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510(k) Data Aggregation
(445 days)
UB analyzer UA-2 and its exclusive reagent kit are designed to determine both total and unbound bilirubin concentration in neonatal serum using exclusive reagent kit, "UB TEST." The total bilirubin and unbound bilirubin concentration in neonatal serum can be used to provide the physician with additional information in the clinical assessment of jaundiced neonates and the possible risk of bilirubin encephalopathy.
The UB analyzer UA-2 is designed to determine both the total and unbound bilirubin concentrations in neonatal serum quantitatively with rapidity and accuracy. Determined concentrations of total bilirubin and unbound bilirubin are digitally displayed on LCD and printed out with UB/TB ratio and determined date. These concentrations of bilirubin can be used by the physician for clinically assessing jaundiced neonates and for the possible association with bilirubin encephalopathy.
The provided document is a 510(k) summary for the ARROWS Co., Ltd. UB analyzer UA-2, reagent kit, and bilirubin control. It primarily focuses on demonstrating substantial equivalence to a predicate device (UB ANALYZER, MODEL UA-1) rather than detailing specific acceptance criteria and the comprehensive study results to prove meeting them.
However, based on the information provided, here's an attempt to extract and infer the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a structured manner. Instead, it emphasizes the device's ability to "measure unbound bilirubin as well as total bilirubin in newborns quantitatively" with "rapidity and accuracy," and that the "modifications are not substantial and do not affect any safety, effectiveness and the intended use of the device."
The closest to "performance" is the assertion of clinical utility for physicians in assessing jaundiced neonates.
| Metric / Characteristic | Acceptance Criteria (Inferred from equivalence)** | Reported Device Performance |
|---|---|---|
| Quantitation of Unbound Bilirubin | Comparable to predicate device (UB ANALYZER, MODEL UA-1) | Achieves quantitative measurement in neonatal serum by enzymatic method (Glucose Oxidase and Peroxidase). |
| Quantitation of Total Bilirubin | Comparable to predicate device (UB ANALYZER, MODEL UA-1) | Achieves quantitative measurement in neonatal serum by enzymatic method (Glucose Oxidase and Peroxidase). |
| Speed | "Rapid" measurement (comparable to predicate) | Device designed for "rapidity" |
| Accuracy | "Accurate" measurement (comparable to predicate) | Device designed for "accuracy" |
| Safety | No adverse impact from modifications | Modifications (LCD, built-in printer) "do not affect any safety." |
| Effectiveness | No adverse impact from modifications | Modifications (LCD, built-in printer) "do not affect any effectiveness." |
| Intended Use | Consistent with predicate device | Measure total and unbound bilirubin in neonatal serum for clinical assessment of jaundiced neonates and possible association with bilirubin encephalopathy. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any specific information on the sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). The submission relies on demonstrating substantial equivalence to a previously approved device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention using experts to establish ground truth for a test set. This type of validation is not detailed in the provided 510(k) summary, which focuses on device modifications and equivalence.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or is not reported in this 510(k) summary. The device is an in-vitro diagnostic instrument, not an interpretative AI system for human readers.
6. Standalone (Algorithm Only) Performance Study
While the device itself is a "standalone" instrument for measuring bilirubin, the document does not detail a specific "standalone" performance study in the way one would describe a new algorithm's performance against ground truth. The submission's core argument is about the device's technical characteristics being equivalent to a predicate. It asserts the device's ability to quantitatively measure bilirubin, implying its standalone functionality.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given the nature of bilirubin measurement, the "ground truth" would typically refer to:
- Reference laboratory methods for bilirubin concentration (e.g., HPLC, Jendrassik-Grof).
- Known concentrations in control samples.
- Correlation with clinical outcomes (though this is more for clinical utility than technical accuracy in a 510(k) for an instrument).
The "enzymatic method utilizing Glucose Oxidase (GOD) and Peroxidase (POD)" is the analytical principle, not the ground truth definition.
8. Sample Size for the Training Set
The document does not provide any information on a training set sample size. This device is an instrument with an enzymatic method, not a machine learning model that typically requires a 'training set'.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of an algorithm or machine learning, no information is provided on how its ground truth would have been established.
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