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The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.

HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent Cartridge. In addition to the Cartridge, the system includes a disposable Sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the Cartridge.

Once the Cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (Sampler) into the reagent compartments (Cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the Cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing.

The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The Cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the Cartridge.

The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within less than six (6) minutes and the results are saved.

Quality Control: Commercial 3-level liquid quality controls, PIX-CBC Hematology Controls, are recommended for use with the HemoScreen. These controls cover all the tested parameters and are sampled the same way whole blood is sampled.

Software: The HemoScreen software displays an intuitive, simple-to-use user interface that is operated via the touch screen. The software is responsible for operating the device, performing the measurements, and recording the results.

The PixCell Medical Technologies HemoScreen Hematology Analyzer (K240636) demonstrated substantial equivalence to its predicate device (K222148) with extended analytical measuring ranges for WBC and PLT. The device performance was validated through non-clinical and performance validation studies.

Here's a breakdown of the acceptance criteria and study details:

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

The document does not explicitly state acceptance criteria in table format but implies that the criteria were met if the comparison to the predicate device (Sysmex XN) showed strong correlation and acceptable Passing-Bablok regression results. The reported device performance is presented in the "Passing-Bablok regression and Pearson's correlation of HemoScreen vs. Sysmex XN" table. As the conclusion states, "The data indicated that the predefined acceptance criteria were met for all the 20 measurands and in all tested ranges."

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

• Sample Size for performance validation (WBC, PLT extended ranges): 232 residual whole blood venous samples.
• Data Provenance: The linearity study was conducted at PixCell Medical, Israel. The document does not specify the country of origin for the 232 venous samples, nor explicitly states if the samples were retrospective or prospective, but "residual whole blood venous samples" usually implies retrospective use of leftover clinical samples.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation was a method comparison study against a legally marketed predicate device, the Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzers (K112605). The Sysmex analyzer served as the reference method.

4. Adjudication method for the test set

Not applicable. The study compares the HemoScreen to a commercially available predicate device (Sysmex XN), not against a human-adjudicated ground truth.

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 device is an automated hematology analyzer, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

Yes, the performance validation data presented is for the standalone device (HemoScreen Hematology Analyzer), with its measurements compared directly to those of the Sysmex XN automated hematology analyzer. There is no human-in-the-loop component described for this specific validation.

7. The type of ground truth used

The ground truth for the performance validation study was established using a legally marketed predicate device: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzers (K112605). This is a comparative method study, where the predicate device acts as the reference standard.

8. The sample size for the training set

The document does not provide information about a training set size. This suggests that the study performed here focused on analytical validation of the device's measurement accuracy against a predicate, rather than an AI/machine learning model whose performance would depend on a training set. The device uses "machine vision algorithms" but the specifics of their training and associated dataset sizes are not detailed in this 510(k) summary.

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

Not applicable, as a training set and its ground truth establishment are not described in this 510(k) summary.

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The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.

HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent Cartridge. In addition to the Cartridge, the system includes a disposable Sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the Cartridge.

Once the Cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (Sampler) into the reagent compartments (Cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the Cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing.

The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The Cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the Cartridge.

The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within six (6) minutes and the results are saved.

Quality Control: Commercial 3-level liquid quality controls, PIX-CBC Hematology Controls, are recommended for use with the HemoScreen. These controls cover all the tested parameters and are sampled the same way whole blood is sampled.

Software: The HemoScreen software displays an intuitive, simple-to-use user interface that is operated via the touch screen. The software is responsible for operating the device, performing the measurements, and recording the results.

The provided text describes the HemoScreen Hematology Analyzer's performance and the study conducted to demonstrate its substantial equivalence. The key change evaluated was the introduction of direct fingerstick sampling, compared to the previously cleared indirect fingerstick sampling method.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for each parameter. Instead, it relies on correlation and regression analysis to show agreement between the new direct sampling method and the previously cleared indirect sampling method. The implicit acceptance criteria are likely based on acceptable Passing-Bablok regression parameters (slope and intercept ideally close to 1 and 0, respectively) and high Pearson Correlation coefficients.

