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Model 1220-MR ArcCHECK-MR is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

Model 1220-MR ArcCHECK-MR is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array.

The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220-MR ArcCHECK-MR by an 8 pin DIN cable and is unchanged from the K142617 predicate device.

This submission introduces Model 1220-MR ArcCHECK-MR. This model is equivalent in form and function to the cleared Model 1220, but has been verified as an MR-conditional product.

The provided document is a 510(k) summary for the ArcCHECK-MR device, which is an ionizing radiation measurement device for radiotherapy quality assurance. It focuses on demonstrating substantial equivalence to a predicate device (ArcCHECK) rather than providing detailed acceptance criteria and a comprehensive study report for the device's performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K142617 Model 1220 ArcCHECK device."

The primary change to the device is its MR-conditional status, achieved through material changes (stainless steel hardware instead of carbon steel). The equivalence is based on the subject device performing "as well as" the predicate.

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

The document states that the device was "tested using appropriate bench testing methods." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This is typically detailed in a full test report, not a 510(k) summary.

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

The document does not provide information regarding experts used to establish ground truth or their qualifications. The testing appears to be primarily bench testing for functionality and MR compatibility, not a clinical study involving human interpretation.

4. Adjudication method for the test set

The document does not provide information regarding an adjudication method. This is not typically relevant for bench testing of a radiation measurement device.

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

No MRMC study was performed or mentioned. The device is a "three-dimensional (3D) ionizing radiation measurement device" for quality assurance, not an AI-powered diagnostic tool for human readers.

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

The device itself is a measurement tool; its performance is inherently "standalone" in the sense that it collects radiation data. The "SNC Patient" software processes this data. The document states that "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate..." indicating standalone performance testing was conducted, but details of this standalone testing (metrics, full results) are not provided.

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

For a radiation measurement device, the "ground truth" would likely be based on established physics principles and validated reference dosimetry measurements from calibrated instruments or computational models. The document does not explicitly state the type of ground truth but implies it through "bench testing methods" and comparison to a predicate device's established performance.

8. The sample size for the training set

The device is a hardware measurement device with associated software. It does not appear to be an AI/machine learning model that requires a "training set" in the conventional sense. The "SNC Patient" software is described as "unchanged from the K142617 predicate device," suggesting its algorithms are already developed and validated.

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

As there is no indication of an AI/machine learning training set, this information is not applicable/provided.

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ArcCHECK, Model 1220 is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

ArcCHECK, Model 1220 is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array.

The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220 ArcCHECK by an 8 pin DIN cable, includes the following functions:

• . Array and dose calibration.
• Measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan.
• . Save measurements.
• Import treatment plan dose map in the phantom and compares with the measurement dose points.
• . Compare the measured and planned dose distribution using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria.
• Report of the analysis including a percent pass rate. ●
• Perform quality assurance (QA) on the planned versus delivered multi leaf ● collimator (MLC) pattern as a function of time. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf.

This submission introduces a 'primary' software modification to the cleared Model 1220 ArcCHECK device (K131466). Sun Nuclear intends to introduce a software feature which allows for the user to perform quality assurance (QA) on the planned versus delivered Multi Leaf Collimator (MLC) pattern. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf. This 'primary' modification which is believed to affect the indications for use, but not the intended use, is the subject of this premarket notification.

I am sorry, but the provided text is a 510(k) summary for a medical device (ArcCHECK Model 1220 from Sun Nuclear Corporation) and does not contain the specific information required to answer your request regarding acceptance criteria and a study that proves the device meets those criteria.

The document focuses on:

• Regulatory classification and predicate device information.
• Description and intended use of the device.
• Technological characteristics.
• A general statement about performance data and comparison with the predicate device.

It explicitly states: "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K131466 ArcCHECK device." However, it does not provide a table of acceptance criteria, reported performance, details of a specific study, sample sizes, data provenance, expert qualifications, adjudication methods, or specific ground truth information.

Therefore, I cannot extract the requested information from this document.

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Model 1177 MapCHECK 2 is a two-dimensional (2D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

ArcCHECK, Model 1220 is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

The Model 1177 MapCHECK 2 and Model 1220 ArcCHECK devices are diode detector arrays that allow the user to perform radiation therapy delivery quality assurance (QA) and dosimetry.

