(42 days)
For flow cytometer set up and monitoring of instrument performance.
The procedure employs a Becton Dickinson flow cytometer and recommended computer hardware and software.
Becton Dickinson CaliBRITE 3 Color and FACSComp are intended for use on the Becton Dickinson flow cytometers FACScan™ or FACSort or FACSCalibur™. FACSComp Software and CaliBRITE 3 Color Beads are used to optimally adjust instrument settings, to monitor the sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp Software and CaliBRITE 3 Color Beads are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with three FL channels. FACSComp Software and CaliBRITE 3 Color Beads are used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on thow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. CaliBRITE 3 Color will be provided as a Kit, comprising unstained, FITC, PE and PerCP beads. CaliBRITE PerCP beads will also be provided as a separate product, to be used with CaliBRITE Kits having unstained FITC and PE beads only.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Stability: | |
| Storage stability | 8 months under conditions of use |
| Diluted preparation stability | 1 hour after dilution |
| Reproducibility: | |
| Within instrument (over 30 days) | Within that for the predicate device |
| Between lot | Within that for the predicate device |
Note: The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format, but rather describes the performance achieved. The implied acceptance criteria for reproducibility is that it should be comparable to or better than the predicate device.
2. Sample Sized Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Several studies were performed" and "Performance of this product was established by testing." It doesn't provide specific numbers of beads, runs, or iterations for these tests.
- Data Provenance:
- Country of Origin: San Jose, California, USA (specifically, Becton Dickinson Immunocytometry Systems laboratories).
- Retrospective or Prospective: The studies appear to be prospective as they were conducted as "design verification studies" to establish the device's performance before market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This device (CaliBRITE 3 Color and FACSComp) is a calibration and instrument monitoring system for flow cytometers. Its performance is evaluated based on its ability to accurately set instrument parameters, monitor sensitivity, and set compensation for spectral overlap – not on its interpretation of clinical data or images that would require expert human review to establish ground truth. The "ground truth" here is the physical properties of the beads and the accuracy of the instrument settings they enable.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable. As above, the nature of the device means that adjudication by human experts for interpreting diagnostic outcomes is not relevant here. The "adjudication" is inherent in the device's ability to consistently provide expected fluorescent signals and enable proper instrument calibration, likely verified through instrument readouts and established laboratory protocols.
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
- No. This is not an AI-assisted diagnostic or interpretive device. It's a calibration and quality control product for flow cytometry. MRMC studies are not relevant for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The performance studies described (stability, reproducibility) appear to evaluate the standalone performance of the CaliBRITE beads and FACSComp software in setting instrument parameters. While a human interacts with the flow cytometer and the software, the "performance" being measured is the consistent and accurate functioning of the calibration system itself, independent of the variable human interpretation of clinical results. The software's ability to set compensation and PMT voltages is its "algorithm only" performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for this device is based on physical and chemical properties of the CaliBRITE beads (e.g., their known fluorescence intensities and spectral characteristics) and the expected accurate operational parameters of a flow cytometer.
- For stability, the ground truth is the consistent performance over time.
- For reproducibility, the ground truth is the consistent output despite different runs or different lots, ideally matching established standards or predicate device performance.
- The "truth" is the instrument being correctly calibrated to known standards.
8. The Sample Size for the Training Set
- Not applicable. This document describes a calibration and instrument monitoring device, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a system would be its initial design, engineering, and factory calibration based on the known properties of the beads and flow cytometers.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this device does not utilize a machine learning model that requires a labeled training set, the concept of establishing ground truth for a training set is not relevant. The "ground truth" for its development would stem from fundamental principles of fluid dynamics, optics, chemistry of fluorescent dyes, and electrical engineering relevant to flow cytometry.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”