(198 days)
The CRC 15BT dose calibrator is intended to be used by trained medical physicists, or qualified technologists to measure the activity or output of radioactive brachytherapy sources, including HDR, LDR and IVBT sources.
The CRC 15BT dose calibrator is a well type ionization chamber specifically designed to accurately and rapidly measure all types of brachytherapy sources with appropriate calibration and source positioning device. The ionization chamber is connected to a readout, which converts measured current into a displayed value in units of either Ci (activity) or U (air kerma strength). The unit is sealed and pressurized with UPC Argon. which improves sensitivity and eliminates the need for temperature and pressure corrections.
Based on the provided text, the device in question is the Capintec CRC 15BT calibrator, a radionuclide dose calibrator. The document is a 510(k) submission review with an acceptance letter from the FDA. This type of document typically focuses on establishing "substantial equivalence" to a predicate device rather than detailing specific acceptance criteria and performance studies in the way a clinical trial might for a new drug or an AI-powered diagnostic device.
Therefore, much of the requested information (related to AI algorithms, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this device and this type of regulatory submission. The CRC 15BT is a physical medical device for measuring radioactive sources, not a software-based diagnostic tool with AI components.
However, I can extract the relevant information regarding the device's validation and "acceptance criteria" as described in the document, framed within the context of a 510(k) submission for a physical device.
Here's the breakdown of what can be synthesized from the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as implied by text) | Reported Device Performance (as stated in text) |
|---|---|---|
| Intended Use Suitability | Suitable for all clinically available gamma and high-energy beta brachytherapy sources, including HDR, LDR, and IVBT in any number of configurations (seeds, ribbons, source trains). | "evaluated by the University of Wisconsin ADCL, and found to be a suitable instrument for all clinically available gamma and high-energy beta brachytherapy sources, including HDR, LDR, and IVBT in any number of configurations including, seeds, ribbons, and source trains with appropriate source holders." |
| Accuracy/Measurement | Accurately and rapidly measure activity or output of radioactive brachytherapy sources. | Converts measured current into a displayed value in units of Ci (activity) or U (air kerma strength). The core design is a minor modification of the CRC 15R, which has an "excellent reputation for long term stability, reliability, safety and effectiveness." The 15BT is expected to "maintain the same excellent quality as the CRC 15R." |
| Activity Range | Accommodate higher activity range required for HDR sources. | Modifications to the 15BT include "reduced fill gas pressure and an increased bias voltage to accommodate a higher activity range required for HDR sources." |
| Stability, Reliability, Safety, Effectiveness | Maintain high standards comparable to the predicate device (CRC 15R). | Expected to maintain "excellent quality... same level of safety and effectiveness and long term reliability" as the CRC 15R, which has been commercially available for over 10 years with an "excellent reputation." |
| Compliance with Safety Standards | Adherence to relevant medical electrical equipment safety standards. | "tested and approved to the following safety standards for medical equipment: EN60601-1:1990+A1+A2, IEC60601-1:1998+A1+A2, EN60601-1-2, IEC60601-1-4:1996, Can/CSA C22.2 No.606101-M90, IEC 606601-1-1:1993+A1." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of a specific number of brachytherapy sources tested. The evaluation was done by the University of Wisconsin ADCL, implying a testing protocol was followed, but the "sample size" of sources is not quantified.
- Data Provenance: The testing was carried out by the University of Wisconsin ADCL (Accredited Dosimetry Calibration Laboratory), an independent, accredited laboratory. This indicates an objective, third-party evaluation. The data would be prospective testing data, specifically for the CRC 15BT.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable in the AI/Diagnostic Sense. For a dose calibrator, "ground truth" is typically established by physical standards and reference measurements, often against primary standards maintained by national metrology institutes or through cross-calibration with other precisely calibrated instruments. The University of Wisconsin ADCL is accredited for dosimetry calibration, indicating they possess the expertise and equipment to establish accurate reference measurements for brachytherapy sources. The text doesn't mention "experts" in the context of subjective interpretation like radiologists, but rather a specialized laboratory performing objective measurements.
4. Adjudication method for the test set
- Not Applicable. This concept is for subjective interpretations/diagnoses (e.g., by human readers in an AI study). For a physical measurement device like a dose calibrator, the "adjudication" is the verification of the calibration and measurement accuracy against established physical standards by the ADCL.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical device, not an AI software requiring human reader interaction or augmentation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Interpreted Differently. The device is standalone in its operation of measuring radiation. It's a sensor system that performs its function without human interpretation of its core measurement (though humans operate it and use its output). There is no "algorithm" in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the CRC 15BT, the "ground truth" for its performance would be physical measurement standards and reference sources with known activities or air kerma strengths, established and traceable to national or international primary standards. The University of Wisconsin ADCL's role is to ensure the calibrator accurately measures these known quantities.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for this type of device, this question is irrelevant.
§ 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.