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The CRC 55t series, which includes the standard 55tR dose calibrator, reduced pressure chamber (CRC 55tPET) and well counter (CRC55tW), 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 beta and gamma emitters for diagnostic, therapeutic, or in vitro laboratory tests. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions in vitro laboratory test applications. This device is also used in numerous research applications for measurement of radioactive materials.

Capintec's CRC 55t series dose calibrators are designed for measurement of radioactive materials used in nuclear medicine, therapy, laboratory tests, and research applications. The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, radiopharmacists, or medical physicists for diagnostic, in vitro, and therapeutic applications. The CRC 55t series uses the same principles of operation, same basic electronic circuitry, and same detector technology as the predicated device, CRC 25 series. The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device. There are no differences in intended use or effectiveness. The 55t replaces the traditional keypad interface with a larger color touch screen display. The CRC 55t provides enhanced user interface features associated with newer touch screen technology. In addition, the CRC 55t provides an expanded MCA for isotope identification. The predicate device contains 6 fixed channels which provides only preliminary information. The CRC 55t includes a 256 channel MCA which permits spectral identification.

The provided text describes a Capintec CRC 55t series dose calibrator, focusing on its features, intended use, and substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of quantitative performance metrics (e.g., accuracy, precision for dose calibration).

The document is a summary of safety and effectiveness information for a 510(k) premarket notification and an FDA clearance letter. It highlights the device's adherence to various EMC and electrical safety standards, but these are related to electrical and operational safety, not directly to the accuracy or performance of the dose measurement function in a clinical context that would require a ground truth study or human reader evaluations.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: The CRC 55t series dose calibrators measure radioactive materials in nuclear medicine, therapy, laboratory tests, and research.
• Technological Equivalence: The 55t series uses the same principles, circuitry, and detector technology as the predicate CRC 25 series.
• Key Differences: The 55t introduces a larger color touchscreen and an expanded 256-channel MCA for isotope identification, replacing the 6 fixed channels of the predicate device.
• Intended Use: For trained nuclear medicine technologists, physicians, radiopharmacists, and medical physicists in diagnostic, in vitro, and therapeutic applications, as well as research.
• Safety and Effectiveness Justification: Enhanced user interface and improved MCA are cited as features that enhance safety and effectiveness.
• Compliance: The device has been tested and approved to various IEC, UL, and CAN/CSA electrical and safety standards for laboratory equipment.

There is no data presented in the document regarding:

• A table of acceptance criteria and reported device performance (quantitative measurements).
• Sample sizes for test sets or data provenance for performance evaluation.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size or methods for establishing ground truth for a training set (as this device is not an AI/ML-based diagnostic algorithm in the way a computer-aided detection system would be).

The FDA's substantial equivalence determination is based on the new device being as safe and effective as a legally marketed predicate device, primarily through technological similarity and adherence to safety standards, rather than a clinical performance study with defined ground truth and statistical endpoints for diagnostic accuracy.

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