(109 days)
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.
This appears to be a 510(k) summary for a medical device called "Triage® TOX Drug Screen Controls." This specific document is a premarket notification for a control material, not a diagnostic device or an AI-powered system that requires performance studies with acceptance criteria in the traditional sense described in your request.
The core of this submission is to demonstrate substantial equivalence to an existing predicate device (Biosite Triage® TOX Drug Screen Controls K050037). Therefore, the "study" is a comparison to a legally marketed device rather than a performance study against predefined clinical acceptance criteria.
Here's how to address your questions based on the provided document:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for performance in the way a diagnostic device would (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criterion implicitly is "substantial equivalence" to the predicate device.
- Reported Device Performance: Instead of performance metrics, the document provides a table comparing characteristics to the predicate device. This comparison serves as the "proof" of substantial equivalence.
Characteristic Acceptance Criteria (Implicit: Substantially Equivalent to Predicate) Reported Device Performance (Proposed Device Characteristics) Intended Use Assayed control for monitoring urine-based drugs of abuse assays Assayed control for monitoring urine-based drugs of abuse assays Matrix Human Urine Human Urine Form Liquid Liquid Analytes Commonly abused drugs Commonly abused drugs Storage -20 °C or colder -20 °C or colder -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is not a clinical performance study with patient samples. The "test set" is essentially the characteristics of the proposed control material being compared to the predicate.
- Data Provenance: Not applicable. The "data" here refers to the specifications and qualitative characteristics of the control materials themselves, not clinical data from patients.
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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)
- Not applicable. There is no "ground truth" in the sense of expert assessment of clinical cases. The ground truth for the control material is its chemical composition and intended function as defined by the manufacturer for monitoring performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This isn't a study involving human readers or interpretation.
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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
- No. This is a control material, not a diagnostic device involving human readers or AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a control material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a control material is its manufactured composition and the established values/ranges determined during its production, ensuring it challenges the assay appropriately. This document implies that the "truth" is that the proposed control is essentially the same as the predicate in its fundamental properties.
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The sample size for the training set
- Not applicable. This is a physical control material, not an AI model or a device requiring a training set in that context.
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How the ground truth for the training set was established
- Not applicable. See point 8.
In summary: This 510(k) pertains to a control material used to monitor the performance of drug screen tests, not a diagnostic device or an AI-powered system that would typically undergo the types of performance studies you've outlined. The "study" here is a qualitative comparison demonstrating the new control material is substantially equivalent in its characteristics and intended use to a previously cleared predicate device.
§ 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.