(30 days)
The CRC PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be used only with the TEMA Karls 100 radiopharmaceutical dose administration system.
The Capintec CRC PC Smart Family of dose calibrators are sealed, pressurized reentrant well style ionization chambers which use a networked PC as the user interface. The CRC PC Smart Chamber K1 is modified CRC PC Smart Chamber, which has been shortened in height to fit into the Karl 100 Dose Administration System, which is manufactured by TEMA.
This document describes the CRC PC Smart Chamber K1, a radionuclide dose calibrator. The information provided heavily relies on a comparison to a predicate device and states that safety and effectiveness were confirmed through "verification and validation testing." However, it does not provide details about a specific study designed to prove the device meets defined acceptance criteria in the way a clinical study for an AI/CADe device would.
Instead, the submission focuses on demonstrating substantial equivalence by highlighting design similarities with a previously cleared device (CRC-PC Smart Chamber, K141413) and confirming compliance with relevant electrical and safety standards.
Therefore, I cannot populate most of the requested fields as they pertain to a detailed performance study with defined acceptance criteria and human expert evaluation, which is not described in this document.
Here's how I can address the specific points based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a dedicated study. It generally mentions:
- "Risk assessment confirms that all identified risks were either mitigated or are within acceptable limits."
- "Verification and validation testing confirmed the CRC-PC Smart Chamber K1 meets all stated specifications and functions as expected."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No specific test set data is described. The device is a physical instrument, and its performance is likely evaluated through engineering verification and validation against technical specifications, not typically through a "test set" of patient data in the way an AI algorithm might be.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described.
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 not an AI/CADe device that assists human readers. It's a dose calibrator for radiopharmaceuticals.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical device. Its "standalone" performance would be its accuracy and precision in measuring radioactivity, which is stated to meet "all stated specifications."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable directly in the context of clinical "ground truth." For a dose calibrator, "ground truth" would be established by reference standards or highly accurate laboratory measurements of radioactivity, which are typically used during calibration and verification processes.
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.