However, the reported performance is provided as follows:

Performance of HemoScreen (Direct Fingerstick) vs. HemoScreen (Indirect Fingerstick) for 20 Parameters

2. Sample size and Data Provenance

• Test Set Sample Size: 42 subjects.
• Data Provenance: The study described is a "prospective clinical study" involving "matched fingerstick collections." The document does not explicitly state the country of origin, but the company (PixCell Medical Technologies, Ltd.) is based in Israel. Given the FDA submission, it's likely the study was conducted to meet US regulatory requirements, but the specific location isn't provided.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a "ground truth" in the traditional sense of consensus reading for images. The study compares two different methods of sampling with the same device (HemoScreen) – direct vs. indirect fingerstick. The "ground truth" for the comparison is essentially the measurement obtained by the indirect sampling method, which was previously cleared. There are no mentions of radiologists, pathologists, or similar experts reviewing cases to establish a ground truth for a diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. This was a method comparison study for quantitative measurements, not a diagnostic AI study requiring adjudication of expert interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on comparing two sampling methods for a highly automated hematology analyzer, not on human readers' interpretive performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The HemoScreen device itself is described as using "machine vision algorithms" to analyze images of cells. Therefore, the reported performance metrics (Pearson correlation, Passing-Bablok regression) represent the standalone performance of the device's algorithms in quantifying blood parameters. The study specifically compared the input method (direct vs. indirect fingerstick) to the device, not an AI assisting a human.

7. Type of Ground Truth Used

The ground truth used for performance comparison was the quantitative measurements obtained from the HemoScreen device itself, using the indirect fingerstick sampling method. This method was previously cleared (K180020) and served as the reference for evaluating the new direct sampling method. It's a "device-to-device" or "method-to-method" comparison, rather than comparison to a clinical expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" for the "machine vision algorithms." The algorithms are inherent to the device's operation. It's possible the algorithms were developed and validated internally during the device's initial design and prior K180020 clearance, but this specific submission focuses on validating the direct fingerstick sampling method rather than training new algorithms or updating existing ones. Thus, the sample size for a training set is not provided in this document.

9. How Ground Truth for Training Set Was Established

As mentioned above, information regarding a specific "training set" and its ground truth establishment is not provided in this document. The existing HemoScreen device's core technology and algorithms were already cleared under K180020. This submission primarily validates a new sample collection modality for the same device and its existing algorithms.

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The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, E0%, E0%, BASO %, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.

HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent cartridge. In addition to the cartridge, the system includes a disposable sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the cartridge. Once the cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (sampler) into the reagent compartments (cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing. The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the cartridge. The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within six (6) minutes and the results are saved.

Here's a breakdown of the acceptance criteria and study information for the HemoScreen Hematology Analyzer based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are generally implied by the statement "the redefined acceptance criteria were met for all the 20 measurands and in all tested ranges" for precision, and "the 95% confidence intervals for mean bias / mean relative bias were within the acceptance limits" and "the correlation point estimates met the acceptance criteria" for method comparison. Specific numerical acceptance limits are not explicitly stated in the provided text for all parameters (e.g., a specific Pearson correlation threshold, or a specific mean bias range), but the tables present the reported device performance.

Table of Acceptance Criteria (Implied) and Reported Device Performance (Focus on Method Comparison data, as this provides a clearer standard for comparison):

Note on Basophils (BAS# and BAS%): The initial method comparison notes that basophil data were "not meaningful" due to the distribution of samples. A separate "BASO Study" was conducted for basophils, which yielded specific correlation and bias values as shown.

