(193 days)
The neonatal bilirubin test intended use on the Rapidlab 1245 and Rapidlab 1265 analyzers is an in vitro diagnostic test for the determination of total neonatal bilirubin (nBili) concentration in the whole blood of newborn infants. Measurement of nBili aids in assessing the risk of kernicterus.
Neonatal Bilirubin (nBili) is a new parameter enabled on models 1245 and 1265 of the Rapidlab® 1200 blood gas family of instruments. It is intended as an in vitro diagnostic test for the determination of total neonatal Bilirubin (nBili) concentration in the whole blood of newborn infants. Enabling the nBill measurement is accomplished through software design changes introduced in Rapidlab Software Version 2.1. No hardware /mechanical changes were needed.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance for Neonatal Bilirubin (nBili) on Rapidlab® 1200 Blood Gas Systems
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Coefficient of determination (r) > 0.90 | For 2,241 samples, the coefficient of determination (r) values were "well within the acceptance criteria (>.90)" for all model, device, and mode combinations. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 2,241 samples.
- Data Provenance: The samples were described as "unconjugated bilirubin in oxygenated whole blood (neonatal type samples)". The text does not explicitly state the country of origin or if the data was retrospective or prospective, but the nature of the samples suggests clinical relevance to neonates. It was an "internal evaluation study."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not provide information on the number of experts, their qualifications, or their role in establishing the ground truth if a gold standard method was used. The study primarily compares the device's measurement against predicate devices, rather than an expert human interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The study involved instrumental measurements, not human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device measures a biochemical marker (bilirubin concentration) rather than interpreting medical images or clinical observations that would typically involve human readers. The study compared the device's performance against predicate devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed. The "nBili internal evaluation study" assessed the performance of the Rapidlab 1245 and 1265 in measuring neonatal bilirubin concentrations. This device, being a diagnostic instrument (blood gas system), inherently operates in a standalone manner to provide quantitative results. The human involvement is in operating the device and interpreting its output, not in performing the measurement itself.
7. Type of Ground Truth Used:
The ground truth for the test set was established by comparing the Rapidlab 1200 systems' nBili measurements against "predicate devices" (Radiometer ABL735 and ABL800 FLEX). The study aimed to demonstrate "substantial equivalence" to these established devices across the reporting range. Therefore, the ground truth was effectively the measurements obtained from these predicate devices.
8. Sample Size for the Training Set:
The document does not provide information about a separate training set or its sample size. The focus is on the performance of the device's software, which "was enabled through software changes." The 2,241 samples appear to be for validation/testing, not for training a machine learning model. This suggests that the "software changes" were likely based on established physiological models or signal processing algorithms, rather than iterative machine learning training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no explicit training set for a machine learning model is mentioned. The device's measurement technology relies on "multiple wavelength spectrophotometry (CO-oximetry)" and "iterative least squares analysis" to determine bilirubin values, which are then "corrected for hematocrit." This description points to a deterministic algorithm based on scientific principles and calibration, rather than a system trained on data with established ground truth.
§ 862.1113 Bilirubin (total and unbound) in the neonate test system.
(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.