(7 days)
The SYNCHRON® Systems DAT Low and High Urine Controls 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.
The SYNCHRON® Systems DAT Low and High Urine Controls 1 are used for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine reagents in the clinical laboratory.
This document describes the SYNCHRON® Systems DAT Low and High Urine Controls 1 by Beckman Coulter, Inc. as a quality control material for specific drugs of abuse in urine.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it refers to a "Summary of Performance Data" that claims:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate toxicology controls | "supports a finding of substantial equivalence to toxicology controls already in commercial distribution." |
| Stability | "Stress stability studies of the DAT Low and High Urine Controls 1 support the Beckman stability claim of 18 months." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the test set, data provenance (country of origin), or whether the study was retrospective or prospective. It only mentions "Stress stability studies."
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 provided in the document. The device is a control material for laboratory tests, so the "ground truth" would generally be established by the known concentration of analytes in the control material itself, rather than expert interpretation of a diagnostic image or clinical case.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for a quality control material.
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 information is not applicable and not provided. The device is not an AI-assisted diagnostic tool or an imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a chemical control material for laboratory instruments, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" for the performance of the device itself would be the known, manufactured concentrations of the target analytes (Amphetamines, Cocaine Metabolite, Opiate 2000 ng, Phencyclidine) within the Low and High Urine Controls. The document doesn't explicitly state how these concentrations were verified, but it's an inherent part of manufacturing such controls.
8. The sample size for the training set
This information is not applicable and not provided. As a quality control material, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(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 the limitations in § 862.9.