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Scannerside Dose check is intended for providing Computed Tomographic (CT) Dose Check feature to CT X-ray systems. The Scannerside Dose Check is specifically indicated for providing the Computed Tomography Dose Check feature with notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose is above a predefined threshold. This device is intended for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.

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This document is an FDA 510(k) clearance letter for a device called "ScannerSide DoseCheck." It doesn't contain information about the device's technical specifications, acceptance criteria, or the study conducted to prove it meets those criteria. The letter primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe acceptance criteria, nor does it detail a study proving device performance against such criteria. It's a regulatory clearance, not a technical performance report.

To answer your request, I would need a document from Right Dose Inc. (the manufacturer) that details their V&V (Verification and Validation) study for the ScannerSide DoseCheck device, including the testing methodology, acceptance criteria, and study results.

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Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.

DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS). DoseCHECK utilizes the DICOM RT Plan, RT Structure Set, and CT Image Set from the TPS as inputs for the calculation, along with a linear accelerator characterization and CT-to-ED curve. The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check. This comparison allows for detection of errors or inaccuracies that may occur within the TPS such as with beam modeling, calculation algorithm, and inhomogeneities.

The provided text describes the regulatory clearance for the device "Model 1217028 DoseCHECK" which is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose. However, the document provided does not contain detailed information about specific acceptance criteria, a comprehensive study proving the device meets those criteria, or the methodology (sample size, ground truth establishment, expert qualifications, adjudication, training set details) typically found in a clinical performance study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Mobius3D) through performance data from "appropriate bench testing methods."

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

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

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

• Adjudication method: Not specified.

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. This device is a software for independent dose calculation, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement is not applicable in this context.

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

• Standalone Performance: Yes, the essence of the device's function is standalone dose calculation. The document states: "DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS)." and "The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check." This implies the algorithm performs its calculation independently. The "bench testing methods" would assess this standalone performance against typically accepted benchmarks or the predicate device.

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

• Type of Ground Truth: Not explicitly stated. For a dose calculation software, the "ground truth" would likely be a highly accurate or gold-standard dose calculation result, possibly from a very sophisticated and validated calculation engine, or physical dosimetry measurements in phantoms. The comparison is stated as being to the "TPS dose distribution," implying the TPS result is the primary reference for the check, but the device aims to provide an independent check, suggesting it performs its own calculation to a certain expected accuracy. The document mentions "beam modeling, calculation algorithm, and inhomogeneities" as areas where errors might occur in the TPS, which DoseCHECK is designed to detect, implying DoseCHECK has its own accurate model.

8. The sample size for the training set

• Sample Size: Not specified. The document does not mention "training" in the context of machine learning, as this is a physics-based calculation software. It uses "linear accelerator characterization and CT-to-ED curve" as inputs, which are configuration data rather than a "training set" in the AI/ML sense.

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

• Ground Truth Establishment for Training Set: Not applicable, as there's no mention of a training set in the machine learning sense. The device utilizes pre-characterized parameters (e.g., linear accelerator characterization, CT-to-ED curve) for its calculations.

Summary of Missing Information:

The provided document, being a 510(k) summary, focuses on substantial equivalence. It lacks the granular detail about specific performance metrics, the number of cases/patients in test sets, the methodologies for establishing ground truth (other than implicitly comparing to TPS or a "predicate device"), and expert involvement that would be needed to fully answer the detailed questions about acceptance criteria and study particulars. The "bench testing methods" are mentioned but not elaborated upon.

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