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510(k) Data Aggregation
(161 days)
LDM
A software package and instrument interface that is used for quantitative analyses of high performance liquid chromatography (HPLC) test kits.
The CDM makes use of a 486 IBM compatible computer and a separate communications interface. The system accepts signals from a detector, integrates the chromatograms, identifies reference peaks and performs calculations of percent area. In addition, the CDM can control pumps and an automated sampler and store quality control data.
The provided document describes the Bio-Rad Laboratories Clinical Data Management (CDM) system, which is a software package and instrument interface used for quantitative analyses of high-performance liquid chromatography (HPLC) test kits. The study described aims to establish substantial equivalence of the CDM to existing predicate devices, specifically the Hewlett-Packard 3392A Reporting Integrator and, for analytical comparison, the Shimadzu CR501.
Acceptance Criteria and Reported Device Performance
The acceptance criterion implicitly is comparability to the existing Shimadzu CR501 integrator for analytical sensitivity and accuracy across various HPLC tests. The device performance is deemed acceptable if the results (standard deviation, coefficient of variation, correlation coefficient, y-intercept, and slope) are comparable to those obtained with the CR501.
| Test | Performance Metric | CR501 (Reference) | CDM (Device Performance) | Acceptance Criteria Met (Yes/No) |
|---|---|---|---|---|
| HVA by HPLC | Analytical Sensitivity (SD) | 0.018 | 0.020 | Yes (Comparable) |
| Analytical Sensitivity (CV) | 3.6% | 4.0% | Yes (Comparable) | |
| Accuracy (Correlation Coefficient) | N/A (implied high) | 0.9999 | Yes (Comparable) | |
| Accuracy (y-intercept) | N/A (implied near 0) | 0.011 | Yes (Comparable) | |
| Accuracy (slope) | N/A (implied near 1) | 0.994 | Yes (Comparable) | |
| Urinary Metanephrines by HPLC | ||||
| Metanephrine | Analytical Sensitivity (SD) | 0.986 | 0.796 | Yes (Comparable) |
| Analytical Sensitivity (CV) | 6.8% | 5.5% | Yes (Comparable) | |
| Accuracy (Correlation Coefficient) | N/A | 0.9999 | Yes (Comparable) | |
| Accuracy (y-intercept) | N/A | -1.074 | Yes (Comparable) | |
| Accuracy (slope) | N/A | 1.017 | Yes (Comparable) | |
| Normetanephrine | Analytical Sensitivity (SD) | 1.118 | 1.345 | Yes (Comparable) |
| Analytical Sensitivity (CV) | 6.0% | 7.6% | Yes (Comparable) | |
| Accuracy (Correlation Coefficient) | N/A | 0.9999 | Yes (Comparable) | |
| Accuracy (y-intercept) | N/A | -2.867 | Yes (Comparable) | |
| Accuracy (slope) | N/A | 1.023 | Yes (Comparable) | |
| 3-Methoxytyramine | Analytical Sensitivity (SD) | 0.750 | 0.546 | Yes (Comparable) |
| Analytical Sensitivity (CV) | 9.6% | 7.8% | Yes (Comparable) | |
| Accuracy (Correlation Coefficient) | N/A | 0.999 | Yes (Comparable) | |
| Accuracy (y-intercept) | N/A | -0.552 | Yes (Comparable) | |
| Accuracy (slope) | N/A | 0.999 | Yes (Comparable) | |
| VMA by HPLC | Analytical Sensitivity (SD) | 0.010 | 0.010 | Yes (Comparable) |
| Analytical Sensitivity (CV) | 1.9% | 1.9% | Yes (Comparable) | |
| Accuracy (Correlation Coefficient) | N/A | 0.9998 | Yes (Comparable) | |
| Accuracy (y-intercept) | N/A | -0.002 | Yes (Comparable) | |
| Accuracy (slope) | N/A | 0.994 | Yes (Comparable) | |
| Plasma Catecholamines by HPLC | ||||
| Epinephrine | Analytical Sensitivity (SD) | 2.72 | 1.32 | Yes (Comparable) |
| Analytical Sensitivity (CV) | 18% | 13% | Yes (Comparable) | |
| Accuracy (Correlation Coefficient) | N/A | 0.9998 | Yes (Comparable) | |
| Accuracy (y-intercept) | N/A | -2.90 | Yes (Comparable) | |
| Accuracy (slope) | N/A | 0.979 | Yes (Comparable) | |
| Norepinephrine | Analytical Sensitivity (SD) | 5.04 | 3.74 | Yes (Comparable) |
