(20 days)
The Aspartate Aminotransferase assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Measurement of aspartate aminotransferase is used in the diagnosis and treatment of certain types of liver and heart disease.
Aspartate Aminotransferase is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase assay is a clinical chemistry assay in which NADH is oxidized to NAD. The resulting decrease in absorbance at 340 nm is indicative of the presence of aspartate aminotransferase.
Here's an analysis of the provided text regarding the Aspartate Aminotransferase assay, framed by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient | High correlation to predicate (Boehringer Mannheim AST assay on Hitachi 717) | 0.999 |
| Slope | Close to 1.0 (indicating proportional agreement) | 0.893 |
| Y-intercept | Close to 0 U/L (indicating minimal constant bias) | -1.815 U/L |
| Total %CV (Within-run, Between-run, Between-day) - Level 1 | Undefined, but expected to be low for precision | 1.6% |
| Total %CV (Within-run, Between-run, Between-day) - Level 2 | Undefined, but expected to be low for precision | 1.2% |
| Linearity | Undefined, but expected to cover a relevant clinical range | Up to 4,202 U/L |
| Limit of Quantitation (Sensitivity) | Undefined, but expected to be clinically relevant | 1.5 U/L |
Note: The acceptance criteria are implied by the substantial equivalence claim. The filing states the new assay "yields similar Performance Characteristics" to the predicate, and the provided results are presented as demonstrating this equivalence. Specific numerical thresholds for acceptance are not explicitly defined in the document.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Comparative performance studies were conducted," but does not specify the number of samples or patients used in these studies.
- Data Provenance: Not explicitly stated. It is an in vitro diagnostic assay, so data would likely be from human serum or plasma samples. The country of origin and whether the data was retrospective or prospective are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an in vitro diagnostic assay for a quantitative measurement, not a device relying on expert interpretation (e.g., imaging devices). The "ground truth" for comparative performance is the measurements obtained from the predicate device.
4. Adjudication method for the test set
Not applicable. As noted above, this is for a quantitative assay validation, not a study requiring human adjudication of results. The comparison is directly between the new device's readings and the predicate device's readings.
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 in vitro diagnostic assay. MRMC studies are typically for devices that assist human interpretation, such as AI in medical imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics reported are for the device operating in a standalone capacity (i.e., algorithm only without human-in-the-loop performance). The device directly quantifies aspartate aminotransferase in serum/plasma.
7. The type of ground truth used
The "ground truth" for the performance study establishing substantial equivalence was the measurements obtained from the legally marketed predicate device: the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer. This is a common approach for in vitro diagnostic devices seeking 510(k) clearance by demonstrating equivalence to an existing product.
8. The sample size for the training set
Not applicable. This document describes the validation of an in vitro diagnostic assay based on chemical reactions, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As specified in point 8, there is no "training set" in the context of this device's validation.
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(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.