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The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry. This is the same intended use as previously cleared for the BD FACSCanto system with BD FACSCanto clinical software.

Indications for Use:

• Immunophenotyping in clinical laboratories, using previously cleared IVD I 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*.
• For in vitro diagnostic use.
• For use with or without the BD FACS Sample Prep Assistant II.

The BD FACSCanto system with BD FACSCanto clinical software is a flow cytometry system designed for analyzing samples prepared with the lyse / no-wash method. The BD FACS Sample Prep Assistant II is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA II combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis with a flow cytometer.

The SPA II pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning protocols. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

Device Acceptance Criteria and Study Details:

This document describes the acceptance criteria and study findings for the BD FACSCanto system with BD FACSCanto clinical software, specifically when used with the BD FACS Sample Prep Assistant II (SPA II). The device is intended for the identification and enumeration of lymphocyte subsets in human cells.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided document does not explicitly state numerical acceptance criteria or specific thresholds for "comparable accuracy," "acceptable system precision," or "acceptable system carryover." These are derived from the interpretation of the study design and the reported conclusions. The predicate device (BD FACSCanto system with manual pipetting) serves as the benchmark for comparison.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified in the provided document. The "Accuracy" study mentions "Patient Samples" but does not provide a number.
• Data Provenance: Not specified. It can be inferred that the studies were conducted by the manufacturer, BD Biosciences, but the country of origin of the data (e.g., patient samples) and whether it was retrospective or prospective are not mentioned.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Not applicable. The document describes studies for accuracy, precision, and carryover of a sample preparation system, not for diagnostic interpretation by human experts. Therefore, no experts were used to establish ground truth in the context of diagnostic assessment. The "ground truth" for these studies would be derived from the reference methods outlined in the NCCLS guidelines for accuracy and precision, and specific carryover protocols.

4. Adjudication Method (Test Set):

• Not applicable, as no expert adjudication was involved in these performance studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices where human interpretation is a primary component. The BD FACSCanto system is an automated cell counter, and the studies focus on its analytical performance (accuracy, precision, carryover) relative to a manually operated predicate device, not on improving human reader performance.

6. Standalone (Algorithm Only) Performance:

• Yes, a form of standalone performance was assessed. The studies evaluate the performance of the BD FACSCanto system with the automated BD FACS Sample Prep Assistant II (SPA II) as a complete, integrated system. The SPA II itself is an automation component that replaces manual pipetting. The evaluation implicitly defines its "standalone" performance within the context of the overall system's ability to prepare and analyze samples. The comparison is between the automated preparation method and the manual preparation method using the same core BD FACSCanto system.

7. Type of Ground Truth Used:

• The ground truth for the performance studies would be established using reference methods and guidelines defined by NCCLS (National Committee for Clinical Laboratory Standards) documents EP9-A (Accuracy) and EP5-A (Precision). For carryover, it would be based on Class II Special Controls Guidance Document for Automated Differential Cell Counters. These guidelines provide standardized methods for assessing the analytical performance characteristics of laboratory devices, where "ground truth" is determined by well-controlled experiments and established reference measurements (e.g., highly accurate standard solutions or a gold-standard manual method if applicable, for accuracy studies).

8. Sample Size for the Training Set:

• Not applicable. The provided document concerns the performance evaluation of a device, not the development or training of an AI algorithm on a dataset. Therefore, there is no mention of a "training set" in the context of machine learning.

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

• Not applicable, as no training set for an AI algorithm is mentioned or relevant to the described device and studies.

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The BD FACSCanto System with BD FACSDiva software is intended for use as an In Vitro Diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse wash sample preparation method for flow cytometry.

Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method.
Immunophenotyping of lymphocyte subsets including CD3CD8, CD3 CD4, CD3 CD16* and/or CD56*, CD3 -CD19*, and CD3*.

The BD FACSCanto System with BD FACSDiva software is comprised of a flow cytometer, a wet cart, and a computer. The wet 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 one software package for manual immunophenotyping and is compatible with the BD FACSLoader for automatic sample introduction.

Here's an analysis of the provided text regarding the BD FACSCanto System with BD FACSDiva software, focusing on the requested acceptance criteria and study information:

The provided document is a 510(k) summary for the BD FACSCanto System with BD FACSDiva software. It's important to note that a 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device, rather than proving that a device meets specific, pre-defined acceptance criteria in the same way a novel device might with a comprehensive clinical trial. The performance data presented here are primarily to support this claim of substantial equivalence.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each performance metric in the way a clinical study protocol might. Instead, it refers to industry guidelines and a comparative assessment against a predicate device. The "acceptance criteria" are implied by the statement that the new device "demonstrated comparable accuracy relative to the predicate" or "demonstrated acceptable system precision/carryover/linearity."

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

• Sample Size: The document does not specify the sample size used for any of the performance studies (Accuracy, Precision, Carryover, Linearity).
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. The studies are cited as being based on NCCLS (now CLSI) documents, which are general guidelines for laboratory methods, not specific to a data set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts or the establishment of a ground truth through expert review for any of the performance studies. These types of studies (accuracy, precision, carryover, linearity for a flow cytometer) typically rely on quantitative measurements against known standards or reference methods rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable, as no expert review or adjudication process is mentioned or implied by the type of studies conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The studies listed are technical performance evaluations (accuracy, precision, carryover, linearity) of the instrument itself, not studies involving human readers or AI assistance. The document is for a flow cytometer system, not an image interpretation or diagnostic AI device in the context of human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable in the context of this device. The BD FACSCanto System with BD FACSDiva software is an automated differential cell counter (flow cytometer) that generates quantitative data. While it contains software ("algorithm"), its performance is evaluated in terms of instrument accuracy, precision, linearity, and carryover, rather than a standalone diagnostic "algorithm" that interprets images or makes diagnoses without human interaction in the clinical workflow. Its function is to count and identify cells, which is then used by a human operator for diagnostic purposes.

7. The Type of Ground Truth Used

For the studies mentioned:

• Accuracy: Implied ground truth would be a reference method or predicate device performance, adhering to NCCLS guidance.
• Precision, Carryover, Linearity: Implied ground truth would be quantitative measurements against internal controls, reference materials, or known dilutions, assessed according to NCCLS and FDA guidance documents for these specific performance characteristics of an automated counter. The device's output (cell counts, percentages) is compared against expected values or its own repeatability/reproducibility.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a 510(k) submission for a medical device (flow cytometer system) with associated software, not a machine learning model that typically goes through a distinct training phase on a data set. The software likely contains algorithms and predefined parameters, but these are developed through engineering and design processes, not typically "trained" on a large dataset in the way a modern AI model would be before its performance is evaluated.

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

Not applicable, as no training set (in the context of machine learning) is mentioned or implied. The functional specifications and performance characteristics are likely established through engineering specifications and validation against reference methods during device development.

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