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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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The beads are for use on a BD FACSCanto™ flow cytometer equipped with BD FACSCanto software. The beads are used to adjust detector voltages, to set fluorescence compensation and to monitor daily instrument performance. For In Vitro Diagnostic Use.

BD FACS 7-color setup beads are intended for use on the BD FACSCanto flow cytometer equipped with a 488-nm blue laser, a 633-nm red laser, and six fluorescence detectors. BD FACS 7-color setup beads are provided as a lyophilized pellet contained in 25 individually packaged test tubes along with a bottle of BD FACS setup bead diluent.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" sample size. The reproducibility study was conducted using "three bead lots," which serves as the sample size for evaluating lot-to-lot consistency. The data provenance is Becton Dickinson Immunocytometry Systems laboratories in San Jose, California, suggesting a prospective, in-house study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This document does not indicate the involvement of external experts to establish ground truth for a test set. The performance data seems to be based on internal laboratory testing and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a ground truth established by experts or a need for adjudication in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is a set of quality control beads for a flow cytometer, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical product (beads) for instrument setup and monitoring, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for performance evaluation appears to be based on established laboratory testing methods for stability and reproducibility, with a comparison to the performance of a legally marketed predicate device (CaliBRITE™ beads).

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm that requires a training set.

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MultiTEST CD3/CD16+56/CD45/CD19 and MultiTEST IMK kit

• For use with Becton Dickinson FAC® flow cytometers equipped with a blue (488-nm) and red diode (635-nm) laser.
• Monoclonal antibody reagents for identification and enumeration of mature human lymphocyte subsets in peripheral blood of normal individuals and patients with certain immune dysfunction.
• MultiTEST CD3/CD16+56/CD45/CD19 provides percentages and absolute counts of T (CD3'), NK(CD3 CD16'CD56'), and B (CD3'CD19') lymphocytes.
• MultiTEST CD3/CD8/CD45/CD4 provides percentages and absolute counts of T (CD3*), helper/inducer T (CD3CD4) and suppressor/cytotoxic T (CD3CD8) lymphocytes.
• For use with erythrocyte lysed whole blood without an isotype control.
• To characterize and monitor forms of auto immune diseases, such as lupus.
• To characterize and monitor congenital or acquired immunodeficiences, such as SCID or AIDS.
• For in vitro diagnostic use

The Becton Dickinson CD3 fluorescein isothiocyanate (FITC)/CD16+56 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP)/CD19 allophycocyanin (APC) reagent is a four-color, direct immunofluorescence reagent for identifying and enumerating percentages and absolute counts of CD3+ T lymphocytes, CD3-CD16+56+ natural killer (NK), and CD3-CD19+ B lymphocyte subsets in erythrocyte-lysed whole blood. Each vial of reagent yields 50 tests. The reagent is intended for use on the Becton Dickinson FACSort™ or FACSCalibur™ flow cytometers equipped with the FL4 Option, the Apple® Macintosh® Quadra or PowerPC computer, and CELLQuest™ or MultiSET™ software. Daily instrument set-up requires CaliBRITE™ beads (unlabeled, FITC, PE, PerCP, and APC) and FACSComp™ software. The four-color method permits the identification and enumeration of T, NK, and B lymphocyte subsets using MultiSET software's expert lymphocyte gate and automated single-tube quality control algorithms. A lymphocyte gate is drawn for the CD45 * leucocytes with low side scatter and the lymphocyte subsets are provided as an absolute count or percentage of total lymphocytes.

This document describes the performance data for the Becton Dickinson MultiTEST CD3/CD16+56/CD45/CD19 and MultiTEST IMK Kit, which are flow cytometry reagents used for identifying and enumerating lymphocyte subsets. The goal of the studies was to demonstrate substantial equivalence to predicate devices (TriTEST CD3/CD16+56/CD45 and TriTEST CD3/CD19/CD45).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with specific numerical thresholds (e.g., a certain percentage agreement or coefficient of variation). Instead, the studies conclude that the performance is "acceptable" or "equivalent" to the predicate devices. The reported device performance is based on these qualitative assessments.

