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The Caltag Fetal Hemoglobin Test, containing either FITC, R-PE or TRI-COLOR® conjugated monoclonal antibodies to fetal hemoglobin (hemoglobin F), is intended for the identification followed by enumeration of fetal red blood cells. Fetal red cells are identified by the presence of fetal hemoglobin by a flow cytometric method. Fetal cells, when found in the maternal circulation, may be an indication of fetal or maternal complications. The hemorrhage of Rh+ fetal blood into Rh- maternal blood may result in the formation of sensitizing Rh antibodies in the mother. This Rh immunization may be prevented by the administration to the mother of Rh immune globulin (RhIg) soon after delivery. The Caltag Fetal Hemoglobin Test may be used as an aid in detecting incompatible fetal-maternal hemorrhage and determining the need for immunoprophylaxis with Rh immune globulin.

An anticoagulated peripheral blood sample is drawn from an appropriate donor. The erythrocyte count is determined and adjusted, followed by brief fixation of the cells in gluteraldehyde. Fixed and washed cells are permeabilized with a detergent in a manner that is frequently used to enable macromolecules such as monoclonal antibodies to penetrate cellular membranes. Caltag HbF FITC, HbF R-PE and HbF TRI-COLOR monoclonal antibodies bind to fetal hemoglobin in fetal red cells. To identify cells containing fetal hemoglobin, fixed and permeabilized cells are incubated with the monoclonal antibody, and washed to remove unbound antibody. Antibody stained cells are subsequently analyzed by flow cytometric methods. Positive and negative control samples must be used with sample analysis, to establish that all reagents are performing in a consistent manner and that the positive fluorescence attributed to antibody-stained fetal red cells is differentiated from unstained normal red blood cells, leukocytes and any cellular debris. If cord blood is not available for the performance of positive controls, the assay cannot be performed reliably. The recommended positive control samples consist of both 1% and 5% fetal erythrocyte-containing placental cord blood in normal adult blood. The recommended negative control sample consists of 1% anticoagulated sample from a normal male or non-pregnant adult female.

Here's a breakdown of the acceptance criteria and the study details for the Caltag Fetal Hemoglobin Test, based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for this device revolves around demonstrating substantial equivalence to the predicate device (Sure-Tech Fetal Hemoglobin Test, K892241). This is primarily shown through correlation studies and assessments of expected values and reproducibility.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a diagnostic device, the acceptance criteria are not explicitly stated as pass/fail thresholds in the same way they might be for a therapeutic device. Instead, the performance is demonstrated by showing strong correlation with the predicate device and acceptable levels of specificity, reproducibility, and linearity.

2. Sample Size and Data Provenance

• Correlation Studies (Test Set):

  • Site 1: 50 prepared samples, 30 patient samples.
  • Site 2: 15 prepared samples, 38 patient samples.
  • Site 3: 15 prepared samples, 13 patient samples.
  • Total: 80 prepared samples, 81 patient samples (summing across sites, noting some overlap in prepared samples).
  • Provenance: "patient samples were obtained from women having clinical indications that were consistent with fetal-maternal hemorrhage and prepared samples consisted of mixtures of fetal cord blood in normal adult blood." The studies were conducted in three independent laboratories in geographically diverse areas within the United States. This implies retrospective for patient samples with specific clinical indications, and prospectively prepared for mixed samples.

• Expected Values Data:

  • Sample Size: 161 adult female normal donors.
  • Provenance: Collected from "adult female normal donors" across "three independent laboratories" in "geographically diverse areas within the United States, including the Northern, South-central and Western regions." Donors were of "differing ethnic origins, including adult Caucasians, Blacks, Orientals and Hispanics." This data is prospective.

• Specificity Data:

  • Sample Size: Not explicitly stated but "blood samples were obtained from healthy normal donors of Caucasian, Black, Hispanic and Oriental ethnic origins." (likely a subset of the 161 from expected values, or similar cohort).
  • Provenance: Healthy normal donors, likely prospective.

• Reproducibility Data (Intra-lab & Inter-lab):

  • Sample Size: 6 replicated determinations for each antibody at high, medium, and low levels, performed across three independent laboratories. The samples were "varying mixtures of placental cord blood in normal adult blood." For inter-lab, "unstained and unfixed samples containing mixtures of cord blood in normal adult blood representing the appropriate ranges were prepared by one of the participating laboratories for staining and analysis by each of the participating laboratories." This involved prepared samples, likely prospective.

