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The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios EX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, non-Hodgkin lymphoma, myeloma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

These reagents provide multiparameter, qualitative results for the surface antigens listed below:

ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45
ClearLLab 10C T Cell Tube: TCRy8, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45
ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45
ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD34, CD38, HLA-DR, CD19, CD45

The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

The Navios EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, and 405 mm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

Device Description

The new ClearLLab 10C reagent system is comprised of various components and is described below. Figures 2 and 3 illustrate the anticipated workflow from instrument setup through data analysis with a breakout of the standardization and Quality Control sequence for the new reagent system. As the figures show, the process is in-line with standard flow cytometry protocol.

Four ClearLLab 10C Panels [B, T, M1 and M2]
Navios and Navios EX flow cytometers [3 laser/10 color configurations]
ClearLLab Compensation Kit
ClearLLab Compensation Beads
ClearLLab Control Cells, normal and abnormal
Kaluza C data analysis software
Flow-Check Pro Fluorospheres
Flow-Set Pro Fluorospheres
IOTest 3 Fixative Solution
IOTest 3 Lysing Solution

The ClearLLab 10C reagent system is run on Beckman Coulter's Navios or Navios EX flow cytometer (3 Laser/10 Color configurations). It requires off-line manual sample processing and use of the accompanying lysing reagent. As part of the ClearLLab 10C reagent system, to allow proper utilization of this application, the indications for the Navios and Navios EX flow cytometers include all ten fluorescent detection channels and three laser configurations (blue, red and violet).

LMD data analysis is performed manually using the Kaluza C Analysis Software. This Analysis Software package is supplied separately from the Navios EX system softwares and must be installed on an independent computer workstation for off-line analysis of listmode files generated on the flow cytometer with the associated reagents and cytometer system software package, including Control Cell OC data and sample data analysis. The Navios and Navios EX analysis software are NOT be recommended for use with this application (Note that QC data from Flow-Set Pro, Flow-Check Pro, and Compensation products will continue to be analyzed using the on-board instrument software).

Kaluza C Software is a software tool designed to work with *.Imd files generated from flow cytometers.

Preset Kaluza C analysis templates for the ClearLLab 10c reagent system are provided.

AI/ML Overview

The provided text describes the ClearLLab 10C Panels and associated Navios and Navios EX Flow Cytometers. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table delineating acceptance criteria and reported device performance for each metric. Instead, it lists various studies performed, their objectives, and their results, which implicitly demonstrate an acceptance of performance. The "Testing Results" column in the tables effectively serves as the "Reported Device Performance," and the objective of each study implies the acceptance criteria (i.e., demonstrating stability, linearity, equivalency, specificity, etc.).

Below is a summary derived from the "Testing Results" section (pages 18-19):

ClearLLab 10C Panels, Navios and Navios EX Flow Cytometers Acceptance Criteria and Performance Summary

