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The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

The HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin Measurement System. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.

The DM (Data Management) system allows enhanced data management features.

For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes.

A modified azide methemoglobin method is used in the HemoPoint® H2 system.

In the HemoPoint® H2, however, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed.

In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured.

For this purpose, light is directed through the blood sample and the transmission T is measured. From the amount of light absorbed by the sample, the concentration of the hemoglobin in the cuvette can be calculated using Lambert-Beers Law.

Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.

Here's an analysis of the acceptance criteria and the study that proves the HemoPoint® H2 DM Hemoglobin Measurement System meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly listed in a separate table, but they can be inferred from the "Comparison to Predicate Device" table and the "Correlation Study" and "Precision" sections.

Study Details

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

   • Precision Test Set: The number of individual samples for the precision study is not explicitly stated as a single "test set" size. However, the study for "Between-Day Imprecision" mentions "Single observation, 20 days," which implies at least 20 measurements for each hemoglobin level (high, low, normal). The "Within-Run Precision" and "Total Precision" are based on NCCLS EP5-A, which typically involves multiple replicates over several days, but the exact number of unique samples is not given.
   • Correlation Study Test Set: For both correlation studies (vs. NCCLS H15-A3 and vs. HemoCue), the sample size was N=100 duplicate measurements.
   • Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective studies conducted by the manufacturer to demonstrate performance.

2. 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" in the sense of human readers adjudicating results for the ground truth.
   • The ground truth for the correlation studies was established using NCCLS H15-A3 reference method and the HemoCue system (predicate device). These are established laboratory methods, not human expert consensus.

3. Adjudication method for the test set:

   • No adjudication method (like 2+1, 3+1) was used as the ground truth was based on laboratory reference methods (NCCLS H15-A3) or comparison to a predicate device (HemoCue), not on human expert interpretation requiring consensus.

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 MRMC comparative effectiveness study was done. This device is a quantitative hemoglobin measurement system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

   • Yes, the studies conducted are standalone performance evaluations of the HemoPoint® H2 system. The device itself performs the measurement and calculation of hemoglobin concentration. The "DM (Data Management) software modification" merely allows for data storage and retrieval, it does not involve an AI algorithm for diagnosis or interpretation that would typically require human-in-the-loop assessment for performance studies.

6. The type of ground truth used:

   • Reference Method: For the accuracy and correlation studies, the ground truth was established by a recognized reference method: the NCCLS H15-A3 reference method for hemoglobin determination.
   • Predicate Device Comparison: The HemoCue system (a legally marketed predicate device) was also used as a comparator/ground truth source in some correlation and precision studies.

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of an algorithm or AI model development. The HemoPoint® H2 System is a photometric device, and its core principle (Lambert-Beer's Law) and calibration are based on established chemical and optical principles, not on a machine learning model requiring a training set in the typical sense. Calibration is performed against the NCCLS reference method.

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

   • Since there's no "training set" for an AI algorithm, this question is not applicable. The device is calibrated against the NCCLS reference method, which serves as the standard for establishing accuracy for the device's measurements.

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The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.

For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoglobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

Here's an analysis of the acceptance criteria and study details for the HemoPoint® H2 Hemoglobin Measurement System based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for HemoPoint® H2 Hemoglobin Measurement System

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical targets for all parameters. However, it presents "Comparison to Predicate Device" that implies the acceptance criteria are met if the device's performance is "equivalent" to the predicate or within acceptable clinical ranges. For precision and correlation, specific numerical results are provided.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test set sample size: For the correlation studies, the sample size was N=100 duplicate measurements for each comparison (HemoPoint H2 vs. NCCLS H15-A3, HemoPoint H2 vs. HemoCue, HemoPoint H2 cuvettes in HemoCue vs. HemoCue).
• Data provenance: The blood samples used were stated as venous blood. The country of origin is not specified in the provided summary, but the manufacturer is Stanbio Laboratory, located in Boerne, Texas, USA. The studies appear to be prospective as they are reported as experimental data for a device seeking 510(k) clearance, implying new testing was performed to support the submission.

