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510(k) Data Aggregation
(30 days)
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
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.
| Metric / Parameter | Acceptance Criteria (Implied by Predicate Comparison or Performance Goal) | Reported HemoPoint® H2 Device Performance (HemoPoint® H2 cuvette measured in HemoPoint® H2 device) | Reported HemoPoint® H2 Device Performance (HemoPoint® H2 cuvette measured in HemoCue device) |
|---|---|---|---|
| Precision (Within-run imprecision) | ≤ 2% (overall stated goal) | ||
| Hemoglobin/high (15.7 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.087 g/dL, CV 0.5% | Swr 0.102 g/dL, CV 0.7% |
| Hemoglobin/low (11.8 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.070 g/dL, CV 0.6% | Swr 0.105 g/dL, CV 0.9% |
| Hemoglobin/normal (8.0 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.058 g/dL, CV 0.7% | Swr 0.068 g/dL, CV 0.8% |
| Precision (Total Precision) | (Not explicitly stated as a target, but compared) | ||
| Hemoglobin/high (15.7 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.1747 g/dL, CV 1.1% | ST 0.302 g/dL, CV 1.9% |
| Hemoglobin/low (11.8 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.162 g/dL, CV 1.4% | ST 0.198 g/dL, CV 1.6% |
| Hemoglobin/normal (8.0 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.122 g/dL, CV 1.5% | ST 0.158 g/dL, CV 1.9% |
| Correlation Coefficient (vs. NCCLS H15-A3 reference) | ≥ 0.998 (for comparison to predicate) or high correlation for self-system | 0.999 (R=0.999) | Not applicable (this comparison is for HemoPoint H2 system vs. reference) |
| Correlation Coefficient (vs. HemoCue System) | > 0.995 (for HemoPoint® H2 cuvettes on HemoCue) | 0.995 (R=0.995) (for HemoPoint® H2 system vs. HemoCue) | 0.997 (R=0.997) (for HemoPoint® H2 cuvettes in HemoCue device vs. HemoCue) |
| Measurement range | 0 - 25.6 g/dL (Equivalent to predicate) | 0 - 25.6 g/dL | Equivalent (same as HemoPoint H2 self-system) |
| Specified accuracy | ± 0.3 g/dL at ≈ 14 g/dL (Equivalent to predicate) | ± 0.3 g/dL at ≈ 14 g/dL | Equivalent (same as HemoPoint H2 self-system) |
| Sample material | venous, arterial or capillary human blood (Equivalent to predicate) | venous, arterial or capillary human blood | Equivalent (same as HemoPoint H2 self-system) |
| Measuring time | Approximately 30 - 60 sec (Equivalent to predicate) | Approximately 30 - 60 sec | Equivalent (same as HemoPoint H2 self-system) |
| Measuring units | mol/L, g/dL, g/L (Equivalent to predicate) | mol/L, g/dL, g/L | Equivalent (same as HemoPoint H2 self-system) |
| Calibration | against NCCLS reference method (Equivalent to predicate) | against NCCLS reference method | Equivalent (same as HemoPoint H2 self-system) |
| Method | Azidemethemoglobin method (Vanzetti) (Equivalent to predicate) | Azidemethemoglobin method (Vanzetti) | Equivalent (same as HemoPoint H2 self-system) |
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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(73 days)
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
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.
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