(246 days)
The intended use of the device is
- quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)
- quality assurance of the radiation delivery system.
The device is an instrument specifically designed to check delivered treatment plans by medical accelerator systems used for radiation therapy applications for quality assurance (QA) purposes.
The device consists of a 2-dimensional matrix of semiconductors and associated acquisition, display and analysis computer programs. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used in both quantitative and subjective assessments of the performance of radiation therapy treatment planning systems and therapeutic radiation delivery systems.
The detector matrix is inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the detectors a signal is created and transferred to a computer where it is evaluated (e.g. by comparing planned with measured dose distributions).
The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, expert involvement, or sample sizes related to algorithms. The document is a 510(k) premarket notification summary for the "Delta4 Discover" and "Delta4 Discover+" devices, which are quality assurance (QA) tools for radiation therapy.
Here's an analysis of what is available in the text, and where specific requested information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The document mentions that "The new device is designed in full accordance with the applicable sections of the following standards: IEC 60601-1, IEC 60601-1-2", which are general safety and essential performance standards, not specific clinical performance acceptance criteria for its QA function.
- Reported Device Performance: Not detailed in terms of specific metrics like accuracy, sensitivity, or specificity. The document broadly states, "The new device is superior or at least equivalent with the predicate devices regarding safety, design and performance." It does not provide any quantitative comparison or performance data to support this claim.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not present in the provided text. No test set or data provenance is mentioned.
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 present in the provided text. Given the device is a QA tool for radiation dose distributions, ground truth would likely refer to highly accurate dose measurements or calculations, not necessarily expert image interpretation. However, the exact methodology is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not present in the provided text.
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
- This information is not present in the provided text. The device is described as a QA instrument for measuring radiation dose, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC study related to human reading improvement with AI assistance would not be applicable or expected for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies standalone performance for the device in its role as a QA instrument, as it "enabling detailed mapping of therapeutic radiation dose distributions" and "evaluates (e.g. by comparing planned with measured dose distributions)." However, no specific study methodology for standalone performance is described, and no quantitative results are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document does not explicitly state the type of ground truth used for any studies. For a radiation dose QA device, the "ground truth" for dose distributions would typically be based on highly accurate measurements from a reference dosimetry system or physics-based calculations.
8. The sample size for the training set
- This information is not present in the provided text. The document does not mention a training set, as it describes a measurement device, not an AI/machine learning algorithm that would typically require a training set.
9. How the ground truth for the training set was established
- This information is not present in the provided text, as no training set is mentioned.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.