(74 days)
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage MeterPlus to assist the laboratory in monitoring test performance.
The Triage TOX Drug Screen Controls are to be used with the Triage TOX The Thage TOX Drug Triage MeterPlus to assist the laboratory in monitoring test performance.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study, structured according to your request:
Based on the provided document, there is no detailed information about acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary for a Class I medical device (Quality Control Material), which typically relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies with predefined acceptance criteria.
The document focuses on the substantial equivalence of the Triage® TOX Drug Screen Controls to existing predicate devices (Triage TOX Drug Screen Controls K012999, BIO-RAD Liquicheck Urine Toxicology Controls, Dade Behring Emit Calibrators/Controls). The "Summary of Comparison Data" section compares characteristics like intended use, matrix, form, analytes, and storage, aiming to show that the new device is fundamentally similar to the already approved devices.
Therefore, many of the requested points cannot be answered from the provided text as the nature of the submission does not require such detailed efficacy or performance studies with acceptance criteria as might be expected for a Class II or Class III medical device or a device making novel performance claims.
However, I will extract what can be inferred or directly stated, noting where information is absent:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics. The underlying acceptance criterion for this 510(k) is "substantial equivalence" to predicate devices.
- Reported Device Performance: Not reported in terms of specific performance metrics (e.g., accuracy, precision, sensitivity, specificity). The performance is implicitly assumed to be equivalent to the predicate devices due to the similar characteristics.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Substantial Equivalence to Predicate Devices | Meets characteristics of predicate devices (Intended Use, Matrix, Form, Analytes, Storage) |
-
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 specified.
- Data Provenance: Not specified. The document only references "information provided in the premarket notification," which might include internal testing data.
-
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)
- Number of experts: Not applicable/Not specified. This type of quality control material typically wouldn't use expert-derived ground truth in the same way a diagnostic imaging device would.
- Qualifications of experts: Not applicable/Not specified.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not specified.
-
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
- MRMC study: No. This is a quality control material, not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.
- Effect size of human improvement with AI: Not applicable.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a quality control material, not an algorithm. Its "performance" refers to its consistency and accuracy in verifying the performance of other diagnostic tests.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not explicitly stated. For quality control materials, ground truth would typically refer to the known, certified concentration of analytes within the control solution. This would be established through highly accurate analytical methods (e.g., mass spectrometry) during the manufacturing and characterization process of the controls themselves.
-
The sample size for the training set
- Sample Size: Not applicable. This device is not an AI algorithm and does not have a "training set."
-
How the ground truth for the training set was established
- How ground truth was established: Not applicable.
Summary of Study (Based on Provided Information):
There is no "study" in the traditional sense of a clinical trial or performance evaluation with specific acceptance criteria detailed in the provided document. The submission is a 510(k) premarket notification which demonstrates substantial equivalence to already legally marketed predicate devices.
The "study" that proves the device meets the (inferred) acceptance criteria is the comparison of technical characteristics between the Triage® TOX Drug Screen Controls and the predicate devices, as presented in "Summary of Comparison Data" section E. This comparison focuses on:
- Intended Use: Assayed control for monitoring urine-based drugs of abuse assays.
- Matrix: Human Urine.
- Form: Liquid.
- Analytes: Commonly abused drugs.
- Storage: -20 °C or colder (Triage TOX), 2-8 °C (Bio-Rad, Dade Behring).
The conclusion states: "The information provided in the premarket notification demonstrates that the Triage TOX Drug Screen Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage TOX Drug Screen Controls are safe and effective for their intended use."
This confirms that for a Class I device of this nature, the "proof" is centered on a strong technical comparison showing it is not significantly different from current market offerings, rather than a de novo clinical performance study against specific metrics.
§ 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.