(52 days)
Immunophenotyping in clinical laboratories, using previously cleared in vitro . diagnostic assays for flow cytometry.
Identification and enumeration of lymphocyte subsets in human cells in . suspension.
For in vitro diagnostic use. .
For use with or without the BD FACS Sample Prep Assistant II. .
The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer workstation. 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 subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping of assays prepared using the lyse/no-wash method, and BD FACSDiva software for manual immunophenotyping of assays prepared using the lyse/wash method.
The BD FACSCanto II system can optionally be used with the BD FACS Loader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software, and with the BD FACS Sample Prep Assistant II for automatic sample preparation of assays utilizing the lyse/no-wash method.
The BD FACSCanto II system is a modification of the BD FACSCanto system, bearing the same intended use, indications for use, and operating principle as its predicate device. Modifications have been made to the fluidics, optics, and electronics subsystems. Changes were also made to the sample introduction system, the BD FACS Loader option, and to the two software applications. These changes have been made to enhance the system's usability.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the performance studies. Instead, it indicates whether the device met the criteria by stating "acceptable" or "comparable accuracy." The performance is evaluated relative to a predicate device or established CLSI guidelines.
| Study | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Comparable accuracy to predicate device (CLSI EP9-A2) | Demonstrated comparable accuracy relative to the predicate |
| Precision | Acceptable precision (CLSI EP5-A2) | Demonstrated acceptable precision |
| Linearity | Acceptable linearity (CLSI EP6-A) | Demonstrated acceptable linearity |
| % Agreement | Acceptable % agreement (CLSI EP12-A) | Demonstrated acceptable % agreement |
| Reproducibility | Acceptable reproducibility | Demonstrated acceptable reproducibility |
| Carryover | Acceptable carryover (FDA Special Controls Guidance, Dec 4, 2001) | Demonstrated acceptable carryover |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test sets in any of the performance studies (Method Comparison, Precision, Linearity, % Agreement, Reproducibility, Carryover).
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, the studies refer to CLSI (Clinical and Laboratory Standards Institute) documents, which are international standards, implying a robust design. The mention of "patient samples" in the Method Comparison study suggests the use of clinical specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any of the performance studies. It describes various study designs (e.g., "multiple operators" for reproducibility), but not how a definitive "ground truth" was established for each measurement.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any information about the effect size of human readers improving with or without AI assistance. The device is an automated differential cell counter, which implies it performs the analysis rather than assisting human readers in interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, the performance studies described (Method Comparison, Precision, Linearity, % Agreement, Reproducibility, Carryover) represent standalone performance of the BD FACSCanto II system. The system is designed for "automatic immunophenotyping" and "identification and enumeration of lymphocyte subsets," indicating an algorithm-only workflow for these specific functions.
7. The Type of Ground Truth Used
The concept of "ground truth" in this context refers to the reference method or established standard against which the device's performance is compared.
- Method Comparison: The predicate device (BD FACSCanto system) is implicitly the "ground truth" or reference method for comparison.
- Precision, Linearity, % Agreement, Reproducibility, Carryover: For these studies, the "ground truth" is typically defined by the established and validated methods and controls as outlined in the referenced CLSI documents and FDA guidance. This would involve highly accurate and precise reference measurements or accepted ranges for the parameters being tested. For example, in linearity, the "truth" for different concentrations would be prepared reference materials.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This is a 510(k) summary for a modified device, primarily focused on demonstrating substantial equivalence to a predicate. The device performs automated functions based on established flow cytometry principles and likely relies on pre-defined algorithms rather than a dynamically trained AI model in the modern sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or implied to exist in the context of a modern machine learning model, the document does not discuss how ground truth for a training set was established. The device utilizes fixed algorithms for immunophenotyping.
§ 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.”