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The Piccolo Sodium Test System (contained on the MetLyte 7 Reagent Disc), used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of sodium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

The sodium assay is used for the quantitation of sodium in human heparinized whole blood, heparinized plasma, or serum. Sodium measurements are used in the diagnosis and treatment of dehydration, diabetes insipidus, loss of hypotonic gastrointestinal fluids, sait poisoning, selective depression of sense of thirst, skin losses, burns, sweating, hyperaldosteronism, CNS disorders, dilutional, depletional and delusional hyponatremia and syndrome of inappropriate ADH secretion.

The Piccolo Sodium Test System (contained on the Piccolo MetLyte 7 Reagent Disc) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

Here's a breakdown of the acceptance criteria and study information for the Piccolo® Sodium Test System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Summary of Safety and Effectiveness" and the "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence." Since this is a 510(k) submission, the primary acceptance criterion is substantial equivalence to the predicate device. The performance data presented are used to support this claim.

• Correlation Coefficient: 0.937
• Slope: 0.782
• Intercept: 27.70
• SEE: 3.79
• R-Square: 0.878 (These values are provided for comparison to the predicate, with no explicit predicate values given for these metrics other than it is the comparator.) |
  | Linearity | Statistically linear at the 99% significance level (F-test with 99% Critical F of 2.99). | - F-Ratio: 0.99
• Slope: 0.99
• Intercept: -1.00
• Corr. Coefficient: 1.00
  (Data found to be statistically linear at the 99% significance level by the F-test.) |
  | Precision (Within-Run) | Low standard deviation (SD) and coefficient of variation (CV) at different concentration levels (Moni-Trol 1 and Moni-Trol 2). | Moni-Trol 1 (Mean 144):
• SD: 2.3
• CV: 1.6
  Moni-Trol 2 (Mean 120):
• SD: 2.1
• CV: 1.8 |
  | Precision (Total) | Low standard deviation (SD) and coefficient of variation (CV) at different concentration levels (Moni-Trol 1 and Moni-Trol 2). | Moni-Trol 1 (Mean 144):
• SD: 2.3
• CV: 1.6
  Moni-Trol 2 (Mean 120):
• SD: 2.1
• CV: 1.8 |
  | Sample Type Comparability | Venous whole blood and serum result in comparable sodium measurements. | Serum and whole blood comparability were established for sodium. |

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

• Accuracy Test Set Sample Size: 113
• Precision Test Set Sample Size: 80 (Results pooled from 4 instruments, each running 20 discs)
• Data Provenance: Not explicitly stated, but given the context of a US 510(k) submission, it is assumed to be from a US-based study. It is a prospective study as tests were "performed" using the system to demonstrate equivalence.

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

Not applicable. The ground truth for this type of in vitro diagnostic device (IVD) study is typically established by measurements from a legally marketed predicate device or a recognized reference method, rather than expert interpretation of images or clinical assessments. The predicate device (Radiometer KNA™ 2 Sodium-Potassium Analyzer, K830805) serves as the comparator.

4. Adjudication Method for the Test Set

Not applicable. This type of study for an IVD does not involve expert adjudication as it is comparing quantitative measurements against a predicate device.

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

Not applicable. This is an in vitro diagnostic device (chemistry analyzer) and does not involve human readers or AI assistance in the context of interpretation that would require an MRMC study.

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

Yes, this is a standalone performance study. The Piccolo® Sodium Test System, as an IVD, performs the measurement and provides a quantitative output by itself. The reported performance metrics (accuracy, linearity, precision) are reflective of the device's standalone performance.

7. The Type of Ground Truth Used

The ground truth for the accuracy study was established by comparison to a legally marketed predicate device, the Radiometer KNA™ 2 Sodium-Potassium Analyzer (K830805). Other studies like linearity and precision use reference solutions or controls with known concentrations.

8. The Sample Size for the Training Set

Not applicable. This device is a chemistry analyzer, not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" is in its engineering design, calibration, and manufacturing, not data-driven machine learning.

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

Not applicable, as there is no training set in the context of AI/ML. The device's calibration and operational parameters are established through manufacturing processes and quality control, which would involve known reference materials and standards to ensure accurate measurements.

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