(64 days)
AST/GOT measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
The Wako L-Type GOT.J2 test is an in vitro assay for the quantitative determination of glutamic-0xaloacetic transaminase (GOT) activity in serum.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Correlation | 0.9996 correlation coefficient against predicate | Comparative Study |
| Regression Equation | y = 1.055x + 2.38 against predicate | Comparative Study |
| Precision | Acceptable values obtained on a day-to-day basis | Precision Studies |
| Minimum Detectable Level | 4 IU/L | Analytical Performance |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "comparison studies," but the number of samples or patients included in these studies is not provided.
- Data Provenance: Not explicitly stated. There is no mention of the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not stated. The ground truth for this diagnostic device (Wako L-Type GOT.J2 test) is established by comparing its performance against a predicate device (Wako UA 30R GOT product) and through analytical precision studies, not through expert consensus on interpretation.
- Qualifications of Experts: Not applicable/not stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the comparison is analytical (device vs. predicate device), an adjudication method for human interpretation is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) for quantitative determination of GOT activity, not an imaging device or a device requiring human interpretation of complex outputs in the same way an AI-assisted diagnostic tool might. The comparison is between two analytical assays.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, the described performance is a standalone performance of the L-Type GOT.J2 test. As an in vitro diagnostic assay, its performance (correlation, regression, precision, minimum detectable level) is inherent to the assay itself and does not involve a human-in-the-loop for its primary function of measuring GOT activity.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth is indirectly established by comparison to a legally marketed predicate device (Wako UA 30R GOT product) for which safety and effectiveness have already been demonstrated. The predicate device's results serve as the reference standard for the "correlation" and "regression equation" studies. For "precision," the ground truth is the inherent reproducibility of the assay itself.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not stated. This document describes a traditional in vitro diagnostic assay, not a machine learning or AI-based device that would typically involve a "training set" in the common sense. The development of such assays involves reagent formulation and analytical validation, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, this document does not describe an AI/ML development process with a training set and corresponding ground truth.
§ 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.