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Instant-View™ Morphine Urine Cassette Test is a qualitative immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is for health care professional use only.

This test is a one-step lateral flow chromatographic immunoassay.

Here's an analysis of the provided text, outlining the acceptance criteria and the study details:

Acceptance Criteria and Study Details for Instant-View™ Morphine Urine Cassette Test

1. Acceptance Criteria and Reported Device Performance

The provided text implies acceptance criteria for two key areas:
i) Correlation with a legally marketed predicate device, and
ii) Accuracy compared to expected results.

Note: The document states "The correlation of results from the Instant-View ™ Morphine Urine Cassette Test, and the legally marketed test device compared, is higher than 91.6 %." This phrasing can be interpreted as the acceptance criterion itself, and the device met it. Similarly, "The Accuracy evaluation results...agreed 96.5 % with the expected results" indicates the performance achieved.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact numerical sample size used for the test set. However, it mentions:

• "The correlation of results from the Instant-View ™ Morphine Urine Cassette Test, and the legally marketed test device compared, is higher than 91.6 %." This suggests a comparison was made on a set of samples.
• "The results from all three POL sites agreed 92.5%." This indicates testing was conducted at multiple Physician's Office Laboratories (POLs) on a set of samples.
• "The Accuracy evaluation results from the Clinical Laboratory and three Physician's Offices conducted by persons with diverse educational background and working experience agreed 96.5 % with the expected results." This implies a set of samples was tested in a clinical laboratory and at the three POLs.

Data Provenance: The data appears to be prospective in nature, as it describes a study conducted to evaluate the device. The country of origin is not explicitly stated within the provided text, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or followed U.S. regulatory guidelines.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. It mentions "persons with diverse educational background and working experience" conducted the accuracy evaluation, but these are presumably the test operators, not necessarily the experts establishing the ground truth if a confirmatory method was used.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. It mentions "The correlation of results" with a legally marketed device and "Accuracy evaluation results" with "expected results." This implies a gold standard or reference method was used to determine the "expected results" or for comparison with the predicate device, but the process of resolving discrepancies (adjudication) is not detailed. The intent for positive results is that "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method." This suggests GC/MS would serve as the ultimate ground truth, but how initial discrepancies in the study were handled is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a qualitative immunoassay for detecting morphine in urine, intended for standalone use by healthcare professionals. The study focuses on its performance characteristics, correlation with a predicate, and accuracy against expected results. It does not involve human readers interpreting images, nor does it assess the improvement of human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The Instant-View™ Morphine Urine Cassette Test is a "qualitative immunoassay device" designed for direct use to produce a result. The performance data presented (correlation, agreement across sites, accuracy) reflects the performance of the device itself, providing a direct interpretation (appearance of lines) without human interpretation beyond reading the indicated result. It is described as a "one-step lateral flow chromatographic immunoassay."

7. The Type of Ground Truth Used

The type of ground truth used is implied to be:

• Comparison with a predicate device: For the correlation study, the results from the predicate device (QuikStrip One Step Opiate Test) served as a reference.
• Expected results: For the accuracy evaluation, results were compared against "expected results," which, given the context of drug testing, would typically refer to results obtained from a highly accurate, quantitative reference method. The document explicitly states that for confirmation, "Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method," strongly suggesting that a similar method or a prepared reference standard was used to define these "expected results" for the study samples. This aligns with chemical analysis/quantitative reference method as the ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. The Instant-View™ Morphine Urine Cassette Test is described as a "lateral flow chromatographic immunoassay," implying a chemical/biological test rather than a machine learning or AI-based algorithm that would require a distinct training set. The study detailed focuses on evaluating the performance of the manufactured device.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set in the context of this immunoassay device, the method for establishing its ground truth is not applicable.

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