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The X100/X100HT with Full Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in-vitro diagnostic use only. For professional use only.

The X100 / X100HT with Full Field Peripheral Blood Smear (PBS) Application ("Full Field PBS") is a digital cell morphology solution, presenting high resolution digital images of fixed and stained microscopy Peripheral Blood Smears. The Full Field PBS was previously cleared by the Agency on October 2, 2020, throughout the review of K201301 and on May 3, 2022, throughout the review of K220013. The system automatically locates and presents images of peripheral blood cells and streamlines the PBS analysis process with a review workflow composed of four steps: (1) full field review, (2) white blood cells (WBC) review (DSS for WBC Pre-Classification is available), (3) red blood cells (RBC) review and (4) platelet review (DSS for platelet estimation is available).

Under the proposed modification, subject of this 510(k) submission, additional DSS component is added to the RBC and Platelet review steps. Concerning RBC analysis, system-suggested RBC morphological pre-gradings are added as proposed DSS to the user by means of a dotted line around a suggested grading selection box. Notably, the user is still required to review the slide and actively mark the final grading, exactly as performed in the cleared workflow review.

The same approach is used with regard to the update to the platelet review step; A system-suggested platelet clump indication is presented to the user by means of a dotted line around a selection box. Notably, the user is still required to manually mark whether platelet clumps were detected, exactly as currently performed in the cleared workflow review.

The changes under discussion do not affect the cleared indications for use or intended use; the user's workflow of scanning and analyzing peripheral blood smears using the Full Field PBS Application remains otherwise unchanged as well.

The Scopio Labs X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application has received FDA 510(k) clearance (K243144) based on a modification that adds system-suggested pre-gradings for RBC morphology and platelet clump indications. The study involved a method comparison study, repeatability study, reproducibility study, and software verification and validation.

1. Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly state the numerical acceptance criteria for the method comparison study. However, it indicates that "The results met the pre-defined acceptance criteria." The reported performance metrics are presented as overall agreement, Positive Percent Agreement (PPA), and Negative Percent Agreement (NPA).

The precision studies (repeatability and reproducibility) also "met the pre-defined acceptance criteria." However, the specific numerical criteria for these studies are not detailed in the provided document.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: A total of 1200 anonymized PBS slides were used for the method comparison study.
• Data Provenance: The slides were collected from the laboratory routine workload of three medical centers. The country of origin is not specified, but the submitter information lists "Tel Aviv, Israel" as the sponsor address, which may suggest the data originated from Israel, though this is not explicitly stated for the clinical evaluation. The data is retrospective, as it was collected from "routine workload."

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., years of experience). It implies that the ground truth was established by referring to "pre-defined acceptance criteria" and a "method comparison study," which typically involves comparison against human expert interpretation. However, the details of this expert interpretation are not provided.

4. Adjudication Method for the Test Set

The adjudication method used to establish the ground truth for the test set is not specified in the provided document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The study described is a method comparison study between the modified device (with added DSS) and either the previous cleared device or human expert consensus, but not a comparative effectiveness study measuring improvement in human reader performance.

6. Standalone Performance Study (Algorithm Only)

The document describes the device as providing "system-suggested RBC morphological pre-gradings" and "system-suggested platelet clump indication" by means of a dotted line, and that "the user is still required to review the slide and actively mark the final grading." This indicates that the device functions as an assistive tool (human-in-the-loop) rather than a completely standalone algorithm making final diagnoses. The performance metrics presented (Overall Agreement, PPA, NPA) are likely comparisons of the system's suggestions against ground truth, which implicitly reflects a standalone component, but the final reported performance is within the context of assisting a qualified technologist, not solely the algorithm's output. Therefore, a purely standalone (algorithm-only without human-in-the-loop) performance is not explicitly presented or claimed for clinical use.

7. Type of Ground Truth Used

Based on the description of the "method comparison study" and the nature of the device (assisting a qualified technologist), the ground truth was likely established by expert consensus or through a reference method performed by qualified experts in hematology/morphology. The context of "laboratory routine workload" and comparison implies an existing gold standard interpretation.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the AI/DSS components. It only details the test set used for performance evaluation of the modified device.

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

The document does not provide information on how the ground truth for the training set was established. It states that "Cell images are analysed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells." This implies a training process, but the details of ground truth establishment for that training are omitted.

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