(56 days)
Liquichek Cardiac Markers Plus Control, Cardiac Markers Plus Control LT and Cardiac Markers Plus Control LT Low are intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
These products are prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. These controls are provided in liquid form.
The provided text is a 510(k) summary for the Liquichek™ Cardiac Markers Plus Controls. It describes a new quality control device and claims substantial equivalence to a predicate device. The document does not describe a study involving an AI/digital health device, nor does it provide acceptance criteria and performance data in the context of such a device.
Instead, the document focuses on:
- Device Identification: Product names, classification, and regulation details.
- Predicate Device: K040277, Liquichek™ Cardiac Markers Control LT.
- Device Description: Made from human serum with added constituents.
- Intended Use: Quality control serum to monitor precision of laboratory testing.
- Comparison to Predicate: Highlights new analytes (BNP, Creatine Kinase, Total, CRP) and extended open vial stability (20 days vs. 10/5 days).
- Supporting Data: Mentions stability studies for open vial (20 days at 2-8°C) and shelf life (3 years at -20°C to -70°C). These are described as "product claims" based on "stability studies" that "will be ongoing to support the shelf life."
Therefore, I cannot fulfill your request for the specific items (1-9) as they pertain to an AI/digital health device study because the provided text is for a laboratory quality control material and not a software algorithm or a device that would typically undergo such studies.
The document is a submission to the FDA seeking clearance for a new in-vitro diagnostic (IVD) quality control product, asserting its substantial equivalence to a previously cleared product. The "acceptance criteria" and "study" mentioned refer to the stability testing performed to establish shelf life and open-vial stability of the control material itself, ensuring it performs consistently over time for its intended purpose of monitoring laboratory test precision.
Here's how I can address the request based on the actual content of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in the typical sense of sensitivity, specificity, accuracy for an AI/digital health device. Instead, it makes product claims supported by stability studies.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Product Claims) |
|---|---|
| Open Vial Stability | All analytes stable for 20 days at 2-8°C. |
| Shelf Life Stability | 3 years at -20°C to -70°C. |
| Functionality (Intended Use) | Functions as a quality control serum to monitor the precision of laboratory testing procedures. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Plus Control." It also mentions "Real time studies will be ongoing to support the shelf life of this product."
- Sample Size: Not specified. (For stability studies, this usually refers to the number of control vials tested over different time points and conditions, not patient samples).
- Data Provenance: Not explicitly stated, but assumed to be internal data from Bio-Rad Laboratories (Irvine, California, USA), given they are the submitter. The studies are described as prospective in nature, especially with "real time studies... ongoing."
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 is not applicable. The product is a laboratory quality control material. Ground truth in this context would be the certified values of the analytes within the control material, established through rigorous manufacturing and assay procedures, not by expert consensus or interpretation of medical images/data. The "experts" would be the scientists and chemists involved in the formulation and analytical validation of the control.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., radiology reads). This is irrelevant for a chemical quality control product.
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 for an AI/digital health device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an AI/digital health device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" (or target values) for the analytes within it are established during manufacturing and assay validation using reference methods and calibrated instruments. This is an analytical/chemical ground truth, not based on expert clinical consensus or patient outcomes.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.