MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM by MEDX, INC.

The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals.

Device Description

The MEDX NuQuquest™ - InteCam™ SPECT 37-75 System is a Nuclear Medicine Gamma Camera System consisting of:

A modified (remanufactured) Siemens Digitrac™ Orbiter™ . Gamma Camera and its associated Gantry which also was modified to operate with our computer (see bullet below) and software.
NuQuest™ Nuclear Medicine Computer and related . software.
The modification to the Siemens Orbiter Gamma Camera consisted of removal of certain low voltage circuit boards in the gamma camera and the gantry portions of the Siemens" device and installing proprietary low voltage circuit boards that allow the use of our NuQuest™Nuclear Medicine Computer to replace the Siemens computer and related imaging software.
The Detector (Gamma Camera) portion of the system may have 37 or 75 photomultiplier tubes depending on whether the Siemens Digitrac 3700 or 7500 were converted to operate with the MEDX NuQuest Computer and its software.

AI/ML Overview

This is a 510(k) summary for a gamma camera system, which means it evaluates the substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and performance metrics in the context of a de novo study is not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The provided document describes a 510(k) submission, where the primary "acceptance criterion" is substantial equivalence to a predicate device. This is a regulatory pathway, not a performance study against predefined numerical targets.

Acceptance Criteria (Implicit for 510(k)): The device, MEDX NuQuest™ - InteCam™ SPECT 37-75 System, must demonstrate that it is as safe and effective as the predicate device (Siemens Integrated ORBITER™ Gamma Camera System) and has the same intended use. This is achieved by showing that any differences do not raise new questions of safety or effectiveness.
Reported Device Performance: The document does not provide specific performance metrics (e.g., spatial resolution, sensitivity, processing speed) of the MEDX NuQuest™ system in comparison to the predicate. Instead, it focuses on the modifications made to a remanufactured Siemens device and the integration of previously cleared components (NuQuest™ Nuclear Medicine Computer and IM512P imaging software). The implication is that by using a modified version of a Siemens device and cleared components, the performance is at least equivalent.

| Acceptance Criterion (Implicit for 510(k)) | Reported Device "Performance" (via Substantial Equivalence Claim) |
| :------------------------------------------------------ | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Substantially equivalent to predicate device | The MEDX NuQuest™ - InteCam™ SPECT 37-75 System is substantially equivalent to the Siemens Integrated ORBITER™ Gamma Camera System. |
| Same Intended Use and Indications for Use | The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals, which is the same as commonly accepted uses for gamma cameras. |
| Differences do not raise new questions of safety/effectiveness | The device consists of a modified (remanufactured) Siemens Digitrac™ Orbiter™ Gamma Camera (with its gantry) and a previously cleared NuQuest™ Nuclear Medicine Computer (K953255) with previously cleared imaging software (IM512P, K945792). The modification involved replacing low-voltage circuit boards in the Siemens device to operate with the new computer and software. This implies that the core imaging hardware (detector) is a known design, and the modifications are primarily in the control and processing electronics, which are covered by the cleared components. No new safety or effectiveness concerns are indicated. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For a substantial equivalence claim based on modifications to an existing device and integration of pre-cleared components, extensive clinical test sets with patient data are often not required if the changes are deemed non-significant to safety and effectiveness. The focus would typically be on technical verification and validation, possibly using phantom studies, rather than a clinical dataset for performance evaluation against ground truth.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as a formal clinical study with a ground truth assessment by experts for a test set is not described in this 510(k) summary.

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

This information is not provided as a formal clinical study with adjudication is not described.

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

An MRMC comparative effectiveness study is not mentioned and would not typically be performed for a 510(k) submission for a gamma camera system claiming substantial equivalence, especially one based on modifications and integration of pre-cleared components. This device is a primary imaging acquisition and processing system, not an AI-assisted diagnostic tool.

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

This device itself is the "standalone" imaging system. While it has algorithms for image processing and analysis (as indicated by the "processing, display and analysis" function and the cleared IM512P software), the 510(k) does not detail specific algorithm performance studies or metrics as it focuses on the substantial equivalence of the overall system.

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

Since a specific clinical performance study against ground truth is not described, this information is not provided. The ground truth for proving substantial equivalence usually revolves around technical specifications and engineering validation of the modified components and integrated system to ensure they perform equivalently to the predicate and comply with relevant standards.

8. The sample size for the training set

This information is not provided. The device is a gamma camera system, and while it uses software and processing, it's not described as a machine learning/AI classification algorithm that would require a "training set" in the common sense of AI development for diagnostic tasks. The software it uses (IM512P) was previously cleared, indicating its development and validation occurred prior to this submission.

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

This information is not provided as no training set (in the AI/ML context) is described for this specific 510(k) submission.

Summary

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K041840

AUG 2 0 2004

510(k) SUMMARY

Submitted by:	MEDX, Incorporated3456 N. Ridge Ave. #100Arlington Height, IL 60004
Telephone:	(847)-463-2020
Fax:	(847)-463-2019
Contact Person:	Floyd R. Rowan, ExecutiveVice President
Date Summary Prepared:	July 6, 2004
Trade Name of Device:	MEDX NuQuest™ - InteCam™SPECT 37-75 System.
Common Name	Gamma Camera System.
Classification:	This device is classified as aClass II Device. Radiology PanelClassification Name: System,Tomography, Computed, Emis-sion. Ref. 21CFR892.1200,Product Code: KPS.
Substantial Equivalence:	The MEDX NuQuest - InteCamSPECT 37-75 is substantiallyequivalent to the Siemens Inte-grated ORBITER™ GammaCamera System.