Study Information:

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

• Method Comparison & Clinical Sensitivity/Specificity:
  • Sample Size: 495 normal and pathological residual whole blood specimens.
  • Data Provenance: Collected across three clinical sites (retrospective, as they were "residual" samples).
• Basophil-specific study ("BASO Study"):
  • Sample Size: 95 whole blood samples that included high levels of basophils.
  • Data Provenance: Not explicitly stated if it's from the same three clinical sites or if it's retrospective/prospective, but likely similar to the main method comparison.
• Flagging Study:
  • Sample Size: 402 whole blood specimens.
  • Data Provenance: Analyzed across three clinical sites (retrospective, as samples were "analyzed").
• Reference Intervals:
  • Sample Size: Minimum of 120 male subjects and 120 female subjects (total 243 subjects reported: 123 female, 120 male).
  • Data Provenance: Single US site, freshly collected K2EDTA venous blood from healthy (self-reported) adult (19-69 years old) male and female volunteers on a single occasion (prospective).
• Vein to Capillary Equivalency:
  • Sample Size: 75 normal and pathological paired capillary and venous whole blood specimens.
  • Data Provenance: Drawn from volunteer subjects across three clinical sites (prospective, as samples were "drawn").

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

• Method Comparison & Clinical Sensitivity/Specificity, Flagging, Vein to Capillary Equivalency Studies:
  • For blood smear analysis (part of the ground truth for differentials and flagging), "Experienced operators trained to use the automated blood smear performed the differentials, including morphology evaluation, and the results were verified by these operators." The exact number or specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, other than "experienced operators."
  • For the comparative instrument (Sysmex XN Series), "laboratory personnel" performed the analyses. Specific qualifications are not detailed.
• BASO Study (ground truth for basophils):
  • Light microscopy (standard reference method) was used for %basophils, performed by "experienced operators" (implied, similar to other blood smear analyses).
  • Sysmex method was used for absolute counts, performed by "laboratory personnel."

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

• The document mentions that for blood smear analysis, "the results were verified by these operators," suggesting internal verification rather than a formal multi-expert adjudication method like 2+1 or 3+1. It does not explicitly state a formal adjudication process for discordant results between the device and the ground truth.

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:

• No, a MRMC comparative effectiveness study involving human readers improving with/without AI assistance was not done. The HemoScreen is an automated hematology analyzer, not an AI-assisted diagnostic tool for human readers. The clinical studies compare its performance against established laboratory methods (Sysmex) and manual blood smear analysis, not evaluating human reader performance.

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

• Yes, the studies evaluate the standalone performance of the HemoScreen Hematology Analyzer. The device is an automated system that performs enumeration and classification using its internal machine vision algorithms. The "method comparison" sections directly assess the algorithm's performance against reference methods.

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

• For enumeration parameters (WBC, RBC, HGB, PLT etc.): The ground truth was primarily established by a legally marketed predicate device, the Sysmex XN Series, and in some cases, by other reference methods like centrifugation for LoB/LoD/LoQ studies.
• For differential parameters (NEUT%, LYM%, MONO%, EOS%, BASO%): The ground truth was established by the predicate device (Sysmex XN Series) and manual blood film differential counts (microscopy) performed by "experienced operators trained to use the automated blood smear," following CLSI H20-A2 guidelines (2 slides / 200 cells counted per slide for a total of 400 cells). This falls under a form of expert consensus/manual review.
• For Flagging: Ground truth was based on differential results from the predicate and manual blood smears.
• For LoB/LoD/LoQ: Processed blood samples measured by a "comparative method" (likely a reference method capable of precise low-level measurement).

7. The sample size for the training set:

• The document does not explicitly state the sample size for the training set. The provided information pertains to the validation studies (nonclinical and clinical data proving performance). Automated analyzers like HemoScreen employ machine vision algorithms, which would have been trained on a separate dataset, but the details of this training dataset are not included in the 510(k) summary.

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

• As the training set size is not provided, the method for establishing its ground truth is also not described in this document. For such devices, ground truth for training would typically involve large datasets of images with expert-verified cell classifications and counts.

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