• Linearity of Measurement:

  • Sample Size: 10 samples (mixtures of cord blood cells in normal adult blood).
  • Provenance: Prepared samples, prospective.

• Detection of 100% Cord Blood:

  • Sample Size: 5 different cord blood samples.
  • Provenance: Cord blood samples, likely prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document does not explicitly mention "experts" being used to establish ground truth for this device in the sense of trained clinicians making diagnoses that the device is then compared against.
• Instead, the Kleihauer-Betke (KB) test is used as the comparative "ground truth" to which the Caltag device is correlated. The KB test is an established, widely used microscopic staining method for detecting fetal hemoglobin. The interpretation of KB tests typically involves trained laboratory technicians or pathologists.
• The document states that the correlation study was conducted in 3 independent laboratories, implying that personnel trained in both flow cytometry and the KB method were involved in generating the data. No specific qualifications (e.g., "Radiologist with 10 years of experience") are provided for these individuals, as the device measures a quantitative biological marker rather than interpreting images.

4. Adjudication Method for the Test Set

• No explicit adjudication method (e.g., 2+1, 3+1) is mentioned.
• The "ground truth" for the correlation studies was the result from the Kleihauer-Betke (KB) test. This is a laboratory test with an established protocol, and the agreement is between the Caltag device's quantitative output and the KB test's quantitative output, rather than human expert interpretations requiring adjudication.

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

• No MRMC comparative effectiveness study was done.
• This device is a diagnostic assay that directly quantifies fetal hemoglobin. It is not an AI-assisted interpretation tool for human readers, so comparing human readers with and without AI assistance is not applicable to this type of device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• Yes, the performance presented for the Caltag Fetal Hemoglobin Test is its standalone performance. The flow cytometric analysis is an automated process after sample preparation and staining with the monoclonal antibodies. The reported percentages of positive cells (e.g., mean % positive, r² values) represent the device's output. While human technicians perform the sample preparation and operate the flow cytometer, the measurement itself is performed by the instrument and its associated software, making it a standalone quantitative measurement.

7. Type of Ground Truth Used

• The primary ground truth used for comparison and validation is the Kleihauer-Betke (KB) microscopic staining method. This is a laboratory-based, established diagnostic test for quantifying fetal red blood cells.
• For the 100% cord blood samples, the "ground truth" is the known composition of the sample (i.e., that it should be 100% fetal cells), effectively using known sample composition.
• For expected values and specificity, healthy normal donors were the "ground truth" for what constitutes a normal, non-pregnant sample result.

8. Sample Size for the Training Set

• The document describes studies for validation and substantial equivalence, not a machine learning "training set" in the modern sense. Therefore, there isn't a "training set" sample size like one would find for an AI/ML algorithm.
• The "expected value" data (161 donors) and "specificity" data implicitly contribute to defining the normal operating parameters and behavior of the test, which could be considered analogous to internal validation or establishing reference ranges.

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

• As mentioned, there isn't a "training set" in the AI/ML context.
• For the data that helps define the device's characteristics (e.g., expected values, specificity), the ground truth was established by:
  • Using healthy normal donors to determine normal ranges and confirm specificity (i.e., no fetal cells expected, or very low baseline).
  • Using known prepared samples (mixtures of cord blood and adult blood) to assess linearity and reproducibility. These samples have a known, pre-determined percentage of fetal cells.

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Caltag Cal-Lyse is a lysis solution to enable the lysis of erythrocytes in samples of anticoagulated human peripheral blood. Cal-Lyse lysing solution is intended as an aid in the enumeration of leukocytes that have been stained with Caltag monoclonal antibodies for analysis by flow cytometric methods.

Caltag monoclonal antibodies bind to the surfaces of viable blood cells that express the corresponding antigens. To identify cells bearing these antigenic determinants, peripheral blood samples are incubated with fluorochromeconjugated monoclonal antibodies. Cells are subsequently washed to remove unbound antibody. Prior to the removal of unbound antibody. Cal-Lyse lysing solution is added to lyse red blood cells. Cells may subsequently be washed. resulting in the elimination of red cell debris as well as unbound antibody. Cal-Lyse lysing solution contains paraformaldehyde as fixative, and no additional fixation is required. Antibody-stained and fixed leukocytes are subsequently analyzed by flow cytometric methods.

