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Drug Calibrator II is intended to be used to calibrate the Acetaminophen (ACTM), Carbamazepine (CRBM), Gentamicin (GENT), Tobramycin (TOBR), Valproic Acid (VALP), and Vancomycin (VANC) methods for the Dimension® clinical chemistry system.

Drug Calibrator II is an in vitro diagnostic product intended for use in an in vitro test system to establish points of reference that are used in the determination of values in the measurement of human substances.

Drug Calibrator II (K962817) is being modified to add valproic acid as an additional constituent on the product labeling. Drug Calibrator II is a liguid product. Level 1 is bovine albumin. Levels 2 through 5 contain acetaminophen, carbamazepine, gentamicin, tobramycin, valproic acid and vancomycin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 5 mL each.

The provided document is a 510(k) summary for a Drug Calibrator II device. It describes a modification to an existing calibrator to include valproic acid. The document explicitly states that the modified device is substantially equivalent to the predicate device and does not contain any information regarding performance studies, acceptance criteria, sample sizes, or ground truth establishment.

Therefore, many of the requested details cannot be extracted from this document, as it focuses on the administrative process of claiming substantial equivalence rather than a detailed scientific study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the provided text. The document states that the modified Drug Calibrator II is "substantially equivalent" to the predicate device. It does not provide any specific acceptance criteria or reported device performance metrics for either the original or modified device. The comparison table lists "Intended Use," "Analyte," "Matrix," "Form," "Volume," and "Levels" as attributes, but not performance-based acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from the provided text. No test set, studies, or data provenance information is mentioned.

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)

• Cannot be answered from the provided text. As no test set or ground truth establishment is described, neither the number nor the qualifications of experts are mentioned.

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

• Cannot be answered from the provided text. No adjudication method is described because no test set or study requiring adjudication is present.

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

• Cannot be answered from the provided text. This is not an AI-powered device, nor is any MRMC study or human reader performance mentioned. The device is a calibrator for a clinical chemistry system.

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

• Cannot be answered from the provided text. This is not an algorithm-based device. It is a physical calibrator product.

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

• Cannot be answered from the provided text. No ground truth is described. For a calibrator, "ground truth" would typically refer to the certified concentrations of the analytes within the calibrator solutions, established through rigorous chemical analysis, but this information is not included in the 510(k) summary.

8. The sample size for the training set

• Cannot be answered from the provided text. No training set is applicable or mentioned for this type of device.

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

• Cannot be answered from the provided text. As there is no training set, there is no discussion of how its ground truth might be established.

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence of a modified medical device to a legally marketed predicate device. The only change described is the addition of valproic acid as a constituent to an existing drug calibrator product.

• Device Name: Drug Calibrator II (Modified)
• Intended Use: To calibrate Acetaminophen (ACTM), Carbamazepine (CRBM), Gentamicin (GENT), Tobramycin (TOBR), Valproic Acid (VALP), and Vancomycin (VANC) methods for the Dimension® clinical chemistry system.
• Predicate Device: Drug Calibrator II (K962817)
• Comparison: The modified device is identical to the predicate except for the inclusion of valproic acid in its labeling and composition. Both are liquid products in a bovine albumin matrix, 5.0 mL per vial, and come in 5 levels.
• Conclusion: The modified Drug Calibrator II is substantially equivalent to the currently marketed Drug Calibrator II.

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Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges.

Drug Calibrator II is a liquid bovine serum base product containing weighed-in quantities of purified drugs. It is packaged as 10 vials, two vials each of five levels. Each vial contains 5.0 mL.

The provided document is a 510(k) summary for a medical device called "Drug Calibrator II." This document describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document does not contain any information regarding acceptance criteria or a study that evaluates the device's performance against such criteria. It is a regulatory submission focused on demonstrating substantial equivalence for an in vitro diagnostic calibrator, not a study report detailing performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text.

To be clear, the document:

• Does not include a table of acceptance criteria and reported device performance.
• Does not specify sample sizes for a test set, data provenance, or details about a study design.
• Does not mention experts, ground truth establishment methods, or adjudication.
• Does not discuss MRMC comparative effectiveness studies or standalone algorithm performance.
• Does not provide details on training set size or ground truth establishment for a training set.

The document is purely a descriptive regulatory filing for a calibrator product.

Ask a specific question about this device