Study Name	Objective (Implied Acceptance Criteria)	Reported Device Performance
Laser Performance Characteristics	Verify stability of the laser performance of the Navios and Navios EX flow cytometer over time.	Navios and Navios EX laser performance is stable over time.
Instrument Carryover	Verify carryover using Flow-Check Pro fluorospheres meets performance specifications.	Navios and Navios EX meet the carryover performance requirements.
Instrument Linearity	Verify fluorescence detection is linear using standard Navios and Navios EX settings.	Linearity of fluorescence measurements was demonstrated.
Navios vs. Navios EX Percent Cell Recovery Equivalence Study	Demonstrate the equivalent performance in % cell recovery between Navios and Navios EX flow cytometers when running ClearLLab 10C application.	Navios and Navios EX Flow Cytometry Systems are equivalent when running the ClearLLab 10C application.
Antibody Specificity Characterization	Demonstrate antibody specificity including Fluorescence Minus One.	Specific antibody clones and polyclonal antibody reagents are identified for ClearLLab 10C reagent panel markers.
Reagent Dosing Characterization	Titrate for optimal reagent dosage.	Antibody conjugate dosing values were defined for each antibody of ClearLLab 10C reagents.
Non-Specific Binding Characterization	Assess of Non-Specific Binding.	Solutions implemented to reduce and/or obtain acceptable level of non-specific binding.
Lot-to-Lot Reproducibility (ClearLLab 10C panels)	Demonstrate variability of multiple lots of material.	The ClearLLab 10C panels have acceptable lot variability performance.
Stability (ClearLLab 10C panels)	Demonstrate reagent stability.	The ClearLLab 10C panels met performance requirements in support of the product's stability claims.
Carryover - Specimen and Reagent	Verify carryover of specimen and reagents on the Navios and Navios EX meets performance specifications.	The Navios and Navios EX meet carryover performance requirements.
Bulk vs. Single Wash	Demonstrate equivalency of sample preparation methods.	Equivalency of single tube wash and bulk wash methodology was demonstrated.
Detection Capability	Verify that the ClearLLab 10C panels with the Navios or Navios EX meet the performance requirements for the ability to differentiate between abnormal and normal populations.	The ClearLLab 10C panels with the Navios or Navios EX meet the performance requirements for Detection Capability.
Specimen Age and Prepared Sample Stability (Whole Blood and Bone Marrow)	Verify whole blood and bone marrow specimen and prepared sample stability claims.	The ClearLLab 10C panels meet the requirements for specimen and prepared sample stability (Whole Blood and Bone Marrow).
Specimen Age and Prepared Sample Stability (Lymph Node)	Verify lymph node samples prepared sample stability claim.	The ClearLLab 10C panels meet the requirements for prepared sample stability (Lymph Node).
Anticoagulant Equivalency – Whole Blood	Demonstrate equivalent performance of whole blood specimens collected in several different anticoagulants (K2EDTA, Heparin and ACD) on the Navios system using ClearLLab 10C panels.	Performance of ClearLLab 10C panels with whole blood specimens collected in K2EDTA, Heparin and ACD anticoagulants was demonstrated to be equivalent.
Anticoagulant Method Comparison - 10C to 5C	Demonstrate equivalency of anticoagulants used with bone marrow and whole blood specimens with the ClearLLab 10C panels in reference to the ClearLLab 5 color reagents.	For all conditions evaluated, the data collected demonstrates that the various anticoagulants are equivalent.
Precision - Control Material	Demonstrate system imprecision using control material as a surrogate for a stabilized sample.	The ClearLLab 10C panels meet performance requirements for repeatability and reproducibility.
Precision - Multi-Site with Clinical Specimens	Demonstrate assay repeatability and reproducibility using both normal and clinical specimens.	The ClearLLab 10C panels meet performance requirements for repeatability and reproducibility.
Precision - Operator and Instrument Variability	Demonstrate system imprecision performance of the ClearLLab 10C panels using the same specimen prepared by three (3) operators, twice a day, on two (2) Navios EX flow cytometers.	The ClearLLab 10C panels when run on each specimen type by different operators on different Navios EX flow cytometers demonstrated acceptable precision performance and met acceptance criteria.
Clinical Accuracy	Evaluate the clinical accuracy of the ClearLLab 10C Panels in identifying an abnormal or normal phenotype vs. the site's clinical diagnosis of malignant or non-malignant outcome from the current standard of care.	The ClearLLab 10C panels are able to identify the abnormal population when compared to clinical outcome.
IOTest 3 Fixative and IOTest 3 Lysing Solution - Lot-to-Lot Reproducibility	Demonstrate variability of multiple lots of material.	The IOTest 3 Fixative and Lysing Solutions have acceptable lot variability performance.
Flow-Set Pro Lot-to-Lot Variability	Demonstrate variability of multiple lots of material.	The Flow-Set Pro have acceptable lot variability performance.
Flow-Check Pro Lot-to-Lot Variability	Demonstrate variability of multiple lots of material.	The Flow-Check Pro have acceptable lot variability performance.
ClearLLab Compensation Kit with ClearLLab Compensation Beads Reagent Stability	Demonstrate reagent stability.	The Compensation Kit and Compensation Beads meet performance requirements in support of the products' stability claims.
IOTest 3 Lysing Solution and Fixative Reagent Stability	Demonstrate reagent stability.	The IOTest 3 Fixative Solution and Lysing Solutions meet performance requirements in support of the product's stability claims.
Flow-Set Pro Fluorospheres Reagent Stability	Demonstrate reagent stability.	The Flow-Set Pro Fluorospheres meet performance requirements in support of the product's stability claims.
Flow-Check Pro Fluorospheres Reagent Stability	Demonstrate reagent stability.	The Flow-Check Pro Fluorospheres meet performance requirements in support of the product's stability claims.
Flow-Set Pro Analyte Value Assignment	Define Flow-Set Pro Target ranges for use with the ClearLLab 10C panels and define a process for ranges transfer from one lot of Flow-Set Pro Fluorospheres.	Appropriate Flow-Set Pro target ranges are defined for use with the ClearLLab 10C panels and that a process for ranges transfer from one lot of Flow-Set Pro Fluorospheres to another one is in place.

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

Sample Size for Test Set: The document does not specify a distinct "test set" sample size for all studies. However, for the "Precision - Multi-Site with Clinical Specimens" and "Precision - Operator and Instrument Variability" studies, typical clinical specimens (both normal and abnormal) were used. The specific number of specimens for each study is not explicitly stated in the provided text.
Data Provenance: The document does not explicitly state the country of origin. The "Clinical Accuracy" study mentions "the site's clinical diagnosis," indicating that the data likely came from clinical sites where the study was conducted. The studies appear to be prospective in nature, as they involve actively verifying performance, stability, and equivalency.

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

For the "Clinical Accuracy" study, the comparison was made against "the site's clinical diagnosis of malignant or non-malignant outcome from the current standard of care." The interpretation of results for the device itself is stated to "be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings" (page 2). This indicates that pathologists or equivalent professionals establish the ground truth for clinical cases. The number of such experts is not specified.

4. Adjudication Method for the Test Set

The document implies that the ground truth for "Clinical Accuracy" is established by "the site's clinical diagnosis...from the current standard of care" and confirmed by a "pathologist or equivalent professional." However, it does not explicitly describe an adjudication method (such as 2+1, 3+1, or none) for resolving discrepancies among multiple expert opinions on a specific case.

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

The provided text does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance (which is not relevant for this device as it's a diagnostic reagent and flow cytometer system, not an AI interpretative software for human review).

6. Standalone Performance Study

The studies described, particularly those evaluating laser performance, instrument linearity, carryover, and reagent characteristics, are inherently standalone (algorithm/system only) performance studies. The system is evaluated on its ability to accurately detect and characterize cell populations. The "Clinical Accuracy" study also assesses the device's ability to identify abnormal populations against clinical outcomes, which is a standalone evaluation of its diagnostic capability.

7. Type of Ground Truth Used

For various analytical studies (e.g., linearity, carryover, precision), the ground truth is established by reference standards, control materials, and comparative methods (e.g., predicate devices).
For the "Clinical Accuracy" study, the ground truth is based on clinical diagnosis of malignant or non-malignant outcome from the current standard of care, confirmed by pathologist or equivalent professional consensus in conjunction with other clinical and laboratory findings.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as the devices described are diagnostic reagents and flow cytometers, not AI models that require specific training data in the context of machine learning. The studies listed are for performance verification and validation.

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

As there is no explicit mention of a "training set" in the context of an AI/machine learning model, this information is not applicable and is not provided in the document.

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