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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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The X100 with the Full Field Bone Marrow Aspirate (BMA) Application is an automated cell locating device, intended for in vitro use only. The Full Field BMA application automatically locates and presents images of hematopoietic cells to trained operators for visual evaluation of Romanowsky stained bone marrow aspirate (BMA) smears. The Full Field BMA application assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation. A qualified operator must review, confirm or modify classification of each cell according to type, and verify results before finalizing and releasing the report.

The X100 with the Full Field Bone Marrow Aspirate (BMA) application presents images of Prussian Blue stained BMA smear.

X100HT with Full Field BMA Application:

The X100HT with the Full Field Bone Marrow Aspirate (Full Field BMA) Application is an automated cell locating device. intended for in vitro use only. The Full Field BMA application automatically locates and presents images of hematopoietic cells to trained operators for visual evaluation of Romanowsky stained bone marrow aspirate (BMA) smears. The Full Field BMA application assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation. A qualified operator must review, confirm or modify classification of each cell according to type, and verify results before finalizing and releasing the report.

The X100HT with the Full Field Bone Marrow Aspirate (BMA) application presents images of Prussian Blue stained BMA smear.

The X100 and X100HT instruments include a digital scanner and processing unit (computer) capable of acquiring high-resolution digital images from Romanowsky or Prussian Blue stained BMA slides with software application (Full Field Bone Marrow Aspirate (BMA) Application) for evaluation of acquired images. The X100 allows for three slides while X100HT comes with an additional component, a slide loader, a mechanical loading mechanism that holds up to 30 slides in three 10-slide cassettes and performs cover slipping and slide loading into the X100 scanner. The Full Field BMA application contains two scan modes - Romanowsky stain and Prussian Blue stain.

The X100 and X100HT devices with the Full Field Bone Marrow Aspirate (BMA) Application are automated cell-locating devices intended to assist trained operators in evaluating Romanowsky or Prussian Blue stained bone marrow aspirate smears. The application specifically aids in bone marrow smear quality assessment, blast cell estimation, plasma cell estimation, and Myeloid:Erythroid (M:E) ratio estimation. A qualified operator must review, confirm, or modify classifications and verify results before finalizing reports.

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for the device performance are indicated by the successful completion of the studies and the reported sensitivities, specificities, and agreements, particularly for the key parameters of specimen quality, blast cells, plasma cells, and M:E ratio. The tables show the performance results from the clinical study comparing the device to manual microscopy and to de-identified medical data.

Clinical Study: Comparison of Candidate Device to Manual Microscopy

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The X100HT with Full Field Peripheral Blood Smear (PBS) 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.

X100HT with Full Field Peripheral Blood Smear (PBS) Application automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears. The user browses through the imaged smear to gain high-level general impressions of the sample. In conducting white blood cells (WBC) differential, the user reviews the X100HT with Full Field PBS suggested classification of each automatically detected WBC and may manually change the suggested classification of any cell. In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images. In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelets estimation and may manually change the detections or the estimation. The X100HT with Full Field PBS enables efficient slide loading by providing three cassettes, each can be loaded with up to ten peripheral blood smear slides. The slide loader automatically adds mounting media and coverslips to the slides and loads them into the X100 for scanning and analysis. The X100HT with Full Field PBS is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

The provided text describes the regulatory clearance of the Scopio X100HT with Full Field Peripheral Blood Smear (PBS) Application, comparing it to a predicate device (X100 with Full Field PBS Application). While it outlines the device's intended use and the general types of testing performed (software, hardware, EMC, safety), it does not contain explicit details on the acceptance criteria or the specific study results that prove the device meets these criteria for the AI/automation components of the system.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, particularly highlighting the addition of a 'Slide Loader' and minor software modifications for workflow efficiency, rather than a detailed performance study of the AI's diagnostic capabilities. The core image analysis and AI components ("standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells") are stated to be "identical" to the predicate device. Therefore, a comprehensive performance study as requested, particularly regarding the AI's diagnostic accuracy against a ground truth and comparative effectiveness with human readers, is not present in this document.

However, based on the information provided, here's what can be extracted and inferred, with acknowledgments of missing details:

Acceptance Criteria and Device Performance (Inferred/General)

Since the core AI/analysis technique is stated to be "identical" to the predicate device, it's implied that the performance of the X100HT (regarding cell classification accuracy, etc.) would be similar to what was demonstrated for the predicate device's clearance. The document focuses on the new functionality (slide loader) and how it does not raise new questions of safety or effectiveness, meaning the existing performance of the analytical portion is presumed acceptable.

Table 1: Acceptance Criteria and Reported Device Performance

Details on the Study Proving Device Meets Acceptance Criteria:

1. Sample Size Used for the Test Set and Data Provenance:

   • Not specified in the provided text. The document states "Verification and validation testing was conducted and documentation was updated," but does not list sample sizes for these tests, nor the origin (country) or nature (retrospective/prospective) of the data. Given the device's classification and the focus on "substantial equivalence," it's possible detailed clinical performance data was not a primary requirement for this 510(k), as the core AI was already cleared.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not specified in the provided text. The document mentions the device "assists a qualified technologist" and is for "skilled users, trained in the use of the device and in the identification of blood cells," but does not detail the experts used for ground truth generation in any validation studies.

3. Adjudication Method for the Test Set:

   • Not specified in the provided text.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not specified in the provided text. The document emphasizes that the user "reviews the suggested classification" and "may manually change the suggested classification," indicating a human-in-the-loop workflow. However, an MRMC study comparing human performance with and without AI assistance is not described.