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

• Accuracy Study:

  • Sample Size: 129 lysed whole blood (LWB) specimens.
    • 70 normal donors
    • 59 abnormal donors
  • Data Provenance: The study was conducted at two clinical sites, indicating prospective collection from human subjects. The country of origin is not specified but implied to be the US given the FDA submission.

• Within-site Reproducibility:

  • Sample Size: LWB specimens from 3 normal and 6 abnormal donors (total 9 donors). Each specimen was divided into 10 aliquots.
  • Data Provenance: Not explicitly stated but likely prospective data from human subjects.

• Across-site Reproducibility:

  • Sample Size: LWB specimens from a total of 16 normal and 30 abnormal donors (total 46 donors). Each specimen was divided into 5 aliquots.
  • Data Provenance: Conducted at three clinical sites, indicating prospective collection from human subjects.

• Stability Studies:

  • Sample Size: Samples from 10 normal and 20 abnormal donors (total 30 donors).
  • Data Provenance: Not explicitly stated but likely prospective data from human subjects.

• Linearity and Recovery:

  • Sample Size: Blood specimens from 3 normal donors.
  • Data Provenance: Not explicitly stated but likely prospective data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not describe the use of human experts to establish "ground truth" in the traditional sense (e.g., radiologists interpreting images). For flow cytometry reagents, the "ground truth" and comparison are typically established by comparing the results of the new device to a legally marketed predicate device (which itself would have established its performance against other methods or clinical outcomes), or by established laboratory reference methods. In this case, the test set's ground truth for accuracy was based on the performance of the predicate devices. The "normal" and "abnormal" classifications of the donor samples would likely be based on clinical diagnosis or established laboratory ranges, but no explicit expert involvement in defining the ground truth for each individual sample's classification is mentioned beyond the comparison to the predicate.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" in this context refers to the comparison of the new device's results with those of the predicate device, or established reference methods in a laboratory setting. There is no mention of a human adjudication process by multiple experts for discrepancies in interpretations.

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

Not applicable. This is not a study involving human readers interpreting medical images or data with or without AI assistance. It's a performance study of diagnostic reagents used in flow cytometry.

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

This study evaluates the performance of a diagnostic reagent kit in conjunction with specific flow cytometers and software (Becton Dickinson FACSort or FACSCalibur flow cytometers, Apple Macintosh computers, CELLQuest™ or MultiSET™ software). While the software includes "expert lymphocyte gate and automated single-tube quality control algorithms," the overall system involves human operation and interpretation of the flow cytometer output. Therefore, it is not a "standalone algorithm only" study in the sense of a fully automated AI system without human interaction. The performance is of the device (reagent kit + specific instrumentation/software) as an integrated system in a laboratory setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary "ground truth" for the accuracy study was the results obtained from the predicate devices (TriTEST CD3/CD16+56/CD45 and TriTEST CD3/CD19/CD45). The study aimed to demonstrate "equivalence" to these already-marketed and accepted devices. For the other studies (reproducibility, stability, linearity), the "ground truth" would be inherent in the expected biological or technical performance for those assays, often against established laboratory controls or expected ranges. The classification of samples as "normal" or "abnormal" would be based on clinical criteria and laboratory values but not necessarily a separate "expert consensus" on the specific flow cytometry results themselves for the purpose of validating the device.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" as it would apply to a machine learning algorithm. This submission describes the validation of a laboratory reagent and associated instrumentation/software, where the "algorithms" (e.g., for gating) are likely rule-based or pre-programmed, rather than learned from a large, labeled training dataset.

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

Not applicable, as a distinct "training set" and associated ground truth establishment process, typical for machine learning models, is not described for this device. The software's "expert lymphocyte gate and automated single-tube quality control algorithms" would have been developed based on scientific understanding of cell populations and validated through internal R&D processes, rather than a single, distinct "training set" in the AI sense.

