(71 days)
A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Idetnification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
When a sample is mixed with Buffer and Antibody, albumin in the sample combines specificaaly with anti-human albumin antibody (goat) in the Antibody to yeild an insoluble aggregate that causes increases turbidity in the solution. The degree of the turbidity of solution can be measured optically and is proportional to the concentration of albumin in the patient's sample.
The provided text describes a 510(k) summary for the "Wako Autokit Micro Albumin" device, which is a urinary protein or albumin (nonquantitative) test system. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Minimum Detectable Level | 0.33 ug/dL |
| Correlation Coefficient (vs. predicate device) | 0.9984 |
| Regression Equation (vs. predicate device) | y = 1.0179x - 0.9619 |
| Precision (day-to-day) | Acceptable values can be obtained |
2. Sample size used for the test set and the data provenance
The document states "In comparison studies against the predicate, Wako Micro Albumin B assay". However, it does not specify the sample size used for these comparison studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The comparison is made against a predicate device (Wako Micro Albumin B assay), implying the predicate device's results serve as the reference, but there's no mention of expert involvement in establishing ground truth for the test set.
4. Adjudication method for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This device is an in-vitro diagnostic test for albumin measurement, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance reported (minimum detectable level, correlation, regression) represents the standalone performance of the Wako Autokit Micro Albumin device when quantitatively measuring albumin, likely through its optical turbidity measurement method. There is no human-in-the-loop component for the direct measurement reported.
7. The type of ground truth used
The ground truth for the comparison studies was established using results from a legally marketed predicate device, the "Wako Micro Albumin B assay". This implies a comparison to an established, presumably accurate, laboratory method.
8. The sample size for the training set
This information is not provided in the document. The device is a laboratory assay, not a machine learning algorithm that typically undergoes a training phase with a dedicated training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not a machine learning algorithm. If a "training set" were to refer to samples used during the development of the assay's reagents or method, the document does not elaborate on how ground truth for such samples would have been established.
§ 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.