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ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The ProBeam 360° Proton Therapy System v2.0 (Multiroom) is designed to deliver radiation treatment in accordance with the physician's prescribed treatment plan. Proton radiation therapy takes advantage of the Bragg peak characteristic of proton attenuation to minimize radiation of normal tissue outside the target volume. Varian markets two lines of proton therapy systems, the standard ProBeam Proton Therapy Systems and the smaller, newer ProBeam 360° Systems. The ProBeam 360° Proton Therapy System line of proton systems includes single-room (cleared in K221791) and multi-room configurations. The ProBeam 360° System Multiroom (subject device) introduces the multi-room, compact configuration and includes the following primary components: Cyclotron (226MeV), Beam Transport System (energy selection system and beam transport system), Two (2) to five (5) Treatment Rooms: Rotating Isocentric Gantry room with attached scanning nozzle; and a treatment table, One Treatment Control Room for each treatment room within the chosen configuration.

The provided FDA 510(k) summary for the ProBeam 360° Proton Therapy System v2.0 (Multiroom) does not include specific acceptance criteria and detailed study results in the manner requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ProBeam 360° Proton Therapy System v1.0, K221791) and a reference device (ProBeam Proton Therapy System v2.0, K133191). The study described is a design verification and validation process, rather than a clinical trial or performance study with defined statistically-based acceptance criteria against a specific benchmark.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

Acceptance Criteria and Device Performance Study for ProBeam 360° Proton Therapy System v2.0 (Multiroom)

The ProBeam 360° Proton Therapy System v2.0 (Multiroom) primarily underwent design verification and validation testing to demonstrate that it performs as intended and meets its essential performance, confirming its substantial equivalence to previously cleared devices. The document does not specify quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) typically associated with medical device studies, nor does it provide a table of measured device performance against such criteria. The "performance" described is in the context of functionality and safety.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. The testing described is non-clinical design verification and validation testing of the system components and software. This typically involves engineering tests, simulations, and hardware/software testing rather than patient data. Therefore, details regarding country of origin or retrospective/prospective nature are not applicable to the described non-clinical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. As the described testing is non-clinical design verification and validation, the concept of "ground truth" as established by experts (e.g., clinicians) in the context of diagnostic accuracy or treatment efficacy is not directly relevant. The "ground truth" for these engineering tests would be the design specifications and expected functional behavior, which are internally verified by the manufacturer's engineers.

4. Adjudication Method for the Test Set

This information is not provided in the document. The adjudication method (e.g., 2+1, 3+1) is typically used in studies where human readers independently assess cases, and their discrepancies are resolved. This is not applicable to the non-clinical design verification and validation testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, or at least not described in this 510(k) summary. The submission explicitly states: "No animal studies or clinical tests have been included in this submission." This type of study would involve human readers (possibly with and without AI assistance) evaluating clinical cases, which is not what was conducted for this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm in a clinical context (e.g., diagnostic accuracy for a specific disease) was not performed, or at least not described in this 510(k) summary. The device described is a proton therapy system, not typically a diagnostic AI algorithm. While software is a component, its performance testing is framed within system functionality and safety, not as an isolated algorithm performance study against clinical ground truth.

7. Type of Ground Truth Used

The ground truth for the non-clinical design verification and validation testing would be the engineering specifications, design requirements, and recognized industry standards (e.g., electrical safety, electromagnetic compatibility). These are validated through a series of tests to ensure the device performs according to its design and regulatory requirements. Clinical ground truth (e.g., pathology, outcomes data) was not used, as no clinical studies were submitted.

8. Sample Size for the Training Set

This information is not applicable/not provided. The document describes a medical device (proton therapy system), not an AI model that requires a "training set" of data in the typical machine learning sense. The software development follows a lifecycle process (IEC 62304) and involves verification and validation, but not training on a dataset of clinical cases.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided, for the same reason as in point 8. No "training set" in the context of machine learning was used or described.

In summary: The provided document is an FDA 510(k) summary for a hardware-based medical device (a proton therapy system) with associated software. The "study" it describes is the design verification and validation process to demonstrate the device's safety and effectiveness compared to existing, cleared devices, rather than a clinical performance study with specific quantitative acceptance criteria and clinical outcome measures.

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