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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.

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.

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BD Multitest™ 6-color TBNK reagent with optional BD Trucount™ tubes is a sixcolor direct immunofluorescence reagent for use with BD FACSCanto™ and BD FACSCanto™ II flow cytometers to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.

BD Multitest 6-color TBNK reagent and BD Trucount tubes can be used with the BD FACS™ Loader.

Human lymphocytes can be divided into three major subset populations based on their biologic function and cell-surface antigen expression: T Ivmphocytes (CD3+), B lymphocytes (CD19+), and Natural Killer (NK) cells (CD16+ and/or CD56+). CD3+ T lymphocytes can be further divided into CD4+ T lymphocytes and CD8+ T lymphocytes.

BD Multitest 6-Color TBNK Reagent is a monoclonal antibody cocktail of CD3-FITC/ CD16-PE + CD56-PE/ CD45-PerCP-Cy5.5/ CD4-PE-Cy7/ CD19-APC/ CD8-APC-Cy7.

When the reagent is used to stain a known volume of whole blood, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS™ Lysing Solution to lyse erythrocytes prior to acquisition and analysis on the BD FACSCanto or BD FACSCanto II flow cytometer. During acquisition, the cells travel past two spatially separated laser beams. The cells scatter the laser light and the cell-bound fluorochrome-labeled antibodies fluoresce. These scatter and fluorescence signals are detected by the flow cytometer and provide information about the cell's relative size, internal complexity and fluorescence intensity. During analysis by BD FACSCanto clinical software, the lymphocyte population percentages are determined. Lymphocyte population absolute counts may be determined if Ivmphocvte data from another method is manually entered.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

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 the sample size used for the clinical test sets in either the precision or method comparison studies. It also does not explicitly state the country of origin or whether the data was retrospective or prospective. It generally refers to these as "clinical studies."

For non-clinical studies (software functionality and file-based equivalency), it's implied that various tests were performed, but no sample sizes or data provenance are provided.

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 device in question is a reagent and flow cytometer system for identifying cell populations, and the "ground truth" seems to be established through comparison to a predicate device and internal performance metrics, rather than expert interpretation of images or other data.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The studies described involve quantitative measurements and comparisons to a predicate device and predefined statistical criteria, not subjective human adjudication of results in the way it would be used in image-based diagnostic studies.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study, nor is there any discussion of human readers or AI assistance. This device is an automated diagnostic assay, not an AI-powered image analysis tool for human readers.

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

Yes, the performance studies described are essentially standalone in terms of the device's function. The "investigational system" (BD Multitest 6-color TBNK Reagent with BD FACSCanto/II flow cytometers) is evaluated directly for its precision and agreement with a predicate device. While a human operates the equipment, the "performance" refers to the automated output of lymphocyte percentages and counts by the system itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The primary "ground truth" implicitly used for the clinical and non-clinical method comparison studies is the predicate device (BD Multitest™ 6-Color TBNK with Trucount™ Tubes [510(k) # K060375]). The new device's performance is compared against this legally marketed and accepted predicate to establish substantial equivalence. For precision, the ground truth is statistical variability within the system itself. For software, the ground truth is its ability to meet specified functional requirements and provide equivalent results to a previous software version.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. As this is a reagent and flow cytometry system, it operates based on established immunological principles and chemical reactions, not on algorithms that are "trained" on data in the modern AI sense.

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

As there is no mention of a "training set" in the context of an AI/machine learning model, this question is not applicable. The device's operation is based on pre-defined scientific principles and reagent characteristics.

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BD FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

BD FACSCount CD4 reagents are intended for use in enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood using the BD FACSCount instrument system. The product offers a single test that requires one convenient, ready-to-use reagent tube labeled CD4. It is intended for use on a BD FACSCount instrument. The reagent kit consists of the following components: 50 reagent tubes of CD4 PE/CD14 PE-Cy5/CD15 PE-Cy5/fluorescent nuclear dye and counting reference beads, 65 reagent tube caps, One 5-mL vial of 5% formaldehyde in phosphate-buffered saline (PBS), used as fixative solution.

