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510(k) Data Aggregation
(98 days)
The Piccolo Magnesium Test System used with the Piccolo Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
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The provided document is a 510(k) clearance letter from the FDA for the Piccolo Magnesium Test System, which is an in vitro diagnostic device. This type of document typically does not contain detailed information about acceptance criteria, study designs, sample sizes, or ground truth establishment in the way that would apply to AI/ML or imaging devices.
The FDA 510(k) clearance process for in vitro diagnostics usually relies on demonstrating substantial equivalence to a predicate device, which involves analytical performance studies (e.g., accuracy, precision, linearity, interference) rather than clinical outcome studies or expert-based ground truth for image interpretation.
Therefore, many of the specific details requested in your prompt (e.g., test set sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory document for an in vitro diagnostic test system.
However, I can extract what is explicitly stated or can be inferred:
1. A table of acceptance criteria and the reported device performance:
This information is typically found in the summary of safety and effectiveness, which is not fully included in this clearance letter. The letter confirms substantial equivalence without detailing the specific performance metrics used to establish that.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. Studies for IVDs are typically performed by the manufacturer, but country of origin isn't stated here.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable for an in vitro diagnostic magnesium test. Ground truth for an IVD refers to the correct concentration of the analyte, often determined by a reference method, not by human expert interpretation.
4. Adjudication method for the test set:
This is not applicable for an in vitro diagnostic magnesium test. Adjudication is relevant for subjective assessments, typically in imaging or clinical endpoints.
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 Piccolo Magnesium Test System is an automated in vitro diagnostic device, not an AI-assisted imaging or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is inherently a "standalone" system in the sense that it performs the
quantitative determination of magnesium without human-in-the-loop interpretation of the result once the sample is loaded. However, this question's phrasing is more suited to AI/ML software. The device itself is the "algorithm," and its performance is determined directly.
7. The type of ground truth used:
For a quantitative diagnostic test like magnesium, the ground truth would typically be established by a reference method or a thoroughly validated, higher-accuracy method of measuring magnesium concentration (e.g., atomic absorption spectroscopy or another established/calibrated clinical chemistry analyzer). The document does not explicitly state the reference method used.
8. The sample size for the training set:
This is not applicable in the context of this device as it's an analytical instrument, not an AI/ML model that learns from a training set in the conventional sense. The "training" for such a device would be its calibration and validation based on chemical and electrical engineering principles, not a data-driven learning process.
9. How the ground truth for the training set was established:
This is not applicable as explained in point 8. The "ground truth" for calibration would be based on certified reference materials or highly accurate standards.
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(10 days)
The Piccolo Magnesium Test System (presently contained on the Renal Function Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
The Piccolo Renal Function Panel Plus Reagent Disc (which contains the Piccolo Magnesium Test System) 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 plasma with diluent, and delivers 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.
The provided document describes the safety and effectiveness of the Piccolo® Magnesium Test System. The device is intended for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum.
Here's an analysis of the acceptance criteria and the study performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with pass/fail thresholds for each metric. Instead, it presents performance data (linearity, precision) and draws a conclusion of substantial equivalence to a predicate device. For the purpose of this analysis, we will infer the "acceptance criteria" through comparison to the predicate device's characteristics and general expectations for clinical laboratory devices.
| Performance Metric | Predicate Device (Vitros 950 Magnesium Slides) | Piccolo Magnesium Test System Reported Performance | Implied Acceptance Criteria (Based on Substantial Equivalence) | Met? |
|---|---|---|---|---|
| Linearity | Not explicitly stated (implied to be acceptable) | Slope: 0.992, Intercept: -0.05, Corr. Coefficient: 0.999 | Correlation Coefficient ≥ 0.99 (or comparable to predicate) | Yes |
| Sensitivity | 0.2 mg/dL | 0.1 mg/dL | Equal to or better than predicate (≤ 0.2 mg/dL) | Yes |
| Assay Range | 0.2 - 10.0 mg/dL | 0.1 - 8.0 mg/dL | Comparable to predicate's clinical relevance Range | Yes* |
| Within-Run Precision (CV) | Not explicitly stated | Level 1: 1.7%, Level 2: 1.0% | CVs typically < 5% or comparable to predicate | Yes |
| Total Precision (CV) | Not explicitly stated | Level 1: 3.4%, Level 2: 2.6% | CVs typically < 5% or comparable to predicate | Yes |
| Sample Type Comparability | Heparinized plasma, serum, urine | Heparinized venous whole blood, serum | Demonstrated comparability for declared sample types | Yes |
*Note on Assay Range: While the Piccolo's upper range (8.0 mg/dL) is slightly lower than the predicate (10.0 mg/dL), the lower range is better (0.1 mg/dL vs 0.2 mg/dL). The document concludes that these values support substantial equivalence, implying the clinical utility of the 0.1 - 8.0 mg/dL range is acceptable.
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity Study: Sample sizes are not explicitly stated, but are generally multi-point dilutions across the assay range.
- Precision Study:
- Within-Run and Total Precision: "n=80" for each level (Level 1 and Level 2) for Magnesium. This 'n' likely refers to the number of replicates performed to achieve the precision data.
- Sample Type Comparison: Sample sizes are not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective as they were specifically performed to evaluate the performance of the Piccolo Magnesium Test System.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. For in vitro diagnostic devices like the Piccolo Magnesium Test System, "ground truth" is typically established by reference methods or comparison to established, legally marketed devices. The document references the Vitros 950 Chemistry System as the predicate device, implying its performance serves as a comparative "ground truth" or benchmark.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1) are typically used in clinical trials where human interpretation or expert consensus is required to establish a diagnosis, especially in imaging studies. For a quantitative chemical analyzer, the "truth" is derived from the analytical performance (e.g., linearity, precision, accuracy against a reference method or validated predicate).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI or new technologies on human reader performance, often in diagnostic imaging. The Piccolo Magnesium Test System is a standalone analytical device, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The entire document focuses on the analytical performance of the Piccolo Magnesium Test System as a standalone device (algorithm only, in the sense of the instrument's processing logic), without human-in-the-loop performance as it relates to diagnostic interpretation. The studies on linearity, precision, and sample type comparability are all standalone performance assessments.
7. The Type of Ground Truth Used:
The primary "ground truth" used for comparison appears to be the performance characteristics of a legally marketed predicate device (Vitros 950 Chemistry System - Magnesium Slides) and established analytical chemistry principles. While not explicitly stated, the linearity and precision studies would have used control materials or patient samples with known or well-characterized magnesium concentrations, which act as the ground truth for those measurements. The "gold standard" for magnesium measurement itself is a well-defined chemical assay.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The Piccolo Magnesium Test System is a traditional in vitro diagnostic device, not an AI/ML device that requires a distinct "training set" in the computational learning sense. The device's factory calibration and lot-specific data, referenced in the calibration method, suggest internal validation and calibration processes, but not a "training set" like that used for algorithms.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above (not an AI/ML device). The "ground truth" for its calibration would be based on certified reference materials and established metrological traceability for magnesium concentrations.
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