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

• Not Applicable. This device is an automated hemoglobin measurement system. The "ground truth" is established through a recognized reference method (NCCLS H15-A3 standard) or comparison to an established predicate device (HemoCue System), rather than requiring expert qualitative assessment or interpretation.

4. Adjudication Method for the Test Set:

• None. As an automated quantitative measurement device, there is no need for an adjudication method in the context of expert review. The method for determining the reference values is through the specified chemical or instrumental reference methods.

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

• No. This type of study is typically performed for devices that involve human interpretation, such as imaging systems or diagnostic aids. The HemoPoint® H2 is an automated quantitative measurement device and does not involve human interpretation of results that would necessitate an MRMC study.

6. Standalone Performance (Algorithm only without human-in-the-loop performance):

• Yes. The reported "Experimental Data" and "Precision" data represent the standalone performance of the device. The device provides a direct numerical output for hemoglobin concentration without requiring human intervention for interpretation beyond operating the instrument and collecting the sample. The comparisons are made against established reference methods or other automated devices.

7. Type of Ground Truth Used:

• The primary ground truth used is a reference method: NCCLS H15-A3. This is a recognized standard for total hemoglobin determination (cyanmethemoglobin method).
• Additionally, the device's performance (specifically the HemoPoint® H2 cuvettes) was compared against the HemoCue System, which serves as a predicate device and an established clinical standard for point-of-care hemoglobin measurement.

8. Sample Size for the Training Set:

• Not specified. The document does not provide details on a separate "training set" or how the device's algorithms (e.g., for calculating Hb from light absorbance) were developed or calibrated. The provided data focuses on validation and comparison to established methods. Automated systems like this are typically calibrated against known standards during manufacturing and do not usually have a "training set" in the machine learning sense that would be described in a 510(k) summary.

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

• Not applicable / Not specified. As mentioned above, a "training set" in the typical machine learning context is not detailed. The ground truth for calibration would generally be established using internationally recognized hemoglobin standards and the NCCLS H15-A3 reference method, but this process is part of the device's design and manufacturing standards rather than a specific "training set" described in this summary. The device's calibration itself is stated to be "against NCCLS reference method."

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The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Creatinine LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. To calibrate the test kit, a calibrator is used that has values determined by a similar method.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Creatinine LiquiColor® device:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, explicit acceptance criteria for novel performance claims. However, the performance data presented implicitly sets the "acceptance criteria" by showing performance comparable to the predicate device and within generally accepted analytical limits for clinical assays.

Here's a table summarizing the reported performance, with the understanding that these values, by virtue of leading to substantial equivalence, implicitly served as the 'acceptance criteria' for this submission.

| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-|
| Method Comparison (Correlation with Predicate) | Serum: Correlation coefficient (r) ≥ ~0.99 (based on observed 0.9991) Regression slope (y) ≈ 1.0 (based on observed 1.4815x - 0.5831, acknowledging a notable slope difference, but still showing strong correlation). | Serum: r = 0.9991, regression equation: y = 1.4815x - 0.5831 |
| | Urine: Correlation coefficient (r) ≥ ~0.98 (based on observed 0.9854) Regression slope (y) ≈ 1.0 (based on observed 1.0545x + 0.3607, showing good agreement). | Urine: r = 0.9854, regression equation: y = 1.0545x + 0.3607 |
| Precision (Intra-assay CV%) | Low CV% (e.g.,

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The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2.

Here's a breakdown of the acceptance criteria and study information for the Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® devices, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance thresholds for each criterion but presents the results of the performance studies. It is implied that these reported performance metrics were considered acceptable for demonstrating substantial equivalence. For instance, the high correlation coefficients (r) suggest strong agreement with the predicate devices, which is a common acceptance criterion for equivalence in such tests.

