(219 days)
The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test books of the following test analyte: potassium. Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of conditions characterized by low or high blood potassium levels. The CAC Bio-Chem Analyzer™ is a point-of-care device intended for hospital-use settings.
The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test books of the following test analyte: potassium.
Here's an analysis of the provided text regarding acceptance criteria and study details for the CAC Bio-Chem Analyzer™, formatted as requested:
Acceptance Criteria and Study Details for CAC Bio-Chem Analyzer™
The provided document is a 510(k) clearance letter from the FDA. It does not contain detailed information about specific acceptance criteria, study design, or performance metrics. It primarily states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, many sections of your request cannot be fully answered directly from this document. However, based on the nature of a 510(k) submission for an in vitro diagnostic device (specifically a potassium test system), we can infer the types of studies and acceptance criteria that would have been required for substantial equivalence, even if the specifics are not present here.
1. Table of Acceptance Criteria and Reported Device Performance
As the specific acceptance criteria and performance data are not detailed in this clearance letter, this table cannot be populated with precise values. For a potassium test system, typical acceptance criteria would relate to:
| Metric Type | Acceptance Criteria (Likely for a Potassium Test System) | Reported Device Performance (Not available in provided text) |
|---|---|---|
| Accuracy (Bias) | Agreement with a reference method (e.g., within X% or Y mmol/L) | Not reported in provided document |
| Precision (Reproducibility) | Within-run, between-run, and total precision (e.g., CV% 0.95 or specific regression statistics) | Not reported in provided document |
| Reference Interval | (If applicable and defined by the manufacturer) | Not reported in provided document |
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 does not specify the sample size, country of origin, or whether the study was retrospective or prospective. For a 510(k) for an in vitro diagnostic device, a clinical validation study demonstrating performance on patient samples (or samples mimicking patient samples) would be expected. The sample size would be determined to show statistical significance for the performance claims.
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 to an in vitro diagnostic device like a potassium test system. Ground truth is typically established by:
- A reference method (e.g., flame photometry, ion-selective electrode on a large laboratory analyzer) considered the "gold standard."
- Comparison with a legally marketed predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable in the context of an in vitro diagnostic device for quantitative chemical analysis. Adjudication methods are typically used for subjective assessments (e.g., image interpretation where multiple experts might disagree).
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 not an imaging device or an AI-assisted diagnostic tool that involves human "readers." It's a quantitative chemical analyzer.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a standalone instrument (CAC Bio-Chem Analyzer™) for quantitative determination. Its performance inherently represents standalone algorithm-only performance in terms of chemical analysis. Its output (potassium levels) does not typically require human interpretation in the same way an image or complex waveform might. The "human-in-the-loop" would be the clinician using the result to guide treatment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a potassium test system, the ground truth would be established by:
- Measurements obtained from a recognized reference method (e.g., highly accurate laboratory electrolyte analyzer using an established measurement principle).
- Comparative measurements against a predicate device that has already been cleared or approved by the FDA and is considered accurate and reliable.
8. The sample size for the training set
The document does not provide any information about a "training set." For an in vitro diagnostic device like this, the development process would involve extensive R&D and calibration, but the clinical validation (performance study) would be distinct from a "training set" in the machine learning sense. Data used during the development and calibration of the instrument's reagents and measurement algorithms would be analogous to a training set, but its size is not specified.
9. How the ground truth for the training set was established
Similar to point 7, ground truth for any internal development/calibration of the device would be established using:
- High-purity reference materials with known concentrations of potassium.
- Certified reference methods to define the true concentration of analytes in calibrator and control materials.
- Comparison to established predicate methods during the design and optimization phases.
Summary of Limitations from the Provided Document:
The provided FDA 510(k) clearance letter is a regulatory approval document. It confirms that the FDA found the device "substantially equivalent" based on information submitted by the manufacturer. It does not include the detailed scientific and clinical study reports that contain the specific acceptance criteria, performance data, sample sizes, and ground truth establishment methods. These details would be found within the 510(k) submission itself, which is typically proprietary at the time of submission and not fully disclosed in the public clearance letter.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.