(211 days)
The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. These instruments are used exclusively by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation.
The CNMC Model 206 is a dosimetry electrometer intended for measuring the output charge of an Ionization chamber or dosimetry diode that is used in a radiotherapy beam.
The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. These instruments are used exclusively by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CNMC Model 206 Electrometer/Dosimeter:
General Note: The provided document is a 510(k) Premarket Notification Summary from the FDA. This document primarily focuses on establishing "substantial equivalence" to a predicate device, rather than providing a detailed report of a new clinical study with specific acceptance criteria and performance data for a novel device. Therefore, many of the requested items (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not typically found in this type of regulatory submission because the device is not a complex AI/ML system requiring extensive clinical validation. Instead, the focus is on demonstrating that the new device performs comparably to an already approved device.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The CNMC Model 206 Electrometer/Dosimeter is primarily evaluated for "substantial equivalence" to a predicate device (Sun Nuclear Model 1010/206 – K002444). The acceptance criteria are implicitly defined by the specifications of the predicate device and the new device's ability to meet those specifications. The "study" demonstrating this involves comparing the technical specifications and intended use of the CNMC Model 206 to the predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are the performance specifications of the predicate device, and the "reported device performance" is how the CNMC Model 206 matches or is equivalent to those specifications.
| Parameter | Acceptance Criteria (Predicate Device: Model 1010/206 K002444) | Reported Device Performance (CNMC Model 206) |
|---|---|---|
| Charge: | ||
| Range | 0.0001 pC to 1999.9 nC | 0.0001 pC to 1999.9 nC |
| Resolution | 10 fC | 10 fC |
| Current: | ||
| Range | 0.001 pA to 1999.9 uA | 0.001 pA to 1999.9 uA |
| Resolution | 1 fA | 1 fA |
| Bias voltage | -300/-150 to +300/+150 | -300/-150 to +300/+150 |
| Leakage Current |
§ 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.