Study Details

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

   • Direct Bilirubin Test Set:
     • Correlation: 85 samples.
     • Comparison (Plasma vs. Serum): 22 samples.
     • Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
   • Total Bilirubin Test Set:
     • Correlation: 247 samples.
     • Comparison (Plasma vs. Serum): 19 samples.
     • Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that these are in vitro diagnostic devices for measuring analytes in human samples, the samples would typically be human serum or plasma.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are quantitative assays for chemical analytes, not image-based or clinical diagnostic tests requiring expert interpretation to establish ground truth in the traditional sense. The "ground truth" for the correlation and comparison studies is established by the results from a "commercially available test" (Roche Direct Bilirubin/Total Bilirubin tests).

3. Adjudication method for the test set: Not applicable. No human interpretation or adjudication process is involved in determining the "ground truth" for these types of quantitative assays.

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: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance data (precision, sensitivity, linearity) represents standalone performance, as it is a fully automated/instrument-based chemical assay. The "correlation" and "comparison" studies are essentially comparisons of the new device's standalone performance against another commercially available standalone device.

6. The type of ground truth used:

   • For Correlation studies, the ground truth was established by the measurements obtained from the predicate devices: Roche Direct Bilirubin (K910593) and Roche Total Bilirubin (K910591).
   • For Precision, Sensitivity, and Linearity, the ground truth is effectively the expected chemical value of the calibrators and samples used in the study, and the assessment is of the device's ability to consistently and accurately measure those values.

7. The sample size for the training set: Not applicable. This is a chemical assay, not an machine learning/AI model that requires training data.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The Sirrus® Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes to include Glucose, Cholesterol, and Triglycerides.

The Sirrus® Clinical Chemistry Analyzer is an automated system for quantitative analysis of clinical chemistries. The analyzer is intended for clinical use in conjunction with certain materials to measure a variety of analytes.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving the device meets those criteria:

Device: Sirrus® Clinical Chemistry Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are presented through correlation and precision studies, comparing the Sirrus® Clinical Chemistry Analyzer to the predicate device, Roche Cobas Mira®. The summary outlines the performance criteria for correlation via correlation coefficient, slope, and y-intercept, and for precision via Standard Deviation and %CV.

Note on Acceptance Criteria: For this type of device (clinical chemistry analyzer), the "acceptance criteria" are implicitly met by demonstrating performance (correlation and precision) that is comparable to a legally marketed predicate device (Roche Cobas Mira®). The summary doesn't explicitly state numerical acceptance thresholds for these metrics beyond the reported predicate performance, but rather presents the Sirrus's performance against the predicate's expected performance through various trials. The FDA's substantial equivalence determination implies that these results were found acceptable.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the sample size (number of patient samples) used for the correlation and precision studies. It refers to "Sam #1" and "Sam #2" for precision, implying multiple samples or control levels were tested, but not the total number of individual runs or replicates.
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be laboratory-based evaluations for performance characteristics. There is no information to indicate if the data is retrospective or prospective patient data, it's more likely referring to control samples or spiked samples in a laboratory setting typical for instrument validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (a clinical chemistry analyzer) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging AI might. The "ground truth" for the test set is established by the reference values obtained from the predicate device (Roche Cobas Mira®) for correlation studies, and through the inherent accuracy and precision of the analytical methods themselves for precision studies, often using certified reference materials or control solutions with known values. Therefore, this section is not applicable in the traditional sense.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the "ground truth" for a clinical chemistry analyzer's performance (correlation and precision) is determined by comparison to a predicate device and established analytical methods, not by expert adjudication of individual cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not applicable for a standalone clinical chemistry analyzer like the Sirrus®. This type of study is relevant for diagnostic imaging AI devices where human readers interpret results with and without AI assistance.

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

Yes, the performance data presented (correlation and precision) represents the standalone performance of the Sirrus® Clinical Chemistry Analyzer. It's an automated system intended to duplicate manual analytical procedures, meaning its performance is evaluated based on its own output against established reference methods or predicate devices, without human intervention in the result generation process.

7. The Type of Ground Truth Used

• Correlation Study: The ground truth for the correlation study is implicitly the results obtained from the predicate device (Roche Cobas Mira®). The Sirrus® device's measurements are compared against these predicate values to establish correlation.
• Precision Study: The ground truth for the precision study involves known concentrations of analytes in control samples ("Sam #1," "Sam #2"). The consistency of the Sirrus® device's measurements around these known means or its own calculated mean demonstrates its precision.

