(103 days)
The intended use of the device is
• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).
• quality assurance of the radiation delivery system.
The device consists out of matrices of semiconductors embedded in a phantom. These matrices are inserted into the radiation field of a medical linear accelerator. If radiation from a radiotherapy treatment field) hits the semiconductors a signal is created and transferred to a computer where it is analysed and among others compared with the intended dose distribution.
The new device Delta4 Phantom+ MR is equivalent in form and function to the cleared device Delta4 Phantom+, but has been verified as an MR-conditional product.
The provided text describes a medical device called the "Delta4 Phantom+ MR", which is a pre-treatment verification system for quality assurance in radiation therapy. It is a new version of an existing device, the "Delta4 Phantom+", with the key difference being that the new device is MR-conditional.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format with corresponding reported device performance values. Instead, it describes equivalence to the predicate device. The core acceptance criterion for the new device is its equivalence in safety, design, and performance to the predicate device ("Delta4 Phantom+"), with the added capability of being MR-conditional.
Specifically, the document states:
- "The new device is equivalent, in most cases identical with the predicate devices regarding safety, design and performance."
- "Comparison tests have been performed with the predicate device in clinical and nonclinical situations. Among others pre-treatment verification measurements of numerous treatment plans have been performed with both the new device and the predicate device. The results were compared with each other and it was determined that the results had very good correlation."
Therefore, the acceptance criteria are implicitly that the Delta4 Phantom+ MR performs equivalently to the Delta4 Phantom+ in pre-treatment verification measurements for radiation therapy, specifically in IMRT, VMAT, and 4DRT QA, while additionally being MR-conditional. The reported device performance is that it achieved "very good correlation" with the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Equivalence in safety, design, and performance to Delta4 Phantom+ (predicate device) in clinical and nonclinical situations for QA measurements. | Achieved "very good correlation" with the predicate device in pre-treatment verification measurements of numerous treatment plans. |
| MR-conditional capability. | Successfully designed to be MR-conditional by substituting ferromagnetic parts with non-magnetic materials (ee.g., aluminum). |
Study Information
The document provides limited details about a formal study with a defined test set.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "numerous treatment plans" were used for pre-treatment verification measurements. A specific numerical sample size is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It suggests "clinical and nonclinical situations," implying some real-world or simulated clinical scenarios.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The comparison is against the predicate device, not against an expert-established ground truth in the traditional sense of diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- An adjudication method is not applicable/not provided as the comparison is between two devices' measurement outputs, not expert interpretations of data.
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:
- An MRMC study was not conducted. This device is a measurement and quality assurance tool, not an AI-assisted diagnostic device requiring human reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance comparison described is essentially a standalone (device-only) comparison between the new device and the predicate device, both operating without human intervention for the measurement aspect directly. The software then analyzes these measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance comparison is the measurements provided by the predicate device, which is already cleared and considered reliable for QA purposes. The new device's measurements are compared to those of the predicate device.
8. The sample size for the training set:
- This device is not an AI/machine learning model in the typical sense that would require a "training set." It is a physical measurement device. Therefore, a training set is not applicable/not provided.
9. How the ground truth for the training set was established:
- As a training set is not applicable, this information is not provided.
§ 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.