(36 days)
The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.
The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).
The provided document describes the safety and effectiveness summary for the Bayer ADVIA® 1650™ Ammonia assay. This device is an in vitro diagnostic device used to quantitatively measure ammonia levels in human plasma. The information pertains to an analytical performance study rather than an AI/ML medical device. Therefore, several sections of the requested output (2, 3, 4, 5, 6, 7, 8, and 9) related to AI/ML and human experts are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but presents performance data for imprecision, correlation, and interfering substances, comparing the ADVIA 1650 to a predicate device (Roche Ammonia on Hitachi). The acceptance is implied by the presentation of the data itself against the predicate device's performance.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA 1650) |
|---|---|---|
| Imprecision | CV(%) comparable to Roche Ammonia (e.g., 3.9%, 0.7%, 7.33%) | CV(%) at various levels: |
- 3.8% (at 69.7 ug/dL)
- 1.7% (at 150.6 ug/dL)
- 0.7% (at 387.9 ug/dL) |
| Correlation | Strong linear correlation (r value close to 1) and low Syx compared to Roche (On Hitachi) | $Y = 1.05x + 7.19$
(where Y = ADVIA 1650, X = Roche)
Syx = 62.18
r = 0.98 |
| Interfering Substances Recovery | Recovery % should be within an acceptable range (typically 90-110% or similar) despite interferents | Hemoglobin: 105.18%
Bilirubin conj: 95.30%
Bilirubin unconj: 100.48%
Intralipid: 91.06%
TRIG Concentrate: 108.98% |
| Analytical Range | 25 to 1300 ug/dL (This is the stated range, implying it meets internal criteria) | 25 to 1300 ug/dL (Serum/Plasma(Lithium heparin)) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Correlation Test: 94 plasma specimens (N=94).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. 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. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML medical device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" (or reference method) for comparison is the predicate device's measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an analytical performance study of an in vitro diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials with human readers.
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
Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the study describes the standalone analytical performance of the ADVIA 1650 Ammonia assay. The performance metrics (imprecision, correlation, interference) are inherent to the device's measurement capabilities.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" or reference for comparison in this analytical study is the measurements obtained from the predicate device, the Roche Ammonia assay (on Hitachi).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device is a chemical analyzer.
9. How the ground truth for the training set was established
Not applicable. Refer to point 8.
§ 862.1065 Ammonia test system.
(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.