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510(k) Data Aggregation
(194 days)
CRC-77tHR
The CRC-77tHR is intended to be used by qualified radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.
The Capintec CRC-77tHR is dose calibrator which uses a touch screen user interface and sealed reentrant well chamber as the detector. The gas fill pressure has been lowered in order to extend the maximum activity range for isotope manufacturing and radiopharmaceutical production environments.
The provided document pertains to the FDA 510(k) clearance for the Capintec CRC-77tHR radionuclide dose calibrator. The information details the device's technical specifications and performance data, but it does not describe a study involving AI assistance, human readers, or image-based diagnostics with associated ground truth and expert adjudication methods.
The document outlines a traditional medical device clearance process for a dose calibrator, focusing on:
- Substantial equivalence to a predicate device (CRC-55t Dose Calibrator series).
- Technical specifications, including measurement range, resolution, energy range, electrometer accuracy, linearity, and reproducibility.
- Compliance with electrical safety, electromagnetic compatibility (EMC), and usability standards (e.g., IEC 60601-1, IEC 62304 for software).
- Software verification and validation testing, with a "moderate" level of concern.
- Evaluation at an isotope production site.
Therefore, many of the requested points regarding AI, human-in-the-loop performance, multi-reader multi-case studies, and specific ground truth methodologies for image-based diagnostics are not applicable to this device's clearance information.
However, I can extract and present the acceptance criteria and reported device performance related to the dose calibrator's technical specifications from the provided text.
Acceptance Criteria and Reported Device Performance (CRC-77tHR Radionuclide Dose Calibrator)
The acceptance criteria for this device are primarily tied to its technical specifications and its performance metrics, which demonstrate substantial equivalence to its predicate device (CRC-55t) while operating at a higher activity range.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Measurement Range | Must be able to measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. | Maximum activity for Tc-99m: approximately 400 Curies |
| Maximum activity for F-18: approximately 130 Curies | ||
| Resolution | Not explicitly stated as acceptance criteria, but a key performance metric. | 0.01 mCi (10 µCi) |
| Minimum Activity Range | Must be suitable for levels > 100 µCi (implies that less than 100 µCi is not an intended use). | Minimum activity range > 100 µCi |
| Energy Range | Not explicitly stated as acceptance criteria, but a key performance metric. | 15 keV to 3 MeV |
| Electrometer Accuracy | Not explicitly stated as acceptance criteria, but a key performance metric. | ± 2% |
| Electrometer Linearity |
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