Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment parts, and accessories.

Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient's chest region and body extremities. Virgo supports radionuclides within the energy range of 60 -170 keV

Device Description

The Virgo system design comprises a gantry supporting a fixed 90 degree dual head detector and a patient chair. The Virgo system is operated through interaction with a graphical user interface situated on the acquisition PC and a dedicated Virgo hand controller.

AI/ML Overview

The provided text describes acceptance criteria and reported device performance for the Virgo Gamma Camera System. The study conducted to prove the device meets these criteria is a non-clinical test following documented verification plans, often adhering to the NEMA Standard NU 1-1994.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specification)	Reported Device Performance (Test Result)
Intrinsic Spatial Resolution, FWHM, UFOV: $\leq \pm 3.7mm$	"All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated)
Spatial Resolution, FWHM, LEGP collimator @ 10cm, Tc-99m: $< 9.2 mm$	"All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated)
Energy Resolution, @Tc-99m: $\leq9.4%$	"All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated)
Spatial Linearity, UFOV: $<\pm 0.5$ mm absolute.	"All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated)
Intrinsic Flood Field Uniformity, UFOV Integral: $< \pm 2.5 %$	"All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated)
Maximum Count rate: $> 180k$ cps with scatter, $> 290k$ cps w/o scatter	"All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated)
Count rate @ 20 % loss: $> 225k$ cps	"All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated)
Detector Background Sensitivity, @180 °, 140 keV: $< 2.0 %$	"The maximum % was calculated according to [missing details, but implies compliance given it's listed as a verified specification]."

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

The provided text describes non-clinical performance testing of the device's physical and technical specifications. It does not involve human subjects or a "test set" in the context of clinical trials or AI/algorithm performance. The provenance of the data is from laboratory testing conducted by the manufacturer, 3D, Danish Diagnostic Development A/S, following recognized standards like NEMA Standard NU 1-1994. No information is given about the country of origin of the data beyond the manufacturer's location (Denmark), or if it's retrospective or prospective, as these terms are not applicable to this type of testing.

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

This information is not applicable to the provided non-clinical performance data. The "ground truth" for these tests is established by physical measurement protocols defined by standards like NEMA, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical measurements against predefined specifications. There is no individual "test set" requiring expert adjudication.

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 or any study involving human readers and AI assistance was not done and is not described in the provided document. This document focuses on the technical specifications and performance of a medical imaging device (Gamma Camera System), not on an AI algorithm for image interpretation.

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

This information is not applicable as the device is a Gamma Camera System, not an AI algorithm. The performance described is of the hardware and integrated software for image acquisition.

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

For the non-clinical tests described, the "ground truth" is based on defined physical standards and measurement protocols (e.g., NEMA Standard NU 1-1994) using test equipment and phantoms, rather than clinical outcomes or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable. The device is a Gamma Camera System, and the described testing is for its inherent physical and technical performance. There is no mention of an algorithm requiring a "training set" in the context of machine learning.

