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510(k) Data Aggregation
(194 days)
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 CuriesMaximum 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 | < 2% (implied acceptance limit) | < 2% over a dynamic range of 10-11 A to 10-6 A |
| Reproducibility | ± 1% in 24 hours with unit powered at all times (implied acceptance limit) | ± 1% in 24 hours with unit powered at all times |
| Electrical Safety | Compliance with IEC 60601-1, AAMI ES60601-1, CSA C22.2#60601-1. | Compliance demonstrated through testing (listed standards). |
| EMC | Compliance with IEC 60601-1-2. | Compliance demonstrated through testing (listed standard). |
| Usability | Compliance with IEC 60601-1-6. | Compliance demonstrated through review of usability. |
| Software V&V | Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software level of concern: Moderate. | Software verification and validation testing conducted appropriately; documentation provided. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that the CRC-77tHR was also evaluated at an isotope production site. It does not specify the sample size for this evaluation (e.g., number of measurements, number of isotopes tested, duration of testing). The data provenance is implied to be prospective as it's an evaluation of the device being submitted for clearance, and the location is an isotope production site, presumably in the US where Capintec is based. No specific country of origin is stated for the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a measurement instrument (dose calibrator), not an AI-powered diagnostic device requiring expert review of output. Its ground truth for performance metrics (e.g., accuracy, linearity) would be established against traceable standards and reference sources, not human expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. As a measurement device, performance is evaluated against physical standards and known values, not through human adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is typically done for diagnostic tools that assist human readers in interpreting medical images or data. The CRC-77tHR is a standalone measurement device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is a standalone device. Its performance metrics (accuracy, linearity, reproducibility) were evaluated intrinsically without a human 'in-the-loop' assisting in its primary measurement function. The performance data presented are for the device itself.
7. The Type of Ground Truth Used:
The ground truth for the performance metrics (e.g., measurement accuracy, linearity, reproducibility) would be based on:
- Reference sources/standards: Calibrated radioactive sources with known activity levels are used to verify the device's accuracy and linearity.
- Traceable measurements: Comparisons to other calibrated instruments or standards in a laboratory setting.
- Engineering specifications: Adherence to designed operational parameters.
Essentially, the ground truth is derived from physics and dosimetry principles, relying on metrological standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a "training set." It's a traditional medical device based on established physics principles and internal calibration.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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