| Analytical Sensitivity (CV) | 14% | 12% | Yes (Comparable) | |
| Accuracy (Correlation Coefficient) | N/A | 0.9999 | Yes (Comparable) | |
| Accuracy (y-intercept) | N/A | -4.43 | Yes (Comparable) | |
| Accuracy (slope) | N/A | 1.003 | Yes (Comparable) | |
| Benzodiazepines by HPLC | Mean Analytical Sensitivity (SD) | 1.64 | 1.59 | Yes (Comparable) |
| Mean Analytical Sensitivity (CV) | 6.44% | 5.92% | Yes (Comparable) | |
| Mean Accuracy (Correlation Coefficient) | N/A | 0.9998 | Yes (Comparable) | |
| Mean Accuracy (y-intercept) | N/A | -0.156 | Yes (Comparable) | |
| Mean Accuracy (slope) | N/A | 0.9982 | Yes (Comparable) | |
| Tricyclic Antidepressants by HPLC | Mean Analytical Sensitivity (SD) | 1.37 | 1.24 | Yes (Comparable) |
| Mean Analytical Sensitivity (CV) | 5.23% | 4.74% | Yes (Comparable) | |
| Mean Accuracy (Correlation Coefficient) | N/A | 0.9997 | Yes (Comparable) | |
| Mean Accuracy (y-intercept) | N/A | 4.25 | Yes (Comparable) | |
| Mean Accuracy (slope) | N/A | 0.955 | Yes (Comparable) |
1. Sample sizes used for the test set and the data provenance:
The document does not explicitly state the sample sizes (e.g., number of specimens or chromatograms) used for the analytical comparison. It mentions "each of the following five tests" and provides sensitivity and accuracy data for various analytes within these tests. The data provenance is not specified, but it implies a laboratory setting where these HPLC tests were performed. It is a retrospective analysis of the device's performance against a comparative device rather than a prospective clinical study involving patient data.
2. 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 study is an analytical comparison of two laboratory instruments (integrators) for quantitative analysis. The "ground truth" here is the quantitative analytical results obtained by a well-established and accepted method (Shimadzu CR501 integrator). Therefore, there were no human experts establishing a "ground truth" in the diagnostic sense (like radiologists interpreting images). The accuracy is measured against the output of the reference instrument.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is an analytical device comparison, not a diagnostic study requiring adjudication of expert interpretations.
4. 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 not an AI-assisted diagnostic study or an MRMC study. It's a comparison of two analytical instruments.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this study represents a standalone comparison of the CDM system's performance (algorithm-driven integration and calculation) against another standalone instrument (CR501 integrator). There is no "human-in-the-loop performance" in evaluating the integrators' quantitative outputs. The humans operate the HPLC systems, but the comparison is on the data processing output.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" is established by the analytical measurements and calculations performed by the well-accepted and commercially available Shimadzu CR501 integrator. This is an analytical reference standard rather than a clinical ground truth like pathology or expert consensus. The assumption is that the CR501 provides accurate and precise measurements.
7. The sample size for the training set:
Not applicable. This document describes a performance evaluation of a device, not the development or training of a machine learning algorithm. The CDM is a "Clinical Data Management System" that performs calculations, integration, and control, rather than a learning AI system requiring a specific training set as understood in modern AI.
8. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set for an AI algorithm.
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