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

This information is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

10 June 2003

1PMN0397-C04

DDD

ADMINISTRATIVE INFORMATION в

B-1 Summary of Safety and Effectiveness Statement

Ref. CFR 807.92 B-1-1

1	Submitted by:	3D, Danish Diagnostic Development A/SDr. Neergaardsvej 5F2970 Horsholm, DenmarkTel: +45 45 768888Fax: +45 45 164659
	Contact person:	Niels SorensenTel: +45 45 768888Fax: +45 45 164659E-mail: nes@3dnm.dk
	Preparation date:	29 April 2003
2	Device Trade Name:	Virgo
	Common Name:	Gamma Camera System
	Classification name:	Emission computed tomography system
3	Predicate Device:	3D, Danish Diagnostic Development A/S, CardioMD
	510(K) Number:	K011611
		3D, Danish Diagnostic Development A/S, Unicorn (K001888)Refer to section C3 Comparison of the New and Predicate Device, subpart;Indications for use statement.
4	Device description:	The Virgo system design comprises a gantry supporting a fixed 90 degreedual head detector and a patient chair. The Virgo system is operated throughinteraction with a graphical user interface situated on the acquisition PC and adedicated Virgo hand controller.
	Functional description:	The patient ascends the chair. When the acquisition setup has been completedon the acquisition PC, preprogrammed motions declines the chair and patientto slanted position and the detectors brought to a predetermined position.
		When a tomography is acquired, the handset is used to position the detector inclose proximity to the patient to enter contour marks to determine the detectororbit for the acquisition.
		For planar imaging, the handset is used to position the detectors.
		When the detectors are in position, the acquisition is started. Duringacquisition, the detector detects gamma photons emitted from the patient. Foreach photon detected, the detector determines the energy and position (two-dimensional) from where the photon originated within the patient. Thedetector corrects for uniformity and linearity errors before sending energy and
DDD		VIRGO 510(K) SUBMISSION
1PMN0397-C04		10 June 2003
	position data to the acquisition PC. The acquisition PC frames the receiveddata into images. Once the acquisition terminates, the resulting images anddata is stored in the acquisition PC database for later reviewing and export viaDICOM to the OEM customer provided processing station.
5	Intended use:	Virgo is an emission computed tomography system intended to detect thelocation and distribution of gamma ray radionuclides in the body and producecross-sectional images through computer reconstruction of the data. Thedevice includes display equipment, patient and equipment supports,component parts, and accessories.Virgo is primarily intended for cardiac applications but the Virgo design alsosupports non-cardiac procedures of the patient's chest region and bodyextremities.Virgo supports radionuclides within the energy range of 60 - 170 keV
6a	Summary of technologicalcharacteristics:	The device has the same technological and functional characteristics as thepredicate device. However, the gantry with patient support device is in designsignificantly different:
	Submitted device: Virgo	Predicate device: CardioMD
	Design:	A gantry base on the floor supports aconsole with electronics and arobotic detector arm. The detectorarm serves as detector support in anunbalanced design.Detector motions for positioning thedetectors and for orbiting thedetectors circularly and non-circularly around the patient isachieved by a combination of:Horizontal translation of theconsole with detector arm anddetector towards the patient.Rotation of the robotic arm withthe detector.Rotation of the detector on therobotic arm.Further the gantry base supports apatient chair in which the patient isseated during acquisition and a standfor the acquisition PC.
		A gantry base on the floor supports atower that holds the detector in anunbalanced design.Detector motions for positioning thedetectors and for orbiting the detectorscircularly and non-circularly aroundthe patient is achieved by acombination of:Horizontal translation of the towerwith the detector towards thepatient.Vertical translation of the detector.Rotation of the detector on thetower.Further the gantry base supports atable console with electronics that actsas support for a patient table on whichthe patient is lying during acquisition.The acquisition PC is located on aseparate rollable PC cart.
	Material:	Painted and cromated iron andaluminum plates and casts.Aluminum plate covers.
		Painted and cromated iron andaluminum plates and casts.Aluminum plate covers.
Energy source:	Mains supply.100 VAC - 240 VAC	Mains supply.100 VAC - 240 VAC
Patient Support:	The patient support comprises a chair mounted on the gantry base in which the patient is seated supine during acquisition.The chair consists of a back pad and a seat pad mounted onto an S-shaped iron frame.The back pad has a cutout towards the detector to enable close detector proximity to small patients.The chair includes a rotate motion capable of tilting the entire chair with patient between upright position (patient load) and a declined scan position about 20 degrees from horizontal.By manual control, the seat of the chair (with patient) can be moved up and down to position the heart of both tall and short patients within the detector field of view.	The patient support comprises a table mounted on the table console on which the patient is lying horizontally supine or prone during acquisition.The table consists of a thin aluminum plate with a mattress. The aluminum table has a cutout towards the detector to enable close detector proximity to small patients.By manual control, the table can be translated manually to position patient's heart within the detector field of view.
