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The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It can be used in conjunction with the following monoclonal antibody reagents and software package:
• CYTO-STAT letraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT terrCHROME CD45-FITC/CD56-F • C Y (O-S FAT TetraCHKOME CD4-FFTCCO4+KD7/CDV-Fc2/CD3 P ovide identification and numeration of CD3+CD4+CD4+CD4+CD4+CD4+ KDI/CDI9-ECD/CD3+CS monocolal antibody reagains. There reges and absolute counts in peripleral whole blood. Absolute method) CD3+CD8+, CD3+, CD19+ and CD3-CD3+ Tymphoeyto percomes (single platform lections of the may be in closing acrescription of parient counts may be celermined by the Navio Cyclinece asng I to "Outlier" (o" on the in the immunologic assessment of patients having or suspected of having immune deficiency.
• Navios tetra Software for automated and results with CYTO-STAT terraCHRONE CD45-FFTC/CD4-RD/VCD8-ECD/CD3-FCD/CD3-• Navios letta Soltware for adionated and results will of 10 0 010 11:40 pm
PC5 and CYTO-STAT ietraCHROME CD45 FITC/CD56-RDI/CD19-ECD/CD3-PCS monoclonal antibody reagents.
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Navios Software may be installed on an independent computer workstarion for off issues of listed of line against must he Navios Soltware may be installed on the incependent compaise frectorial and software package listed above. The off-line analysis must be performed in accordance with the product labeling.

The Navios tetra Software is intended for use as an in vitro diagnostic device for immunophenoyping with CYTC/CDS6 RD/A The Navios tera Software is mielided to use as an in Thir Glightshouse on minutes of the Subsition of the National Provincial Provinces of CD19-FITC/CD56-RDI/CD19-ECV/ CD3-PC5 monoclonal antibody reagents on the Navios Flow Cytometer.
It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD19+, CD19+, and If provides and results for the nemation and while blood. Absolute counts may be determined by the except of the CD3+CD5+ iymphocyte percentages and alsolute counts in perfined in separate hematology results (dual Navios now cycomerer use in the immunologic assessment of patients having or suspected of having immune deficiency.
platform method). It is indicated for use in the immunolog

Flow-Set Pro Fluorospheres is a suspension of fluorescent microspheres used as an aid in standardizing forward scatter, side scatter, and fluorescence detectors (FL1-4) on the Cytomics FC 500 and Navios Flow Cytometers.

The Navios Flow Cytometer system is composed of the following components:

• Navios Flow Cytometer .
• Navios tetra Software .
• Navios Software (off-line analysis tool) .
• Flow-Set Pro Fluorospheres .
• CYTO-STAT teiraCHROME reagents .
• COULTER IMMUNOPREP Reagent System .
• TQ-Prep Workstation (Accessory for Sample Preparation) .
• PrepPlus™ 2 Workstation (Accessory for Sample Preparation) .

The Navios Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through the laser beam(s) in single file.

The Navios tetra software is an optional locked algorithm application plug-in that is designed for the Navios flow cytometer. It provides automated analysis and results for tetraCHROME reagents; this application cannot be modified by the user.

The Navios Flow Cytometry System also offers an optional standalone offline software package, Navios software, which may be installed on an independent computer workstation for off-line analysis of listmode files generated by the Navios Flow Cytometer with tetraCHROME reagents and Navios tetra software according to the product labeling.

tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 CYTO-STAT reagent provides identification and enumeration of CD3+CD4+, CD3+CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 reagent provides identification and enumeration of CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood.

Flow-Set Pro Fluorospheres is a suspension of fluorospheres with uniform and stable size and fluorescence intensity. The stability of these product parameters allows for the standardization of light scatter and fluorescence intensity instrument settings.

The COULTER ImmunoPrep Reagent System is comprised of 3 ready-to-use reagents: Reagent A lyses the red blood cells, Reagent B buffers the solution and stops the lysing process, and Reagent C fixes the cells. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.

The Navios Flow Cytometer uses sample preparation devices as part of the overall workflow system. The COULTER TQ-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for quantitative immunofluorescence measurements on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Here's a breakdown of the acceptance criteria and study information for the Navios Flow Cytometer System, based on the provided text.

Acceptance Criteria and Device Performance

The submission details several studies conducted to demonstrate the performance of the Navios Flow Cytometer system. The "Study Results" column in the table below directly indicates if the device met acceptable results for the respective criteria.

Study Information

The document is a 510(k) summary, which typically provides a high-level overview of validation studies rather than detailed protocols. As such, some specific details like exact sample sizes for training/test sets, data provenance, and expert qualifications are not explicitly stated in the provided text.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The "Accuracy" study mentions using "Patient Samples" based on CLSI EP9-A2. The "Precision" study used "Whole Blood Repeatability." The "Manual Pipette vs. PrepPlus 2 Method Comparison" also used "specimens." However, the exact number of samples or patients for any of these studies is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective validation studies conducted by the manufacturer, Beckman Coulter, Inc.