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For the FACS® family of flow cytometers equipped with a blue (488-nm) and a red t diode (635-nm) laser.
A monoclonal antibody reagent for identification and enumeration of mature human T . lymphocyte subsers in human peripheral blood.
For use with crythrocyte lysed whole blood. .
To characterize and monitor forms of autoimmune diseases, such as lupus. .
To characterize and monitof congenital or acquired immunodeficiencies, such as . SCID or AIDS.
For in vitro diagnostic use.

The Becton Dickinson CD3 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP)/CD4 allophycocyanin (APC) reagent is a four-color, direct immunofluorescence reagent for identifying and enumerating percentages of CD3+ T Lymphocytes, CD3+CD4+ helper/inducer, and CD3+CD8+ suppresser/cyroroxic T-Lymphocyte subscts in erythrocyce-lysed whole blood. Each vial of reagent yields 50 tests. The reagent is intended for use on the Becton Dickinson FACSCalibur 10 flow cycomerers equipped with the FL4 Option, the Apple Macintosh Quadra or PowerPC computer, and CELLQuest or MultiSET software. Daily instrument set-up requires CaliBRITE beads (unlabeled, FITC, PE, Per CP, and APC) and FACSComp software.

Here's an analysis of the provided text to extract the acceptance criteria and supporting study details:

Note: The provided document is a 510(k) summary for a medical device (MultiTEST CD3/CD8/CD45/CD4 reagent). These summaries often focus on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" and then proving each one. Instead, they describe performance testing to show the new device is "as safe and effective" as the predicate. Therefore, the "acceptance criteria" in this context are interpreted from the performance claims and the comparison to an equivalent device. The "reported device performance" is the general finding of "acceptable" or "equivalent" performance in each study.

Acceptance Criteria and Study Details for MultiTEST CD3/CD8/CD45/CD4 Reagent

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Accuracy Study: 129 specimens (70 normal, 59 abnormal).
• Within-site Reproducibility Study: 9 donors (3 normal, 6 abnormal), with each specimen divided into 10 aliquots (total 90 samples tested).
• Across-site Reproducibility Study: 46 donors (15 normal, 31 abnormal), with each specimen divided into 5 aliquots (total 230 samples tested).
• Stability Studies: 30 donors (10 normal, 20 abnormal).
• Linearity and Recovery Study: 3 normal donors.

Data Provenance: The studies were performed at:

• Children's Memorial Hospital, Chicago, Illinois (USA)
• Covance Central Laboratory, Indiana (USA)
• Cleveland Clinic Foundation, Cleveland, Ohio (USA)
• Becton Dickinson Immunocytometry Systems, San Jose, California (USA)

The data appears to be prospective for the purpose of demonstrating device performance, as these were specific studies designed for the 510(k) submission.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth for the test set in the conventional sense of human readers for an image. For flow cytometry, "ground truth" is typically established by the reference method (e.g., the predicate device or a clinical laboratory's established procedures for manual cell counting/analysis) and the technical accuracy of the instrument. The "performance data" section describes the studies comparing the new device against the predicate or expected biological ranges.

4. Adjudication Method (Test Set)

Not applicable. This is not a study requiring adjudication by human readers for diagnostic interpretation. The "adjudication" is internal to the flow cytometer's software (MultiSET software's single-tube fluorescence gating and automated quality control algorithms) and comparison to predicate device results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging diagnostics where human readers interpret images with and without AI assistance. This device is a diagnostic reagent for flow cytometry, which involves automated enumeration of cell populations rather than human interpretation of complex images.

6. Standalone Performance Study

Yes, a standalone performance was done for various aspects of the device's function:

• Accuracy: Comparing the new 4-color reagent to the predicate 3-color reagents using the same specimen.
• Reproducibility (within-site and across-site): Assessing the consistency of results generated by the device.
• Stability: Evaluating the device's performance under different storage conditions.
• Linearity and Recovery: Determining the device's ability to accurately measure cell concentrations across a range.

