(136 days)
For in vitro diagnostic use in the quantitative determination of calcium in human serum, plasma, and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal failure, and tetany.
Summary and Explanation: the Calcium 2 (CA 2) method is based on the work of Michaylova and Illkova, (Anal Chem Acta 1971; 53: 194), who found that Arsenazo III could form a stable complex with calcium with high selectivity at low pH.
Principles of the Procedure: Calcium ions form a colored complex with Arsenazo III, which is measured at 658/694 nm. The amount of calcium present in the sample is directly proportional to the intensity of the colored complex formed.
Reaction Equation: Ca2+ + Arsenazo III ---> Ca-Arsenazo III Complex (purple)
The provided document is a 510(k) summary for the ADVIA® Chemistry Calcium 2 Method, which is an in vitro diagnostic device for quantitative determination of calcium. It aims to demonstrate substantial equivalence to a predicate device. The document describes the device, its intended use, and a comparison with the predicate. However, it does not contain specific acceptance criteria, detailed study results (like sample sizes for test/training sets, data provenance, expert details, or MRMC studies), or a comprehensive description of how ground truth was established, beyond stating "comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance."
Therefore, much of the requested information cannot be extracted from this document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states that "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance," but it does not present the acceptance criteria for that testing or the specific performance metrics achieved against those criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | Not specified in this document |
2. Sample size used for the test set and the data provenance
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Establishing ground truth for a clinical chemistry assay typically involves reference methods or certified reference materials, not human experts in the same way as imaging analysis. However, the document does not specify how ground truth was established for the comparative performance study.
4. Adjudication method for the test set
This information is not provided in the document.
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
This is not applicable to this type of chemical assay device. MRMC studies are typically used for imaging or diagnostic devices where human interpretation is involved. This device is an automated quantitative chemical analysis system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is essentially a standalone algorithm/system. Its performance is measured independently of human interpretation in the analytical sense. The document implicitly supports this by describing it as a "quantitative determination of calcium" on automated chemistry systems. However, a formal "standalone study" in the context of an algorithm's performance vs. a human reader for a specific diagnostic task (like in imaging AI) is not relevant here. The comparison is between the new device and a predicate device, both automated diagnostic tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated. For quantitative chemical assays, ground truth is typically established using:
- Reference methods (e.g., atomic absorption spectroscopy for calcium)
- Certified reference materials with known analyte concentrations
- Comparative analysis against a legally marketed predicate device (as done here, for substantial equivalence)
The document refers to "comparative testing" against the predicate device (ADVIA Chemistry 1650 Calcium method), implying that the predicate's results might serve as a form of reference or comparison for the new device's accuracy and precision.
8. The sample size for the training set
This information is not provided in the document. Algorithms for chemical assays like this are typically developed and validated using calibration materials and quality control samples, rather than a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This information is not provided in the document. As mentioned for #8, the concept of a "training set" with established ground truth is less directly applicable for this type of device. Calibration and quality control procedures involve materials with known concentrations, but these are part of the operational system rather than a "training set" for a learning algorithm.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.