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The ProTom Radiance 330 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation.

The ProTom Radiance 330® is a medical device designed to produce and deliver a proton beam for the treatment of patients with solid tumors or other diseases susceptible for treatment by radiation. The device includes a method for delivering an accelerated proton beam to the treatment station. The device also includes equipment to position the patient and direct the beam angle.

The system is comprised of six main subsystems that function in tandem to generate the desired dose level and distribution at the target site.

• 1. Beam Production Subsystem. Produces a proton beam at the desired energy level
• 2. Beam Transport Subsystem. Transports the beam from the Beam Production Subsystem to the Beam Delivery Subsystem
• 3. Beam Delivery Subsystem. Monitors and steers the beam to the desired treatment location
• Gantry Subsystem. Mechanically orients the Beam Transport and Beam Delivery Subsystems: providing a means of patient x-ray registration
• 5. Patient Positioning Subsystem. Mechanically orients the patient; provide a separate and means of patient x-ray registration
• Control Subsystem. Synchronizes the various subsystem actions and connects with hospital oncology information systems

This document is a 510(k) summary for the ProTom Radiance 330™ Proton Beam Therapy System. It describes the device, its intended use, and compares it to a previously cleared predicate device (K134052).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it describes various tests performed and concludes that the device functioned as intended and was "substantially equivalent in terms of performance and safety in comparison to the predicate."

Here's a breakdown of the types of performance criteria implied and the general reported outcome:

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

The document describes verification and validation testing of the device and its subsystems. This typically involves engineering tests, simulations, and potentially phantom studies, rather than a clinical "test set" of patient data in the sense of an AI/imaging device.

Therefore:

• Sample Size for Test Set: Not applicable in the context of a "test set" of patient data. The testing described is hardware and software functional and safety testing.
• Data Provenance: Not applicable for patient data. The data provenance would be from internal engineering tests and measurements conducted by the manufacturer, ProTom International Holding Corporation. It's a prospective study in the sense of testing a newly manufactured or modified device.

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

This information is not provided because a "ground truth" derived from expert consensus on patient data (as seen in AI/diagnostic device submissions) is not relevant for the type of device and testing described. The "truth" for this device's performance testing is based on engineering specifications, physical measurements, and compliance with performance standards.

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

Not applicable. This device is a radiation therapy system, not an AI or diagnostic imaging device that requires human expert adjudication of results from a diagnostic 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:

Not applicable. The ProTom Radiance 330™ is a proton beam therapy delivery system. It is a fundamental treatment delivery device, not an AI-assisted diagnostic tool that would involve human readers or analysis of AI's improvement on human performance. The document does not describe any MRMC studies or AI involvement in human interpretation.

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

Not applicable. This is not an algorithm or AI product. It is a medical device for delivering radiation therapy.

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

Not applicable. The "ground truth" for the performance of a radiation therapy device is its ability to accurately and safely produce and deliver a proton beam according to its design specifications and relevant safety standards. This is established through physical measurements, dosimetric evaluations, and engineering tests.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. There is no training set for this device.

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