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The PEM 2400 PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

The PEM 2400 PET Scanner is a high spatial resolution small field-of-view PET imaging system specifically developed for close-range spot imaging. The PEM 2400 PET Scanner is a partial-ring PET scanner, equipped with lutetiumcontaining gamma-ray detectors, which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. The PEM 2400 PET scanner is designed to collect gamma rays from a patient's body part with high efficiency. In order to achieve this high efficiency, the detectors should be positioned as close as possible to the body part under examination. The PEM 2400 PET Scanner can display images obtained from a digital imaging modality for correlative purposes.

The provided text is a 510(k) summary for the PEM 2400 PET Scanner. This document focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical characteristics and intended use. However, it does not contain the specific details required to answer all sections of the request regarding acceptance criteria and a detailed study report.

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

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

• Cannot be fully answered.
  The document states that "performance data are provided" and that "in-vitro and in-vivo performance testing were conducted in accordance with the 'Guidance for Industry - Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems,' issued by FDA on December 3, 1998." However, it does not explicitly list the acceptance criteria or the reported device performance metrics in a table format, nor does it detail the specific results of these tests. It only concludes that the testing "demonstrates substantial equivalence."

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

• Cannot be answered.
  The document mentions "in-vivo performance testing" but does not provide any details about the sample size (number of patients or scans) in 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)

• Cannot be answered.
  The document does not describe how ground truth was established for any test set or the involvement or qualifications of experts.

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

• Cannot be answered.
  No information is provided regarding adjudication methods for any 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

• Cannot be answered.
  The PEM 2400 PET Scanner is a medical imaging device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device as described.

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

• Not applicable as described in the context of typical AI/CAD devices.
  The PEM 2400 PET Scanner is a physical imaging system. Its "standalone performance" would relate to its physical imaging capabilities (spatial resolution, sensitivity, etc.), which are part of the "in-vitro and in-vivo performance testing" mentioned but not detailed. This question typically pertains to the performance of a diagnostic algorithm independent of human interpretation.

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

• Cannot be answered.
  While "in-vivo performance testing" is mentioned, the document does not specify the type of ground truth used for these tests.

8. The sample size for the training set

• Not applicable / Cannot be answered.
  As a physical PET scanner, the concept of a "training set" in the context of machine learning or AI algorithms is not directly applicable to its performance evaluation for regulatory submission. Its performance is typically demonstrated through physical measurements, phantom studies, and possibly clinical studies with human subjects, not via a machine learning training process.

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

• Not applicable / Cannot be answered.
  Similar to point 8, the concept of a "training set ground truth" is not relevant for the regulatory submission of a physical PET scanner.

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