(104 days)
The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® clinical chemistry system Cyclosporine Fr, it® 2000 Cyclosporine Specific Assay.
The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of one vial of each calibrator level 0-5. The target concentrations of the calibrator levels are approximately 0, 200, 400, 800, 1400 and 2000 ng/mL of cyclosporine. Level 0 is used for dilution of over-range samples (>2000 ng/mL) in order to obtain Lover o lood for analyange; it is not used in calibration. Levels 1 through 5 are used for calibration of the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.
The provided text is a 510(k) Premarket Notification for a medical device (Dimension® CSAE Cyclosporine Extended Range Calibrator). This type of document is administrative and regulatory, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, and MRMC studies is not contained within the provided document. The document describes the device, its intended use, and claims equivalence to a previously cleared calibrator, but it does not detail a study proving specific performance metrics against pre-defined acceptance criteria.
To directly address your request given the provided text:
1. A table of acceptance criteria and the reported device performance
- Information not provided in the document. The document does not define specific performance acceptance criteria (e.g., accuracy, precision targets) for the calibrator, nor does it report performance metrics against such criteria. It states that the device is "substantially equivalent" to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided in the document. There is no mention of a test set, sample size, or data provenance.
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)
- Information not provided in the document. The concept of "ground truth" as it applies to an image analysis or diagnostic AI device (along with experts to establish it) is not relevant to a calibrator for a clinical chemistry assay, and therefore, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided in the document. Adjudication methods are not applicable to the assessment of a calibrator's performance described in this type of regulatory submission.
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
- Information not provided in the document. MRMC studies are not applicable to a calibrator. This type of study is relevant for diagnostic imaging AI tools that assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not provided in the document. This question is not applicable to a calibrator. The calibrator itself is a reagent used in an automated clinical chemistry system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided in the document. "Ground truth" in the context of calibrators typically refers to the accurately assigned values of the analytes (cyclosporine in this case) within the calibrator vials. The document states the "target concentrations" are approximately 0, 200, 400, 800, 1400, and 2000 ng/mL, but it does not describe how these precise ground truth values were established methodologically for validation purposes.
8. The sample size for the training set
- Information not provided in the document. The concept of a "training set" is not applicable to a chemical calibrator.
9. How the ground truth for the training set was established
- Information not provided in the document. Not applicable.
In summary, this 510(k) submission focuses on regulatory equivalence for a chemical calibrator and does not contain the detailed clinical study performance data or methodology typically found for diagnostic AI devices, which your questions are geared towards.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.