(196 days)
The neonatal bilirubin test used on RAPIDPoint® 405 systems 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. This test is intended for use in point of care or laboratory settings.
Neonatal Bilirubin (nBili) is a new parameter offered on the RAPIDPoint 405 (RP405) blood gas system. The RP405 system is a point of care and laboratory testing blood gas analyzer and currently measures a variety of parameters that have been previously cleared. Enabling the nBili measurement is accomplished through software design changes introduced in Software Version 3.7. No hardware or mechanical changes were needed.
Here's a breakdown of the acceptance criteria and study information for the Siemens RAPIDPoint® 405 System Neonatal Bilirubin (nBili) Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for substantial equivalence to predicate) | Reported Device Performance (nBili internal & external evaluation) |
|---|---|
| Correlation coefficient (r) value > 0.90 | Correlation coefficient (r) value was within the acceptance criteria (>0.90) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Approximately 200 samples (combining internal and external evaluations).
- Data Provenance:
- Internal Evaluation: Unconjugated bilirubin in oxygenated cord whole blood (mimics neonatal samples). This suggests laboratory-controlled samples, likely prepared in a laboratory setting.
- External Evaluation: Intended use neonatal whole blood samples from multiple point-of-care sites. This indicates prospective, real-world clinical samples collected from neonates within various healthcare facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth. The ground truth was established by comparison to the predicate devices.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Performance was assessed by comparing the device's measurements directly to those of the predicate devices.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an automated in vitro diagnostic system for measuring bilirubin, not an imaging device requiring interpretation by human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was done. The "Assessment of Performance" section describes the device's performance in measuring nBili directly, without human intervention in the measurement process itself. The system uses "iterative least squares analysis" and "correction for hematocrit to produce nBili results," indicating an automated algorithm.
7. Type of Ground Truth Used
The ground truth used was comparison to a predicate device. Specifically, "Specimens were evaluated against the RAPIDLab 1245 and 1265 predicate devices." This means the measurements from the RAPIDPoint® 405 System were compared against the established measurements from the legally marketed and previously cleared predicate devices to demonstrate substantial equivalence.
8. Sample Size for the Training Set
The document does not provide information on a separate training set or its sample size. This type of 510(k) submission for an in vitro diagnostic device, especially one involving a software update to an existing platform for a new parameter, often focuses on validation against a predicate rather than detailed machine learning model training data.
9. How the Ground Truth for the Training Set Was Established
Since no independent training set or machine learning model training details are described, the document does not explain how ground truth for a training set was established. The focus is on demonstrating clinical performance and substantial equivalence.
§ 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.