The document describes the Caltag Cal-Lyse™ Lysing Solution. The acceptance criteria and supporting studies are presented to demonstrate its substantial equivalence to predicate devices (Coulter CD19 monoclonal antibodies) when used for lysing red blood cells in flow cytometric procedures for enumerating leukocytes.

Please note that this is a summary of a 510(k) submission, focused on proving substantial equivalence to existing devices rather than a standalone AI performance study. Therefore, some of the requested categories (like number of experts, adjudication methods, MRMC studies, training set details) are not applicable or explicitly mentioned in the provided text, as they are typically relevant for novel AI/ML device evaluations.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" is implicitly demonstrated through the "Substantially equivalent" comparison in the technical characteristics table and the high correlation (r^2 values) found in the clinical correlation data to the predicate devices. The performance is assessed by comparing the device with predicate devices in terms of intended use, specificity, target cell, chemical form, fluorochromes, available forms, sample prep methods, expected values, leukocyte recovery, and red blood cell lysis efficiency.

2. Sample size used for the test set and the data provenance

• Expected Value Data: 155 apparently healthy adult normal donors (age 16-72, mean 41).
  • Provenance: Geographically diverse areas of the United States, including Western, Eastern, and SouthCentral regions. Included Caucasians, Blacks, Orientals, Hispanics.
  • Retrospective/Prospective: Prospective (samples were "collected" and "analyzed" as part of the study).
• Specificity Data: Blood samples from healthy normal donors of Caucasian, Black, Hispanic, and Oriental ethnic origins. The exact number of donors for specificity is not explicitly stated, but it refers back to "each donor" from the expected value pool.
  • Provenance: As above, diverse ethnic origins.
• Leukocyte Recovery Data: 5 normal donors (Caucasian, Black, Hispanic, Oriental).
  • Provenance: Diverse ethnic origins.
• Red Blood Cell Lysis Data: 5 normal donors.
  • Provenance: Not explicitly stated but likely the same pool as the recovery data.
• Correlation Data:
  • Normal Donors: 155 normal donor samples.
  • Abnormal Donors: 20 abnormal donors.
  • Total for Correlation Studies: 175 donors (155 normal + 20 abnormal).
  • Provenance: Geographically diverse areas of the United States (Western, Eastern, SouthCentral regions) and diverse ethnic origins (Caucasian, Black, Oriental, Hispanic) for normal donors. Abnormal donor provenance is not specified beyond "a single site."
  • Retrospective/Prospective: Prospective (samples were "collected and analyzed").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a lysing solution and monoclonal antibody, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the established performance of predicate flow cytometry reagents and procedures using standard laboratory quantification (flow cytometers, hematology analyzers).

4. Adjudication method for the test set

Not applicable. See point 3. The measurements are objective counts by laboratory equipment.

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 an AI/ML device involving human readers or interpretation. The study compares the performance of the device (lysing solution with Caltag antibodies) against predicate devices (Coulter antibodies) using flow cytometric analysis.

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

The device itself (lysing solution) is a reagent, not an algorithm. Its performance is evaluated in a standalone manner in conjunction with Caltag monoclonal antibodies as part of a flow cytometric procedure, comparing its output to that obtained with predicate antibodies and lysing agents. The "standalone" performance here refers to the measured results from the flow cytometer after using the Caltag Cal-Lyse solution and antibodies, rather than human interpretation of images. The objective measurements (e.g., % positive cells, cell counts) are the direct output being evaluated.

7. The type of ground truth used

The "ground truth" is established by:

• Comparison to predicate devices: The study aims to prove substantial equivalence to existing, legally marketed devices (Coulter CD19 monoclonal antibodies used with their lysing solutions). Their established performance serves as a benchmark.
• Objective laboratory measurements: Quantification using flow cytometers (FACscan or Profile) and appropriate hematology analyzers for cell counts, percent lysed cells, and percent recovered leukocytes.
• Reference Ranges: Expected values are compared to general established ranges for T and B cells in healthy adults, though the study also establishes a range for its own device.

