(14 days)
The Clinical Reference Dosimetry Phantom WP 1D is used to position various radiation detectors in water or air. It consists of a cubic tank and a precision onedimensional hand crank or motor driven servo. By design it is suitable to act as a phantom according to various dosimetric protocols (e.g. AAPM's TG-51 or IAEA's TRS-398). The device is intended to be used by experienced professionals entrusted with dosimetric functions only.
The Clinical Reference Dosimetry Phantom WP 1D comprises a one-dimensional precision servomechanism attached to a Perspex (PMMA) water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs.
The "Manual Version" consists of the basic phantom, equipped with a self-locking hand crank to move the detector. That hand crank is coupled to a battery powered, reset-able position indicator that displays the depth.
The "SCU Version" consists of the basic phantom, equipped with a motor/potentiometer device to move the detector. An electronic servo control unit (SCU) consisting of a handheld Remote Control and a Motor Control unit is used to position the detector to a user definable or stored depth.
The provided text for device K032594 does not contain information about acceptance criteria or a study proving that the device meets such criteria. This document is a 510(k) summary for a clinical reference dosimetry phantom, which is a physical device used to position radiation detectors, rather than an AI/software device that would typically have performance metrics.
The 510(k) summary focuses on:
- Description of the Device: It details the physical components and modes of operation (manual or motorized).
- Intended Use: It specifies that the device positions radiation detectors in water or air for dosimetric protocols and is to be used by experienced professionals.
- Technological Comparison: It establishes substantial equivalence to a predicate device (MEDTEC Inc. Depth Dose Apparatus, K943199) based on similar design and function.
Since this device is a physical phantom and not an AI/software product, the concepts of "acceptance criteria," "sample size for test set," "ground truth," "MRMC study," or "standalone performance" as they relate to AI/software performance evaluations are not applicable and are not discussed in this document.
§ 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.