Here's a breakdown of the acceptance criteria and the study results for the BD FACSCount™ CD4 Reagents, based on the provided 510(k) summary:

This device is a reagent kit for an automated differential cell counter, not an AI/ML powered device. Therefore, several of the requested categories related to AI/ML or expert adjudication in medical imaging are not applicable and will be marked as such.

Acceptance Criteria and Device Performance for BD FACSCount™ CD4 Reagents

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined "acceptance criteria" with numerical targets for metrics like R-squared, slope, intercept, or CV. Instead, it presents the results of equivalency studies (method comparison, precision, linearity, stability) to demonstrate that the new device performs comparably to the predicate device and within expected performance ranges for such assays.

Here's how we can infer "met acceptance criteria" based on the reported results, assuming the FDA reviewed these results and granted substantial equivalence:

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

• Test Set Sample Size:
  • Method Comparison:
    • CD4 Absolute Count: n = 101 samples
    • CD4 Percentage: n = 99 samples
  • Precision: Not explicitly stated as a number of individual patient samples, but rather as results from "low control" and "normal control" measurements across multiple runs/devices.
  • Linearity, Stain Stability, Reagent Stability: Specific sample sizes (e.g., number of replicates or distinct samples used for dilution series) are not provided.
• Data Provenance: Not explicitly stated in the summary document. It's common for such studies to be conducted internally by the manufacturer or through clinical sites, but specific country of origin or whether it was retrospective/prospective is not detailed here. Given the nature of a 510(k) submission, it's generally assumed to be prospective data collection, but this is not confirmed.

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

• Not applicable (N/A) for this type of device. This device is an in vitro diagnostic reagent kit for automated cell counting. The "ground truth" for comparison is typically established by the predicate device and/or reference methods, not by human experts adjudicating images or clinical findings.

4. Adjudication Method for the Test Set

• Not applicable (N/A). As explained above, for laboratory assays, "adjudication" in the sense of multiple experts reviewing and reaching consensus on findings is not a typical methodology. Performance is assessed against a predicate device or established reference methods.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic reagent kit designed for automated analysis, not an AI system assisting human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.

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

• Yes, in spirit, a standalone performance was done for the device system. The BD FACSCount™ CD4 Reagents are used with the BD FACSCount instrument, which performs automated analysis. The "algorithm" in this context is the instrument's automated processing and counting of labeled cells. The performance data presented (method comparison, precision, linearity, etc.) reflects the standalone performance of this integrated system (reagents + instrument) in enumerating CD4 cells. There is no human "in-the-loop" decision-making for the actual cell counting process with this automated system.

7. The Type of Ground Truth Used

• Comparison to a Predicate Device: The primary "ground truth" or reference for demonstrating substantial equivalence was the performance of the BD Tritest CD3/CD4/CD45 with and without BD Trucount absolute count tubes on a BD FACSCalibur instrument (the predicate device).
• Reference Intervals/Expected Performance: For precision and linearity, the "ground truth" is implied by expected biological ranges, established control values, and the design of dilution series to assess assay performance across its claimed dynamic range.

8. The Sample Size for the Training Set

• Not applicable (N/A) in the context of AI/ML training. This device is a reagent kit for a traditional analytical instrument. There is no "training set" in the sense of data used to train an AI/ML algorithm. The "training" of the system (instrument and reagents) would involve internal development and optimization processes by the manufacturer, but not in the AI/ML paradigm.

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

• Not applicable (N/A). As there is no AI/ML training set, the establishment of ground truth for such a set is irrelevant. The "ground truth" reference for the general development and calibration of such assays would derive from established laboratory techniques, reference materials, and predicate device performance during the product development lifecycle.

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The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/uL.
For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510-545 nm, 562-607 nm, and >650 nm.
For use in erythrocyte-lysed whole peripheral blood.
For use with or without 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 BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/μL. If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™, CELLQuest Pro™ or LYSYS™ II software. The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes vields 50 tests.

