(90 days)
EquiDose™ Solid State Diode Detectors are intended to be used for the collection of radiation beam data from radiation therapy treatment machines in air, water, or in other suitable material. The data acquired with this type of detector can be used to compile radiation beam data over time as part of a quality assurance program, to verify treatment machine energy and output, and to measure therapeutic doses delivered to patients during treatment.
The EquilDose™ Solid State Diode Detector is intended to be used for the collection of radiation beam data from radiation-producing machines.
MasTek's EquiDose™ Solid State Diode Detectors are classical solid state diode detectors used for verification measurements in radiation therapy. All of the diodes share the same design, manufacturing process, are made of the same materials and they are all waterproof. With the exception of their higher input impedance and standard 2 meter cable length, the EquiDose™ Solid State Diode Detectors are exactly the same as the predicate ISORAD™ Solid State Diode Detectors.
EquiDose™ Solid State Diode Detectors, when connected to an appropriate electrometer like the PTW-UNIDOS, K951764, are used to collect and verify beam data from radiation therapy treatment machines and to verify therapeutic amounts of radiation delivered during treatments.
The provided text is a 510(k) submission for the EquiDose™ Solid State Diode Detectors. It does not contain acceptance criteria or the results of a study designed to prove the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (ISORAD™ Solid State Diode Detectors, K912250).
The core of the submission states:
- "The indications for use are exactly the same as the predicate devices..."
- "The designs are exactly the same."
- "The manufacturing and testing, process and procedures are exactly the same."
- "The materials used are the same as in the predicate devices."
- "The specifications are the same as the predicate devices."
- "The indications for use, design, materials, manufacturing, and specifications of the EquiDose™ Solid State Diode Detectors do not raise any issues with regard to safety and effectiveness. MasTek D.E.M., Inc. considers all of these solid state diode detectors equivalent to the predicate devices for radiation therapy beam data measurements."
This means that instead of conducting a new study with defined acceptance criteria for the EquiDose™ device itself, the manufacturer is relying on the previous clearance of the predicate device (ISORAD™) and asserting that the EquiDose™ device is essentially identical in all relevant aspects that would impact safety and effectiveness.
Therefore, I cannot populate the requested table or answer the specific questions about standalone studies, MRMC studies, sample sizes, or ground truth establishment for the EquiDose™ device's performance, as this information is not present in the provided 510(k) summary. The submission's approach is to demonstrate equivalence, not to re-prove performance against new 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.