These studies assess the device's performance in isolation with human involvement mainly in sample preparation and operation.

7. Type of Ground Truth Used

The primary ground truth used for the performance studies was comparison to a legally marketed predicate device. Specifically:

• For accuracy, the results from the new device (MultiTEST CD3/CD45/CD4) were compared to those obtained using the predicate devices (TriTEST CD3/CD8/CD45 and TriTEST CD3/CD4/CD45).
• For other performance metrics (reproducibility, stability, linearity), the ground truth was implied by the expected biological ranges for "normal" and "abnormal" donors and the device's ability to consistently and accurately measure these populations against established laboratory methods.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" for an algorithm in the way that an AI deep learning model would have. The "MultiSET software" includes automated quality control algorithms, but no details are given about a distinct training set for these algorithms. The development of such software would have involved internal validation and calibration using various samples, but this information is not disclosed in the 510(k) summary.

9. How Ground Truth for the Training Set Was Established

As no specific training set is outlined in the document, how ground truth for such a set was established is not provided. If the "MultiSET software" involved machine learning or complex algorithms, its development would have required internal validation and calibration, likely using well-characterized samples or a gold standard method. However, this is outside the scope of the information provided in the 510(k) summary.

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For flow cytometer set up and monitoring of instrument performance prior to performing reticulocyte ennumeration or immunophenotyping applications. Flow cytometry has been found useful in monitoring some forms of immune disease.

For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur).

An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping.

For adjusting instrument settings: aligning the signal from the blue and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time.

For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals.

For monitoring the sensitivity of the side scatter (SSC) and fluorescence (FLI, FL2, FL3, and FL4) detectors and verifying adequate separation of system noise from forward scatter (FSC) signals.

For in vitro diagnostic use.

Becton Dickinson FACSComp software and the CaliBRITE 4 bead kir (FACSComp/CaliBRITE 4) are intended for use on the Becton Dickinson flow cytometers, FACSort™ or FACSCalibur™, equipped with the FL4 Option. FACSComp/CaliBRITE 4 are used to check laser alignment, optimally adjust instrument settings, monitor sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp/CaliBRITE 4 are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with four fluorescence (FL) channels FACSComp/CaliBRITE 4 is used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on flow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. The CaliBRITE beads are provided as a separate vial of CaliBRITE APC beads and the four-vial CaliBRITE 3 kit, comprised of unstained, FITC-, PE- and PerCP-labeled beads.

The provided text describes the Becton Dickinson Immunocytometry Systems (BDIS) CaliBRITE™ APC beads, CaliBRITE 4 kit, and FACSComp™ software. This 510(k) submission (K973483) specifically aims to demonstrate substantial equivalence to a predicate device, the CaliBRITE™ 3 kit and FACSComp™ software (K961623).

The summary indicates that the new device is essentially the predicate device plus an additional component, the CaliBRITE APC beads, designed to facilitate the setup of the FL4 Option on certain flow cytometers. Due to this nature, the "acceptance criteria" and "device performance" are framed around demonstrating equivalence to the predicate device and the stability and reproducibility of the new components/system.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance of the predicate device and the stability/reproducibility of the new system. The document does not explicitly list numerical acceptance criteria with target values. Instead, it states that the performance was "equivalent to the predicate device" for reproducibility aspects and provides stability durations.

