(18 days)
For in vitro diagnostic use only. VITROS CI Slides quantitatively measure chloride (CI) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI', ECO2, HDLC, K+, Na*, and TRIG.
The VITROS Chemistry Products Cli Slide assay is performed using the VITROS Chemistry Products Cli Slide and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS CI Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry' for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS Chemistry Products Cli slide. The slide consists of two ion-selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of bromide and uric acid
VITROS Chemistry Products CI Slides use ion-selective electrodes for potentiometric measurements of ionic chloride. Ionic chloride determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products CI slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge in approximately 20 seconds. The chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.
After a 2 or 3-minute (depends on the VITROS Chemistry System used) incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of chloride ions in the respective fluids to produce a potential for the concentration cell. The VITROS Chemistry System's microcomputer uses this measurement and the stored calibration parameters to determine the concentration value of the chloride ion in the sample fluid. The test result is reported in millimoles per liter (mmol/ L).
VITROS Chemistry Products Calibrator Kit 2 contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which bovine cholesterol, chicken egg yolk, inorganic salts, electrolytes, buffers, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. In addition, Calibrator 4 Diluent contains 0.5 M diethylaminoethanol and 0.01 M (ethylenedinitrilo) tetraacetic acid.
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided document is a 510(k) summary for the VITROS Chemistry Products CI Slides and VITROS Chemistry Products Calibrator Kit 2. It discusses the substantial equivalence of a modified version of the CI Slides to a predicate device. However, it does not contain detailed information about specific acceptance criteria, a comprehensive study design with reported performance metrics, sample sizes for testing or training, ground truth establishment methods, or expert qualifications as requested in your prompt.
The document states that equivalence was demonstrated using "manufactured slides along with patient and quality control samples with measured chloride values spanning the assay range." However, it does not provide specific details on:
- Quantitative acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds).
- Reported device performance against such criteria.
- Sample sizes used for the test set or training set.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone algorithm performance (as this is a chemical assay, not an AI algorithm).
- Type of ground truth (beyond "measured chloride values").
- How ground truth for the training set was established.
Therefore, I cannot populate the table or provide the requested details using only the information in the provided text.
Based on the content, here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured chloride values spanning the assay range." This implies that the acceptance criteria revolved around demonstrating substantial equivalence to the predicate device, likely through performance studies that showed comparable accuracy, precision, and linearity across the assay range for chloride concentration. However, specific numerical acceptance criteria (e.g., bias limits, correlation coefficients, or percentages of samples within agreement) and the actual reported performance values against these criteria are not provided in the summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Not explicitly stated in detail) |
|---|---|
| Substantial equivalence to predicate device (K800054) | Demonstrated equivalence through studies using patient and QC samples. |
| Performance across the assay range for chloride concentration | Demonstrated performance across the assay range using patient and QC samples. |
| (Specific numerical performance data, e.g., accuracy, precision, correlation, bias, are not provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document mentions "patient and quality control samples."
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This is a chemical assay, and the "ground truth" would typically refer to established reference methods or known concentrations in quality control materials, not expert interpretation.
4. Adjudication method for the test set
Not applicable. Adjudication is typically for subjective assessments, not objective chemical measurements.
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 device is a chemical assay for measuring chloride concentration, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a chemical assay. Its performance is inherent to the chemical reactions and measurement system, not an AI algorithm.
7. The type of ground truth used
The ground truth for the test set was based on "measured chloride values" in "patient and quality control samples." This strongly implies:
- For quality control samples: Known, certified concentrations.
- For patient samples: Chloride concentrations measured by a reference method or the predicate device itself, assuming comparability studies.
8. The sample size for the training set
Not applicable/Not specified. This is a chemical assay. The concept of a "training set" as understood in machine learning (where an algorithm learns from data) does not apply directly here. The development of the assay would involve optimization and validation processes rather than algorithmic training.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.