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The SelectaLyte™ Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in vitro diagnostic use only.

The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl) is an automated, microprocessor-controlled electrolyte analyzer for measurement of Sodium (Na*), and Chloride (Cl`) in serum, whole blood and QC aqueous solutions. The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl') utilizes ion selective electrodes (ISE) to measure test samples, and display the results automatically. The instrument features automatic and on-demand calibration, patient data storage, and interactive LCD touch screen.

Acceptance Criteria and Device Performance for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

The provided text details the performance evaluation of the SelectaLyte Electrolyte Analyzer as part of its 510(k) premarket notification. The acceptance criteria and the device's performance are primarily demonstrated through studies on precision, linearity, method correlation, and interference.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values in table format (e.g., "CV must be

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ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.

ChemWell, also known as project 2900, used for United Biotech. Inc. (UBI) kits.

This is an FDA Premarket Notification (510(k)) decision letter. It states that the device, 'ChemWell, also know as project 2900, used for United Biotech, Inc. (UBI) kits', is substantially equivalent to a predicate device. This letter does not include acceptance criteria or a study proving the device meets acceptance criteria. It mentions the indications for use, but no performance data. Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details.

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This accessory program may be used by customers with the general purpose analyzer (K882938) who want to link their instrument to a PC for the purpose of transferring the data from the general purpose instrument to the PC, instead of having the data typed manually by a data entry person

Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stat Tracks device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "Design Assurance Testing" and that "Stat Tracks has been tested," but does not provide details on the number of tests, cases, or scenarios included in this testing.
• Data Provenance: Not specified. It's likely that the testing was internal to Awareness Technology, Inc., given the nature of a software interface. There's no indication of independent testing or specific geographical origin beyond the company's location in Palm City, FL, USA. The testing appears to be prospective in the sense that it was conducted as part of the device's development and verification.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The testing would have likely involved "laboratory professionals" as they are the intended users, but their specific qualifications for evaluating the software's performance are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a software interface for data transfer, it's unlikely that a formal adjudication process involving multiple readers was employed in the same way it would be for diagnostic image interpretation. The testing likely focused on functional verification and error checking.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes a software tool for data transfer, not a diagnostic aid that would typically involve human readers interpreting complex cases. The comparison is made to "other commercially available software" and "manual methods," but this is a statement of equivalence rather than a formal MRMC study.
• Effect Size of Human Reader Improvement with AI vs. Without AI Assistance: Not applicable, as this was not an AI-assisted diagnostic tool for human readers.

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

• Yes, a standalone performance assessment was done. The "Design Assurance Testing" described is essentially a standalone assessment of the software's functionality, focusing on whether it produces intended results, activates error messages, and avoids patient mis-identification. The device's primary function is to automate data transfer, which it does without direct human intervention during the transfer process itself (though a human initiates it). The phrase "No device-induced case of mis-identification of a patient result has been found under any circumstance of testing" directly refers to the algorithm's standalone performance in preventing errors.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device appears to be defined by:
  • Functional correctness: Whether data is transferred accurately and as intended.
  • Error message activation: Whether specific error conditions correctly trigger appropriate messages.
  • Absence of data mis-identification: Verifying that patient results are not mistakenly linked to the wrong patient or test.
  • This is essentially a form of functional verification against predefined specifications and expected outputs.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a software interface and reporting tool, not a machine learning or artificial intelligence algorithm that requires a "training set" in the conventional sense. Its "training" would be its development and debugging process.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no traditional "training set" for this type of software. The "ground truth" for the software's development would be its functional specifications and adherence to programming logic.

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