(55 days)
The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.
The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette. A blood sample is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Hb 301 Analyzer. The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO.isobestic point. The system is factory calibrated and needs no further calibration.
The provided text describes the HemoCue Hb 301 system, its intended use, and its technological characteristics. It mentions that studies were conducted to demonstrate the performance of the system and that the intended user can easily operate it and obtain expected results. However, the text does not contain specific acceptance criteria or detailed study results that prove the device meets said criteria.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document claims "The HemoCue Hb 301 system is a convenient method for measuring whole blood hemoglobin and can be used by typical users and provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices." This is a general statement, not a quantifiable acceptance criterion (e.g., accuracy within X%, precision within Y%).
- Reported Device Performance: No specific numerical performance data (e.g., accuracy, precision, correlation coefficients, sensitivity, specificity) is provided. The text only states that the system "provide clinical results comparable to other test methods."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Studies were "conducted in-house, in clinical laboratory settings and point of care centers." Country of origin is not explicitly stated, although the submitter is in Sweden and the contact is in the USA. The text does not indicate whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not specified. The ground truth is described as being established by the hemiglobincyanide (HiCN) method, which is an international reference method. This implies a method-based ground truth rather than expert consensus on individual cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. The ground truth method (HiCN) does not suggest an adjudication process as typically seen in image or subjective interpretation studies.
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
- Not applicable. This device is an automated hemoglobin system; it doesn't involve human 'readers' interpreting results in the way an AI medical imaging device might. The comparison is between the automated system and other test methods, not human performance with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes. The HemoCue Hb 301 system is an automated device, described as an "analyzer" for quantitative determination. The performance studies would inherently be standalone, comparing the device's output to a reference method, rather than involving human interpretation or modification of results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Method-based ground truth: The HemoCue Hb 301 System is calibrated against the hemiglobincyanide (HiCN) method, which is explicitly stated as "the international reference method for the determination of the hemoglobin concentration in blood."
8. The sample size for the training set
- Not applicable/Not specified. The device is "factory calibrated and needs no further calibration." This suggests that the calibration was done during manufacturing, likely using a set of samples, but the text does not refer to it as a "training set" in the context of machine learning, nor does it provide a sample size.
9. How the ground truth for the training set was established
- Not applicable/Not specified as a "training set." The system is "calibrated against the hemiglobincyanide (HiCN) method." This method would have been used to establish the true hemoglobin values for the samples used in the factory calibration process.
In summary, while the document confirms performance studies were conducted, it lacks the specific quantitative details (acceptance criteria, numerical performance results, sample sizes, and expert qualifications) that would be needed to fulfill many of your requested points. The focus of this 510(k) summary is on establishing substantial equivalence to a predicate device (HemoCue Hemoglobin 201 system), rather than providing a detailed breakdown of validation study results with specific performance metrics against pre-defined acceptance criteria.
§ 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).