(26 days)
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:
| Study | Acceptance Criteria (Implied from Study Design) | Reported Device Performance |
|---|---|---|
| Accuracy | Based on Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, NCCLS document EP9-A. (Implies the new device's results should be comparable to the predicate device within acceptable bias limits). | The BD FACSCanto system with the BD FACS Sample Prep Assistant II demonstrated comparable accuracy relative to the predicate. |
| Precision | Based on Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline, NCCLS document EP5-A. (Implies the new device should show acceptable repeatability and/or reproducibility). | The BD FACSCanto system with the BD FACS Sample Prep Assistant II demonstrated acceptable system precision. |
| Carryover | Based on recommendations contained in 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. (Implies that carryover of samples should be below a specified acceptable limit). | The BD FACSCanto system with the BD FACS Sample Prep Assistant II demonstrated acceptable system carryover. |
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.
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.