(34 days)
The Albumin BCG assay is used for the quantitation of albumin in human serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Albumin BCG is an in vitro diagnostic assay for the quantitative determination of albumin human serum. The Albumin BCG assay is a clinical chemistry assay in which the analyte in the sample binds specifically to bromcresol green to produce a colored complex. The absorbance at 600 nm of the complex is directly proportional to the albumin concentration in the sample.
The provided text describes a 510(k) submission for the Albumin BCG assay, which is an in vitro diagnostic device. The study described focuses on demonstrating substantial equivalence to a predicate device, rather than a typical clinical efficacy study with acceptance criteria often seen for AI/ML devices. Therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, etc.) is not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|
| Correlation Coefficient (with predicate) | 0.9864 |
| Slope (with predicate) | 0.844 |
| Y-intercept (with predicate) | 0.699 g/dL |
| Total %CV for Level 1/Panel 111 | 2.1% |
| Total %CV for Level 2/Panel 112 | 2.3% |
| Linearity | Up to 7.0 g/dL |
| Limit of Quantitation (Sensitivity) | 0.2 g/dL |
Note: The acceptance criteria themselves are implied by the reported performance figures being deemed "acceptable" and demonstrating "substantial equivalence." No explicit numerical thresholds for acceptance were stated, but the values indicate a high degree of correlation and precision.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "comparative performance studies" and "precision studies" conducted using control material, but does not provide the number of patient samples or the specific sample sizes for these studies.
- Data Provenance: Not explicitly stated. The studies were conducted using the ALCYON™ Analyzer, but the country of origin of the data or whether it was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is Not Applicable for this type of in vitro diagnostic device 510(k) submission. Ground truth for clinical chemistry assays is typically established through reference methods and internal validation, not through expert consensus in the way imaging or diagnostic AI algorithms might require.
4. Adjudication Method for the Test Set
This is Not Applicable. Clinical chemistry assays do not typically involve adjudication by experts for establishing ground truth; rather, performance is assessed against established measurement principles and reference materials.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is Not Applicable. The device is an in vitro diagnostic assay, not an AI-powered diagnostic system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Albumin BCG assay is a standalone in vitro diagnostic assay. Its performance is evaluated intrinsically through its chemical reaction and measurement capabilities. Its "performance" refers to the accuracy and precision of its quantitative output, not its ability to interpret complex data that a human might also interpret.
7. The Type of Ground Truth Used
The ground truth for this device's performance assessment is largely established by:
- Predicate Device Comparison: The Boehringer Mannheim® Albumin BCG assay (K81194) on the Hitachi® 717 Analyzer served as the reference standard for comparison, implying its results were considered "ground truth" for demonstrating substantial equivalence.
- Control Material: Precision studies were performed using "two levels of control material," which are laboratory standards with known concentrations, serving as a form of ground truth for evaluating assay variability.
8. The Sample Size for the Training Set
This is Not Applicable. The Albumin BCG assay is a chemical-based in vitro diagnostic method, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying principles are chemical reactions and spectrophotometric measurements.
9. How the Ground Truth for the Training Set was Established
This is Not Applicable for the same reason as above. There is no concept of a "training set" for this type of device.
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.