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

• Sample Size: The document does not explicitly state the sample size (number of runs, number of beads tested, etc.) for the reproducibility or stability studies. It only mentions "Several studies were performed."
• Data Provenance: The testing was "at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California." This indicates the data is retrospective (performed as part of device development/verification) and from a single country of origin (USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of device (flow cytometer calibration beads and software) does not typically involve human expert interpretation for establishing "ground truth" in the way, for example, an imaging diagnostic AI would. The "ground truth" here is the expected performance of a well-calibrated flow cytometer, based on physical and chemical properties of the beads and the instrument's known specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, human adjudication is not relevant for this type of device and its performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for a calibration product like the CaliBRITE system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a calibration system used to set up and monitor flow cytometers. The FACSComp software automates certain tasks (e.g., setting PMT voltages, fluorescence compensation), which could be considered an "algorithm only" component in its execution of these tasks. However, its overall function is to prepare the instrument for human operators to then run diagnostic tests. The performance data presented focuses on the consistency and stability of this automated setup. It isn't a standalone diagnostic algorithm that produces a medical output without human oversight of the instrument's readiness.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Instrument Specifications: The expected ideal readings for properly calibrated flow cytometers using the CaliBRITE beads.
• Predicate Device Performance: The established performance characteristics of the CaliBRITE 3 kit and FACSComp software (K961623) served as the benchmark for "equivalence."
• Physical/Chemical Properties: The known characteristics of the fluorescent beads themselves (e.g., their fluorescence intensity) are inherent ground truth for their intended use in calibration.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model in the contemporary sense that requires a "training set" of data. It's a calibration system whose "logic" or algorithms are based on established flow cytometry principles, not on learned patterns from a large dataset.

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

Not applicable, as there is no "training set" in the context of this device.

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For in vitro diagnostic use to identify and enumerate absolute counts of T lymphocyte (CD3+), helper/inducer T lymphocyte (CD3+CD4+) and suppressor/cytotoxic T lymphocyte (CD3+CD8+) subsets in blood.

• For use with any flow cytometer equipped with a 488 nm last and capable of detection in . the ranges: 515-545 nm, 562-607 nm, and >650 nm
• For use with erythrocyte lysed whole blood .
• For in vitro diagnostic use .
• To identify and enumerate absolute counts of CD3+ and CD3+CD4+ and CD3+CD8+ . lymphocytes
• To characterize and monitor some forms of immunodeficiency, such as in HIV infected . individuals
• To characterize and monitor some forms of autoimmune diseases .

The BDIS TriTEST CD4 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD3 peridinin chlorophyll protein (PerCP) reagent is a three-color, direct immunofluorescence reagent. When used with TRUCOUNT Absolute Count Tubes it is used for identifying and enumerating absolute counts of I lymphocytes (CD3+), helper/inducer T lymphocytes (CD3+CD4+) and suppressor/cytotoxic I lymphocytes (CD3+CD8+) in erythrocyte-lysed whole blood (LWB). The Becton Dickinson TnTEST / TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (Tril EST CD4 FITC/CD8 PE/CD3 PeCP) and TRUCOUNT Absolute Count Tubes.

The process to obtain T lymphocyte subset absolute counts includes: 1) obtaining a whole blood sample, 2) adding a precise volume of whole blood directly to the Absolute Count Tube, 3) cell-surface antigen staining with three-color monoclonal antibody reagents, 4) erythrocyte lysis, and 5) flow cytometric acquisition and analysis of list mode data. Analysis for absolute counts requires that the bead region be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is I x (beads/pellet)/(volume of blood sample).

Here's an analysis of the provided text, extracting the requested information about the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance Study for BDIS TriTEST™ Reagent with TRUCOUNT Absolute Count Tubes

This submission does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (FACSCount cleared under K933486). The "acceptance criteria" are therefore inferred as achieving performance equivalent to or demonstrably safe and effective as the predicate device for the specified indications for use.

The study aims to establish this equivalence, particularly for identifying and enumerating absolute counts of T lymphocytes (CD3+), helper/inducer T lymphocytes (CD3+CD4+), and suppressor/cytotoxic T lymphocytes (CD3+CD8+).

1. Table of Acceptance Criteria and Reported Device Performance

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For in vitro diagnostic use to identify and enumerate percentages and absolute counts of T and NK lymphocytes in blood.

