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The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).

The AnemoCheck™ is a semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood. Capillary or venous blood may be used. The assay is rapid (development time is 2 minutes) and is a manual test that does not require electrical power or additional equipment.

The Sanguina AnemoCheck device is a semi-quantitative colorimetric assay for determining total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood.

Here's an analysis of its acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates "substantial equivalence based on accuracy and precision" relative to the predicate device. For a semi-quantitative device measuring hemoglobin, typical acceptance criteria would involve a certain level of agreement or correlation with a reference method, often expressed as a percentage of agreement within a clinically acceptable range or a specific mean difference and standard deviation.

The document states:

• "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision."
• "Test results are comparable to other test methods in clinical laboratory and point-of-care practices."

Without specific numerical targets for accuracy (e.g., within X% of a reference method) or precision (e.g., coefficient of variation below Y%), the exact "acceptance criteria" are not fully detailed. The conclusion of "substantial equivalence" implies that the performance met the FDA's criteria for a device of this type, likely benchmarked against predicate devices like the Hemocue® Hemoglobin Hb 201+ Analyzing System and Siemens® Advia 2120i.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the sample size used for the test set in the "Summary of Non-clinical Testing" or "Assessment of Performance" sections.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and their Qualifications for Ground Truth

• The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. Given that it's an in vitro diagnostic device for hemoglobin measurement, the "ground truth" would typically be established by a laboratory reference method (e.g., a hematology analyzer) rather than expert consensus, though interpretation of results might involve medical professionals.

4. Adjudication Method

• The document does not describe any adjudication method. This is expected given that the ground truth for an IVD device like this would likely be an objective measurement from a reference instrument, not subjective assessment requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed. This type of study is typically relevant for interpretative devices where human readers assess medical images or data. The AnemoCheck is a direct measurement device, not an interpretative one in the context of MRMC studies.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed. The "Summary of Non-clinical Testing" states: "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision." This implies the device's performance was evaluated inherently, as a semi-quantitative colorimetric assay, without human interpretation as part of the core measurement. The output of the device (color change) is interpreted manually to determine the hemoglobin level, making it a "manual test that does not require electrical power or additional equipment."

7. Type of Ground Truth Used

• The type of ground truth used would be objective laboratory measurements from predicate or reference devices. The text states: "Bench testing of AnemoCheck versus the predicate device..." and "Test results are comparable to other test methods in clinical laboratory and point-of-care practices." This strongly indicates the AnemoCheck's measurements were compared against established, quantitative hemoglobin assays (like the Hemocue Hb 201+ or Siemens Advia 2120i) which serve as the ground truth.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for any training set. As a manual, semi-quantitative colorimetric assay, the development process might involve calibration and optimization rather than a "training set" in the machine learning sense. The information provided focuses on the validation of the final device.

9. How Ground Truth for the Training Set Was Established

• The document does not provide information on how ground truth was established for any training set. If a training phase existed (e.g., for optimizing the color scale), it would logically also rely on objective laboratory measurements from reference methods for hemoglobin.

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The ADVIA 2120 and ADVIA 2120i with autoslide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories:

• A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Hct, MCH, MCHC, CHCM, RDW, HDW, CH, Plt, MPV.
• A leukocyte differential count consisting of Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
• A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
• A nucleated red blood cell count consisting of NRBC(%/#).
• Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens.
  Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens with K2 and/or K3 EDTA anti-coagulants).
• Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#),PMN (%/#).
  In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a microscope slide.

The ADVIA 2120/210i Hematology systems with Auto slide are an integrated option of a Hematology analyzers with complete blood cell count, leukocyte differential cell count, reticulocyte analysis capability, nucleated red blood cell count, quantitative determination of blood cells in Cerebrospinal Fluid (CSF), enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens and a slide stainer designed to provide reflexive slide making/staining without user intervention based upon pre-selected, user-definable criteria.
The ADVIA 2120/210i Hematology systems with Auto slide consists of the following: an analytical module that aspirates, dilutes, and analyzes whole blood samples; an auto sampler that automatically mixes, identifies, and presents the samples for processing; a computer workstation that controls the instrument, provides primary user interface with the instrument and manages the data produced by the instrument; a printer that optionally generates reports based on the instrument results and an auto slide module that prepares a wedge smear from a drop of blood, places it on a microscope slide and stains the slide in accordance with Wright, Wright-Giemsa and May-Grnwald Giemsa Staining techniques.

