(73 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Precision | Within-run imprecision HemoPoint® H2 System and HemoPoint® H2 Cuvettes on HemoCue Device ≤ 2% | HemoPoint® H2 device with HemoPoint® H2 cuvettes: |
- 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.
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).