2. 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)

• Not explicitly stated. Given that the device is an "Automated Differential Cell Counter" for immunophenotyping, the ground truth would likely be established through a recognized reference method performed by trained laboratory personnel on an established, validated system. The document compares performance to a predicate device (Cytomics FC 500 with tetraCXP software), implying that the predicate's results served as a comparative "ground truth" or reference.

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

• Not explicitly stated. Adjudication methods are typically relevant for subjective interpretations (e.g., image analysis by multiple radiologists). For quantitative measurements from a flow cytometer, the ground truth is usually derived from a reference method with inherent analytical precision, rather than adjudicated expert opinions.

4. 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 in the context of human readers improving with AI assistance. The Navios system is an automated flow cytometer with software for automated analysis (Navios tetra software). The comparisons are between the new device and a predicate device (another automated system), and between different methods on the same device (e.g., single vs. dual platform absolute counting) or different sample preparation methods. This is not a human-in-the-loop AI system where human reader performance would be the primary metric.

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

• Yes, standalone performance was assessed. The entire suite of performance studies (Accuracy, Precision, Linearity, Carryover, Limits, etc.) for the Navios Flow Cytometer and its associated Navios tetra software (which is an "optional locked algorithm application plug-in that is designed for the Navios flow cytometer. It provides automated analysis and results") represent standalone algorithm performance. The device is intended "for automated analysis and results."

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The ground truth for the analytical performance studies (Accuracy, Precision, Linearity, etc.) appears to be based on:
  • Comparison to a predicate device: The accuracy study directly states "comparable results to the predicate device." The predicate device (Cytomics FC 500 with tetraCXP software) represents an established and accepted method for immunophenotyping.
  • Established analytical methods and guidelines: Studies refer to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP9-A2 for Method Comparison, CLSI EP5-A2 for Precision, CLSI EP06-A for Linearity). These guidelines define methods to establish the true analytical performance characteristics of a quantitative diagnostic device, implicitly establishing a "true value" or "ground truth" to compare against.
  • Reference Intervals: Reference intervals were established for the device, which involves testing healthy populations to define normal ranges.

7. The sample size for the training set

• Not explicitly stated. The document describes performance studies, which are typically conducted on independent test sets after an algorithm has been developed and trained. Information about specific training set sizes used to develop the "Navios tetra software" algorithm is not provided in this regulatory summary.

8. How the ground truth for the training set was established

• Not explicitly stated. As this is a 510(k) summary focused on post-development performance validation, details on the training process and ground truth establishment for the development phase of the "Navios tetra software" algorithm are not included. Generally, for such systems, training data would be meticulously characterized using established laboratory methods or reference instruments, with expert review to ensure accuracy of the labels.

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The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.

The Cytomics FC 500 MPL Flow Cytometer (FC 500 MPL) is a bench top laboratory instrument designed for In Vitro Diagnostic Use in clinical laboratories. The FC 500 MPL provides qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single file. The instrument can simultaneously measure forward scatter, side scatter, and five fluorescent dyes using one or two lasers at 488 nm and either 635 nm (solid-state laser) or 633 nm (HeNe laser). Therefore, the instrument can perform correlated multiparameter analyses of individual cells.

The provided document is a 510(k) summary for the Cytomics FC 500 MPL Flow Cytometer, filed in 2007. It establishes substantial equivalence to a predicate device and describes the device's function, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

The document states:

• The FC 500 MPL is based on the FC 500 flow cytometer.
• Modifications include hardware, software, and labeling changes to support sample presentation/introduction from multi-well plates, and additional software/labeling for 21 CFR Part 11 compliance.
• The FDA reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request to provide acceptance criteria and a study that proves the device meets them based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed study report with performance metrics against acceptance criteria.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness and that the data submitted demonstrate that the device is as safe and effective as the predicate device. It typically doesn't include detailed performance studies with acceptance criteria in the manner requested for AI/diagnostic devices that might involve multi-reader studies or ground truth establishment.

To answer your questions:

1. A table of acceptance criteria and the reported device performance: Not available in the provided document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided document.
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): Not applicable/available in the provided document. This document does not describe a study involving expert-established ground truth for a diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/available in the provided document.
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 cell counter, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Cytomics FC 500 MPL Flow Cytometer" for automated cell counting, implying standalone processing for its function. However, specific standalone performance studies with quantitative metrics are not detailed in this 510(k) summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available/applicable in the context of this 510(k) summary. For flow cytometers, "ground truth" might refer to established reference methods or known cell populations, but typical validation studies are not described here.
8. The sample size for the training set: Not applicable/available. This device predates widespread AI/ML training set concepts in regulatory documents.
9. How the ground truth for the training set was established: Not applicable/available.

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