The provided text is a 510(k) Summary for the ADVIA® 2120/2120i Hematology auto-analyzers. This document focuses on demonstrating substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device. It does not describe a study that proves the device meets specific acceptance criteria in the way you might expect for a novel AI device with a defined set of performance metrics.

Instead, the submission shows the new device with an ARM9 CPU board performs similarly or identically to the predicate device (the ADVIA 2120/2120i with the current CPU board) across various specifications. The "acceptance criteria" here are essentially the established performance characteristics of the predicate device, and the "study" is the comparison data presented to support substantial equivalence.

Here's an attempt to answer your questions based on the provided text, acknowledging that some information you requested (like AI-specific details, ground truth establishment for a training set, and expert adjudication for a test set) are not relevant or present in this type of FDA submission for a hardware/firmware upgrade to an existing analyzer.

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

The acceptance criteria are implied to be the performance characteristics of the predicate device. The "reported device performance" is the expectation that the new device (AVIA 2120/2120i with ARM9 CPU) will exhibit identical performance.

• RBC (10⁶/μL): 0.0 to 7.0 (Max Deviation: 0.1)
• HGB (g/dL): 0 to 22.5 (Max Deviation: 0.2 or 2.0%)
• PLT (10³/μL): 5.0 to 3500 (Max Deviation: 5.0 or 5.0%)
• %RETIC: 0.2 to 24.5 (Max Deviation: 5.0%)
• CN-free HGB (g/dL): 1 to 22.5 (Max Deviation: 0.3 or 3.0%)
• CSF WBC (cells/µL): 0 to 50 (Max Deviation: 5)
• CSF RBC (cells/µL): 50 to 5000 (Max Deviation: 10%)
• BF TNC (10³/µL): 0 to 50 (Max Deviation: 5)
• BF RBC (10⁶/µL): 50 to 1500 (Max Deviation: 10%) | Same |
  | Within-Run Precision| (See detailed table in original text; e.g., WBC: Nominal 7.5, SD 0.2, CV 2.66%) | Same |
  | Carryover | Less than or equal to 1% | Same |
  | Physical/Electrical | (Various detailed specifications for Temperature, Humidity, Noise, Weight, Dimensions, Vacuum/Pressure, Reaction Chamber Temp, Power Pack Temp, Light Intensities, Power Supply Voltages, Sample Mode Volumes, Throughput, Sample Capacity, Tube Sizes/Types, Barcode Reader functionality) | Same |
  | Data Management | TDC version 9 or higher, Database storage, Review/edit, User-defined reports/ranges, Bi-directional communication, QC features, ILQC programs, User assistance | Same |
  | Consumables/Reagents| CBC TIMEPAC Baso HGB RBC/PLT Defoamer CN-Free CBC TIMEPAC; DIFF TIMEPAC, Perox 1, 2, 3, Perox Sheath, autoRetic, EZ KLEEN, Sheath/Rinse, CSF | Same |
  | Calibrators | ADVIA OPTIpoint, ADVIA SETpoint | Same |
  | Controls | ADVIA TESTpoint Low/Normal/High, Retic Low/High, 3-in-1 Abnormal1/Normal/Abnormal2 | Same |

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

The document lists performance specifications (linearity, precision) but does not specify the sample sizes or data provenance (country, retrospective/prospective) used to establish these predicate device performance characteristics. The context is that the new device's performance is expected to be identical to the established predicate performance, implying that these performance metrics have been previously validated and are being maintained.

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)

This is not applicable to this submission. The "ground truth" for hematology analyzers is typically established through reference methods, calibrated controls, and comparison to established, validated manual methods, not through expert consensus in the way an imaging AI algorithm's ground truth might be. The document focuses on the technical specifications and equivalence of a hardware component change.

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

Not applicable. This type of submission does not involve adjudication of diagnostic decisions as would be relevant for an AI algorithm.

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 for a hematology auto-analyzer, not an AI-assisted diagnostic tool for human readers.

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

The device itself is a standalone automated hematology analyzer. The submission is not for a new algorithm, but for a hardware (CPU board) and associated software upgrade to an existing analyzer. The performance characteristics presented are those of the entire automated system.

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

Not explicitly stated for the predicate device's original validation. However, for hematology analyzers, "ground truth" for parameters like cell counts, hemoglobin, etc., is typically established using:

• Reference methods: Highly accurate and precise laboratory methods.
• Calibrated materials: Use of control materials with known values traceable to international standards.
• Manual microscopy or other established techniques: For differential counts or specific cell morphology, comparison to manual review by highly trained laboratorians.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning. It's a change to a pre-programmed analytical instrument.

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

Not applicable, as there is no "training set" in the AI sense.

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