This is primarily a comparative study against a predicate device using objective laboratory measurements rather than pathology or expert consensus on image interpretation.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set in the conventional sense. The studies described are for validation of the lysing solution and antibodies, not for training a model.

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

Not applicable. See point 8.

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CALTAG CD3/CD19/CD45 is a fluorescent reagent containing a combination of CD3. CD19 and CD45 monoclonal antibodies conjugated to fluorescein. phycoerythrin and the tandem fluorochrome PE-Cy5, respectively, This reagent permits the simultaneous identification of CD3+ mature T lymphocytes, CQ19+ inature Bilymphocytes, and CD45+ leukocytes including lymphocytes, monocytes and granulocytes, by flow cytometric methods.

The CALTAG CD3/CD19/CD45 monoclonal antibody combination binds to the surfaces of viable blood cells that express the corresponding antigens. To identify cells bearing these antigenic determinants, peripheral blood leukocytes are incubated with the monoclonal antibody, and washed to remove unbound antibody. Prior to removal of unbound antibody, lysis solution is added to lyse red blood cells. An appropriate fixative solution is added to lysed and washed cells. Stained and fixed cells are subsequently analyzed by flow cytometric methods.

The document provided describes the Caltag CD3 FITC/CD19 R-PE/CD45 TRI-COLOR™ Mouse Monoclonal Antibody Combination and its substantial equivalence to predicate devices and single antibody components. It outlines non-clinical and clinical tests conducted to support this claim.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state formal "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents data to demonstrate substantial equivalence through comparisons (expected values, specificity, and correlation) to predicate devices and single antibody components. The "performance" is the reported mean percentage of positive cells and correlation statistics.

Below is a summary of the relevant performance characteristics presented. The "Acceptance Criteria" are implied by the equivalency claims and strong correlations observed.

Correlation (vs. Caltag CD3 FITC single antibody):

• Mean % positive (component): 69.7%
• Mean % positive (single): 68.3%
• r² value: 94.8%
• Slope: 1.01
• Y intercept: 0.33
• Linear regression: y = 0.33 + 1.01x |
  | Expected Value (CD19 R-PE component) | Range of positive cells for healthy normal donors should be comparable to single CD19 R-PE antibody (Caltag & Coulter). | Device Combination: 13.3% ± 4.5 (Range: 4-22%) for 155 normal donors.
  Single Antibody (Caltag CD19 R-PE): 13.0% ± 4.2 (Range: 5-21%) for 155 normal donors.

Correlation (vs. Caltag CD19 R-PE single antibody):

• Mean % positive (component): 16.8%
• Mean % positive (single): 16.4%
• r² value: 98.9%
• Slope: 1.02
• Y intercept: 0.08
• Linear regression: y = 0.08 + 1.02x

Correlation (vs. Coulter CD19 RD1 single antibody):

• Mean % positive (component): 16.8%
• Mean % positive (Coulter): 16.2%
• r² value: 98.1%
• Slope: 0.95
• Y intercept: 1.29
• Linear regression: y = 1.29 + 0.95x |
  | Expected Value (CD45 TRI-COLOR component) | Range of positive cells for healthy normal donors should be comparable to single CD45 TRI-COLOR antibody. | Device Combination: 100.0% ± 0.1 (Range: 100-100%) for 155 normal donors.
  Single Antibody (Caltag CD45 TRI-COLOR): 99.0% ± 0.9 (Range: 97-100%) for 40 normal donors. (Again, indicating comparable performance). |
  | Specificity (CD3 FITC) | Low non-specific binding to monocytes, granulocytes, platelets, and RBCs. | Mean non-specific binding:
• Monocytes: 1.4%
• Granulocytes: 0.8%
• Platelets: 0.4%
• RBCs: 0.3% (Very low, suggesting good specificity). |
  | Specificity (CD19 R-PE) | Low non-specific binding to monocytes, granulocytes, platelets, and RBCs. | Mean non-specific binding:
• Monocytes: 0.8%
• Granulocytes: 0.5%
• Platelets: 0.3%
• RBCs: 0.3% (Very low, suggesting good specificity). |
  | Specificity (CD45 TRI-COLOR) | High specific binding to lymphocytes, monocytes, and granulocytes; low non-specific binding to platelets and RBCs. | Mean specific binding:
• Lymphocytes: 100.0%
• Monocytes: 100.0%
• Granulocytes: 100.0%
  Mean non-specific binding:
• Platelets: 0.5%
• RBCs: 0.3% (Excellent specific binding to target leukocytes and very low non-specific binding). |
  | Correlation (General) | Strong correlation (high r² value, slope near 1, y-intercept near 0) between the component antibodies in the combination and their respective single antibody counterparts, indicating equivalent performance in quantifying cell populations. | r² values of 94.8% (CD3), 98.9% (CD19 vs Caltag single), and 98.1% (CD19 vs Coulter single) are all very high, demonstrating strong correlation. Slopes are close to 1 (1.01, 1.02, 0.95) and Y-intercepts are close to 0 (0.33, 0.08, 1.29), supporting substantial equivalence. |

