(49 days)
MICROALBUSTIX Reagent Strips are for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. MICROALBUSTIX Reagent Strips are for professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals.
MICROALBUSTIX Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. MICROALBUSTIX Reagent Strips are dipped into a urine specimen and "read" visually by comparing the color of the strip to a color chart on the label. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio can also be determined. Semi-quantitative results are available within one minute.
The MICROALBUSTIX™ Reagent Strips were studied to assess their performance in clinical settings. The studies aimed to demonstrate that typical users in decentralized point-of-care laboratories could obtain clinical test results substantially equivalent to currently used tests for microalbumin and creatinine in urine.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a tabular format. Instead, it describes the expected performance and concludes "substantial equivalence."
| Criterion Type | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Albumin Detection | Detection of urinary albumin at 20 to 40 mg/L | Studied in clinical settings, compared to currently used tests. |
| Creatinine Detection | Detection of creatinine. | Studied in clinical settings, compared to currently used tests. |
| Albumin-to-Creatinine Ratio | Ratio of 30 to 300 mg/g. | Studied in clinical settings, compared to currently used tests. |
| User Performance | Typical users in decentralized, point-of-care laboratories can obtain clinical test results. | Demonstrated that typical users can obtain results "substantially equivalent to current methods." |
| Comparability | Results comparable to other test methods in current clinical laboratory practice. | Studies show results "comparable to other test methods." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size (number of patients or urine specimens) used for the clinical performance studies.
- Data Provenance: The studies were conducted in "clinical settings by typical users of the system," indicating real-world or simulated real-world usage. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the U.S. There is no explicit mention of whether the data was retrospective or prospective, but the phrase "studied in clinical settings" suggests a prospective collection of data for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts used or their specific qualifications for establishing ground truth. The comparison was made against "currently used tests for microalbumin and creatinine in urine," implying that these established methods served as the reference standard (ground truth).
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not describe any adjudication method used for the test set. The comparison was directly against "currently used tests."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document describes studies where "typical users" read the strips and their results were compared to established methods. However, it does not explicitly state that a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed in the context of comparing human readers with and without AI assistance. The device is a visual dip-and-read strip with no explicit AI component mentioned. Therefore, there's no reported effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
The device is described as a "dip-and-read reagent strip" where results are "read visually by comparing the color of the strip to a color chart on the label." This indicates that human interpretation is integral to its operation. There is no mention of an "algorithm only without human-in-the-loop performance" as the technology relies on visual comparison by a human user.
7. Type of Ground Truth Used
The ground truth was established by "currently used tests for microalbumin and creatinine in urine." This suggests that established laboratory methods or predicate devices served as the reference standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or its sample size. The performance assessment describes "studies... in clinical settings by typical users" comparing to existing methods, implying a validation or test set rather than a distinct training set in the context of machine learning. Since this is a colorimetric strip read by eye, there isn't typically a machine learning "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of machine learning, this question is not applicable. For the development and verification of the device's colorimetric reactions and scales (which might be analogous to "training" in a broader sense), the ground truth for establishing the color chart would have been based on known concentrations of albumin and creatinine, but the document does not specify this process.
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.