(269 days)
The BD FACSCanto flow cytometer (4-3-3 configuration) functions as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (640 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III.
For in vitro diagnostic use.
The BD FACSCanto II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III.
For in vitro diagnostic use.
The BD FACSCanto and FACSCanto II (BD FACSCanto II 4-2-2, BD FACSCanto II 5-3 and BD FACSCanto 4-3-3 configurations) are comprised of a flow cytometer, a fluidics cart, and a computer workstation. The flow cytometer acquires and analyzes the sample, the fluidics cart contains operational fluids, 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 assays prepared using the lyse/wash or lyse/no-wash methods, and BD FACSDiva software for installation, service, and manual user-validated applications. The BD FACSCanto and FACSCanto II systems can optionally be used with the BD FACSLoader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software and BD FACSDiva software, and/or the BD FACS Sample Prep Assistant III for automatic sample preparation of assays utilizing the lyse/no-wash method.
The provided text describes a 510(k) premarket notification for the BD FACSCanto and BD FACSCanto II flow cytometers. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The document outlines comparisons between the new configurations and the predicate devices, with emphasis on the performance of IVD (In Vitro Diagnostic) channels.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., a required sensitivity or specificity threshold) with corresponding reported device performance values for the new configurations compared to the predicate device. Instead, it states that the new configurations demonstrated "equivalent performance to the predicate" for various studies. This "equivalent performance" implicitly serves as the acceptance criterion.
| Study Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy/Method Comparison | Equivalent performance to the predicate device. | The BD FACSCanto II system 4-2-2 and 5-3 configurations and BD FACSCanto system 4-3-3 configuration demonstrated equivalent performance to the predicate for the BD Multitest™ IMK Kit (4-color) and BD Multitest™ 6-color TBNK (with Trucount™) assays. |
| Precision | Equivalent performance to the predicate device. | Assay dependent. The BD FACSCanto II system 4-2-2 and 5-3 configurations and BD FACSCanto system 4-3-3 configuration demonstrated equivalent performance to the predicate for the BD Multitest IMK Kit (4-color) and BD Multitest 6-color TBNK (with Trucount) assays. |
| Linearity | Equivalent performance to the predicate device. | Assay- dependent. The BD FACSCanto II system 4-2-2 and 5-3 configurations and BD FACSCanto system 4-3-3 configuration demonstrated equivalent performance to the predicate for the BD Multitest IMK Kit (4-color) and BD Multitest 6-color TBNK (with Trucount) assays. |
| Carryover | Mean carryover met the acceptance criteria described (unspecified). | The mean carryover measured from manual acquisition and the mean carryover from Loader acquisition both met the acceptance criteria described. (The specific numerical acceptance criteria for carryover are not provided in the document, but the device reportedly met them.) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document refers to "patient samples" for the Accuracy/Method Comparison study, "assay dependent" for Precision and Linearity, and "Three samples with a high White Blood Cell concentration" and "three low WBC concentration samples" for the Carryover study.
- Accuracy/Method Comparison: "patient samples" - The specific number of samples is not provided. Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical samples for IVD assays.
- Precision: "Assay dependent" - Specific sample size is not provided. Data provenance is not explicitly stated.
- Linearity: "Assay- dependent" - Specific sample size is not provided. Data provenance is not explicitly stated.
- Carryover: 6 samples (3 high WBC, 3 low WBC) - Data provenance is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies performed are instrument performance evaluations, comparing the new device configurations to the predicate device, rather than comparing to a diagnostic ground truth established by experts. The "ground truth" implicitly relies on the established performance of the predicate device.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the studies are technical performance comparisons of the device itself rather than interpretation by human readers, an adjudication method in the context of expert review would likely not be applicable.
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
This document describes a flow cytometer, which is an instrument for identifying and enumerating cell subsets. It is not an AI-assisted diagnostic tool that human readers would use to interpret images or data in a comparative effectiveness study involving improving diagnostic accuracy. Therefore, an MRMC comparative effectiveness study with human readers improving with AI assistance is not applicable and was not done in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone instrument (flow cytometer) with dedicated clinical software. The performance data presented (accuracy/method comparison, precision, linearity, carryover) represents the standalone performance of the instrument configurations (new vs. predicate). There is no "human-in-the-loop" aspect being evaluated in these specific performance studies, as the instrument performs the measurement and analysis for IVD assays.
7. The Type of Ground Truth Used
For the performance studies (Accuracy/Method Comparison, Precision, Linearity), the "ground truth" is effectively the performance of the legally marketed predicate device (BD FACSCanto 4-2 configuration), as the goal is to demonstrate "equivalent performance." For the Carryover study, the ground truth would be the actual concentration values and the calculated carryover, which is an intrinsic characteristic of the instrument's fluidics and detection system.
8. The Sample Size for the Training Set
This information is not provided. The document describes new configurations of an existing flow cytometer system and its software, demonstrating substantial equivalence to a predicate device. It does not mention machine learning or AI models undergoing a 'training' phase in the traditional sense, for which a training set size would be relevant. The software performs automated immunophenotyping based on established algorithms rather than adaptive learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the context of machine learning is not mentioned as part of this submission, the method for establishing its ground truth is not applicable/not provided. The software algorithms integral to the device's function are based on engineering design and validation, not on a machine learning training paradigm.
§ 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.”