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"This device is intended to be used for diagnostic imaging of organs and lesions."

The Prism XPVT system is a new gantry for a gamma camera system. This device includes adding hardware and software to a gamma camera system.

This 510(k) premarket notification for the PICKER INTERNATIONAL PRISM XPVT SYSTEM does not contain the detailed information required to answer the prompt.

Here's why and what's missing:

• Acceptance Criteria and Reported Device Performance: The document states, "Laboratory tests will be run to validate the image quality performance of the system. The product will perform in accordance with the development specifications." However, it does not provide what those specifications are (i.e., the acceptance criteria) nor does it report the results of those tests (i.e., the actual device performance metrics). A table like the one requested cannot be constructed from this information.

• Study That Proves the Device Meets the Acceptance Criteria: The document mentions "Laboratory tests" and "an investigation as to the causes of safety and effectiveness." However, it does not describe a clinical study or a technical performance study with the level of detail asked for in the prompt.

Specifically, the following information fields from your request are not available in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance data are listed.
2. Sample size used for the test set and the data provenance: No test set or data provenance details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment for a test set.
4. Adjudication method for the test set: No test set or adjudication method mentioned.
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: No MRMC study is mentioned, and the device is a gantry for a gamma camera, not explicitly an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study is indicated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth type is specified.
8. The sample size for the training set: No training set is mentioned (as this is not an AI/ML device in the modern sense described in the prompt).
9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned in the context of an AI/ML device.

Conclusion:

The provided 510(k) notice focuses on establishing substantial equivalence to a predicate device based on functional specifications and safety standards, rather than detailing a performance study with specific acceptance criteria and outcome metrics as would be expected for an AI/ML-driven device or a device requiring detailed clinical performance validation. It mainly states that the device is a new gantry for a gamma camera, and its performance will be validated according to internal specifications.

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