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For flow cytometer set up and monitoring of instrument performance prior to performing reticulocyte ennumeration or immunophenotyping applications. Flow cytometry has been found useful in monitoring some forms of immune disease.

For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur).

An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping.

For adjusting instrument settings: aligning the signal from the blue and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time.

For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals.

For monitoring the sensitivity of the side scatter (SSC) and fluorescence (FLI, FL2, FL3, and FL4) detectors and verifying adequate separation of system noise from forward scatter (FSC) signals.

For in vitro diagnostic use.

Becton Dickinson FACSComp software and the CaliBRITE 4 bead kir (FACSComp/CaliBRITE 4) are intended for use on the Becton Dickinson flow cytometers, FACSort™ or FACSCalibur™, equipped with the FL4 Option. FACSComp/CaliBRITE 4 are used to check laser alignment, optimally adjust instrument settings, monitor sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp/CaliBRITE 4 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 four fluorescence (FL) channels FACSComp/CaliBRITE 4 is used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on flow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. The CaliBRITE beads are provided as a separate vial of CaliBRITE APC beads and the four-vial CaliBRITE 3 kit, comprised of unstained, FITC-, PE- and PerCP-labeled beads.

The provided text describes the Becton Dickinson Immunocytometry Systems (BDIS) CaliBRITE™ APC beads, CaliBRITE 4 kit, and FACSComp™ software. This 510(k) submission (K973483) specifically aims to demonstrate substantial equivalence to a predicate device, the CaliBRITE™ 3 kit and FACSComp™ software (K961623).

The summary indicates that the new device is essentially the predicate device plus an additional component, the CaliBRITE APC beads, designed to facilitate the setup of the FL4 Option on certain flow cytometers. Due to this nature, the "acceptance criteria" and "device performance" are framed around demonstrating equivalence to the predicate device and the stability and reproducibility of the new components/system.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance of the predicate device and the stability/reproducibility of the new system. The document does not explicitly list numerical acceptance criteria with target values. Instead, it states that the performance was "equivalent to the predicate device" for reproducibility aspects and provides stability durations.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the sample size (number of runs, number of beads tested, etc.) for the reproducibility or stability studies. It only mentions "Several studies were performed."
• Data Provenance: The testing was "at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California." This indicates the data is retrospective (performed as part of device development/verification) and from a single country of origin (USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of device (flow cytometer calibration beads and software) does not typically involve human expert interpretation for establishing "ground truth" in the way, for example, an imaging diagnostic AI would. The "ground truth" here is the expected performance of a well-calibrated flow cytometer, based on physical and chemical properties of the beads and the instrument's known specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, human adjudication is not relevant for this type of device and its performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for a calibration product like the CaliBRITE system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a calibration system used to set up and monitor flow cytometers. The FACSComp software automates certain tasks (e.g., setting PMT voltages, fluorescence compensation), which could be considered an "algorithm only" component in its execution of these tasks. However, its overall function is to prepare the instrument for human operators to then run diagnostic tests. The performance data presented focuses on the consistency and stability of this automated setup. It isn't a standalone diagnostic algorithm that produces a medical output without human oversight of the instrument's readiness.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Instrument Specifications: The expected ideal readings for properly calibrated flow cytometers using the CaliBRITE beads.
• Predicate Device Performance: The established performance characteristics of the CaliBRITE 3 kit and FACSComp software (K961623) served as the benchmark for "equivalence."
• Physical/Chemical Properties: The known characteristics of the fluorescent beads themselves (e.g., their fluorescence intensity) are inherent ground truth for their intended use in calibration.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model in the contemporary sense that requires a "training set" of data. It's a calibration system whose "logic" or algorithms are based on established flow cytometry principles, not on learned patterns from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device.

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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

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.

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