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To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

Portable Dosimeter

This document is a 510(k) clearance letter from the FDA for a device called "Portable Dosimeter". This letter does not contain the detailed technical information such as acceptance criteria, study details, and performance metrics that would be present in a 510(k) summary or the original submission itself.

Therefore,Based on the provided text, I cannot extract the requested information. The document is an FDA clearance letter and does not contain details about:

1. Acceptance criteria and reported device performance: This letter states that the device is "substantially equivalent" to a predicate device, but it does not provide specific performance metrics or acceptance criteria used in the substantial equivalent determination.
2. Sample size used for the test set and data provenance: No study details are included.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No study details are included.
4. Adjudication method for the test set: No study details are included.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No study details are included, and given the nature of a dosimeter, an MRMC study is unlikely to be relevant.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is a hardware device (dosimeter), not an AI algorithm.
7. Type of ground truth used: No study details are included.
8. Sample size for the training set: This is a hardware device; a "training set" in the context of an AI algorithm is not applicable.
9. How the ground truth for the training set was established: Not applicable.

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