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510(k) Data Aggregation
K Number
K040958Manufacturer
Date Cleared
2005-02-15
(308 days)
Regulation Number
862.2160Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.
Device Description
The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.
AI/ML Overview
Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Prestige 24i (and equivalent models) details performance characteristics. The acceptance criteria themselves are not explicitly stated as pass/fail thresholds in the document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Roche Cobas Mira Plus) through correlation, linearity, and precision. The reported performance is presented to support this claim of equivalence.
Given this, the table below presents the reported performance values. The implied acceptance criteria are that these values should be comparable to or within acceptable ranges for similar clinical chemistry analyzers for the measurement of sodium, potassium, and chloride, especially when compared to the predicate device.
| Performance Characteristic | Analyte | Reported Device Performance (Prestige 24i) | Implied Acceptance Criteria (Based on Substantial Equivalence) |
|---|---|---|---|
| Correlation Analysis | Correlation Coefficient (r): High (e.g., typically >0.95 for good agreement, though specific threshold not stated). Slope (Least-Squares): Close to 1.0 (indicating proportional agreement). Y-axis intercept: Close to 0 (indicating minimal constant bias). Values presented are considered acceptable for substantial equivalence. | ||
| Sodium | r = 0.97, Slope = 0.95, Intercept = +6.8625 mmol/L | ||
| Potassium | r = 0.99, Slope = 0.98, Intercept = -0.0135 mmol/L | ||
| Chloride | r = 0.98, Slope = 0.97, Intercept = +3.2579 mmol/L | ||
| Linearity | The device should be linear over the clinically relevant range for each analyte; the reported ranges are considered acceptable. | ||
| Sodium | 70 - 200 mmol/L (Serum) | ||
| Potassium | 1 - 50 mmol/L (Serum) | ||
| Chloride | 70 - 200 mmol/L (Serum) | ||
| Precision (Within Run) | Coefficient of Variation (%CV): Low (typically <5% for clinical chemistry, though specific thresholds are not stated). Values presented are considered acceptable. | ||
| Sodium | Sample 1: 1.0%, Sample 2: 0.6% | ||
| Potassium | Sample 1: 1.7%, Sample 2: 1.0% | ||
| Chloride | Sample 1: 0.5%, Sample 2: 0.8% | ||
| Precision (Day by Day) | Coefficient of Variation (%CV): Low (typically <5% for clinical chemistry, though specific thresholds are not stated). Values presented are considered acceptable. | ||
| Sodium | Sample 1: 1.4%, Sample 2: 1.3% | ||
| Potassium | Sample 1: 1.5%, Sample 2: 1.3% | ||
| Chloride | Sample 1: 2.5%, Sample 2: 2.3% |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the total number of patient samples or data points used for the correlation or linearity studies.
- For the precision test, the "N=20" indicates 20 measurements were taken for both "Within Run" and "Day by Day" precision calculations for each analyte (Sodium, Potassium, Chloride) and for two different samples (Sample 1 and Sample 2). This refers to the number of replicates, not necessarily unique patient samples.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- This device is a clinical chemistry analyzer, which measures analytes directly. Therefore, the "ground truth" for the test set is established by the measurement itself from a reference method (the predicate device, Roche Cobas Mira Plus) or controlled samples with known concentrations for linearity and precision.
- No human experts (e.g., radiologists) were involved in establishing the ground truth for this type of device performance study.
4. Adjudication Method for Test Set
- Not applicable. As a clinical chemistry analyzer, the "ground truth" is based on the analytical measurements from a reference method or known concentrations, not on expert interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for image-interpretation devices where human readers' performance is assessed. For a clinical chemistry analyzer measuring analytes, the direct comparison is between the new device's readings and a reference method's readings.
- Therefore, there is no effect size reported for human readers' improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance
- This is a standalone device in the sense that its measurements are directly compared to a predicate device. The performance characteristics (correlation, linearity, precision) are measures of the algorithm/device's analytical performance on its own. It's not an "AI algorithm" in the typical sense of interpreting complex data like images, but rather an automated analytical instrument.
7. Type of Ground Truth Used
- The ground truth for the correlation study was established by comparison to a legally marketed predicate device (Roche Cobas Mira Plus).
- For the linearity test, the ground truth would be samples with known, incrementally varied concentrations of the analytes.
- For the precision test, the ground truth would be repeated measurements of control or patient samples to assess the variability.
8. Sample Size for Training Set
- The document does not specify a separate "training set" or its sample size. Clinical chemistry analyzers are typically developed and validated using a range of samples and controls, but the concept of a "training set" like in machine learning models is not explicitly mentioned or typically applicable in the same way for these types of analytical instruments. The performance data presented are from validation studies, which serve to demonstrate the device's accuracy and reliability.
9. How Ground Truth for Training Set Was Established
- Given that a "training set" is not explicitly defined or described in the context of this device in the provided text, the method for establishing its ground truth is not specified. The validation relies on comparisons to known materials and a predicate device as described in point 7.
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