The MapCHECK 2 is a two-dimensional detector array intended to measure radiation dose distribution. The 1527 diode detectors are embedded in polymethyl methacrylate (PMMA) phantom in an array size of 32 cm, with a detector spacing of 7.07 mm and a weight of 7.1 kg. With the provided software installed on the user's computer and connected to the MapCHECK 2 with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.

The ArcCHECK is a three-dimensional cylindrical detector array designed for coherent measurement geometry during rotational treatment delivery. The 1386 diode detectors are embedded in a PMMA phantom on a cylindrical geometric surface with an array size of 21 cm diameter x 21 cm length, with a detector spacing of 10 mm and a weight of 16 kg. This cylindrical array allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array. With the provided software installed on the user's computer and connected to the ArcCHECK with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.

Both MapCHECK 2 and ArcCHECK use the same software application that includes functions for array and dose calibration; measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan; saving the measurement; importing the treatment planning system (TPS) calculated dose distribution; comparing the measured and planned dose distributions using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria; and a report of this analysis that includes percent pass rates.

The provided document describes the Sun Nuclear MapCHECK 2 and ArcCHECK devices, which are radiation therapy dosimetry quality assurance (QA) systems. However, it does not explicitly state quantitative acceptance criteria or a detailed study proving the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (RIT113 Film Analysis System, K935928) based on intended use, performance testing, safety, and effectiveness.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria (e.g., pass rates for gamma analysis, dose difference thresholds) are provided in the document. The performance is described qualitatively as having "correlation with the actual treatment plan" and "good correlation" when compared to film dosimetry devices.

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

• Sample Size: Not explicitly stated. The document mentions "known patient treatment plan outputs" and "tests were also performed to compare the results... with film dosimetry devices." This suggests a test set was used, but its size is not quantified.
• Data Provenance: The tests were conducted in "non-clinical and clinical settings," but no specific country of origin is mentioned. It discusses "patient treatment plan outputs," implying patient-specific data, but it's unclear if this refers to retrospective clinical data or simulated patient plans. The design suggests these are phantom-based measurements against planned data, not direct measurements on patients.

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

• This information is not provided in the document. The "ground truth" for the device's comparison is the "simulated dose distribution... as calculated by the treatment planning system (TPS)" and "film dosimetry devices." This implies the "ground truth" is derived from computational models and established dosimetry methods rather than expert human interpretation of image data.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. The testing described involves comparing a measured dose distribution from the device to a calculated dose distribution from a TPS or a measured distribution from a film dosimetry device. This is an objective, quantitative comparison (e.g., gamma analysis, dose difference, DTA) rather than a subjective human adjudication process.

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:

• No. This document describes a device for objective dose measurement and QA in radiation therapy, not an AI-assisted diagnostic tool that would involve human readers or interpretation of complex medical images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device and was not performed.

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

• This device essentially operates in a "standalone" manner in terms of its measurement capabilities. It measures the radiation dose distribution, and its software then provides quantitative comparisons (e.g., gamma analysis, dose difference). The output (pass rates, dose maps) is then presented to a human user for review and decision-making. The core measurement and comparison functionality within the software can be considered an "algorithm only" performance, as it objectively compares two dose distributions based on predefined criteria. The human's role is to define the comparison criteria (e.g., gamma parameters) and interpret the results, but the device's primary function is the automated measurement and comparison.

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

• The ground truth used for performance evaluation is primarily:
  • Treatment Planning System (TPS) calculated dose distributions: The device's measurements are compared against the expected dose distributions generated by the TPS.
  • Film dosimetry results: Comparisons were also made against measurements from established film dosimetry devices, which themselves serve as a reference for dose distribution measurement.

8. The sample size for the training set:

• Not applicable/Not provided. The MapCHECK 2 and ArcCHECK are hardware devices with associated software for measurement and analysis, not machine learning or AI algorithms that require a "training set" for model development.

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

• Not applicable/Not provided. As stated above, these devices do not involve machine learning and therefore do not have a "training set" in the conventional sense.

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