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The ClearLLab reagents are intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on an FC 500 flow cytometer. 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, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood collected in EDTA (K2 and K3EDTA), Acid Citrate Dextrose 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 Cluster of Differentiation (CD) parameters listed below:

• ClearLLab T1: CD2, CD56, CD7, CD5, CD7, CD5, CD45
• ClearLLab T2: CD8, CD4, CD3, CD45
• ClearLLab B1: Kappa, Lambda, CD19, CD5, CD45
• ClearLLab B2: CD20, CD10, CD10, CD19, CD38, CD45
• ClearLLab M: CD7, CD13, CD34, CD33, CD45

The Clear LLab Reagents panel is used with the following reagents with their respective indicated uses. A description of the reagents provided is described below in Table 1.

The ClearLLab Reagents are intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on an FC 500 flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having hematopoietic neoplasms.

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

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

• Test Set Sample Size: A total of 279 abnormal hematologic specimens were enrolled in the clinical performance study.
  • 137 hematologically abnormal but no malignancy.
  • 142 with hematolymphoid malignancy (23 Acute Leukemia, 36 Chronic Leukemia, 62 Lymphoma, 8 Plasma Cell Neoplasm, 13 Others: MDS/MPN).
  • An additional analysis was performed on 160 whole blood specimens (78 hematologically abnormal with no malignancy and 82 with hematolymphoid malignancy) from this larger set.
• Data Provenance: The study was a multi-center, retrospective study conducted at four sites. While the document does not explicitly state the country of origin, the reference to "WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues" suggests an international context for clinical guidelines, but the specific locations of the four sites are not detailed.

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):

• Number of Experts: Two qualified flow experts evaluated the ClearLLab flow cytometry results.
• Qualifications of Experts: The document states "Two qualified flow experts evaluated the ClearLLab flow cytometry results independently of each other..." However, specific details on their years of experience or exact professional titles (e.g., "radiologist with 10 years of experience") are not provided. It does state that "The device labeling states that interpretation of specimens should be performed by a pathologist or equivalent professional who has the appropriate training." This implies the experts would hold such qualifications.

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

• Adjudication Method: The two flow experts evaluated the ClearLLab results independently of each other and were blinded to the final diagnosis. There is no mention of an adjudication method like 2+1 or 3+1 to resolve discrepancies between the two experts' interpretations of the ClearLLab device output. However, the expert interpretations of the ClearLLab results were then compared against the clinical outcome ("malignant" or "non-malignant") established by the clinical sites' final patient diagnosis.

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 study did not appear to be an MRMC comparative effectiveness study in the context of human readers improving "with AI vs without AI assistance." The ClearLLab Reagents are a device for qualitative identification of cell populations using flow cytometry for aid in diagnosis. The study focused on the performance of these reagents (a diagnostic tool), interpreted by human experts, against clinical diagnosis. There is no mention of AI assistance in the interpretation of the device results or a comparison of human reader performance with and without such assistance.

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

• No, a standalone (algorithm only) performance was not done. The ClearLLab Reagents are a diagnostic tool that produces flow cytometry data. The interpretation of this data by human "flow experts" was an integral part of the clinical performance study. The device's output itself isn't a definitive diagnosis but an aid, requiring expert interpretation.

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

• The ground truth used was the clinical outcome of "malignant" or "non-malignant" based on the clinical sites' final patient diagnosis. This diagnosis was established by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings, adhering to WHO guidelines. This can be categorized as a form of outcomes data or established clinical diagnosis, rather than simply expert consensus on the device's output.

8. The sample size for the training set:

• The document focuses on the performance of the ClearLLab Reagents and associated interpretive processes. There is no mention of a "training set" in the context of an algorithm or AI model development, as this device submission is for reagents and their clinical performance when interpreted by human experts, not an AI diagnostic algorithm.

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

• As there is no mention of a "training set" for an algorithm or AI model in this document, the method for establishing its ground truth is not applicable or described.

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