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510(k) Data Aggregation
(267 days)
BeamDose is a software for the following purposes in radiotherapy:
- absolute dose measurements as field class dosemeter (according to IEC 60731)
- monitor calibration
- positioning of detectors in PTW water phantoms
The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.
The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results.
Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.
The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel.
The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values.
The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms.
The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters.
The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor.
The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.
The provided text describes the BeamDose software, its intended use, and its performance relative to a predicate device, DoseView 3D, in the context of a 510(k) premarket notification. The document states that the BeamDose software was tested to evaluate and verify that it meets the required performance specifications which are defined in the product standard IEC 60731:2011 (Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the BeamDose software are primarily derived from the product standard IEC 60731:2011. The reported device performance is presented as fulfilling these criteria when used with specific electrometers (BEAMSCAN, TANDEM, TANDEM XDR).
| Performance Metric (Acceptance Criteria per IEC 60731:2011) | Reported Device Performance (BeamDose with BEAMSCAN) | Reported Device Performance (BeamDose with TANDEM/TANDEM XDR) |
|---|---|---|
| Measuring specifications: | ||
| Zero drift | ≤ ± 0.5 % | ≤ ± 1 % |
| Non-linearity | ≤ ± 0.5 % | ≤ ± 0.5 % |
| Effect of influence quantities: | ||
| Range changing (response) | ≤ ± 1 % | ± (0.5 % + 1 digit) of display |
| Stabilization time (response) | < ± 0.5 % | ± (0.5 % + 1 digit) of display |
| Temperature (response) | < ± 0.25 % | ± (1 % + 1 digit) of display |
| Temperature (zero drift) | ± 0.5 % | ± (1 % + 1 digit) (lower limit of measuring range) |
| Stray radiation (zero drift) | ≤ ± 1 % | ± (1 % + 1 digit) (lower limit of measuring range) |
| Stray radiation (zero shift) | ≤ ± 1 % | ± (1 % + 1 digit) (lower limit of measuring range) |
| Dose rate (response) | < ± 0.5 % | < ± 0.5 % |
The text also provides ranges for Charge and Current for the electrometers, but these are descriptions of the instrument's capabilities rather than direct performance metrics against an acceptance criterion in the provided tables.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that "The BeamDose software was tested to evaluate and verify that it meets the required performance specifications which are defined in the product standard IEC 60731:2011". However, the specific sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective, are not explicitly mentioned in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. The ground truth (acceptance criteria) is established by the IEC 60731:2011 standard. The testing involved measuring specifications and effects of influence quantities of the devices to demonstrate compliance with this standard. There is no mention of experts directly establishing ground truth for a test set in the context of image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods are not applicable nor mentioned in this document. The tests described are quantitative measurements against an international standard (IEC 60731:2011) for dosimeters, not interpretive tasks requiring adjudication of expert opinions.
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 comparative effectiveness study was conducted or mentioned. This device is a software for absolute dose measurements and control of water phantoms in radiation therapy, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The provided performance data are for the BeamDose software in combination with specific electrometers (BEAMSCAN, TANDEM, TANDEM XDR). The testing assesses the software's ability to process and display measurements according to the IEC 60731 standard. The "standalone" performance in this context refers to the software's ability to accurately control electrometers, apply corrections, and display results; it is not a human-in-the-loop system. The document states, "The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel." This implies a human check after the software's output, but the performance testing itself is on the software-hardware system's measurement accuracy. So, while a human reviews the output, the measurement itself is algorithmic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance study is the specifications and requirements defined by the international standard IEC 60731:2011 (Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy). The device's performance metrics (e.g., zero drift, non-linearity, response to temperature) are compared against the limits set by this standard.
8. The sample size for the training set
This information is not provided nor applicable to this type of device. The BeamDose software described here is a measurement and control software, not a machine learning or AI model that typically requires a training set. Its functionality is based on established physics principles and algorithms for dosimetry, not on trained data.
9. How the ground truth for the training set was established
This question is not applicable as there is no mention of a training set for this device.
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