For use with any flow cytometer with specified detection ranges.
For use with erythrocyte lysed whole blood.
For use with or without an isotype control.
For in vitro diagnostic use.
To identify and enumerate percentages and absolute counts of CD3+ and CD16+CD56+ lymphocytes in normal individuals and patients with certain tumors and viral infections

The BDIS TriTEST CD3 fluorescein isothiocyanate (FITC)/CD16+CD56 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Natural Killer lymphocytes (CD3- and CD16+ and/or CD56+) in erythrocytelysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/uL. The Becton Dickinson TriTEST/TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (TriTEST CD3 FITC/CD16+CD56 PE/CD45 PerCP) and TRUCOUNT Absolute Count Tubes.

The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow cytometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events to the CD45 positive events, and expressing the ratio as a percentage.

To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, the bead region, be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is P x (beads/pellet)/(volume of blood sample).

When monoclonal antibody reagents are added to human whole blood, the fluorochromelabeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam.

The three-color reagent permits identification of lymphocyte subsets using fluorescence gating instead of scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gating on the CD45-positive population, a maximum number of lymphocytes may be captured in the gate and non-lymphocyte contamination may be minimized.

This document describes the Becton Dickinson TriTEST™ reagent CD3 FITC/CD16+CD56 PE/CD45 PaCP; TRUCOUNTTM Absolute Count Tubes.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table. Instead, it describes performance characteristics and concludes that the device is "as safe and effective as the predicate device" based on these studies. The equivalence to predicate devices (Simultest IMK-Lymphocyte Tube F for percentages, and Simultest IMK-Lymphocyte Tube F plus ADCC for absolute counts) is the primary "acceptance criterion" indirectly.

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

The document provides some information about sample sizes but is not comprehensive for all studies.

• Accuracy Studies: Not explicitly stated. The studies were performed at "Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina, and at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California." This implies a prospective design across multiple geographical locations (USA and potentially international due to "Institute of Tropical Medicine").
• Within-specimen Reproducibility:
  • BDIS: 10 replicates from 3 specimens.
  • 3 Clinical Sites: 3 aliquots from each donor (number of donors not specified).
• Linearity: Blood samples from 3 normal donors.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number of experts or their qualifications used to establish ground truth. It mentions "testing at Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina, and at Becton Dickinson Immunocytometry Systems laboratories." This implies clinical laboratory professionals were involved, but their specific roles, number, and qualifications (e.g., medical technologists, pathologists, immunologists, experience levels) are not detailed.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or resolving discrepancies in the test results. The studies focused on demonstrating equivalence to predicate methods, implying direct comparison rather than a separate expert-driven ground truth adjudication process.

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 device is not an AI-assisted diagnostic tool. It is a reagent and system for flow cytometry. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The device is a system comprising reagents, tubes, and analysis performed on a flow cytometer. While the analysis part involves computing ratios and identifying regions, it's not described as a standalone "algorithm" in the modern AI sense. The performance assessment implicitly covers the entire system's ability to enumerate cell populations, which is an automated process once the sample is prepared and run on the flow cytometer.

7. The Type of Ground Truth Used:

The ground truth for establishing performance (particularly accuracy) was based on comparison to predicate devices/methods:

• For percentages: Simultest IMK-Lymphocyte Tube F.
• For absolute counts: Simultest IMK-Lymphocyte Tube F plus automated differential cell counter (ADCC).

This is a clinical comparison against established and predicate laboratory methods, rather than pathology, expert consensus (in the sense of independent review of an image), or outcomes data.

8. The Sample Size for the Training Set:

The concept of a "training set" in the context of machine learning or AI algorithms is not applicable here. This device is a biochemical reagent and flow cytometry system, not a learning algorithm. The studies described are performance validation studies, not training.

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

As mentioned above, there is no "training set" in the AI sense for this device. The performance was validated against established predicate methods.

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For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD8+ lymphocytes in blood.
For use with any flow cytometer equipped with a 488 mm laser and capable of detection in the ranges: 515-545 nm, 562-607 nm, and > 650 nm.
For use with erythrocyte lysed whole blood.
For use with or without an isotype control.
To characterize and monitor forms of autoimmune diseases, such as lupus.
To characterize and monitor congenital or acquired immunodeficiencies, such as SCID or AIDS.

