(68 days)
Sebia's HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL ACID(E) HEMOGLOBIN(E) lines of devices are intended as an aid in the detection and identification of human hemoglobin abnormalities, namely hemoglobinopathies (structural hemoglobin abnormalities) and thalassemias (regulation abnormalities). The uses are indicated as follows:
The HYDRAGEL HEMOGLOBIN(E) and HYDRAGEL MINI HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize alkaline agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams are interpreted visually for pattern abnormalities. Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions. The kits are intended for the normal hemoglobins (A and A2) and the major hemoglobin variants S or D and C or E. They are indicated for screening for clinically important abnormal hemoglobins. Electrophoresis on acidic gel, e.g., HYDRAGEL ACID(E) HEMOGLOBIN(E), should follow to confirm the identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D and E from C.
The HYDRAGEL ACID(E) HEMOGLOBIN(E) and HYDRAGEL MINI ACID(E) HEMOGLOBIN(E) Kits are designed for use in conjunction with a manual electrophoretic apparatus. The HYDRAGEL 7/15 ACID(E) HEMOGLOBIN(E) Kits are designed for use with the semi-automated HYDRASYS electrophoretic apparatus. All these kits utilize acid buffered agarose gels for electrophoretic separation of human hemoglobins. The electrophoregrams serve for qualitative, visual interpretation of the patterns. The kits are indicated for confirming the identity of clinically important abnormal hemoglobins that have been previously detected on alkaline buffered HYDRAGEL HEMOGLOBIN(E) gels. Primarily, they serve for differentiation of hemoglobins S from D and E from C.
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This document is a 510(k) premarket notification from the FDA for a device called HYDRAGEL Hemoglobin (E). It does not contain the detailed information necessary to answer all aspects of your request. The document describes the device's intended use and FDA's determination of substantial equivalence to predicate devices, but it does not detail a study conducted to establish acceptance criteria or demonstrate performance in the way a clinical trial report would.
However, I can extract some information based on the typical regulatory context of such devices.
Here's what can be inferred or directly stated from the provided text, along with what cannot be answered:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. A 510(k) often focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data from a new, standalone study for the device itself. The document mentions "electrophoregrams are interpreted visually for pattern abnormalities" and "Densitometry can serve as an aid in the interpretation by providing relative concentrations of individual fractions," which are methods of interpretation, but not performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not present in the provided 510(k) summary.
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)
This information is not present in the provided 510(k) summary. The document states that "electrophoregrams are interpreted visually for pattern abnormalities," implying human interpretation, but does not specify the number or qualifications of interpreters.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present in the provided 510(k) summary.
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
This information is not present in the provided 510(k) summary. The device described (HYDRAGEL Hemoglobin (E)) is an in vitro diagnostic electrophoresis kit, and as such, it predates widespread AI assistance in this specific application. The document describes visual interpretation and densitometry, which are human-centric methods.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided 510(k) summary. Given the nature of the device as an electrophoresis kit with visual interpretation, it's highly unlikely that a standalone algorithm-only performance study was conducted or would even be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated in the provided 510(k) summary. However, for a device intended to aid in the detection and identification of hemoglobin abnormalities, the ground truth would typically be established by:
- Reference methods: Other established, highly accurate laboratory tests for hemoglobin variants.
- Clinical diagnosis: Confirmation through patient clinical presentation and other diagnostic findings.
- Expert interpretation: Consensual agreement among experienced laboratory professionals specializing in hemoglobinopathies.
The document states the device is intended for "screening for clinically important abnormal hemoglobins" and "confirming the identity of clinically important abnormal hemoglobins," implying that the outcome of these tests would need to align with established clinical knowledge.
8. The sample size for the training set
This information is not present in the provided 510(k) summary. This type of device (electrophoresis kit) is not "trained" in the machine learning sense. Its performance relies on the biochemical principles of electrophoresis and the reagents provided.
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" in the context of this device. The device itself (the kit and electrophoretic method) is the "system," and its performance is evaluated against established diagnostic accuracy, not by training an algorithm.
§ 864.7440 Electrophoretic hemoglobin analysis system.
(a)
Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.(b)
Classification. Class II (performance standards).