Search Results

This device is a Positron Emission Tomography (PET) system used to detect and display the distribution of positron emitting radionuclides in parts of the human body that will fit in the patient aperture. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.

The PhotoDetection Systems' NeuroPET is a small aperture positron emission tomography PET scanner that produces images based on the distribution of positron emitting isotopes in parts of the human body that will fit in the patient aperture for medical diagnostic and research purposes. The NeuroPET system consists of three subsystems (shown below); the NeuroPET Ring Gantry/Acquisition System, Patient Table and the Console/PC. The NeuroPET Ring detects coincident gamma pairs emitted from positron annihilation and contains all the data acquisition electronics and reconstruction computers. The Patient Table is used to comfortably position the patient relative to the scanner. The Console/PC provides the operator interface for the system including such functions as system and scan control, reconstruction, data archiving, image viewing, analysis, and network connectivity.

This summary is based on the provided text, and it appears the document is a 510(k) summary for the NeuroPET system. These summaries typically describe the device, its intended use, and substantial equivalence to a predicate device, but often do not include detailed study results, acceptance criteria, or ground truth methodologies in the way explicitly requested in your prompt. Therefore, some of the information you've asked for may not be present in the provided text.

Here's the information that can be extracted:

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

The provided text does not explicitly state acceptance criteria or provide a table of performance metrics for the NeuroPET device. Instead, it concludes "Based on submitted non-clinical and image data consistent with FDA's guidance for PET systems and for devices that include software, the NeuroPET is substantially equivalent in technology, intended use, safety, and effectiveness to the PET imaging component of the Toshiba PCA-8000A/Mark II." This indicates that the device met the requirements to demonstrate substantial equivalence, but the specific quantifiable acceptance criteria and performance data are not detailed in this summary.

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

The document mentions "submitted non-clinical and image data" but does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective.

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)

The document does not provide any information on the number or qualifications of experts used to establish ground truth for a test set.

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

The document does not provide any information on an adjudication method for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The NeuroPET is described as a PET scanner, not specifically an AI-based diagnostic tool for human readers.

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

The document states that the NeuroPET "produces images based on the distribution of positron emitting isotopes" and provides "image viewing, analysis," suggesting it functions as a standalone imaging device. However, it does not explicitly detail a "standalone (algorithm only without human-in-the-loop performance)" study in the context of an AI-driven algorithm. It's a PET system that generates images, which are then interpreted by trained healthcare professionals.

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

The document does not specify the type of ground truth used for any studies.

8. The sample size for the training set

The document does not provide a sample size for a training set.

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

The document does not provide information on how the ground truth for a training set was established.

Ask a specific question about this device