5. Standalone (Algorithm Only) Performance:

   • A standalone performance study of the algorithm's accuracy in classifying cells (without human review/override) is not explicitly detailed in the provided text for the X100HT. The description of the device's function clearly outlines a "pre-classified" stage where the ANN suggests classifications, which are then reviewed and potentially modified by a human user. The performance reported is thus implicitly a human-in-the-loop performance, but the standalone accuracy is not quantified.

6. Type of Ground Truth Used:

   • Not specified in the provided text. Since the device "pre-classifies" cells, the ground truth for training and validating the ANN would likely involve expert consensus or manual expert classification of blood cells. However, this is not explicitly stated.

7. Sample Size for the Training Set:

   • Not specified in the provided text. The document mentions "deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells," but the size of the training dataset is not provided.

8. How the Ground Truth for the Training Set Was Established:

   • Not specified in the provided text. Similar to point 6, it can be inferred that expert classification was used, but the specific process (e.g., number of experts, consensus methods) is not described.

Summary of Missing Information:

The provided 510(k) summary focuses almost entirely on demonstrating that the X100HT, with its new slide loader, is substantially equivalent to an already cleared predicate device (K201301). It highlights that the core analytical software and imaging technology responsible for AI-assisted cell classification are "identical" to the predicate. Therefore, details regarding new performance studies for the AI component itself (acceptance criteria, test set sizes, ground truth establishment, MRMC studies) are not present in this document, as the performance aspect of the AI was likely covered in the predicate device's clearance. This document serves to demonstrate that the modifications (primarily the slide loader) do not negatively impact the previously established safety and effectiveness.

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The X100 with 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.

X100 with Full Field Peripheral Blood Smear Application (Scopio's Full Field PBS) automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears. The user browses through the imaged smear to gain high-level general impressions of the sample. In conducting white blood cells (WBC) differential, the user reviews the suggested classification of each automatically detected WBC, and may manually change the suggested classification of any cell. In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images. In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelet estimation, and may manually change the detections or the estimation. The X100 with Full Field Peripheral Blood Smear Application is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

The provided text describes the performance data for the X100 with Full Field Peripheral Blood Smear Application, comparing its results to those achieved by using a manual light microscope, which serves as the reference method.

Here's a breakdown of the requested information:

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

The document does not explicitly state pre-defined acceptance criteria for the percentage values (e.g., correlation coefficient, efficiency, sensitivity, specificity). However, it consistently states that "All method comparison testing met acceptance criteria." This implies that the achieved performance met internal or regulatory thresholds. Based on the provided performance data, here's a table:

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

• Sample Size for Test Set: A total of 645 specimens.
  • 335 specimens were from normal (healthy) subjects.
  • 310 specimens were from subjects with specific disease conditions.
• Data Provenance:
  • Country of Origin: Not explicitly stated. The study was conducted at "three sites" but their geographical location is not specified.
  • Retrospective or Prospective: Not explicitly stated, but the description "specimens were collected and analyzed at three sites" with slides being "randomly selected, blinded and read" suggests a prospective or at least prospectively designed evaluation of collected samples.

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

• Number of Experts: "two examiners at each site." Since there were three sites, a total of 6 examiners were involved in establishing the ground truth.
• Qualifications of Experts: The document states that the ground truth was established by "trained examiners" using a "manual light microscope." It also mentions elsewhere that the device is intended for "skilled users, trained in the use of the device and in the identification of blood cells." While specific certifications or years of experience are not detailed, the implication is that these examiners are qualified clinical laboratory professionals adept at manual blood smear analysis.

4. Adjudication method for the test set

• The text states, "The slides were randomly selected, blinded and read by two examiners at each site." It does not explicitly mention a formal adjudication method (e.g., 2+1, 3+1 consensus). It simply states that results were compared between the "Test Method" (X100) and the "Reference Method" (manual light microscope). It is implied that the manual readings by the two examiners constituted the reference. There is no information provided about how discrepancies between the two examiners' manual readings (if any) were resolved or if their results were averaged.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was not the primary focus described.
• The study primarily functions as a method comparison study, comparing the device's performance (which assists human readers) directly against the manual light microscope method (the established reference/ground truth).
• The device "assists a qualified technologist" by locating and displaying images and suggesting classifications. The study evaluates the device-assisted technologist's performance against the manual technologist's performance.
• Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not reported in the context of a dedicated MRMC study.

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

• No, a standalone (algorithm-only) performance was not described or evaluated.
• The device's intended use and the study design clearly state that it "assists a qualified technologist." The performance data reflects the combined system of the device and the human user, where the user reviews and can modify the device's suggestions (e.g., "may manually change the suggested classification of any cell," "may manually change the detections or the estimation"). It is a human-in-the-loop system.

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

• The ground truth was established by expert readings using a manual light microscope. This is effectively expert consensus if the two examiners at each site agreed, or if their readings were somehow combined to form the reference. The manual light microscope process itself is described as the "Reference Method."

8. The sample size for the training set

• The document does not specify the sample size for the training set. The performance data provided is solely for the "Method Comparison" study, which used the 645 specimens as the test set.

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

• The document does not provide details on how the ground truth for the training set was established. Since the training set size is not mentioned, neither is the method for its ground truth. However, given that the device's "Analysis Technique" for WBCs uses "deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells," it is highly probable that the training ground truth was also established by expert classification of blood cells.

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