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For in vitro diagnostic use only. VITROS Cl- DT Slides quantitatively measure chloride (CI-) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of clectrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

The VITROS Chemistry Products CI Slide assay is performed using the VITROS Chemistry Products Cl DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT Chemistry Systems. The VITROS CI DT 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 CI DT Slide. The slide consists of two ionselective electrodes, each containing a protective laver, a silver laver 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 DT 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 CT DT 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. The chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium. Each electrode produces an electrical potential in response to the activity of chloride ions applied to it. The potential difference poised between the two electrodes is proportional to the chloride concentration in the sample. The test result is reported in millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from boyine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS DT Systems and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study conducted.

It's important to note that this document is a 510(k) summary for a modified device, demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed here relate to showing that the modified device performs comparably to the previously cleared predicate, rather than establishing completely new performance benchmarks from scratch.

Acceptance Criteria and Device Performance

Summary of the Study Proving Acceptance Criteria:

The study was designed to demonstrate "substantial equivalence" of the modified VITROS Chemistry Products CI DT Slides to the previously cleared predicate device. This is a common approach for 510(k) submissions when minor modifications are made to an existing device.

1. Sample size used for the test set and the data provenance:

   • The document states: "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured chloride values spanning the assay range."
   • Specific sample size is not provided in this 510(k) summary. This information would typically be in a more detailed technical report.
   • Data Provenance: Not explicitly stated, but clinical samples are implied ("patient samples"). It is common for such studies to use retrospective or prospective samples, often from diverse geographic regions for generalizability, but this summary doesn't specify.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not specified. For in vitro diagnostic (IVD) devices like this, "ground truth" is typically established by reference methods or validated comparative methods, not by human experts interpreting results. The predicate device itself acts as the "gold standard" or reference in a substantial equivalence study. The "ground truth" here is the measured chloride values from patients and quality control samples.

3. Adjudication method for the test set:

   • Not applicable. As stated above, this is an IVD device measuring a chemical analyte. There is no human interpretation or adjudication in the sense of image review or clinical decision-making. The comparison is quantitative between the modified and predicate device results.

4. 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:

   • No. This is an in vitro diagnostic (IVD) assay for measuring chloride concentration, not an imaging or AI-assisted diagnostic device that involves human readers.

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

   • Yes, effectively. The "standalone" performance is the direct measurement by the modified chemical assay (VITROS Chemistry Products CI DT Slides) compared to the predicate device. There is no human intervention in the actual measurement process of chloride ions by the device itself.

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

   • The "ground truth" was established by the measured chloride values obtained from the predicate device (VITROS Chemistry Products CI DT Slide, K912844) and/or a comparable referance method using patient and quality control samples. The aim was to show the modified device produces results comparable to these established measurements.

7. The sample size for the training set:

   • For an IVD device substantial equivalence study, particularly for a modification where the fundamental technology is similar, there isn't typically a "training set" in the machine learning sense. The device is calibrated, and its performance is verified and validated. The calibrators themselves (VITROS Chemistry Products DT Calibrator Kit) are used to establish the measurement curve, but this isn't a "training set" for an algorithm. The summary does not specify details about calibrator lots or usage.

8. How the ground truth for the training set was established:

   • As there isn't a "training set" in the typical ML/AI sense, this question is not directly applicable. The calibrator kit (composed of lyophilized standards with known concentrations) is used to establish the instrument's calibration curve. The values assigned to these calibrators would have been established through a primary reference measurement system or by careful gravimetric/volumetric preparation and verification, ensuring accuracy and traceability.

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