(89 days)
The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
The BD FACSLyric™ flow cytometer with the integrated BD FACSDuet™ System is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) aser. It includes an automated sample preparation system used to prepare human peripheral whole blood samples for acquisition and analysis and is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
The BD FACSLyric™ Flow Cytometer is a flow cytometer system. The BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System includes the flow cytometer and an automated sample preparation system. The system includes the BD FACSLyric™ Flow Cytometer, BD FACSTM Universal Loader, BD FACSuite™ Clinical software, BD FACSDuet™ Sample Preparation System, BD Multitest™ 6- Color and 4-Color Assay Modules, BD® FACSFlow™ Sheath Fluid, BD® CS&T Beads, and BD® FC Beads 7-Color Kit. It uses flow cytometry and immunofluorescence assay methodology.
Here's an analysis of the acceptance criteria and study data from the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "All acceptance criteria were met" or "The acceptance criteria were met" for each study, but it does not explicitly list the specific numerical acceptance criteria for each performance metric. It only provides the objective of each study.
| Study | Acceptance Criteria (Objective) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Within-site Precision | To evaluate the within-site precision performance of FACSLyric flow cytometer with FACSDuet instrument. | All acceptance criteria were met. |
| Whole Blood Repeatability | To verify repeatability performance of FACSLyric flow cytometer with FACSDuet instrument using HIV+ patient and normal whole blood specimens. | Repeatability performance was demonstrated across all the instruments. |
| Linearity | To evaluate the linear range of FACSLyric flow cytometer with FACSDuet instrument. | The linear range of FACSLyric flow cytometer with FACSDuet instrument was established based on the acceptance criteria. |
| Limit of Blank (LoB) and Limit of Detection (LoD) | To evaluate the LoB and LoD of FACSLyric flow cytometer with FACSDuet instrument. | LoB and LoD of FACSLyric flow cytometer with FACSDuet instrument were established, and met the acceptance criteria. |
| Limit of Quantitation (LoQ) | To evaluate the LoQ of FACSLyric flow cytometer with FACSDuet instrument. | LoQ of the FACSLyric flow cytometer with the FACSDuet instrument was established, and met the acceptance criteria. |
| In-Use Reagent Stability Performance | To evaluate the in-use reagent stability of the Multitest 6-Color TBNK in the FACSDuet instrument. | All acceptance criteria were met. |
| Equivalency between 15 and 30 minutes Incubation Time | To demonstrate equivalency between 15 and 30 minutes staining incubation time using manual and FACSDuet sample preparation. | All acceptance criteria were met. |
| Specimen Carryover | To evaluate the specimen to specimen and bleach to specimen carryover in FACSDuet instrument. | All acceptance criteria were met. |
| Reagent Carryover | To evaluate the reagent carryover in FACSDuet instrument. | All acceptance criteria were met. |
| Pipette Dispense Accuracy and Precision | To evaluate the dispense accuracy and precision performance of FACSDuet instrument. | All acceptance criteria were met. |
| Clinical Performance | ||
| Method Comparison | To evaluate performance equivalency between FACSLyric flow cytometer with FACSDuet instrument (subject device), and FACSLyric flow cytometer with manual sample preparation (predicate device). | A total of 399 enrolled specimens were tested across 3 sites. 29 samples were non-evaluable. The acceptance criteria were met. |
| Inter-laboratory Reproducibility | To evaluate inter-laboratory reproducibility for FACSLyric flow cytometer with FACSDuet instrument. | The results demonstrated that the variability across three sites, and results met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Whole Blood Repeatability: Used "HIV+ patient and normal whole blood specimens." The sample size for each group is not specified.
- Method Comparison: "A total of 399 enrolled specimens were tested across 3 sites." Data provenance (country of origin, retrospective/prospective) is not specified.
- Inter-laboratory Reproducibility: "variability across three sites." The number of samples for this study is not explicitly stated, but it likely overlaps with or is a subset of the 399 specimens from the Method Comparison study if performed at the same sites.
- Other analytical studies (Within-site Precision, Linearity, LoB/LoD, LoQ, In-Use Reagent Stability, Equivalency between Incubation Times, Specimen Carryover, Reagent Carryover, Pipette Dispense Accuracy and Precision) do not specify sample sizes or data provenance in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an automated differential cell counter (flow cytometer) for immunophenotyping. The performance studies described involve analytical measurements and comparisons between automated and manual sample preparation, not expert interpretation of outputs to establish ground truth in the same way an imaging AI might. Ground truth for immunophenotyping would typically be derived from the inherent properties of the biological samples or established reference methods.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication is not relevant for the type of performance studies described for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance
Not applicable. An MRMC study is typically for evaluating the diagnostic performance of a device (often imaging AI) when used by human readers, and comparing performance with and without AI assistance. This device is an automated instrument with an automated sample preparation system, not an AI intended to assist human interpretation in a diagnostic workflow where "readers" are involved.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are essentially "standalone" in the sense that they evaluate the performance of the automated system itself (the BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System) in performing immunophenotyping, either against its manually-prepared equivalent or against established analytical standards. There is no human-in-the-loop component described for these performance evaluations.
7. The Type of Ground Truth Used
The ground truth for the performance studies appears to be based on:
- Reference Methods/Established Standards: This is implied by adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP05-A3, CLSI EP6-A, CLSI EP17-A2, CLSI H26-A2, CLSI EP25-A, CLSI EP09c). These guidelines typically involve comparing the device's output to known values, spiked samples, or established reference systems.
- Comparison to Predicate Device: For the "Method Comparison" study, the ground truth is essentially the performance of the predicate device (FACSLyric flow cytometer with manual sample preparation), since the objective is to demonstrate equivalency with the new automated system.
- Inherent Sample Properties: For studies like "Whole Blood Repeatability," the ground truth is the expected inherent stability and consistency of measurements from the human whole blood specimens (HIV+ and normal).
8. The Sample Size for the Training Set
The document does not mention a "training set" as it would for a machine learning or AI device. The validation of the device's performance is described, but the underlying development and calibration data (which might be analogous to a training set for a traditional instrument) are not detailed.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is explicitly mentioned in the context of AI/ML, this question is not applicable. For traditional medical devices, the "ground truth" during development (which could be considered analogous to training) is typically established through rigorous analytical testing and adherence to predefined specifications and accepted scientific principles for instrument calibration and performance.
§ 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.”