(58 days)
The THALES 3D MR SCANNER system is designed to measure the characteristic radiation beam for an irradiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.
The THALES 3D MR SCANNER system consists of a water phantom with a carriage system, a manual control unit and a software program. A water basin with the corresponding pump, a control unit with an electrometer, and a motor controller are integrated in the carriage system. The software program is used to control the three axes of the water basin, perform measurements and analyse measured data.
The software program has the following properties: Acquisition of measured data, analysis, and recording of photon beams with the water phantom. Generation and export of beam data libraries for a treatment planning system (TPS) for commissioning of irradiation units. The software program is equipped with a central database and/or a file system for central storage of all recorded data for different irradiation units within a large hospital network with different sites. The software program offers the option of defining different user levels to support the typical clinical workflows.
Here's an analysis of the provided text regarding the acceptance criteria and study for the THALES 3D MR Scanner:
Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a comprehensive efficacy study with predefined acceptance criteria for its performance metrics as one might see in a clinical trial. The "acceptance criteria" here are more about meeting safety, electromagnetic compatibility, and dosimeter standards, and showing that its operational parameters are comparable or superior without introducing new risks. There is no information about a comparative effectiveness study (MRMC) with human readers, nor a standalone algorithm performance study as would be applicable for AI/CADe devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from predicate comparison/standards) | Reported Device Performance (THALES 3D MR Scanner) |
|---|---|---|
| Intended Use | QA for radiation therapy systems, commissioning, and other occasions; use with integrated MRI (up to 1.5T for predicate) | QA for radiation therapy systems, commissioning, and other occasions; use with integrated MRI with magnetic field ≤ 0.35 Tesla |
| Scanning Range | 408mm * 355mm * 248mm (predicate) | 380mm * 380mm * 242mm |
| Tank Shape | Square | Square |
| Wall Material | PMMA | PMMA |
| Chamber Holder Orientation | Horizontal and vertical | Horizontal and vertical |
| Motor Scanning Mode | Step by step | Step by step |
| Step Size | 0.1mm | 0.1mm |
| Maximum Speed | 30mm/s (predicate) | 40mm/s |
| Position Accuracy | +/-0.1mm (predicate) | +/- 0.25mm (at 0.35Tesla) |
| Reproducibility | +/-0.1mm (predicate) | +/- 0.25mm (at 0.35Tesla) |
| MRI Compatibility | Up to 1.5 Tesla (predicate) | Up to 0.35 Tesla |
| Electrometer Channels | 2 entries | 2 entries |
| Electrometer Resolution | 10 fA (predicate) | 1 fA |
| Electrical Safety | IEC 61010 | IEC 61010 |
| Dosimeter Testing | IEC 60731 | IEC 60731 |
| EMC | IEC 60601-1-2:2007 (predicate) | IEC 60601-1-2:2015 |
| MRI Safety | N/A (implied by predicate's MRI compatibility) | Tested in accordance with applicable ASTM standards |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an AI/ML algorithm or a specific patient-data based study. Instead, it details performance characteristics of a physical measurement device (water phantom) for radiation therapy. The performance testing refers to evaluating the device's physical and electrical characteristics against standards (IEC, ASTM). Therefore, there is no information about a sample size or data provenance related to patient data. The "test set" implies physical testing of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device's performance is established by engineering and physics standards (IEC, ASTM) for safety, compatibility, and measurement accuracy, not by human expert consensus on clinical data.
4. Adjudication Method for the Test Set
Not applicable. There's no clinical data or expert review process described that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document makes no mention of an MRMC study or any study involving human readers or comparative effectiveness in a clinical workflow with or without AI assistance. This device is a measurement tool, not an AI diagnostic or assistive tool in the traditional sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI algorithm but a physical device with integrated software to control movement, acquire, analyze, and export measurement data. Its "performance" refers to how accurately it physically measures radiation beams, not its ability to interpret images or suggest diagnoses.
7. The Type of Ground Truth Used
The ground truth used for validating the device's performance comes from established engineering and medical device standards:
- Electrical and mechanical safety: IEC 61010
- EMC: IEC 60601-1-2
- Dosimeter requirements: IEC 60731
- MRI safety: Applicable ASTM standards
- Performance metrics (e.g., position accuracy, electrometer resolution) are likely validated against manufacturer-defined specifications derived from engineering principles and comparison to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model that requires a "training set" of data in the conventional sense. Its software controls hardware and processes raw measurement data based on established physics, not learned patterns from a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.