(90 days)
The PTW T10004 MULTIDOS is a multiple-purpose, multiple-channel electrometer inlended to perform a range of measuring tasks in radiation therapy. As a stand alone dosemeter, MULTIDOS is intended to be used to measure the dose delivered to a palient during a radiation therapy treatment. Dose measurements during treatment may be accomplished by using suitable ionization chambers or solid state detectors and are used to compare and to verify treatment dose to prescribed dose.
When connected to the optional QC6PLUS, MULTIDOS is intended to be used to measure the beam characteristics of radiation therapy treatment machines. Data acquired with the MULTIDOS and the QC6PLUS is used to compile radiation beam data over time as part of a quality assurance program.
High quality dosimetry devices like the PTW T10004 MULTIDOS and the optional T42007 QC6PLUS make it possible to routinely measure, record, document and verify therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision. High quality multiple purpose dosimetry devices are essential if accurate data from trealment machines that produce therapeutic amounts of ionizing radiation are to be properly monitored.
The PTW T10004 MULTIDOS is a field class multiple-purpose multiple-channel electrometer. This device is designed to accurately measure dose, dose rate, charge, and current for photons and electrons in the therapeutic energy ranges. MULTIDOS may be configured as a stand alone 2, 6, or 12 channel electrometer and can be used with suitable ionization chambers and solid state detectors.
The PTW T42007 QC6PLUS is a therapy beam constancy device which may configured with 6 or 10 individual 0.54 cm³ ionization chambers orthogonally arranged and imbedded in a 5 cm thick PMMA slab. When the QC6PLUS is connected to MULTIDOS, therapy beam parameters like flatness, symmetry, energy stability, and central beam dose are easily monitored.
The provided text is a 510(k) Premarket Notification for the PTW T10004 MULTIDOS and PTW T42007 QC6PLUS devices. It declares that the devices are substantially equivalent to their predicate devices and focuses on their technical specifications, intended use, and comparison to existing products.
Crucially, this document does NOT contain information about acceptance criteria or a study proving that the device meets such criteria. It's a regulatory filing for market clearance based on substantial equivalence, not a performance study report.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Results of a standalone (algorithm only) performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily establishes that the new devices have the "same" indications for use, designs, manufacturing processes, materials, and specifications as their predicate devices, which were already on the market. This claim of "substantial equivalence" is the basis for their 510(k) clearance, not a new performance study against defined acceptance criteria.
§ 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.