The BDIS Trilles T CD3 flucescein isothiocyanate (FITC)/CD8 phycocrythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunoflucrescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Tsuppressor/cytotoxic (CD3+CD8+) cells in eythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/JL. The Becon Dickinson Trill BT/TRUCOUNT system for immunophenoryping consists of a flow cycometer (either from BDIS or from another manufacture), conjugated monoclonal reagent (TriTEST CD3 FITC/CD8 PE/CD45 PerCP) and TRICOUNT Absolute Count Tubes.
The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow crometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events to the CD45 positive events, and expressing the ratio as a percentage.
To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, the bead region, be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is I x (beads/pellet)/(volume of blood sample).
When monoclonal antibody reagents are added to human whole blood, the flucrochrome-labeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluctochrome-labeled antibodies and the crythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excired by a laser beam.
The three-color reagent permits identification of lymphocyte subsers using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45positive population using a combination of fluorescence and side scatter parameters. By gaing on the CD45-positive population, a maximum number of lymphocyces may be caprured in the gate and non-lymphocyte contamination may be minimized.

The provided text describes the Becton Dickinson TriTEST™ reagent and TRUCOUNT™ Absolute Count Tubes system. This device is intended for in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD8+ lymphocytes in blood using flow cytometry. The primary claim in the document is about substantial equivalence to predicate devices rather than meeting specific performance criteria against predefined thresholds.

Therefore, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate devices, IMK-Lymphocyte Tube E and the FACSCount System. The "reported device performance" is framed as its equivalence to these predicate devices.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

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For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD4+ lymphocytes in blood.
For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 515-545 nm, 562-607 nm, and > 650 nm.
For use with erythrocyte-lysed peripheral whole blood.
For use with or without an isotype control.
To characterize and monitor some forms of autoimmune disease.
To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals.

The BDIS TriTEST CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and T-helper (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/UL. The Becton Dickinson TriTEST/TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacture), conjugated monoclonal reagent (TriTEST CD3 FITC/CD4 PE/CD45 PerCP) and TRUCOUNT Absolute Count Tubes.
The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow cytometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events (CD3+CD4+) to the CD45 positive events, and expressing the ratio as a percentage.
To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is P x (beads/pellet)/(volume of blood sample).
When monoclonal antibody reagents are added to human whole blood, the fluorochrome-labeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam.
The three-color reagent permits identification of lymphocyte subsets using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gating on the CD45-positive population, a maximum number of lymphocytes may be captured in the gate and non-lymphocyte contamination may be minimized.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device Name: Becton Dickinson TriTEST24 reagent CD3 FITC/CD4 PE/CD45 PerCP; TRUCOUNTTM Absolute Count Tubes

Intended Use: For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD4+ lymphocytes in blood.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a clear, quantitative manner. Instead, performance is generally described in terms of "equivalence," "acceptable," and "good correlation" compared to a predicate device or expected behavior.

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For in vitro diagnostic use to identify and enumerate percentages and absolute counts of T and B lymphocytes in bload.

Indications for Use

• For use with any flow cytometer with specified detection ranges .
• For use with erythrocyte lysed whole blood .
• For use with or without an isotype control .
• For in vitro diagnostic use .
• To identify and enumerate percentages and absolute counts of CD3+ and CD19+ ● lymphocytes
• To characterize and monitor some forms of immunodeficiency .
• To characterize and monitor some forms of autoimmune diseases .

The BDIS TriTEST CD3 fluorescein isothiocyanate (FITC)/CD19 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and B lymphocytes (CD19+) in eythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/uL. The Becton Dickinson Tril EST / TRUCOUNT system for immunophenotyping consists of a flow cytometer (cither from BDIS or from another manufacturer), conjugated monoclonal reagent (TriTEST CD3 FITC/CD19 PE/CD45 PeCP) and TRUCOUNT Absolute Count Tubes.

