Search Results

For in vitro diagnostic use only. VITROS Na Slides quantitatively measure sodium (Na*) concentration in serum, plasma, and urine. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance.

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 Na assay is performed using the VITROS Chemistry Products Na "Slide and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS Nat Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of ionic sodium. All reactions necessary for a single quantitative measurement of sodium take place within the multi-layered analytical element of a VITROS Chemistry Products Nat slide. The slide consists of two ion-selective electrodes, each containing methyl monensin (an ionophore for sodium), a reference layer, and a silver and a silver chloride layer coated on a polyester support.

VITROS Chemistry Products Na Slides use ion-selective electrodes for potentiometric measurements of ionic sodium. Ionic sodium determinations are made by simultaneously depositing 10 uL each of a reference tluid and a sample fluid on separate halves of the VITROS Chemistry Products Na * 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 sodium ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.

After a two-minute 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 sodium 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 sodium 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.

This document describes the VITROS Chemistry Products Na Slides and VITROS Chemistry Products Calibrator Kit 2. The new device is the "modified" VITROS Chemistry Products Na+ Slide, and it is compared to a predicate device, the "current" VITROS Chemistry Products Na+ Slide. The Calibrator Kit 2 is unchanged.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and matching reported device performance in the format commonly seen for diagnostic accuracy studies. Instead, it states that "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured sodium values spanning the assay range." This implies that the acceptance criterion was likely substantial equivalence to the predicate device, demonstrated through comparative performance studies.

The provided text focuses on the device's technical specifications and function, rather than detailed performance metrics against predefined acceptance thresholds.

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 mentions "patient and quality control samples with measured sodium values spanning the assay range" were used. However, it does not specify the sample size for the test set, nor does it provide information on the country of origin of the data or whether the data was retrospective or prospective.

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 information is not applicable as the device is a chemical assay for measuring sodium concentration, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for chemical assays is typically established by reference methods or validated laboratory measurements, not by expert consensus from radiologists or similar medical professionals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of results (e.g., medical images) is involved and discrepancies need to be resolved. For chemical assays, the "ground truth" is determined by the output of the reference method or established laboratory procedures.

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

An MRMC study is not applicable here. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable in the context of an automated chemical assay. The VITROS Na+ Slides, used with the VITROS Chemistry Systems, inherently operate in a "standalone" manner in that the system provides a quantitative measurement without human interpretation of raw data to derive the sodium concentration. The "performance" refers to the accuracy and precision of the instrument's measurements against a known standard or reference method. The core of the submission is to demonstrate that the modified slide performs equivalently to the predicate slide.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device would be established by validated laboratory measurements using a reference method or a legally marketed predicate device. The document implies this by stating "measured sodium values spanning the assay range" were used for comparison. The predicate device's performance would likely serve as the primary reference for demonstrating substantial equivalence.

8. The sample size for the training set

This information is not provided in the document. For in vitro diagnostic assays, especially those based on established chemical principles, the concept of a "training set" in the context of machine learning is not typically applicable in the same way. Development and validation of such assays involve rigorous analytical studies (e.g., linearity, precision, interference) rather than machine learning training.

9. How the ground truth for the training set was established

As the concept of a "training set" in the machine learning sense is not applicable here, the method of establishing ground truth for a training set is not relevant. The device's accuracy is established through analytical performance studies against known standards or reference methods.

Ask a specific question about this device