(24 days)
The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Synchron. The CEDIA Digoxin Calibrators are used to determine drug concentrations.
The CEDIA Digoxin Calibrators are manufactured using bovine serum albumin, digoxin, stabilizers, and preservatives. The drug is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device to ensure correct assay calibration.
The provided regulatory document describes the Boehringer Mannheim Corporation's CEDIA Digoxin Calibrators and their substantial equivalence to a predicate device. It does not contain information related to acceptance criteria, specific device performance statistics, or details of a study meeting such criteria with the level of detail requested in the prompt. The document is primarily a 510(k) summary for a diagnostic device, focusing on its intended use, comparison to a predicate, and performance characteristics in terms of method correlation and stability relative to the predicate.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text.
However, I can extract the information that is present:
No specific acceptance criteria or detailed device performance statistics are provided in the document beyond a qualitative statement of equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The document only states:
- "Method Comparison: equivalent correlation between predicate device Multi-Calibrators and the CEDIA Digoxin Calibrators."
- "Stability: equivalent open vial and shelf-life stability performance to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text.
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 calibrator for an in vitro diagnostic device, not an imaging or diagnostic AI device that would typically involve expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 calibrator for an in vitro diagnostic device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a calibrator for an in vitro diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the "equivalent correlation" or "equivalent stability" studies, but for calibrators, the "ground truth" would typically involve established reference methods or traceable standards for digoxin concentration. The document mentions "in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device."
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.