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Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

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The provided text is a 510(k) summary for an in vitro diagnostic device, the "Diazyme Liquid Stable Enzymatic Sodium Assay." It primarily focuses on the regulatory clearance process and does not contain detailed information about the specific studies, acceptance criteria, or performance metrics typically found in a clinical study report. Therefore, I cannot provide the requested information.

The document states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, indicating that the new device performs as well as, or better than, an existing device for the intended use. However, it does not include the detailed study results to demonstrate this.

To answer your questions, I would need access to the actual study reports or a more detailed technical document submitted with the 510(k) application, which typically contains:

• Acceptance Criteria: Specific thresholds for accuracy, precision, linearity, etc.
• Reported Device Performance: The actual results from the studies that demonstrate how well the device performed against the acceptance criteria.
• Sample Size and Data Provenance: Details about the patient samples used in the studies.
• Ground Truth Establishment: Methods used to determine the true sodium levels for comparison.
• Adjudication Method: If relevant (usually for diagnostic imaging studies).
• MRMC or Standalone Studies: Whether comparative studies with human readers or standalone algorithm performance was evaluated (again, more common for imaging AI).
• Training Set Information: For AI/machine learning devices, details on the training data.

Without this specific clinical performance data, I cannot complete the table or answer the detailed questions about the study design and results.

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Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low and High Calibrators, are intended for the quantitative determination of sodium (NA) in serum.

Diazyme's Sodium Enzymatic assay is proven to be equivalent to ISE method but more user friendly in automated analyzers. Sodium is determined enzymatically via sodium dependent ß-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.

Here's an analysis of the provided text regarding the Diazyme Sodium Enzymatic Assay, structured according to your request:

Acceptance Criteria and Study Details for Diazyme Sodium Enzymatic Assay

This submission focuses on establishing substantial equivalence to a predicate device rather than defining specific performance acceptance criteria against a clinical gold standard. The criteria are largely based on analytical performance compared to an established method.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that the correlation study was performed with "clinical patient serum samples". However, it does not specify the exact sample size used for this comparison. The provenance of the data is not explicitly mentioned but is implied to be clinical samples relevant to sodium measurement. The study design is retrospective in the sense that it evaluates the performance of the new assay against an existing method on collected samples, but it doesn't specify if these were newly collected prospective samples or existing archived samples.

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

This type of information is not applicable to this submission. The "ground truth" for sodium concentration measurements in this context is the result obtained by a legally marketed and accepted method (Ion-Selective Electrode, ISE), not a subjective assessment by human experts.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process involved as the "ground truth" was established by a reference analytical method (ISE).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This submission is for an in-vitro diagnostic (IVD) assay that directly measures a biomarker (sodium concentration). It is not an AI-assisted diagnostic imaging or classification tool that would involve human readers or an MRMC study.

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

The device itself is a "standalone" enzymatic assay in the sense that its results are generated by the chemical reaction and photometric measurement, not requiring direct human interpretation in the same way an imaging algorithm might. The performance described (precision, correlation, etc.) represents the intrinsic performance of the assay system.

7. The Type of Ground Truth Used

The ground truth used for comparison and validation was the results obtained from a legally marketed predicate device using the Ion-Selective Electrode (ISE) method. This represents a well-established and accepted analytical method for measuring sodium.

8. The Sample Size for the Training Set

Not applicable. This submission is for an enzymatic assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The assay's chemical and enzymatic principles are fixed, not learned from a large dataset.

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

Not applicable, as there is no "training set" for this type of device. The assay development would have involved optimizing reaction conditions, reagent concentrations, and measurement parameters based on established biochemical principles and laboratory testing, not by training on a labeled dataset.

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