Detector:	The two fixed 90 degrees detector heads are mounted into a single copper/ zinc/lead alloy (UNS designation; C94300) casting covered by aluminum plate covers with collision sensors and pads.Each detector comprises a NaI crystal and 24 3" square photomultiplier tubes and electronics for position determination and correction for uniformity and linearity errors. The detector outputs corrected events as energy and position data embedded in an IEEE 1394 Firewire bus to the connected acquisition PC.	The two fixed 90 degrees detector heads are mounted into a single copper/ zinc/lead alloy (UNS designation; C94300) casting covered by aluminum plate covers with collision sensors and pads.Each detector comprises a NaI crystal and 24 3" square photomultiplier tubes and electronics for position determination and correction for uniformity and linearity errors. The detector outputs corrected events as energy and position data embedded in an IEEE 1394 Firewire bus to the connected acquisition PC.
	Software:	The Virgo acquisition station isbased on a Windows PC platformrunning a dedicated acquisitionsoftware package.	The CardioMD acquisition station isbased on a Windows PC platformrunning a dedicated acquisitionsoftware package.
		This software is formed by:	This software is formed by:
		A graphical user interface packageincluding the patient database andDICOM interface	A graphical user interface packageincluding the patient database andDICOM interface
		A camera control package designedfor the purpose of controlling systemsetup, gantry/chair motions andimage framing.	A camera control package designedfor the purpose of controlling systemsetup, gantry/patient table motions andimage framing.
6b	Description of how the nonclinical test results havebeen collected.	In general, all non clinical test results have been collected followingdocumented verification plans. Whenever possible, these plans are followingrelevant and recognized standards and guidelines like the NEMA StandardNU 1-1994. Below is a list of a subset of the more important specificationswith a description of how these test results are collected.
	Intrinsic Spatial Resolution,FWHM, UFOV: $\leq \pm 3.7mm$	Test equipment used, test setup and all calculations have all been performedaccording to the NEMA Standard NU 1-1994.
	Spatial Resolution, FWHM,LEGP collimator @ 10cm,Tc-99m: $< 9.2 mm$	Test equipment used, test setup and all calculations have all been performedaccording to the NEMA Standard NU 1-1994.(section 3.5.3)
	Energy Resolution,@Tc-99m: $\leq9.4%$	Test equipment used, test setup and all calculations have all been performedaccording to the NEMA Standard NU 1-1994.
	Spatial Linearity, UFOV:$<\pm 0.5$ mm absolute.	Test equipment used, test setup and all calculations have all been performedaccording to the NEMA Standard NU 1-1994.
	Intrinsic Flood FieldUniformity, UFOV Integral:$< \pm 2.5 %$	Test equipment used, test setup and all calculations have all been performedaccording to the NEMA Standard NU 1-1994.
	Maximum Count rate:> 180k cps with scatter> 290k cps w/o scatter	Test equipment used, test setup and all calculations have all been performedaccording to the NEMA Standard NU 1-1994.
	Count rate @ 20 % loss.> 225k cps	Test equipment used, test setup and all calculations have all been performedaccording to the NEMA Standard NU 1-1994.
	Detector BackgroundSensitivity, @180 °,140 keV: $< 2.0 %$	The Virgo detector was mounted with a Low Energy General Purposecollimator (LEGP). A 140 keV source in source holder (NEMA standard fig.2-4) was placed 10 cm in front of the collimator. With 20% symmetric energywindow setting the count rate was verified (less than 10 k cps). Moving thesource 360 ° around the Detector in X- and Y direction the position of themaximum count rate was found.	The maximum % was calculated according to

{1}------------------------------------------------

{2}------------------------------------------------

VIRGO 510(K) SUBMISSION

DDD 1PMN0397-C04

10 June 2003

{3}------------------------------------------------

1PMN0397-C04

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Danish Diagnostic Development A/S % Ms. Susan Gill Senior Project Engineer Underwriters Lanoratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K031825 Trade/Device Name: "Virgo" Model 9VIR1200 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: June 12, 2003 Received: June 13, 2003

Dear Ms. Gill:

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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN 2 0 2003

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

1PMN0397-C04

Page

10 June 2003

B-2 FDA Indications for Use Form

Indications for Use Form

510(k) Number (if known): K031825
Device Name: Virgo
Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. KL31825

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.