QUEST PET IMAGING SYSTEM by UGM MEDICAL SYSTEMS, INC.

The Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true volumetric imaging. Quest is intended for use as a diagnostic imaging device. When used with appropriate radiopharmaceuticals, it produces images representative of the internal distribution of radioactivity in the head or the body. The system allows you to reconstruct high-resolution three-dimensional, static, gated or dynamic images of biochemical and metabolic processes and then enables you to display, process and analyze these images according to your specific needs.

PET is based on the fact that certain radionuclides decay by positron emission. The positron annihilation results in the emission of two 511 keV gamma-rays which are emitted in opposite directions. Coincidence detection of both gamma rays localizes the decay along a line. By using 6 large position-sensitive detectors around the patient, counts along many parallel lines and at many angles are acquired simultaneously. By using reconstruction algorithms, the internal distribution of radioactivity can be determined.

The scanner provides a 25 cm axial field of view for whole-organ coverage, as well as a 50 cm transverse scan field of view for body studies.

The Ouest uses 6 rectangular NaI(Tl) scintillation crystals, each of which is coupled to 48 photomultipliers (PMTs). 42 of the (PMTs) are 2.5 inch diameter round arranged in a close packed hexagonal pattern, and the remaining six are half-hex (PMTs) positioned at the edges to fill out the rectangular crystal area. The detector separation is 85 cm.

AI/ML Overview

The provided document describes a 510(k) submission for the Quest 300H PET system, indicating improvements to an already approved device. However, this document does not contain information about specific acceptance criteria, performance metrics, or a study designed to prove the device meets those criteria.

The document primarily focuses on:

Identifying the submitter and device.
Describing the device and its intended use.
Listing numerous modifications and improvements made to the original Quest 300H, such as enhanced safety, improved patient data documentation, whole-body scanning, additional reconstruction methods, image registration, improved attenuation correction, and physical design changes (e.g., larger patient aperture).
A letter from the FDA confirming substantial equivalence to a predicate device.

Missing from this submission is the detailed performance data, study design, and acceptance criteria normally found in a clinical or performance validation study report. The improvements described are often qualitative (e.g., "improved patient safety," "better quality images") rather than quantitative against pre-defined acceptance thresholds.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Acceptance Criteria	Reported Device Performance
Not stated in the document.	The document describes improvements but does not provide specific quantitative performance metrics against pre-defined acceptance criteria. For example, it mentions "better quality (i.e. statistically more accurate) images" but does not give a numerical acceptance value or measured performance.

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

Sample size: Not stated.
Data provenance: Not stated.

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)

Not stated. The document focuses on the technical specifications and improvements of the PET scanner itself, not on diagnostic accuracy studies involving human readers or ground truth establishment.

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

Not applicable as no such study is 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

Not applicable. This device is a PET scanner, not an AI-assisted diagnostic tool.

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

Not applicable in the context of diagnostic performance of an algorithm. The device itself is a standalone imaging system.

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

Not applicable as no specific diagnostic performance study involving ground truth is described.

8. The sample size for the training set

Not applicable. This document is about a hardware PET scanner and its software functionalities, not a machine learning model that would require a "training set" in the conventional sense.

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

Not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) summary focused on demonstrating the substantial equivalence of an improved PET scanner to its predicate device by detailing technical modifications. It does not include the type of performance study data you are seeking, which would typically involve clinical or phantom studies with specific endpoints and acceptance criteria.

Summary

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Medical Systems Inc.

1 Market Street. Philadelphia. PA 19104 · (215) 222-4999 · Fax (215) 222-

מחילות משחק המועד למערכת המועד למעשה משפחת המועד המועד למעשה המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המוש

510(k) SUMMARY

1) Submitter:	UGM Medical Systems
	3611 Market Street
	Philadelphia, PA 19104
Contact person:	Gerd Muehllehner
Date of Summary:	September 25, 1997

JAN 21 1998

2) Name of device:	Quest 300H
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Introduction
1. 1 Background
2. 2 Objectives
3. 3 Scope
Literature Review
1. 1 Related Work
2. 2 Existing Systems
Methodology
1. 1 Data Collection
2. 2 Data Preprocessing
3. 3 Model Development
Results and Discussion
1. 1 Performance Metrics
2. 2 Comparative Analysis
Conclusion and Future Work
1. 1 Summary of Findings
2. 2 Limitations
3. 3 Future Directions

Positron emission tomograph Common name: Classification name: Emission Computed Tomography System
PENN-PET Scanner 3) Equivalence: UGM Medical Systems Manufacturer: 510(k) Number: K930428

Description of Device:

The scanner provides a 25 cm axial field of view for whole-organ coverage, as well as a 50 cm transverse scan field of view for body studies.

