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For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to calculate globulin and albumin/globulin ratio from albumin and globulin results generated on the CareSide Analyzer by professionals to aid in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

The CareSide™ Analyzer uses the Total Protein and Albumin cartridge test results from a single patient sample to determine the globulin concentration and A/G Ratio. Globulin is calculated as the difference between the total protein and albumin concentrations.

The provided text describes the CarcSide™ Globulin and A/G Ratio calculation device, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, the document primarily focuses on:

• 510(k) Summary: This is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
• Device Description: Explaining how Globulin and A/G ratio are calculated from Total Protein and Albumin results using the CareSide™ Analyzer.
• Intended Use and Indications for Use: Defining what the device is for.
• Expected Values (Reference Interval): A study to establish a normal range for healthy individuals.
• FDA Clearance Letter: Confirming that the device has been found substantially equivalent to a predicate device.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving their achievement, as this specific information is not present in the provided text.

However, I can extract the information that is present:

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

• This information is not provided in the text. The document focuses on establishing substantial equivalence to a predicate device and defining an expected reference interval for healthy individuals, not on performance against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance:

• Test Set (for establishing Expected Values/Reference Interval):
  • Sample Size: 68 ambulatory, healthy adult workers (27 males, 41 females).
  • Data Provenance: Not explicitly stated, but implies U.S. data (investigator used CareSide™ Total Protein and CareSide™ Albumin test cartridges). It is a prospective study for establishing reference intervals.

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

• Not applicable. The "ground truth" for the test set in this context is simply the measured Total Protein and Albumin values from healthy individuals using the CareSide™ system itself, which are then used to calculate Globulin and A/G ratio. There's no external expert consensus or pathological assessment described for these reference interval values.

4. Adjudication method for the test set:

• None described.

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:

• No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) for calculating biochemical values, not an imaging or interpretive AI device where human readers are directly involved in interpretation that could be "assisted" by AI.

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

• Yes, in essence. The CarcSide™ Globulin calculation is described as an "in vitro diagnostic product intended for the calculation of globulin" based on results from the Total Protein and Albumin cartridges. The "CareSide™ Analyzer automatically calculates the Globulin measurement and the Albumin to Globulin ratio." This is an algorithmic calculation, and its performance (in terms of accuracy of the calculation and consistency with known biochemical principles) is inherent to its function. The provided document, however, mainly demonstrates substantial equivalence for this calculation method to existing methods, rather than providing an independent standalone accuracy study against a "true" globulin value.

7. The type of ground truth used:

• For establishing the "Expected Values (Reference Interval)," the ground truth is biochemical measurement using the CareSide™ Total Protein and Albumin test cartridges on specimens from a healthy population. The calculated globulin and A/G ratio from these measurements are then presented as a reference interval.
• For the device's substantial equivalence claim, the "ground truth" implicitly relies on the established accuracy and clinical utility of the predicate devices (Vitros TP and Albumin DT Slides) for measuring total protein and albumin, from which globulin is calculated.

8. The sample size for the training set:

• Not explicitly stated. This document is a 510(k) summary, which focuses on substantial equivalence and intended use rather than detailed algorithm development and training data. The calculation itself (Globulin = Total Protein - Albumin) is a fundamental biochemical formula, not typically "trained" in the way a machine learning algorithm would be.

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

• Not applicable / not explicitly stated. Given that the device performs a simple calculation (Globulin = Total Protein - Albumin), there isn't a "training set" in the machine learning sense. The accuracy of the calculation relies on the accurate measurement of Total Protein and Albumin by the CareSide™ system, for which substantial equivalence to predicate devices (Vitros TP and Albumin DT Slides) is claimed. The underlying biochemical principles are the "ground truth" for the calculation itself.

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