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VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.

VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide.

The system is comprised of two main elements:

1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB test.
2. The VITROS Chemistry System instrumentation, which provides automated use of the chemistry slides.

The provided document describes a 510(k) premarket notification for a modified in vitro diagnostic device, the VITROS Chemistry Products ALB Slides and VITROS Chemistry Products Calibrator Kit 4. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright performance acceptance criteria against a defined standard.

Therefore, the acceptance criteria and study details are primarily presented in terms of comparative equivalence to the predicate device, rather than explicit numerical thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in the typical sense (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" appear to be demonstration of substantial equivalence to the predicate device, particularly through performance with "patient and quality control samples with measured albumin values spanning the assay range."

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

• Sample Size: The document only generically states "patient and quality control samples." No specific number is provided for the test set.
• Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. For in vitro diagnostic devices like this, "ground truth" for albumin measurement is typically established by reference methods or highly accurate laboratory analyzers, not human expert consensus like in image analysis.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. As an in vitro diagnostic device measuring a quantitative biomarker, adjudication by human readers is not relevant. The "ground truth" would be established by laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs without AI Assistance

This information is not applicable and therefore not provided. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or decision support tool involving human readers.

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

The device itself is a standalone measurement system (an automated chemistry analyzer utilizing specific slides and calibrators). The "algorithm" here refers to the chemical reaction and reflectance spectrophotometry, not a machine learning algorithm. The study effectively assesses the standalone performance of this system against the predicate system. The performance is assessed without human interpretation of raw data, beyond operating the instrument and reviewing results.

7. The Type of Ground Truth Used

For this type of in vitro diagnostic device, the ground truth would be established by:

• Reference laboratory methods: Established, highly accurate methods for measuring albumin concentration.
• Predicate device results: As the goal is substantial equivalence, the results from the predicate device often serve as a comparative ground truth for the new device.
• Known concentrations in quality control samples: Quality control materials have certified albumin concentrations.

The document states "patient and quality control samples with measured albumin values." This implies that these samples had their albumin values determined by a reliable method (likely the predicate device or a reference method) to serve as the ground truth for comparison.

8. The Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. This is a chemical assay, not a machine learning model that requires a "training set" in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and instrument parameters, which is a different process than data-driven machine learning training.

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

As explained above, the concept of a "training set" and associated "ground truth" in the machine learning sense does not directly apply to this in vitro diagnostic device. The development process would involve extensive experimentation and optimization against known chemical standards and clinical samples, but this is not typically referred to as establishing ground truth for a training set in regulatory submissions for chemical assays.

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VITROS Chemistry Products Mg Slides For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine.

VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide. The system is comprised of two main elements: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry slides.

The provided text describes a 510(k) submission for a modified medical device, the VITROS Chemistry Products Mg Slides and VITROS Chemistry Products Calibrator Kit 1. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy, precision targets). Instead, it relies on demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing the characteristics and overall performance of the modified device to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions "patient and quality control samples."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as using "patient and quality control samples with measured Magnesium values spanning the assay range," implying real-world or simulated clinical samples. It is a retrospective or prospective study as it involves testing the modified device against the predicate using samples. The nature of the study (e.g., in-house validation or multi-site trial) is not detailed.

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

This information is not applicable and therefore, not provided. For this type of in-vitro diagnostic device (a chemistry assay), the "ground truth" for Magnesium concentration is established by a reference method or a highly accurate, previously validated method, rather than expert consensus on images or clinical assessments. The reference values for calibrators/controls would typically be determined by highly accurate analytical chemistry techniques.

4. Adjudication Method for the Test Set

This information is not applicable and therefore, not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human readers and subjective interpretations (e.g., radiology studies). For a quantitative diagnostic assay, the "adjudication" is inherent in the analytical measurement process and statistical comparison of results with the predicate device or reference method.

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 information is not applicable and therefore, not provided. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is a key component. This device is a quantitative chemistry assay where the output is a numerical concentration, not an image requiring human interpretation or AI assistance in that interpretation.

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

This information is partially applicable but not explicitly detailed. The device itself is an "algorithm only" in the sense that it is an automated assay system. The study described compares the performance of the modified assay (the "device") to a predicate assay (the "existing device"). There isn't a "human-in-the-loop" component in the direct measurement of Mg concentration by these devices. The study effectively assesses the standalone performance of the modified device against the predicate.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the test set was established by the measured Magnesium values spanning the assay range in both "patient and quality control samples." For quality control samples, the "ground truth" would be pre-assigned target values based on established reference methods. For patient samples, the "ground truth" would likely be values obtained from a comparative method or the predicate device itself, assuming it's considered a highly accurate reference in this context for demonstrating equivalence. It's essentially reference analytics or comparative method data.

8. The Sample Size for the Training Set

This information is not applicable and therefore, not provided. This device is a chemistry assay, not a machine learning or AI model that requires a "training set" in the traditional sense. The development of the assay (e.g., optimizing reagent concentrations) would involve experimental data, but this is distinct from an AI model's training data.

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

This information is not applicable as there is no "training set" for a chemistry assay in the context of AI. The "ground truth" for the experimental data used during the development and optimization of the assay would have been established through standard analytical chemistry techniques and reference methods to determine accurate concentrations for various samples.

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