5) Intended Use:

Quest is intended for use as a diagnostic imaging device. When used with appropriate radiopharmaceuticals, it produces images representative of the internal distribution of radioactivity in the head or the body.

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Comparison to predicate device:

The Quest 300H has been improved and this applications represents a submission of the changes relative to the version of the Quest 300H which has been previously approved.

The following is a list of modification.

a) Improved patient safety. Since the original submission in 1993, we have obtained compliance to the UL standard, the European IEC standard and, when we ship to Europe, obtain CE certification. This has raised the level of patient safety through a variety of small changes.

b) Improved patient data documentation. All programs which display patient images now show the patient's name, the filename, and date of image acquisition. This reduces the risk of misidentification of filmed or printed images.

c) Improved User's Manual. The manual has been expanded significantly and now contains chapters describing the equipment in an overview, contains a chapter on safety, and shows examples of the display on the screen.

d) Whole-body scanning. A whole body scanning mode has been implemented in which the patient is moved axially into or out of the scanner after each frame of data collection. The user is prompted to perform the motion and must depress a button during motion for safety. The images are reconstructed into a single data set which can be viewed as transverse, sagittal and/or coronal images.

e) Additional reconstruction filters and methods. Since 1993 we have improved the reconstruction program by adding several new filters and by including an iterative reconstruction algorithm (OSEM).

f) Image registration & importation of CT/MRI images. In order to help physicians correlate information from PET scans with CT and/or MRI scans, we can now import images from other medical imaging equipment using the DICOM standard. These images can then be displayed either next to or superimposed onto the PET images.

g) Improved method of attenuation correction. The present method of performing attenuation correction uses a Ge-68/Ga-68 source for measurement of the attenuation coefficients. By using Cs-137 instead of Ge-68/Ga-68 and detecting the single gamma-rays of Cs-137 (662 keV) instead of measuring the Ga-68 emissions in coincidence, we can acquire data at a higher data rate and therefore obtain better quality (i.e. statistically more accurate) images in a shorter time.

h) Segmentation of transmission images. The process of segmentation consists of identifying and differentiating between lung, tissue and background. Since the attenuation values in the transmission images are significantly different between these three compartments, the software can identify them and then assign a constant value to each. This process reduces the statistical fluctuations significantly and further improves the attenuation corrected emission images.

i) Curved detectors. We plan to replace the flat detectors with curved detectors in order to improve the spatial resolution for brain imaging.

i) Larger patient aperture. At the present time the patient aperture is 50 cm, which eliminates only very few patients, but which means that approximately 5% of all patients

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need to squeeze into the opening. By enlarging the patient aperture to 56 cm, we make it easier to introduce patients into the scanner.

k) Re-packaging of components. The printed circuit boards necessary to perform the data acquisition have been reduced in size and number to the point that all the electronics can now be packaged inside the scanner itself and does not require a separate electronics cabinet anymore.

l) Improved countrate performance. We have been able to improve the countrate performance by incorporating more processing power into the redesigned electronics. This has been achieved by using better timing discriminators, allowing us to detect coincidence events more accurately and by processing events occurring in different locations and in different detectors in parallel.

All the above changes are improvements to the existing PET scanner without altering its function.

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Image /page/3/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1998

Gerd Muehllehner, Ph.D. President UGM Medical Systems, Inc. 3611 Market Street Philadelphia, PA 19104

Re: K973396

Sentry PET Imaging System Dated: December 5, 1997 Received: December 8, 1997 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Dr. Muehllehner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the includes for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

W. liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973396

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true volumetric imaging.

.:::

PET is based on the fact that certain radionuclides decay by positron emission. The positron annihilation results in the emission of two 511 keV gammarays which are emitted in opposite directions. Coincidence detection of both gamma rays localizes the decay along a line. By using 6 large position-sensitive detectors around the patient, counts along many parallel lines and at many angles are acquired simultaneously. By using reconstruction algorithms, the internal distribution of radioactivity can be determined.

(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)

Over-The-Counter Use	__________
	(Optional Format 1-2-96)

Signature

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological DevicesRadiological Devices
510(k) Number K973396

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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.