(16 days)
The Standard Imaging IVB 1000 Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of high-dose-rate (HDR), low-dose-rate (LDR) and intravascular (IVB) brachytherapy (gamma and beta) sources, with the appropriate (calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the IVB 1000 labeling. To check the bremstralung component of a source, the X-Ray Contamination Test Tool, an accessory to the IVB 1000, should be used.
The Standard Imaging IVB 1000 Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of high-dose-rate (HDR), low-dose-rate (LDR) and intravascular (IVB) brachytherapy (gamma and beta) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the IVB 1000 labeling. To check the bremstralung component of a source, the X-Ray Contamination Test Tool, an accessory to the IVB 1000, should be used. It is recommended that the chamber be calibrated every two years, as is standard practice for other ionization chambers. Initially, the calibration factor is given in the calibration report from an Accredited Dosimetry Calibration Laboratory (ADCL). The measurement of brachytherapy sources requires an electrometer with a calibrated scale for measuring currents in the range from 10-12 A to 10-7A. Alternatively, a calibrated charge scale may be used with timed runs. If integral charge techniques are used with the time determined by the HDR irradiator timer, the contribution from the source transit-time should be taken into account. The IVB 1000 Well Chamber has a vent hole to maintain the internal air at ambient atmospheric pressure. Thus, the readings obtained must be corrected for ambient temperature and pressure to the temperature and pressure of calibration (22º C and 760 mm Hg) at "normal" relative humidity (50% ± 25%non-condensing) in the usual accepted manner. The IVB 1000 has available different inserts for IVB, HDR, LDR and X-Ray contamination measurements. The IVB 1000 Well Chamber has a conventional triax connector and cable to be connected to a suitable electrometer. A bias of 300 volts must be applied to the electrometer low-impedance connection relative to chassis ground. The voltage polarity effect is less than 0.1%. If desired, a second bias level of 150 volts can also be used to determine the ionic recombination loss at 300 V.
The provided text is a 510(k) premarket notification for a medical device, the Standard Imaging IVB 1000 Well Chamber. This document establishes substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a standalone study for the current device's performance.
Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this type of regulatory submission.
However, I can extract information related to the device's validation and the basis for its equivalence.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or detailed performance metrics. The submission focuses on demonstrating substantial equivalence to a previously cleared device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. There is no specific "test set" described for a standalone performance study. The validation mentioned is "calibration testing."
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. The ground truth for a dosimeter is typically established through a highly calibrated and regulated process, not by a panel of medical experts in the way, for instance, image classification ground truth would be established. The calibration testing was conducted by an "Accredited Dosimetry Calibration Laboratory."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no expert adjudication method described for this type of device validation.
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 device is an ionization chamber for measuring radiation, not an AI-powered diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone measurement instrument. The document states: "The Standard Imaging IVB 1000 Well Chamber has been validated through calibration testing conducted by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory." This implies a standalone evaluation of the device's accuracy in measuring radiation. However, no specific performance metrics from this testing are provided in this regulatory summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context would be the highly accurate and traceable measurements provided by a primary or secondary standard dosimetry laboratory during the calibration process. The device's measurements are compared against these known, precise radiation values.
8. The sample size for the training set:
Not applicable. This is a physical measurement device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is known from the provided text:
- Device: Standard Imaging IVB 1000 Well Chamber.
- Purpose: To measure the amount of radiation from high-dose-rate (HDR), low-dose-rate (LDR), and intravascular (IVB) brachytherapy (gamma and beta) sources.
- Validation Method: "Calibration testing conducted by the University of Wisconsin - Madison, Department of Medical Physics Accredited Dosimetry Calibration Laboratory."
- Substantial Equivalence: The device is considered substantially equivalent to the Standard Imaging HDR 1000 Plus/ IVB 1000 Well Chambers (cleared under K001825) in "design concepts, technologies, materials and intended uses."
- Standards: Designed to comply with applicable portions of IEC 601-1:1988 and IEC 60731:1997.
- Operating Conditions: Readings must be corrected for ambient temperature and pressure (to 22ºC and 760 mm Hg at 50% ± 25% non-condensing humidity).
- Bias: Requires a bias of 300 volts, with a voltage polarity effect less than 0.1%.
Conclusion:
This 510(k) summary provides evidence of substantial equivalence to a predicate device and mentions calibration testing by an accredited laboratory as its validation. It does not contain the detailed quantitative performance metrics, acceptance criteria, or study design information typically found for novel device performance studies, especially those involving AI or human interpretation. The "study" here is the calibration process, which verifies the device's accuracy against recognized dosimetry standards.
§ 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.