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Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). The system includes functions for imaging, target and non-target delineation, beam planning, verification and quality assurance. An earlier version of the software was known as "OptiRad" (K993895). In addition to forward planning, users who have the Intensity Modulated Radiation Treatment (IMRT) module can perform inverse planning.

The provided text does not contain specific acceptance criteria or an analytical study proving the device meets them. Instead, it is a 510(k) summary for a medical device (Odyssey radiation treatment planning system) and related FDA correspondence.

Based on the document, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics. The summary focuses on equivalence to predicate devices.
• Reported Device Performance: Not presented as quantitative performance metrics. The document states a general conclusion: "Odyssey is as safe, as effective, and is substantially equivalent to the legally marketed predicate devices."

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not applicable. No clinical testing was required or performed for this 510(k) submission.
• Data Provenance: Not applicable. No test set was used for clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. No test set requiring expert ground truth was used for clinical evaluation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. No test set requiring adjudication was used.

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:

• MRMC Study: No. The document explicitly states: "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of Odyssey." This implies no human reader studies were conducted.
• Effect Size: Not applicable.

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

• Standalone Study: No standalone clinical performance study was conducted. The "Summary of Non-Clinical Testing" mentions "Verification and Validation" and "Hazard Analysis and Failure Modes and Effects Analysis" were completed, demonstrating the device to be safe and effective, but these are typically internal engineering and software validation activities, not a standalone clinical performance study.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable for clinical performance. For the described non-clinical verification and validation, ground truth would be based on engineering specifications, known algorithmic outputs, and safety standards.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. The device is a "Radiation Treatment Planning System" which uses algorithms to compute estimated radiation doses. It's not described as an AI/ML device that requires a training set in the contemporary sense. Its functionality is based on established physics algorithms, not learned patterns from data.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set. The algorithms would be based on well-established mathematical and physical models.

In summary, the document states that:

• Clinical testing was not required for the Odyssey device to demonstrate substantial equivalence.
• The device contains no technological characteristics not already present in its predicate devices (ADAC P3MRT and OptiRad).
• Non-clinical Verification and Validation, along with Hazard Analysis and FMEA, were performed to demonstrate safety and effectiveness.

This submission relies on substantial equivalence to predicate devices and internal verification, rather than clinical performance studies with specific acceptance criteria and ground truth.

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