The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow cytometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events (CD3+ and CD19+) to the CD45 positive events, and expressing the ratio as a percentage.

To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, the bead region, be identified and the events in this region counted. The proportion of reagent positive events to be identified and are trated. The absolute count is P x (beads/pellet)/(volume of blood sample).

When monoclonal antibody reagents are added to human whole blood, the fluorochromelabeled antibodies bind specifically to antigens on the surface of leucocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead peller and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam.

The three-color reagent permits identification of lymphocyte subsets using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gating on the CD45-positive population, a maximum number of lymphocytes may be captured in the gate and non-lymphocyte contamination may be minimized.

The Becton Dickinson TriTEST reagent CD3 FITC/CD19 PE/CD45 PerCP with TRUCOUNT Absolute Count Tubes received 510(k) clearance (K970742) in 1997. The device is intended for in vitro diagnostic use to identify and enumerate percentages and absolute counts of T and B lymphocytes in erythrocyte-lysed whole blood, and to characterize and monitor some forms of immunodeficiency and autoimmune diseases.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

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

• Accuracy: Not explicitly stated for accuracy comparison, but implies a sufficient number of samples were tested to demonstrate equivalence.
• Isotype Control: Sample size not explicitly stated.
• Reproducibility (Within-specimen):
  • BDIS Internal Study: 3 samples (1 high, 1 medium, 1 low concentration of T and B lymphocytes), with 10 replicates each.
  • Clinical Site Study: 92 donors for CD3+ and 80 donors for CD19+, with 3 aliquots assessed from each donor.
• Linearity: Blood samples from 3 normal donors.
• Data Provenance: Studies were performed at Cleveland Clinic, Johns Hopkins Hospital, Institute for Medical Research at the University of North Carolina, and at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California. This indicates a mix of external clinical sites and internal company labs, suggesting prospective data collection for these specific studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided text does not specify the number or qualifications of experts used to establish the ground truth for the test set. Given the nature of the device (flow cytometry for lymphocyte enumeration), the ground truth would likely be established through comparisons with established methods and/or expert review of flow cytometry plots.

4. Adjudication Method for the Test Set

The provided text does not specify any explicit adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

An MRMC study was not done. The device's performance was compared to a predicate device (Simultest™ IMK-Lymphocyte Tube C plus ADCC and the hematology analyzer) and internal reproducibility studies, not through a study involving multiple human readers with and without AI assistance to measure improvement in human performance.

6. Standalone (Algorithm Only) Performance

This device is a reagent and tube system for use with a flow cytometer. Its performance is intrinsically linked to the overall system (reagent, sample preparation, flow cytometer, and analysis software). Therefore, a "standalone algorithm only" performance study in the sense of a pure AI algorithm is not applicable to this type of medical device. The performance data presented (accuracy, reproducibility, linearity, etc.) inherently reflect the "algorithm only" performance within the context of the complete TriTEST/TRUCOUNT system.

7. Type of Ground Truth Used

The primary ground truth used for the performance studies appears to be:

• Comparison to Predicate Device: For accuracy, the device was compared against the established Simultest™ IMK-Lymphocyte Tube C plus ADCC. This implies that the predicate device's results serve as a form of "ground truth" for demonstrating equivalence.
• Internal Consistency/Expected Biological Ranges: For reproducibility, stability, and linearity, the ground truth is based on the expectation of consistent results from the same sample or linear responses over dilution ranges, consistent with established biological principles and laboratory practices.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For in vitro diagnostic reagents and systems like this, the development process (which might involve data analogous to a training set) is not typically detailed in terms of sample size in a 510(k) summary. The performance data presented are from validation studies, which are akin to testing.

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

As no explicit "training set" is mentioned for an AI/algorithm-based device, information on how its ground truth was established is not applicable in this context. The product is a diagnostic reagent and counting tube system, not a machine learning algorithm that requires a labeled training dataset in the modern sense.

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