions. The publication including the sample images from four clinical cases supported the clinical effectiveness of the NeuroLF system. Based upon performance data the NeuroLF System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.