2. Sample size used for the test set and the data provenance:

• Expected Value Study:
  • Sample Size: 155 apparently healthy normal donors (16 to 72 years old, mean age 41).
  • Data Provenance: Prospective collection from geographically diverse areas of the United States (Eastern, SouthCentral, and Western regions). The study was conducted in three independent laboratories. The population included adult Caucasians, Blacks, Orientals, and Hispanics.
• Specificity Study:
  • Sample Size: Not explicitly stated as a distinct number, but "blood samples were obtained from healthy normal donors of Caucasian, Black, Hispanic and Oriental ethnic origins." At least 5 donors are represented in the tables (one for each ethnic origin listed).
  • Data Provenance: Healthy normal donors of various ethnic origins.
• Correlation Study:
  • Sample Size: 175 donors (including 155 normal and 20 abnormal donors). This seems to be a mixed prospective/retrospective set or a different prospective collection from the "expected value" study, as the previous one only mentioned normal donors.
  • Data Provenance: Not explicitly detailed beyond "donors." Given the context of healthy normals and ethnically diverse data in the expected value study, it's likely similar.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a reagent for flow cytometry, which quantifies cell populations based on antibody binding. The "ground truth" here is the physical presence of the antigens on the cells and their subsequent detection by flow cytometry. There is no mention of experts establishing a visual "ground truth" like in imaging studies. The accuracy of the flow cytometer's measurements, itself, establishes the "ground truth" for quantification based on the reagents' performance. The comparison is made against established single antibodies (predicate devices), implying that their performance is the accepted standard.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations, but rather a quantitative measurement of antibody binding and cell population percentages by flow cytometry.

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 document describes an in vitro diagnostic reagent, not an AI or imaging device that involves human readers or an MRMC study.

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

The device itself is a reagent kit. Its performance is evaluated in a standalone manner as an IVD product (antibody binding to cells), without human interpretation as the primary outcome measure. The flow cytometer, an automated instrument, performs the analysis.

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

The "ground truth" is implicitly established by:

• Known antigen expression: CD3 on T lymphocytes, CD19 on B lymphocytes, CD45 on all leukocytes.
• Flow cytometry measurements: The quantification of positive cell populations by the flow cytometer, using the combination reagent compared to established single reagents. The specificity data further supports this by showing where the antibodies do and do not bind.
• Predicate device performance: The performance of the predicate single antibodies serves as the accepted standard for defining the "true" percentages of cell populations.

8. The sample size for the training set:

The concept of "training set" is not applicable in the context of this traditional IVD reagent validation. This is a chemical reagent, not an algorithmic model that learns from data.

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

Not applicable, as there is no training set for this type of device.

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CALTAG CD19 R-PE and CD19 TRI-COLOR are fluorochrome conjugated monoclonal antibody reagents that may be used to enumerate CD19+ lymphocytes in human peripheral blood by flow cytometric methods.

The CALTAG CD19 R-PE and CD19 TRI-COLOR monoclonal antibodies bind to the surfaces of viable blood cells that express the CD19 antigen. To identify cells bearing the CD19 determinant, peripheral blood leukocytes are incubated with the monoclonal antibody, and washed to remove unbound antibody. Prior to removal of unbound antibody, lysis solution is added to lyse red blood cells. An appropriate fixative solution is added to lysed and washed cells. Stained and fixed cells are subsequently analyzed by flow cytometric methods.