Intended Use:

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Description of Device:

The MEDX NuQuquest™ - InteCam™ SPECT 37-75 System is a Nuclear Medicine Gamma Camera System consisting of:

A modified (remanufactured) Siemens Digitrac™ Orbiter™ . Gamma Camera and its associated Gantry which also was modified to operate with our computer (see bullet below) and software.
NuQuest™ Nuclear Medicine Computer and related . software.

The modification to the Siemens Orbiter Gamma Camera consisted of removal of certain low voltage circuit boards in the gamma camera and the gantry portions of the Siemens" device and installing proprietary low voltage circuit boards that allow the use of our NuQuest™Nuclear Medicine Computer to replace the Siemens computer and related imaging software.

The Detector (Gamma Camera) portion of the system may have 37 or 75 photomultiplier tubes depending on whether the Siemens Digitrac 3700 or 7500 were converted to operate with the MEDX NuQuest Computer and its software.

It should be pointed out that the NuQuest Nuclear Medicine Computer has a cleared 510(k): K953255.The imaging software (under the trade name IM512P) also has a cleared 510(k): K945792.

Note: Digitrac and Orbiter are registered trademarks of Siemens Gammasonic, Inc.

Scientific Principle:

Diagnostic Nuclear Medicine began in early 1950's with the availability of short half-life isotopes. Isotopes such as 1131 were injected into the patient and were selectively taken up by organ systems such as the thyroid. Measurement of the resulting radioactivity in the organ provided information on both the size of the organ and the relative amount of the isotope taken up.

Nuclear Medicine cameras work on the principle similar to television cameras. A collimator (lens) "focuses" gamma rays on a scintillation crystal. The scintillation crystal converts gamma rays into light. Photomultiplier tubes are then used to convert the light into electrical signal proportional to the energy of the detected gamma ray.

Early instruments used a single hole lead collimator and detector that was moved in a raster pattern forming a 2-D image of the organ of interest. In the late 1950's

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methods were developed for directly obtaining a 2-D image by using a large crystal with multiple photomultiplier tubes and electronically calculating the position and energy of the gamma event. Two dimensional projections collected position and onergy of be mathematically combined to yield a three dimensional representation of the data. This principle of tomographic reconstruction was roproovered early in this century, but it was not until the advent of high speed computer that the technique could be successfully applied in diagnostic imaging first to CT then to Nuclear Medicine and MRI.

Nuclear Medicine is currently of great interest because of its high contrast, and relatively low cost per study. The ability to attach isotopes to substances that are rolarroly taken up by specific tissue types can provide very high contrast by the organ of interest and the surrounding tissue. This has tended to compensate for the relatively poor spatial resolution of Nuclear Medicine compared to other modalities such as MRI.

In addition the uptake and clearing of the radioisotopes can be observed temporally, providing an indication of the biological activity of the tissue. This is important when attempting to determine tissue viability, or finding areas of abnormal activity such as cancerous tissue.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2004

Mr. Floyd R. Rowan Executive Vice President MEDX. Inc. 3456 N. Ridge Ave., #100 ARLINGTON HTS II_ 60004

Re: K041840

K041840
Trade/Device Name: MEDX NuQuest™ – InteCam™ SPECT 37-75 System Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: July 7, 2004 Received: July 8, 2004

Dear Mr. Rowan:

We have reviewed your Section 510(k) premarket not intent to market the device
tion indication We have reviewed your Section 510(x) jirchitet is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave decembled the devices marketed pressmanteted in interstate for use stated in the enclosure) to regally interest and calcul Device Americal Device Americal Food Drug commerce prior to May 28, 1976, the enactitions of the Federal Food, Drug, devices that have been reclassified in accordance with use and over oval application (PMA).
and Cosmetic Act (Act) that do not required and seasonal sensions of the Act. The and Cosmetic Act (Act) that do not require approvate or a provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general concertirent i You may, therefore, market the device, subject of the general vegistration, listing of
general controls provisions of the Act include requirements for annual management general controls provisions of the Act mende requirements of the samst misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), (1 If your device is classified (sec above) in the major regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affectiv if may be subject to additions. Title 21, Parts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Farts 800 to 898. In addition, FDA may found in the Code of Federal Regulations, Free Beyeve in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determiration aos not mean Please be advised that TDA s issualice of a subslies with other requirements of the Act
that FDA has made a determination that your device addressing - You must that FDA has made a determination that your device or other Federal agencies. You must or any Federal statutes and regulations and to red limited to: registration and listing comply with all the Act s requirements metuding, good manufacturing practice requirements as sch
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice th (2) CFR Part 807); labellig (21 CFR Pair 800); good natif applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 21 CFR 1000-1050 forth in the quality systems (Q5) regulation (21 Of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Scetten $10(k). This letter will allow you to begin national equivalence of your device of your device to alle;ally
prematicet notification - The FDA finding of substant the species to this, premarket notification - The FIDA finding of substantial cours and this, permits your devito proceed to the market

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our faction of the regulation of
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 advectising of your device, please contact the Additionally, for questions on the promotion and an realled, "Misbranding
Office of Compliance at (30) 594-4639. Also, please note the regulation entitled, "Mislor general Office of Compliance at (301) Sylant (2017) Part 807.97 you may obtain. Other general
by reference to premarket notification" (21CPR Part he obtained from the Division of Sm by reference to premarket notheration' (21CA Far 801779) your drom the Division of Small
information on your responsibilities under the Act may be obtained from the Division information on your responsibilities under the Act they of the number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fires mann huml. Manufacturers, International and Consumer Assistance at to tor 2011
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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Indications for Use

510(k) Number (if known):

K 041840

Device Name:

MEDX NuQuest™- InteCam™ SPECT 37-75 System

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Harrison

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number

Page 1 of /

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.