(29 days)
The CRC PC Smart Chamber series is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy befa and gamma emitters for diagnostic and therapeutic applications. It is also designed for use by trained medical physicists for diagnostic and therapeutic applications including measurement of the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. This device is also used in numerous research applications for measurement of radioactive materials.
Capintec's CRC PC Smart Chamber series dose calibrators are designed for measurement of radioactive materials used in nuclear medicine, therapy, and research applications. The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, radiopharmacists, or medical physicists for diagnostic and therapeutic applications. The CRC PC series has the same principles of operation, same basic functionality, and same detector technology as the predicate device, CRC 55t series. The basic detection, measurement process, design concepts, calculations, and response remain the same as the predicate device. There are no differences in intended use or effectiveness. The CPC PC Smart Chamber replaces the touchscreen user interface of the predicate device with a laptop or network PC.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Capintec CRC PC with Smart Chamber Series dose calibrators). It focuses on:
- Substantial Equivalence: Comparing the new device to a predicate device (CRC 55t series) to demonstrate similar principles of operation, functionality, detector technology, intended use, and effectiveness.
- Safety and Effectiveness: Stating that the predicate devices have a long history of safe, reliable, and effective use, and that the new device enhances safety and effectiveness through an improved user interface.
- Compliance with Standards: Listing compliance with various IEC and AAMI standards related to electromagnetic compatibility, general safety, and usability.
- Indications for Use: Defining who can use the device and for what applications (measurement of radiopharmaceuticals, radioactive materials, and brachytherapy sources for diagnostic, therapeutic, and research applications).
- FDA Correspondence: Official FDA letter regarding the 510(k) clearance.
There is no mention of:
- Specific performance acceptance criteria (e.g., accuracy, precision targets).
- A study design or results demonstrating that the device meets such criteria.
- Information about sample sizes, data provenance, expert panels, adjudication, MRMC studies, standalone performance, ground truth establishment, or training sets.
Therefore, I cannot provide the requested table or answer the specific questions about the study design as the information is not present in the provided text.
§ 892.1360 Radionuclide dose calibrator.
(a)
Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.(b)
Classification. Class II.