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The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine.

The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. The cassette COBAS INTEGRA Opiates is based on the kinetic interaction of microparticles in a solutions (KIMS) as a measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugate binds to antibody bound microparticle, causing the formation of particle aggregates. When a urine sample containing the dug in question is present, this drug competes with the drug conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. As aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug. Negative sample drug-polymer conjugate + antibody bound microparticle = particle aggregates (1 absorbance) Positive sample sample drug + antibody bound microparticle = particle aggregation inhibited drug-polymer conjugate + antibody bound microparticle = particle aggregates

The provided text for K992890 describes the device, its intended use, and its similarities to a predicate device, but does not include a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full performance study with acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided document.

Here's a breakdown of what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided 510(k) summary. The summary states: "The Roche COBAS INTEGRA Opiates 300/2000 and the predicate device use the same reagents, and have similar performance characteristics." This implies that performance was assessed for substantial equivalence, but specific acceptance criteria and detailed performance metrics are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not available in the provided 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not available in the provided 510(k) summary.

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:

This is not applicable. The device described is an in vitro diagnostic reagent test system for the detection of opiates in urine, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a reagent test system for an automated analyzer (COBAS INTEGRA 700). Its performance is inherently "standalone" in the sense that it provides a result based on the chemical reaction, without human interpretation of raw data in the same way an imaging algorithm would. However, the details of its standalone performance study (beyond the claim of "similar performance characteristics" to the predicate) are not available in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not available in the provided 510(k) summary. For an in vitro diagnostic device, ground truth for performance evaluation typically involves reference methods like GC/MS (Gas Chromatography/Mass Spectrometry) for confirmatory testing, but this is not specified here.

8. The sample size for the training set:

This information is not available in the provided 510(k) summary. As it's a reagent-based immunoassay, the concept of a "training set" in the context of machine learning algorithms is not directly applicable in the same way. Development would involve reagent optimization and calibration, but not an algorithmic training set in the typical sense.

9. How the ground truth for the training set was established:

This information is not available in the provided 510(k) summary. See point 8 regarding the applicability of "training set" for this type of device.

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