8. The Sample Size for the Training Set

Not applicable. The Sirrus® Clinical Chemistry Analyzer is a hardware device that performs chemical assays based on established photometric principles, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for this device.

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Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders. For In Vitro Diagnostic Use Only.

The device is a system using the reagent and calibrator in combination to directly measure the LDL-Cholesterol. This is achieved by a homogenous method that directly measures serum LDL-Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds HDL, VLDL and chylomicrons leaving the LDL particles exposed. The second reagent (R2) contains enzymes, which then react with the LDLcholesterol present in the sample.

The provided text describes the acceptance criteria and a study for the "Direct LDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system" used for quantitative determination of LDL-C.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 62 patient samples.
• Data Provenance: The text does not specify the country of origin. It indicates "patient samples" without further details, so it's not possible to definitively classify it as retrospective or prospective based solely on the provided information.

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 text. The ground truth for the device's performance relies on comparison with a predicate device, not on expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluation method was a method comparison study against a predicate device, not a human expert review process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The study was a method comparison of the new device against a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the performance data provided (method comparison, precision, linearity, sensitivity, interference) are for the device's standalone analytical performance. This device is a quantitative, in vitro diagnostic system, and its performance is evaluated based on its direct measurement capabilities, not with human interpretation as part of its core function.

7. The Type of Ground Truth Used

• The ground truth for the study was established by the measurements obtained from the legally marketed predicate device, "LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche)." This is a form of comparative reference standard.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The device is a reagent and calibrator system for direct measurement, not an AI or machine learning algorithm that requires a training set in the conventional sense. The performance data presented are for the analytical validation of the device itself.

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

• This information is not applicable/not provided for the same reasons as in point 8.

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Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol. This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed. The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.

Here's a breakdown of the acceptance criteria and study information for the Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state the numerical acceptance criteria for precision and interference. It only states that the results were "within acceptable range." For method comparison, the implied criterion is a strong correlation, which the reported 0.9987 satisfies. The regression equation also indicates minimal bias.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 50 patient samples were used for the correlation (method comparison) study.
• Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the phrasing "using 50 patient samples" suggests it was likely prospective for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the document. The study relies on method comparison against a predicate device, not expert consensus for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth was established by comparison to a predicate device's measurements, not by human interpretation requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in-vitro diagnostic device for quantitative determination of a biomarker, not an imaging device requiring human reader interpretation. Therefore, the effect size of human reader improvement with or without AI assistance is not relevant or measured.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done in the sense that the device's analytical performance (precision, linearity, sensitivity, interference) was evaluated independently. The method comparison study also assesses the device's performance against a reference method without human interpretation as part of the measurement process.

7. Type of Ground Truth Used

• The ground truth for the method comparison study was established by the measurements obtained from a legally marketed predicate device: HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).
• For other analytical performance studies (precision, linearity, sensitivity, interference), the ground truth is typically derived from established laboratory protocols and reference materials but this is not explicitly detailed beyond stating the results were "within acceptable range."

8. Sample Size for the Training Set

• This information is not applicable or provided. This device is a chemical reagent system, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" would relate to its chemical formulation and optimization during development, not data-driven learning.

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

• This information is not applicable or provided for the reasons stated in point 8.

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The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.

For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoqlobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

