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The EasyLyte Na/K/Ca/pH analyzer is used for the in-vitro diagnostic testing of Sodium(Na+), Potassium(K+), and ionized Calcium(Ca++) with pH correction in clinical laboratories by trained technicians.

Sodium test: The sodium (Na+) assay is intended to measure sodium in serum, plasma, and whole blood. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large anounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's discase (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium test: The potassium (K+) assay is intended to measure potassium in serum, plasma, and whole blood. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Calcium-ionized test: The ionized calcium (Ca++) assay is intended to measure the ionized calcium level in serum, plasma, and whole blood. fonized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Acidosis (low pH) causes increase and alkalosis (high pH) a decrease in the amount of ionized calcium.

pH test: The sample pH assay is intended to measure the pH of the ionized calcium assay. Measurements of pH are used to calculate the "normalized ionized calcium value" in samples with pH other than 7.40 units,

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The provided document K112788 is a 510(k) clearance letter for the Medica Corp. EasyLyte Na/K/Ca/pH Analyzer. It does not contain detailed information about acceptance criteria or the specific study details proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria in the format requested.

Therefore, many of the requested points cannot be answered from the provided text.

However, based on the information provided, here's what can be extracted:

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

This information is not present in the provided document. The document is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.

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

This information is not present in the provided document.

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):

This information is not present in the provided document. The EasyLyte Na/K/Ca/pH Analyzer is an in-vitro diagnostic device, so the ground truth would typically be established by a reference method or laboratory.

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

This information is not present in the provided document.

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 as the EasyLyte Na/K/Ca/pH Analyzer is an in-vitro diagnostic device for measuring electrolytes and pH, not an AI-assisted diagnostic imaging device requiring human reader interpretation in an MRMC study.

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

This is not applicable in the context of an AI-driven standalone algorithm. The device itself is a standalone analyzer for in-vitro diagnostic testing, meaning its performance is evaluated based on its own measurement capabilities.

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

This information is not explicitly stated in the provided document. For an in-vitro diagnostic device like this, the ground truth would typically be established by a well-characterized reference measurement method or a validated laboratory standard.

8. The sample size for the training set:

This information is not present in the provided document. The device is not described as a machine learning/AI model that would have a "training set" in the conventional sense. Its development would involve calibration and validation data, but not a training set in the AI context.

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

This information is not present in the provided document due to the nature of the device (see point 8).

In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical study information required to answer most of your questions about acceptance criteria and study design. Such details would typically be found in the 510(k) submission itself or accompanying technical documentation, which is not part of this public clearance letter.

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