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The Model 1203 WaterProof PROFILER is intended for radiotherapy dosimetry measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.

The WaterProof PROFILER, model 1203, is a linear array of radiation detectors that are housed in a water proof enclosure that mounts to the 3D SCANNER's movement mechanisms. The electronics in the array measures charge produced in the detectors due to ionizing radiation. The WaterProof PROFILER provides measurement updates to the 3D SCANNER. The 3D SCANNER correlates the dose information with motor position information and transfers the data to a computer running SNC Dosimetry. SNC Dosimetry then provides a graphical user interface for viewing the measured dose distributions and its parameter analysis; it also provides a tool for exporting the data to treatment planning systems.

The WaterProof PROFILER includes five components:

1. a linear array of radiation detectors;
2. a water proof enclosure;
3. a means for connecting to the 3D SCANNER's movement mechanisms;
4. control electronics and embedded code to manage and transmit the data recorded from the radiation detectors;
5. a cable that connects the water proof enclosure to the 3D SCANNER

This document is a 510(k) premarket notification for the Sun Nuclear Corporation Model 1203 - WaterProof Profiler. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than a typical clinical study with acceptance criteria for a diagnostic algorithm. Therefore, many of the requested fields are not directly applicable.

However, I can extract the information provided about the device's technical specifications and the comparison made for demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

This document describes technical characteristics and a comparison against predicate devices, but it does not specify explicit "acceptance criteria" in the sense of performance metrics with thresholds (e.g., sensitivity, specificity, accuracy for a diagnostic algorithm). Instead, the performance evaluation for this device, a radiotherapy dosimetry measurement tool, focuses on its ability to perform its intended measurements and its compliance with relevant standards.

The table below summarizes the key performance specifications of the Model 1203 WaterProof PROFILER compared to its predicate devices, as presented in the document. The "acceptance criteria" here are implied by the ability to function as intended and similarity to predicate devices.

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

The document does not describe a "test set" in the context of clinical data for an AI/diagnostic algorithm. The device is a physical measurement tool.

• Test Set Description: The "performance data" refers to bench testing of the physical device.
• Sample Size: Not applicable in the traditional sense of a patient cohort. The testing involves the device itself and its components.
• Data Provenance: The testing was conducted by Sun Nuclear Corporation as part of the device's design and verification process. Specific country of origin for the data is not mentioned beyond the manufacturing location. The testing is assumed to be prospective as it's part of the device's development and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is not a diagnostic device relying on expert interpretation for ground truth. Ground truth for dosimetry measurements would typically involve established physics principles, reference detectors, and phantoms.

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or adjudication described for the device's performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a physical dosimetry measurement tool, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a "standalone" measurement tool. Its performance was evaluated through "bench testing" to ensure it met design specifications and correlated with predicate devices. This is analogous to a standalone performance evaluation for a physical device.

7. The Type of Ground Truth Used

The "ground truth" for evaluating this device would be established physical dosimetry standards, reference measurement devices, and known radiation fields. The document states: "Tests that compare known static and dynamic fields required during treatment planning system commissioning have been performed." This implies that the device's measurements were compared against these "known" or established values.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware measurement tool, not a machine learning algorithm that requires a training set of data.

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

Not applicable. As explained above, there is no training set mentioned in the context of this device.

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