Here's a breakdown of the acceptance criteria and the study details for the HemoPoint® H2 Hemoglobin Measurement System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Hemoglobin/high (17.3 g/dL): Swr 0.111 g/dL, CV 0.6 %
• Hemoglobin/low (10.7 g/dL): Swr 0.095 g/dL, CV 0.9 %
• Hemoglobin/normal (12.9 g/dL): Swr 0.084 g/dL, CV 0.7 %
  HemoCue device with HemoPoint® H2 cuvettes:
• Hemoglobin/high (17.3 g/dL): Swr 0.103 g/dL, CV 0.6 %
• Hemoglobin/low (10.7 g/dL): Swr 0.068 g/dL, CV 0.6 %
• Hemoglobin/normal (12.9 g/dL): Swr 0.102 g/dL, CV 0.8 %
  All reported CVs are ≤ 2% |
  | | Total Precision (NCCLS EP5-A) | HemoPoint® H2 device with HemoPoint® H2 cuvettes:
• Hemoglobin/high: ST 0.207 g/dL, CV 1.2 %
• Hemoglobin/low: ST 0.114 g/dL, CV 1.1 %
• Hemoglobin/normal: ST 0.148 g/dL, CV 1.1 %
  HemoCue device with HemoPoint® H2 cuvettes:
• Hemoglobin/high: ST 0.162 g/dL, CV 0.9 %
• Hemoglobin/low: ST 0.086 g/dL, CV 0.8 %
• Hemoglobin/normal: ST 0.134 g/dL, CV 1.0 %
  All reported CVs are ≤ 2% (implicitly met as they align with typical clinical acceptance for total precision given the within-run values) |
  | | Between-Day Imprecision | HemoPoint® H2 device with HemoPoint® H2 cuvettes:
• 10.7 g/dL: SD 0.102 g/dL, CV 1.0 %
• 12.9 g/dL: SD 0.141 g/dL, CV 1.1 %
• 17.3 g/dL: SD 0.169 g/dL, CV 1.0 %
  HemoCue device with HemoPoint® H2 cuvettes:
• 10.9 g/dL: SD 0.094 g/dL, CV 0.9 %
• 13.0 g/dL: SD 0.126 g/dL, CV 1.0 %
• 17.2 g/dL: SD 0.148 g/dL, CV 0.9 %
  All CVs ≤ 2% |
  | Correlation | Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: > 0.98 | R=0.999 (HemoPoint® H2 System compared to NCCLS H15-A3) (Meets criteria) |
  | | Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: ≥ 0.97 | R=0.999 (HemoPoint® H2 cuvettes on HemoCue device compared to HemoCue system) (Meets criteria) |

2. Sample Size Used for the Test Set and Data Provenance

• HemoPoint® H2 System vs. NCCLS H15-A3 Reference Method:
  • Sample Size: N=174 duplicate measurements
  • Data Provenance: Venous blood samples from "4 Clinical Study Sites." The country of origin is not specified but is implied to be within the scope of the manufacturer (USA, Texas). The data appears to be prospective for the purpose of this study.
• HemoPoint® H2 System vs. HemoCue System:
  • Sample Size: N=286 duplicate measurements
  • Data Provenance: Venous blood samples from "4 Clinical Study Sites." Country of origin not specified, implied USA. Appears to be prospective.
• HemoPoint® H2 Cuvettes on HemoCue Device vs. HemoCue System:
  • Sample Size: N=286 duplicate measurements
  • Data Provenance: Venous blood samples from "4 Clinical Study Sites." Country of origin not specified, implied USA. Appears to be prospective.
• Precision Study (Implied Test Set - different samples for different levels): The NCCLS EP5-A standard typically involves multiple replicates over several days for each sample level to determine precision components. Exact sample sizes per level are not explicitly stated as "test set" samples, but the calculation of standard deviation (Swr, ST) and CVs implies a sufficient number of measurements per level to achieve statistical significance for precision.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for this device is based on reference laboratory methods, not expert interpretation of images or clinical cases.

• NCCLS H15-A3 reference method: This is a standardized laboratory method (cyanmethemoglobin method or a modified azide methemoglobin method), not an expert panel. Therefore, no "experts" in the sense of clinicians or radiologists were used to establish the ground truth. The expertise lies in performing a validated laboratory method.
• HemoCue System: This is another established device used as a comparator, representing a reliable measurement itself.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is established by objective laboratory measurements (reference methods or established devices), not by expert opinion requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted as this is a device for quantitative hemoglobin measurement, not an AI-assisted diagnostic imaging interpretation system. The "comparison" is between the device's quantitative output and established reference methods or predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are standalone performance studies for the HemoPoint® H2 system. The device directly measures and calculates hemoglobin levels. There is no human interpretation or intervention in the measurement process that further refines the algorithm's output. The human interaction is limited to operating the device and inserting the sample.