The provided text is a 510(k) premarket notification for the BD™Tritest CD3/CD4/CD45 with Trucount Absolute Count Tubes. The submission pertains to a modification of an already cleared device, specifically to extend the sample stability claim. Consequently, the document focuses on demonstrating equivalency to the predicate device rather than presenting a full de novo study with detailed acceptance criteria and performance data for a new device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not explicitly detailed in the provided 510(k) summary. The summary refers to "Performance data from validation testing supports equivalency" but does not elaborate on the specifics of this data or the methods used to collect it.

However, based on the information provided, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics like sensitivity, specificity, accuracy, or a specific statistical agreement. Instead, the modification aims to demonstrate equivalency to the predicate device for an extended sample stability period (from 48 to 72 hours for EDTA collected samples).

Therefore, the implicit acceptance criterion is that the device's performance for identifying and enumerating percentages and absolute counts of T lymphocytes and T-helper/inducer cells at 72 hours post-collection must be comparable or within acceptable limits of its performance at 48 hours and to the predicate device's performance for the original claim.

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

The summary does not explicitly state the sample size used for the validation testing or the data provenance (country of origin, retrospective/prospective).

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

The summary does not explicitly mention the use of experts to establish ground truth for the test set. For flow cytometry devices like this, the "ground truth" is typically established by the readings from the flow cytometer itself, often compared to an established reference method if a new principle is being introduced. For a modification, the comparison is usually against the predicate device's performance.

4. Adjudication Method for the Test Set

The summary does not explicitly describe any adjudication method for the test set.

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

This device is an automated in vitro diagnostic device (flow cytometer reagent and counting beads) for cell enumeration, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. Therefore, an MRMC study and AI assistance effect size are not applicable to this submission.

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

The device itself, when used with a Becton Dickinson flow cytometer and software (MultiSET™, CELLQuest™, CELLQuest Pro™, or LYSYS™ II), operates in a "standalone" or automated fashion for analysis. The modification submission primarily relates to sample stability. The study would have evaluated the device's performance in this standalone mode at different time points. The summary does not explicitly detail the performance results beyond stating that "Performance data from validation testing supports equivalency."

7. The Type of Ground Truth Used

For this type of device (flow cytometry reagent for cell enumeration), the "ground truth" for the performance study would typically be established by:

• Comparison to a gold standard method: If a new analysis method were being introduced, it might be compared to a manual reference method or another highly validated flow cytometry method.
• Comparison to the predicate device: For a modification, the stability study would involve comparing the results obtained with the modified device at extended stability times to results obtained with the same device or the predicate device at validated shorter stability times.
• Internal consistency and reproducibility: Ensuring that counts and percentages remain consistent and reproducible over the extended stability period.

The summary does not explicitly state the specific ground truth used, but it would revolve around comparing the measurements (percentages and absolute counts of T cells and T-helper/inducer cells) to established or predicate methods under the new conditions.

8. The Sample Size for the Training Set

The summary does not mention a training set in the context of machine learning or AI, as this is not an AI/ML device. For traditional IVDs, "training set" might refer to data used for initial assay development and optimization, but the 510(k) summary for a device modification typically focuses on validation data.

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

As no training set (in the AI/ML sense) is mentioned, this question is not applicable.

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BD Tritest CD3 FITC/CD4 PE/CD45 PerCP is a three-color direct immunofluorescence reagent for identifying and enumerating percentage of mature human T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB).

The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™ , CELLQuest Pro "" or LYSYS™ II software. The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes yields 50 tests.

The provided text is a 510(k) summary for the BD™ TriTEST CD3/CD4/CD45 reagent. The submission is not for a new device but for a modification to an existing, legally marketed device (BD™ TriTEST CD3/CD4/CD45, K946055/S2). The modification only seeks to extend the sample stability claim for EDTA whole blood from 48 to 72 hours.

Therefore, the provided document does not contain the detailed information required to fully answer all aspects of your request, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, or ground truth establishment in the way you might expect for a de novo device submission or a study evaluating a complex algorithm.

