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AnemoCheck Home is intended for home use for the determination of hemoglobin level in whole blood from a finger stick by people over the age of 18. This device is intended for people with anemia caused by iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, or who have chronic anemia due to sickle cell disease or thalassemia. AnemoCheck Home tests are for in vitro diagnostic use only. Prescription Use Only.

AnemoCheck Home is a home use with prescription anemia test that is semiquantitative, color based, single use test for hemoglobin level determination. Simply, a user performs a finger stick, less than one drop of blood (5uL) is collected into a collection tube within the test cap, the test cap is mated with the test body and shaken. After 2 minutes of development time, the resulting color of the test solution correlates to a color on a color card. The color results correlate to total hemoglobin levels. As shown, the colors range from blue to red (blue and green indicating low hemoglobin levels, yellow indicating slightly decreased hemoglobin levels and orange and red indicating high levels of hemoglobin), with 1.0 g/dL color block resolution. Users may assign values in between two color blocks for a resolution of 0.5 g/dL. AnemoCheck Home is rapid (2 minutes), simple to use, disposable, and is a stand-alone system that does not require electrical power, additional equipment, or training. The device is semi-quantitative and designed to use a specific test body, test cap, blood collection tube and chemical reagent solution. The blood collection tube serves as a pipette and measuring instrument. No dilution is required or measuring is required by the lay user. AnemoCheck Home leverages the same chemistry and technology used in AnemoCheck (K163215). When blood is mixed with the pre-filled solution, an oxidation-reduction (redox) 3.3.5.5.5 tetramethylbenzidine (TMB) and hydrogen peroxide, leading to stable oxidized TMB products. The products exhibit different colors based on the amount of total hemoglobin present in the sample. After 2 minutes, the resulting color of the solution then allows for visual interpretation with the naked eye using a color card for determination of hemoglobin (g/dL).

The provided document is a 510(k) summary for the AnemoCheck Home device. It details a semi-quantitative, color-based test for hemoglobin levels from a finger stick, intended for home use by individuals over 18 with certain types of anemia.

Based on the provided text, here's an attempt to extract the requested information, acknowledging that some specific details (like exact sample sizes for training or specific expert qualifications for ground truth) might not be explicitly stated in this high-level summary.

Acceptance Criteria and Device Performance:

The document broadly states that "Analytical testing of AnemoCheck Home versus the predicate device and comparator methods demonstrate substantial equivalence based on accuracy and precision." However, specific numerical acceptance criteria (e.g., a defined range for accuracy or precision) are not detailed in this summary. Similarly, the "reported device performance" in terms of specific quantitative results for accuracy and precision are also not explicitly provided in a table format. The text only offers a general conclusion that the test results are "comparable to other test methods."

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Here's the rest of the information based on the provided document:

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

• Test Set Sample Size: Not explicitly stated in the summary document. It mentions "analytical testing" and "test results in the hands of the intended user," implying a test set was used, but the size is not given.
• Data Provenance: Not specified in the summary document. There is no mention of country of origin of the data, nor whether it was retrospective or prospective.

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

• This information is not provided in the 510(k) summary. The document does not describe the process of establishing ground truth for the test set in detail. It refers to "clinical laboratory and point-of-care settings" as comparator methods, implying these settings generated the reference values, but not how experts specifically established "ground truth" labels for individual samples.

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

• This information is not provided in the 510(k) summary. The document does not describe any specific adjudication method for the test set results or ground truth establishment.

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 device is a semi-quantitative, color-based test for hemoglobin levels. It is interpreted visually by the user based on a color card. There is no mention of an AI component or "human readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study with AI assistance would not be applicable here, and no effect size would be reported.

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

• This is not an algorithm-only device. It is a physical, color-based test that requires user interpretation. Therefore, a "standalone algorithm-only" performance assessment is not applicable. The device's performance is inherently "human-in-the-loop" as the user matches the color to a card. The summary states, "Test results in the hands of the intended user, an untrained lay user, are comparable to other test methods."

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

• The ground truth appears to have been established by "other test methods in clinical laboratory and point-of-care settings." This implies reference laboratory methods (e.g., automated hematology analyzers, or other established POCT devices with known accuracy) were used to determine the true hemoglobin levels for comparison. The specific type of "ground truth" (e.g., expert consensus on visual assessment, or a gold-standard lab test) is not explicitly detailed beyond "comparator methods."

8. The sample size for the training set:

• The 510(k) summary for a medical device (especially one without a complex AI model) typically describes validation studies rather than "training sets" in the machine learning sense. This document describes "analytical testing" and "assessment of performance." The concept of a "training set" for the device's development (e.g., for calibrating the color card) is not explicitly detailed in terms of sample size within this summary.

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

• As above, the concept of a "training set" as it relates to machine learning is not directly applicable or discussed in detail for this type of device in the provided summary. The process of how the color card was developed and correlated to specific hemoglobin values during the device's development (which could be considered analogous to "training") is not described in detail, but it would presumably involve comparing the device's color output to measured hemoglobin values from reference methods in a laboratory setting.

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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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