7. The Type of Ground Truth Used

The ground truth used is laboratory reference methods:

• NCCLS H15-A3 reference method: This is a chemical/photometric method (cyanmethemoglobin method, or modified azide methemoglobin method) considered the gold standard for total hemoglobin determination.
• HemoCue System: An established and legally marketed predicate device, recognized for its accuracy in hemoglobin measurement, also served as a ground truth comparator.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its size. As a photometric measurement device, its underlying principles are based on physicochemical laws (Lambert-Beer's law) and robust chemical reactions, rather than machine learning models that are "trained" on large datasets in the conventional sense. The device is calibrated and validated against reference methods and predicate devices for its performance.

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

Since there is no explicit mention of a "training set" in the context of machine learning, the concept of establishing ground truth for a training set as described for AI algorithms is not applicable here. The device's fundamental function relies on established chemical and optical principles. Any internal calibration or factory adjustments would be against known standards, which are derived from existing reference methods like NCCLS H15-A3 or ICSH.

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QuPID® Plus E.R. pregnancy device is intended for qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.

The test is comprised of colored dye coated with polyclonal antibodies specific for hCG, immobilized antibodies against hCG and monoclonal anti-mouse lgG antibodies. The assay is conducted by adding specimen, urine or serum, to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody hCG colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

The QuPID® Plus E.R. pregnancy device is intended for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size:

  • Accuracy Study: 300 urine specimens and 72 serum specimens.
  • Specificity Study: Not explicitly stated, but implies positive and negative urine/serum specimens were used after addition of interfering substances.
  • Sensitivity Study: Not explicitly stated, but implied by the detection thresholds (10 mIU/mL in serum, 20 mIU/mL in urine).
  • Clinical Studies: Not explicitly stated, but the results showed 100% concordance with other tests. Given the statement of 100% concordance, this would imply a sufficient sample size to establish this, though the exact number is missing for the overall clinical studies.

• Data Provenance: The document does not specify the country of origin of the data. It appears to be a retrospective comparison study against a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their qualifications used to establish the "ground truth" for the test set. Instead, the "ground truth" for comparative effectiveness was established by the results from a "commercially available urine/serum membrane test" (predicate device) and "other commercially available tests" for the clinical studies. The performance of these predicate devices is assumed to be the reference standard.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The study design primarily involved comparing the QuPID® Plus E.R. results directly with the results of the predicate devices. The "ground truth" was established by the predicate device's output.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device itself compared to predicate devices, not on the improvement of human readers with or without AI assistance. This device is a rapid diagnostic test (RDT), not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone Performance

Yes, a standalone performance assessment was done. The accuracy, specificity, and sensitivity studies directly evaluated the QuPID® Plus E.R. device's performance characteristics independently, using predicate devices as internal controls or reference standards. The "100% concordance" specifically speaks to its standalone ability to yield results consistent with established methods.

7. Type of Ground Truth Used

The primary type of "ground truth" used was comparison to a predicate device / commercially available test. For the accuracy and clinical studies, the results from established, legally marketed pregnancy tests served as the reference. For specificity, spiked samples with known interfering substances were used. For sensitivity, likely samples with known hCG concentrations were used (though not explicitly detailed how these were prepared/validated).

8. Sample Size for the Training Set

The document does not mention separate "training sets" or "test sets" in the context of machine learning. This is a traditional in-vitro diagnostic device, not an AI/ML-based device. Therefore, the concept of a training set as understood in AI development is not applicable here. The "training" of the device is inherent in its manufacturing and quality control processes to ensure it meets performance specifications.

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

As explained above, there is no "training set" in the AI/ML sense for this device. The ground truth for establishing the device's operational parameters (e.g., antibody concentrations, conjugate characteristics) would have been based on established biochemical principles, antigen-antibody interactions, and calibration against international standards like the WHO Third International Standard for hCG.

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