However, based on the information provided, here's what can be inferred and stated:

Acceptance Criteria and Device Performance (Extended Sample Stability Claim)

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

Since the submission is for an extended stability claim, the acceptance criteria would revolve around demonstrating that the device maintains its performance (identifying and enumerating specific cell populations) after 72 hours with EDTA-treated samples, compared to its established performance at 48 hours or earlier time points. The document states "Performance data from validation testing supports equivalency." This implies that the accepted performance for the enumeration of T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells at 72 hours is equivalent to, or within acceptable limits of, the established performance at shorter stability times.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text.
• Retrospective or Prospective: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable in the context of this 510(k) summary. The device is a reagent for flow cytometry, and the "ground truth" for enumerated cell populations is typically established by the inherent physical properties and staining characteristics detected by the flow cytometer itself, rather than by expert consensus on images or pathology. The validation would involve assessing the reagent's ability to consistently and accurately identify markers over time.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This type of adjudication is typically used for image-based diagnostics where human interpretation is involved.

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 a reagent, not an AI software assisting human readers.

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

The device is a reagent to be used with flow cytometers and software (MultiSET™, CELLQuest™, CELLQuest Pro™ or LYSYS™ II software). The "standalone" performance here refers to the reagent's ability to consistently label cells correctly over time. The document implicitly confirms this standalone performance was evaluated to support the extended stability claim.

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

The "ground truth" for this type of device (flow cytometry reagent for cell enumeration) would be established by the inherent, reproducible measurement of cell populations by flow cytometry, typically validated against established methods or control materials. It's not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic imaging or disease staging. The validation would verify that the reagent accurately binds to specific cell markers, leading to consistent enumeration results.

8. The sample size for the training set:

Not specified. For a reagent validation, there isn't a "training set" in the machine learning sense. The "training" essentially occurs during the reagent's development and optimization, with verification against known cell populations.

9. How the ground truth for the training set was established:

Not applicable in the machine learning sense. The ground truth for reagent development and validation would involve biochemical characterization of the reagent and its binding specificity, as well as testing against characterized cell lines or human blood samples with known cell population distributions using established flow cytometry protocols.

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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.

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.

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BD Multitest 6-Color TBNK reagent with BD Trucount tubes is intended for in vitro diagnostic use with the BD FACSCanto system to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.

The BD Multitest 6-Color TBNK reagent is a six-color direct immunofluorescence reagent for use with the BD FACSCanto system to identify and determine the percentages and absolute counts (using BD Trucount tubes) of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.

When a known volume of whole blood is added to the reagent in a BD Trucount tube, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS lysing solution to lyse erythrocytes, and the lyophilized pellet in the BD Trucount tube dissolves, releasing a known number of fluorescent beads.

During acquisition, the cells and beads travel past two laser beams and scatter the laser light. The stained cells and beads fluoresce at different intensities. These scatter and fluorescence signals, detected by the flow cytometer, provide information about each cell's size, internal complexity, and relative fluorescence intensity. During analysis, the absolute number (cells/uL) of positive cells in the sample can be determined by comparing cellular events to bead events.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be primarily focused on its accuracy, precision, linearity, and stability in comparison to a predicate device. The performance data is presented in terms of mean bias for accuracy and standard deviation/coefficient of variation for precision.

Note: The document states "Substantial equivalence and the performance of BD Multitest 6-color TBNK reagent with BD Trucount tubes have been demonstrated through accuracy, precision, linearity, and sample and stain stability studies." The acceptance criteria are implicitly met if the reported performance data falls within acceptable ranges relative to the predicate, as interpreted by the FDA's substantial equivalence determination.

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

• Sample Size for Accuracy Study (Test Set): n = 117 for all lymphocyte subsets (CD4, CD8, CD3, CD19, CD16+CD56) for both percentages and absolute counts.
• Sample Size for Precision Study (Test Set): n = 42 for all lymphocyte subsets for both percentages and absolute counts across "Low Sample" and "Normal Sample" groups.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of medical device submissions in the US, it is highly probable that the studies were conducted in the US, and typically prospective data is preferred for performance validation. However, this is not explicitly mentioned.

