(18 days)
For calibration of the Apolipoprotein A-I and Apolipoprotein B assays on BN™ Systems.
N Apolipoprotein Standard Serum is a lyophilized calibrator prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of Apolipoprotein A-I and Apolipoprotein B assays on BNTM Systems.
This document describes the N Apolipoprotein Standard Serum, a lyophilized calibrator for Apolipoprotein A-I and Apolipoprotein B assays. The primary study presented focuses on the stability of the device, rather than a clinical performance study with human readers or standalone algorithm performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability (Shelf Life) | No significant change in recovery for at least 36 months, stored at 2° to 8° C. |
| Stability (Reconstituted) | No significant change in recovery for 15 days, once reconstituted. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Three lots of N Apolipoprotein Standard Serum were used for the stability testing.
- Data Provenance: Not explicitly stated, but given it's a calibrator manufactured by Dade Behring Marburg GmbH and its intended use is for BN™ Systems, the testing would generally occur in a laboratory setting by the manufacturer. The data is retrospective in the sense that stability is assessed over time after manufacturing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study is a stability test for a calibrator, not a study evaluating diagnostic accuracy against a clinical ground truth established by experts. The "ground truth" here is the expected stable performance of the calibrator over time, measured by quantitative recovery.
4. Adjudication Method for the Test Set
Not applicable. This was a direct measurement of quantitative recovery over time, not a qualitative assessment requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This device is a calibrator, not an AI-powered diagnostic tool. Therefore, there's no human reader involvement or AI assistance to measure improvement against.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical calibrator, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this study is the expected quantitative recovery of Apolipoprotein A-I and Apolipoprotein B values over time under specified storage and use conditions. It's an internal quality control standard based on the known composition and intended function of the calibrator.
8. The Sample Size for the Training Set
Not applicable. This device is a calibrator for existing assays and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for one.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.