(144 days)
The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device for identification and cnumeration of lymphocyte subsets in human cells in suspension using a lyse no-wash sample preparation method for flow cytometry.
Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method.
Immunophenotyping of lymphocyte subsets including CD3CD8, . CD3CD4, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*
The BD FACSCanto System with BD FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. The fluidics cart contains operational fluids, the flow cytometer acquires and analyzes the sample, and the computer displays and prints the analysis. The flow cytometer utilizes three sub-systems; fluidics, optics and electronics. It contains two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.
The provided text describes the BD FACSCanto System with BD FACSCanto software, an automated differential cell counter. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study | Acceptance Criteria (Implicit from "equivalent/acceptable") | Reported Device Performance |
|---|---|---|
| Accuracy | Comparable accuracy to the predicate device | The BD FACSCanto with BD FACSCanto software demonstrated comparable accuracy relative to the predicate. |
| Precision | Acceptable system precision | The BD FACSCanto with BD FACSCanto software demonstrated acceptable system precision. |
| Linearity | Acceptable system linearity | The BD FACSCanto with BD FACSCanto software demonstrated acceptable system linearity. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the accuracy, precision, and linearity studies (test sets). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the studies). It only refers to NCCLS documents for the study designs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the test set. Given the nature of the device (automated cell counter), ground truth for performance studies typically involves comparison to a gold standard method or highly calibrated reference instruments, rather than direct expert consensus on images.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance studies focus on the device's accuracy, precision, and linearity as a standalone automated system, not on its assistance to human readers.
6. Standalone Performance (Algorithm only without human-in-the-loop performance):
Yes, the performance studies described (accuracy, precision, linearity) represent standalone performance of the BD FACSCanto System. The device is an "Automated differential cell counter," implying its function is to perform cell counting and immunophenotyping automatically without direct human intervention in the primary measurement.
7. Type of Ground Truth Used:
The document refers to NCCLS (National Committee for Clinical Laboratory Standards) documents (now CLSI - Clinical and Laboratory Standards Institute) for study design. For an automated differential cell counter, ground truth for accuracy, precision, and linearity is typically established by:
- Reference Methods: Comparing the device's results to a recognized gold standard method or another highly accurate and precise instrument.
- Certified Reference Materials: Using materials with known and verified concentrations or characteristics.
- Inter-laboratory Concordance: Comparing results across multiple well-controlled laboratories or instruments.
The document states the device "demonstrated comparable accuracy relative to the predicate," suggesting the predicate device or its established performance served as a form of ground truth or benchmark.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. This type of device (flow cytometer with software for immunophenotyping) often relies on established algorithms and calibration rather than a machine learning "training set" in the modern sense. If there were any learning components, they are not detailed here.
9. How the Ground Truth for the Training Set Was Established:
Since no training set information is provided, there is no description of how ground truth was established for it.
§ 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.”