Search Results

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 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.

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

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.

Ask a specific question about this device