(106 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.
Not Found
This is a premarket notification for a Class II medical device, not a study. Therefore, the information requested in the prompt (acceptance criteria, study design, sample sizes, ground truth establishment, etc.) is not applicable in the typical sense of a clinical or performance study. The 510(k) process is about demonstrating substantial equivalence to a predicate device, not necessarily proving new performance against set acceptance criteria through a standalone study.
However, based on the provided text, I can extract information relevant to the device and its intended use, and explain why the study-related questions are not directly answerable from this document.
Device Name: Hitachi Direct Bilirubin/Hitachi Total Bilirubin
Regulation Number: 21 CFR 862.1110
Regulation Name: Bilirubin (total or direct) test system
Regulatory Class: Class II
Product Code: CIG
Here's an attempt to address the prompt, noting the limitations of the provided document:
- A table of acceptance criteria and the reported device performance
- This document does not specify quantitative "acceptance criteria" in the way a clinical study protocol would, nor does it present "reported device performance" against such criteria. The 510(k) submission mechanism demonstrates substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device performs as well as, or comparably to, the predicate device across various metrics (e.g., precision, accuracy, linearity, interferences). However, the specific data for this comparison is not included in this FDA clearance letter.
| Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Included in Document) |
|---|---|
| (Performance standards for bilirubin assays, e.g., precision, accuracy, linearity, dynamic range, interference studies, comparison with predicate device, typically established by the manufacturer and FDA guidance documents). | (Performance data demonstrating substantial equivalence to a predicate device for direct and total bilirubin measurement in human serum, as submitted by Pointe Scientific, Inc. in K040391). |
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided FDA clearance letter. Such details would be part of the manufacturer's 510(k) submission, which is not publicly disclosed in this summary form. The clearance letter only states that the device was found substantially equivalent based on the submitted information.
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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 applicable/Not provided. For an in vitro diagnostic (IVD) assay like bilirubin measurement, the "ground truth" would typically be established by reference methods or highly accurate laboratory methods, not by expert consensus in the way a diagnostic imaging study might. The specifics of how accuracy/truth was ascertained for the test samples used in the 510(k) submission are not in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This typically refers to adjudication of discrepancies among human readers or expert interpretations, which is not directly relevant for an automated IVD assay's performance evaluation against a reference method.
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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
- Not applicable. This device is an automated in vitro diagnostic test for bilirubin, not an AI-assisted diagnostic imaging device or an AI tool meant to improve human reader performance. Its purpose is to quantitatively measure bilirubin levels in serum.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The device is a "standalone" automated assay intended for use "in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum." The performance shown in the 510(k) submission would have been the device's output (quantitative bilirubin levels) compared to reference methods or a predicate device. It is not an "algorithm only" in the modern AI sense, but an automated chemical analysis system. The human involvement is in operating the instrument and interpreting the results within a clinical context, not in directly forming the diagnostic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For an IVD bilirubin assay, the "ground truth" for evaluating accuracy would typically be established by:
- Reference methods: Highly accurate and precise laboratory methods (e.g., ID-LC-MS/MS, or established spectrophotometric methods).
- Comparison to a legally marketed predicate device: This is the primary method for a 510(k) submission, where the new device's results are compared to those of an already cleared device across a range of samples.
- The specific method used for the Hitachi device is not detailed in this clearance letter.
- For an IVD bilirubin assay, the "ground truth" for evaluating accuracy would typically be established by:
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The sample size for the training set
- Not applicable. This device is a chemical analyzer, not a machine learning or AI model that requires a "training set" in the computational sense. The "development" would involve chemical and engineering principles, calibration, and optimization, not data-driven machine learning training.
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How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this type of device.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.