Here's a breakdown of the acceptance criteria and study information for the CALTAG CD19 R-PE and CD19 TRI-COLOR Mouse Monoclonal Antibodies, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on establishing substantial equivalence to predicate devices rather than defining explicit pass/fail acceptance criteria. However, we can infer some criteria from the comparisons made and the expected values presented. The "Comparison" column in the table implies the acceptance criterion of "Substantially equivalent" to the predicate devices for each item.

Reproducibility (Intra-lab and Inter-lab): While specific acceptance criteria for %CV are not explicitly stated, the data provided implies that the observed %CV values in various ranges (high, mid, low) and across different sites were considered acceptable for demonstrating reproducibility. The ranges of observed %CV were:

• CD19 R-PE (Intra-lab): 0.5% - 7.6%
• CD19 TRI-COLOR (Intra-lab): 1.0% - 6.0%

Correlation: For correlation studies, the acceptance criteria are implicitly that the R-squared (r²) value, slope, and Y-intercept indicate strong linear correlation and agreement with the predicate devices. The reported r² values are very high:

• CALTAG CD19 R-PE vs. Coulter CD19 RD1: r² = 97.7
• CALTAG CD19 R-PE vs. Coulter CD19 FITC: r² = 96.3
• CALTAG CD19 TRI-COLOR vs. Coulter CD19 RD1: r² = 96.7
• CALTAG CD19 TRI-COLOR vs. Coulter CD19 FITC: r² = 97.4
• CALTAG CD19 TRI-COLOR vs. CALTAG CD19 R-PE: r² = 97.6

The slopes are close to 1 (0.92 to 0.99) and Y-intercepts are close to 0 (-0.56 to 2.14), indicating strong agreement.

Study Information

1. Sample size used for the test set and the data provenance:

   • Expected Value Data: 155 apparently healthy normal donors.
   • Specificity Data: An unspecified number of healthy normal donors (Caucasian, Black, Hispanic and Oriental ethnic origins). The table shows data for 5 different donor samples.
   • Reproducibility Data (Intra-lab): For each antibody and each of three ranges (high, medium, low), 10 replicated determinations were performed. This involved 10 separate samples per range. The study was conducted in each of three independent laboratories.
   • Reproducibility Data (Inter-lab): Similar to intra-lab, 10 replicated determinations for each antibody in each of three ranges (high, medium, low). This involved blood samples from "the same blood donors" across three laboratories.
   • Correlation Data: 175 donors (155 normal and 20 abnormal donors).
   • Data Provenance: Geographically diverse areas of the United States, including Western, Eastern, and SouthCentral regions. The studies appear to be prospective, as blood samples were "collected" and "analyzed" for the purpose of this study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study focuses on the performance of monoclonal antibodies for flow cytometry, a lab assay. The "ground truth" is typically established by the assay itself and comparison to established methods (predicate devices), not by expert interpretation of images or other data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is a laboratory assay where results are quantifiable percentages, not subjective interpretations requiring adjudication.

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: Not applicable. This study is about the performance of monoclonal antibodies, not an AI or human reader effectiveness study.

5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The devices are reagents for flow cytometry, which is an automated process for cell counting and phenotyping. The performance presented is of the reagents in conjunction with standard flow cytometric methods, which can be seen as an 'algorithm only' performance in terms of the reagent's interaction with the biological sample and the instrument, without human interpretation as the primary output.

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

   • Expected Values and Specificity: The "ground truth" for the expected values and specificity is derived from flow cytometric analysis of samples from clearly defined populations (healthy donors, specific cell types) using the test device and comparing it to the known performance of predicate devices.
   • Reproducibility: The ground truth for reproducibility is the consistency of the assay results itself, measured by standard deviation (S.D.) and coefficient of variation (%CV).
   • Correlation: The ground truth for correlation is the established performance of the legally marketed predicate devices (Coulter CD19 RD1 and CD19 FITC monoclonal antibodies), against which the new CALTAG antibodies are compared using linear regression.

7. The sample size for the training set: Not applicable. This is a medical device study for reagents, not an AI model requiring a training set. The term "training set" is typically used in machine learning.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI model.

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