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1. VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

2. VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

3. VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products Cl- Slides, VITROS Chemistry Products ECO2 Slides, and VITROS Chemistry Products GLU Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays.

The provided text describes the performance evaluation of VITROS Chemistry Products Cl- Slides, ECO2 Slides, and GLU Slides on the VITROS XT 7600 Integrated System, demonstrating their substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful outcomes of the various performance studies (method comparison, precision, linearity, detection limits, specificity). Explicit numerical acceptance criteria are not always stated for each test result in the summary, but rather the conclusion that performance was "acceptable" or "supported the claimed measuring ranges."

Summary of VITROS XT 7600 Method Comparison Regression Analysis Data

Precision (Representative samples shown for Cl- Serum and ECO2)

The precision tables present the mean, N, SD, and %CV for Repeatability (Within Run), Within Day, Between Day, Between Calibration, and Within Lab (Total) for various fluids. The acceptance criteria are implicitly that the reported %CV and SD values are within acceptable clinical laboratory standards for these analytes, though specific numeric targets are not explicitly stated in this summary.

Detection Limits

The acceptance criterion for LoQ is explicitly mentioned: "Ortho defines LoQ as the lowest concentration with an imprecision of ≤20% and percent total allowable error

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For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides are used on VITROS Systems to quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The VITROS GLU Slide is a multilayered, analytical element coated on a polyester support. A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of the dye is measured by reflected light.

The document describes the non-clinical testing and performance of the VITROS Chemistry Products GLU Slides (modified) to demonstrate its substantial equivalence to the legally marketed predicate device, the VITROS Chemistry Products GLU Slides (current).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with specific thresholds. Instead, it presents results from various analytical performance studies, implying that the obtained performance (e.g., correlation coefficients, precision values, LOB/LOD/LOQ) met the internal criteria for demonstrating equivalence to the predicate device. For the purpose of this response, I will list the reported performance values from the "Non-Clinical Testing Analytical Performance" section, as these are the data used to prove the device meets the underlying requirements for equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Sizes for Test Set (Method Comparison):
  • Serum: 113 observations
  • Urine: 105 observations
  • CSF: 165 observations
• Sample Sizes for Test Set (Precision):
  • Minimum of 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum, urine, and CSF specimens. The tables show 88 observations over 22 days for each pool/control.
• Sample Sizes for Test Set (LoB/LoD/LoQ) and Linearity: Not explicitly stated as distinct sample sizes, but implied to be sufficient for CLSI protocols. For linearity, 14 concentration levels with six replicate determinations for each body fluid type.
• Data Provenance: The document does not specify the country of origin of the data. It indicates these were human samples for method comparison ("human serum, urine and CSF samples") and various pools/controls for precision testing. It implies these were collected prospectively for the purpose of the study to compare the modified device against the current predicate by following CLSI protocols.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable to this document. The device is an in vitro diagnostic (IVD) chemistry product that quantitatively measures glucose concentration. The "ground truth" for its performance studies is established by quantitative comparisons to a predicate device (e.g., method comparison), statistical analysis of precision, and adherence to established analytical performance guidelines (CLSI protocols), not by expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This is not applicable for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology studies) where disagreement among reviewers needs resolution to establish a consensus ground truth. This document describes analytical performance studies of a quantitative measurement device.

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. This document describes an IVD device for quantitative glucose measurement, not an AI-assisted diagnostic tool that involves human readers or interpretation of cases.

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

This is not applicable in the context of "algorithm only." The device itself is an automated chemical analyzer component (slides) for measuring glucose. The performance studies describe the standalone analytical performance of the device (modified VITROS GLU Slides) when used on VITROS Systems, primarily compared to the predicate device and assessed for its inherent analytical characteristics (precision, linearity, limits). There is no "human-in-the-loop" component in the direct measurement process itself beyond loading samples and running the system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in these studies is primarily established by:

• Comparison to a Legally Marketed Predicate Device: For method comparison, the results generated by the predicate VITROS Chemistry Products GLU Slides (current) are used as the reference "truth" to assess the modified device's equivalence.
• CLSI Protocol Standards: For precision, linearity, and detection limits, the "ground truth" is defined by adherence to CLSI (Clinical and Laboratory Standards Institute) protocols and the statistical methodologies they outline for establishing these performance characteristics. This involves statistical calculations and comparisons to pre-defined statistical acceptance criteria (even if not explicitly listed in the table, they are inherent in CLSI guidelines).

8. The Sample Size for the Training Set

This is not applicable. The document describes the analytical performance studies of a modified IVD assay. There is no mention of machine learning or AI components that would require a "training set" in the conventional sense. The "training" of the device is through its manufacturing and calibration, not through a data-driven model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" in the context of this device's development as described.

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