(64 days)
The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine.
Each configuration of the MGC DAU Control Sets is prepared in a human wine matrix, with stabilizers and preservatives added. As is shown in the table below, the MGC DAU Control Set is offered in three configurations differing only in the concentration and number of analytes offered.
The provided text is a 510(k) summary for a medical device called "MGC DAU Control Sets: Primary, Clinical and Select," which are drug mixture control materials. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one might for an AI/ML diagnostic device.
Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable (N/A) in this context, as this submission is for a quality control material and relies on demonstrating similar physical properties and intended use to a previously cleared device.
Here's a breakdown based on the provided text, indicating N/A where information is not present or relevant to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present a formal table of quantitative acceptance criteria and corresponding reported performance data in the typical sense of a diagnostic or therapeutic device. Instead, it relies on a qualitative comparison of characteristics to a predicate device to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (MGC DAU Control Sets) |
|---|---|---|
| Intended Use | For use as unassayed control material with drugs of abuse assays. | The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine. (Substantially equivalent) |
| Analytes | Benzoylecgonine, EDDP, LSD, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, Barbituates (as per predicate's list). | Primary Config: Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, Barbituates |
| Clinical Config: Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, Barbituates | ||
| Select Config: 6-Acetylmorphine, Benzoylecgonine, LSD, MDMA, Benzodiazepenes | ||
| (Variations exist, but presented as acceptable configurations for "stated intended use" via substantial equivalence). | ||
| Matrix | Urine | Urine (Substantially equivalent) |
| Control Form | Liquid | Liquid (Substantially equivalent) |
| Control Levels | Two: Low and High | Two: Low and High (Substantially equivalent) (Specific concentrations are provided for the subject device in a table, implying they were tested and found suitable for the stated purpose within the context of their intended use, which is validation of assays, not necessarily diagnostic accuracy performance). |
| Storage | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date (Substantially equivalent) |
| Stability | Until expiration date noted on vial label | Until expiration date noted on vial label (Substantially equivalent) |
Note: The "acceptance criteria" here are implicitly met by demonstrating that the device characteristics are "substantially equivalent" to those of a legally marketed predicate device (Multi-Drug Control Set, K951135). The study in this context is the comparison itself, showing that "each configuration of the MGC DAU Control Set is substantially equivalent in form and function to the Multi-Drug Control Set (K951135) for its stated intended use."
2. Sample size used for the test set and the data provenance
This submission does not describe a traditional "test set" in the context of diagnostic accuracy or algorithm performance. The evaluation is a comparison of device characteristics and intended use to a predicate device. There are no "samples" of patient data or images. The "data provenance" is the manufacturer's internal characterization of their product and comparison to their previously cleared product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a quality control material submission, not an AI/ML diagnostic. There's no ground truth established by experts for a test set in this context. The "truth" is related to the chemical composition and stability of the control materials, which are characterized through laboratory methods by the manufacturer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No adjudication method is applicable as there's no diagnostic test set with human interpretations requiring consensus.
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
N/A. This is a quality control product, not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like this, the "ground truth" for the control materials themselves would be their assigned target concentrations (expected values) and their stability characteristics, which are determined through highly controlled analytical chemistry methods and manufacturing processes, rather than expert consensus on clinical cases, pathology, or outcomes data. The submission relies on the established safety and effectiveness of a predicate device with similar "ground truth" generation.
8. The sample size for the training set
N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
N/A. This is not an AI/ML 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.