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AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution.
AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.

AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
AccuCheck performs using the TPS Check module to check related parameters in the radiotherapy plan to determine if the plan is executable by the linear accelerator( LINAC).
AccuCheck also performs using the Dose Check module to conduct dose calculation verification for radiation treatment plans before radiotherapy by doing an independent calculation of radiation dose using Monte Carlo algorithm. Radiation dose is initially calculated by a Treatment Planning System (TPS).
AccuCheck performs using the Transfer Check module to verify the integrity of the treatment plan transmitted from TPS to the LINAC to check if errors occur during the transmission.
AccuCheck performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a LINAC's delivery log files to reconstruct executed plan and calculate delivered dose. This is achieved through the software module of the Subject Device called Pre-treatment Check and Treatment Check. The difference lies in the usage scenario, where Pre-treatment Check processes the logs of the first execution of the treatment plan in LINAC without a patient actually being treated, while treatment check processes the logs of the second and subsequent execution of the treatment plan in LINAC with a patient actually being treated. AccuCheck cannot be used for log verification, but rather for dose calculation based on logs such as LINAC delivery log data. The reconstruct of the executed plan and calculation of the delivered dose from delivery logs on LINAC machines, including Varian LINAC and Elekta LINAC, are supported by AccuCheck.
The product provides with multiple tools to assist the analysis, including dose volume histogram, Gamma analysis, target coverage, Gamma passing rate of each ROI, dose statistics and clinical targets evaluation.

AccuCheck: Acceptance Criteria and Performance Study

This document outlines the acceptance criteria for the AccuCheck device and details the study conducted to demonstrate the device's performance against these criteria.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary describes a secondary dose calculation verification test as a key performance evaluation. While explicit numerical acceptance criteria are not presented in a table format, the narrative indicates that "The results of all test cases passed the test criteria". Based on the checked items during the test, the implied acceptance criteria are the accurate and consistent representation of various dose analysis metrics by AccuCheck when compared to FDA-cleared Treatment Planning Systems (TPS).

Table 1: Implied Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: 20 patients.
• Case Distribution:
  • 10 samples for Head and Neck cancers.
  • 5 samples for Chest cancers.
  • 5 samples for Abdomen cancers.
  • Specific cancer types mentioned: Brain, Lung, Head and Neck, and GI cancers.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. However, it mentions that the patients "have been treated with IMRT and VMAT techniques," suggesting the use of retrospective data from actual patient treatments. The joint testing devices included two FDA-cleared LINACs and two FDA-cleared TPS systems, implying that these treatment plans and potentially associated patient data originated from clinical settings where these devices are used.

3. Number and Qualifications of Experts for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the ground truth is established by the "FDA cleared TPS" (Treatment Planning Systems), implying that the generated dose calculations from these cleared systems serve as the reference for accuracy. The expertise is inherently embedded in the design and validation of these cleared TPS and the physics teams operating them in clinical practice.

4. Adjudication Method

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The evaluation appears to be a direct comparison between the AccuCheck's calculations and those of the FDA-cleared TPS, with the "test criteria" seemingly pre-defined based on acceptable differences or concordance metrics.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study described focuses on the device's standalone performance compared to established TPS. There is no information provided regarding human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Secondary Dose Calculation verification test" directly assesses the AccuCheck device's ability to perform secondary dose calculations independently and accurately when compared against established FDA-cleared TPS. The device operates without human intervention in its calculation process for this specific test.

7. Type of Ground Truth Used

The ground truth used for the secondary dose calculation verification test is based on the dose calculations generated by FDA-cleared Treatment Planning Systems (TPS). This implies a reference to established and regulatory-approved dose calculation methods.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set. The descriptions focus solely on the verification and validation (test) phase.

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

The document does not provide information on how the ground truth for any training set was established, as it does not explicitly mention a training phase for the device development. The performance data section describes verification and validation using established TPS as the reference.

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