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

This type of device (automated differential cell counter) does not rely on expert interpretation of images or other subjective data for ground truth. The "ground truth" for the accuracy study is established by comparison to a legally marketed predicate device (BD Multitest IMK kit with BD FACSCanto system and clinical software). The predicate device itself has established performance characteristics, and the ground truth for that device would have been established through methods like flow cytometry standards, reference methods, or clinical correlation. No human experts are used to establish ground truth in the way a radiologist might for an imaging AI.

4. Adjudication Method (for the test set)

Not applicable. As explained in point 3, the ground truth is established by the predicate device's measurements, not by human interpretation or adjudication.

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 device is an automated diagnostic assay (a reagent/instrument system) for quantifying cell populations, not an AI-assisted diagnostic imaging tool or a system that requires human interpretation in the same way. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to its evaluation.

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

Yes, the studies presented (accuracy, precision, linearity) represent the standalone performance of the device system (reagent + instrument + software). The results are generated directly by the system without human interpretation influencing the quantification of the lymphocyte subsets. The comparison is made against another device system (the predicate).

7. The Type of Ground Truth Used

The ground truth for the accuracy study was the measurements obtained from the predicate device, the BD Multitest IMK kit used with the BD FACSCanto system and BD FACSCanto clinical software (K041074). This is referred to as "method comparison."

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device is a flow cytometry assay system, not an AI/ML algorithm that is typically "trained" on data. Its performance is based on the biochemical reactions of antibodies and the physical principles of flow cytometry. If there were any internal device calibration or optimization data, it is not described here as a "training set."

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

Not applicable, as there is no explicitly defined "training set" in the context of an AI/ML algorithm for this device. The system functions based on established biological and chemical principles, not on a machine learning model that requires a trained ground truth dataset in the conventional sense. The "ground truth" for the development of such assays would derive from established laboratory standards and reference methods for cell enumeration and phenotyping.

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The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device for identification and cnumeration of lymphocyte subsets in human cells in suspension using a lyse no-wash sample preparation method for flow cytometry.

Immunophenotyping in clinical laboratories, using previously cleared IVD 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*

The BD FACSCanto System with BD FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. 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 sub-systems; fluidics, optics and electronics. It contains two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.

The provided text describes the BD FACSCanto System with BD FACSCanto software, an automated differential cell counter. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for the accuracy, precision, and linearity studies (test sets). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the studies). It only refers to NCCLS documents for the study designs.

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

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the test set. Given the nature of the device (automated cell counter), ground truth for performance studies typically involves comparison to a gold standard method or highly calibrated reference instruments, rather than direct expert consensus on images.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method for the test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance studies focus on the device's accuracy, precision, and linearity as a standalone automated system, not on its assistance to human readers.

6. Standalone Performance (Algorithm only without human-in-the-loop performance):

Yes, the performance studies described (accuracy, precision, linearity) represent standalone performance of the BD FACSCanto System. The device is an "Automated differential cell counter," implying its function is to perform cell counting and immunophenotyping automatically without direct human intervention in the primary measurement.

7. Type of Ground Truth Used:

The document refers to NCCLS (National Committee for Clinical Laboratory Standards) documents (now CLSI - Clinical and Laboratory Standards Institute) for study design. For an automated differential cell counter, ground truth for accuracy, precision, and linearity is typically established by:

• Reference Methods: Comparing the device's results to a recognized gold standard method or another highly accurate and precise instrument.
• Certified Reference Materials: Using materials with known and verified concentrations or characteristics.
• Inter-laboratory Concordance: Comparing results across multiple well-controlled laboratories or instruments.

The document states the device "demonstrated comparable accuracy relative to the predicate," suggesting the predicate device or its established performance served as a form of ground truth or benchmark.

8. Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. This type of device (flow cytometer with software for immunophenotyping) often relies on established algorithms and calibration rather than a machine learning "training set" in the modern sense. If there were any learning components, they are not detailed here.

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

Since no training set information is provided, there is no description of how ground truth was established for it.

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