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510(k) Data Aggregation
(147 days)
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (HemoPoint® H2) |
|---|---|---|
| Precision | Within-Run Imprecision (CV) | |
| Hemoglobin/high (15.7 g/dL) $\leq$ 2% | CV 0.5% (HemoPoint® H2 device) | |
| Hemoglobin/low (11.8 g/dL) $\leq$ 2% | CV 0.6% (HemoPoint® H2 device) | |
| Hemoglobin/normal (8.0 g/dL) $\leq$ 2% | CV 0.7% (HemoPoint® H2 device) | |
| Total Precision (CV) | ||
| Hemoglobin/high (15.7 g/dL) | CV 1.1% (HemoPoint® H2 device) | |
| Hemoglobin/low (11.8 g/dL) | CV 1.4% (HemoPoint® H2 device) | |
| Hemoglobin/normal (8.0 g/dL) | CV 1.5% (HemoPoint® H2 device) | |
| Between-Day Imprecision (CV) | ||
| 15.7 g/dL | CV 1.1% (HemoPoint® H2 device) | |
| 11.8 g/dL | CV 1.5% (HemoPoint® H2 device) | |
| 8.0 g/dL | CV 1.4% (HemoPoint® H2 device) | |
| Correlation | Correlation coefficient vs. NCCLS H15-A3 reference method | > 0.998 -> Reported R=0.999 (HemoPoint® H2 device) |
| Correlation coefficient vs. HemoCue System | > 0.995 -> Reported R=0.995 (HemoPoint® H2 device) | |
| Accuracy | ± 0.3 g/dL at $\approx$ 14 g/dL | ± 0.3 g/dL at $\approx$ 14 g/dL (equivalent to predicate) |
| Measurement Range | 0 - 25.6 g/dL | 0 - 25.6 g/dL (equivalent to predicate) |
| Sample Material | venous, arterial or capillary human blood | venous, arterial or capillary human blood (equivalent to predicate) |
| Measuring Time | Approximately 30 - 60 sec | Approximately 30 - 60 sec (equivalent to predicate) |
| Measuring Units | mol/L, g/dL, g/L | mol/L, g/dL, g/L (equivalent to predicate) |
| Calibration | against NCCLS reference method | against NCCLS reference method (equivalent to predicate) |
| Method | Azidemethemoglobin method (Vanzetti) | Azidemethemoglobin method (Vanzetti) (equivalent to predicate) |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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