(8 days)
Liquichek™ Urine Toxicology Control Levels S1E and S2E is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.
Liquichek™ Urine Toxicology Control Levels S1E and S2E is prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers. The control is provided in liquid form for convenience.
The provided document is a 510(k) summary for a medical device called Liquichek™ Urine Toxicology Control Levels S1E and S2E. This device is a quality control material, not an AI/ML-driven diagnostic device or an imaging device. Therefore, the questions related to AI performance metrics (like sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set size, and training set ground truth) are not applicable to this type of product.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device by comparing characteristics and providing stability data.
Here's an attempt to answer the relevant parts, interpreting "acceptance criteria" as the product's claimed performance specifications:
1. Acceptance Criteria and Reported Device Performance
For a quality control material, "acceptance criteria" primarily relate to its stability and its ability to function as intended to monitor laboratory performance. The document details two key performance criteria for the new device (Liquichek™ Urine Toxicology Control Levels S1E and S2E) related to stability:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open Vial Stability | All analytes stable for 30 days when stored tightly capped at 2-8°C. |
| Shelf Life (Unopened) | 2 years when stored unopened at 2-8°C. |
Study Proving Acceptance Criteria:
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urine Toxicology Control." It also mentions: "Real time studies will be ongoing to support the shelf life of this product."
- Study Type: Stability studies (both open-vial and shelf-life).
- Methodology: The document does not provide details on the specific methodology of these stability studies (e.g., number of batches tested, frequency of testing, analytical methods used for verification). It only states that the studies were performed and that supporting data is retained on file at Bio-Rad Laboratories.
- Result: The studies supported the claims of 30-day open-vial stability and a 2-year shelf life.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This product is a quality control material, not an AI/ML diagnostic. The concept of a "test set" in the context of diagnostic accuracy for AI models does not apply here. The document describes stability studies, but doesn't detail their sample size or provenance beyond stating they were performed by Bio-Rad Laboratories.
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)
- Not Applicable: This is a quality control material, not an AI/ML diagnostic or imaging device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This is a quality control material, not an AI/ML diagnostic or imaging device requiring adjudication for a test set.
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
- Not Applicable: This is a quality control material, not an AI/ML diagnostic that would be subject to MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a quality control material, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable: For this quality control material, "ground truth" would refer to the assigned concentrations of the analytes within the control, which are established during manufacturing based on precise spiking and analytical methods, not through expert consensus, pathology, or outcomes data in the traditional sense for a diagnostic device.
8. The sample size for the training set
- Not Applicable: This is a quality control material, not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established
- Not Applicable: This is a quality control material, not an AI/ML model for which a training set's ground truth needs to be established.
§ 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.