(60 days)
C-Reactive Protein (CRPME) Reagent, when used in conjunction with Beckman Coulter's Array® 360 System and Calibrator 5 Plus, is intended for the quantitative determination of human C-reactive protein in serum or plasma by rate nephelometry.
The Array 360 System (CRPMPE) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman Coulter's Array 360 System.
The provided document describes a 510(k) submission for the Array® 360 System C-Reactive Protein (CRPMPE) Reagent. This is an in vitro diagnostic device, and the acceptance criteria and study details are focused on analytical performance rather than clinical diagnostic performance based on image analysis or similar AI applications.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission. The provided information centers on demonstrating substantial equivalence to a predicate device through analytical performance studies.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values (e.g., "slope must be between X and Y"). Instead, it presents the results of method comparison and imprecision studies, implying that these results met internal acceptance thresholds for demonstrating substantial equivalence. The predicate device's performance would serve as the implicit benchmark.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (Array® 360 CRPMPE) |
|---|---|---|
| Method Comparison | Close agreement with predicate device | |
| Slope | Near 1.0 | 0.983 |
| Intercept | Near 0.0 | 0.072 |
| Correlation Coefficient (r) | High correlation (near 1.0) | 0.995 |
| Imprecision | Low variability | |
| Within-Run Imprecision | Low %C.V. | Level 1: 10.1% C.V. |
| Level 2: 2.1% C.V. | ||
| Level 3: 3.4% C.V. | ||
| Total Imprecision | Low %C.V. | Level 1: 13.9% C.V. |
| Level 2: 3.6% C.V. | ||
| Level 3: 4.8% C.V. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Method Comparison: 180 samples (referred to as "n=180" for the method comparison study).
- Imprecision Study: 80 measurements per level (N=80) for both within-run and total imprecision, across 3 levels.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted internally by Beckman Coulter, Inc. The document refers to "human serum and plasma samples," implying human-derived biological samples. The studies are retrospective in the sense that they are conducted on collected samples to evaluate the device performance before market release, but not in the context of analyzing previously collected patient data for diagnostic outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not Applicable. This is an in vitro diagnostic reagent evaluating analytical performance (e.g., concentration of a biomarker). Ground truth is established by the reference method (the predicate device for method comparison) or by repeated measurements for imprecision, not by expert interpretation like in imaging studies.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not Applicable. See point 3.
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 not a diagnostic imaging or AI-based device that humans would interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The performance studies (method comparison and imprecision) evaluate the Array® 360 System CRPMPE Reagent as a standalone analytical device, comparing its output to a known predicate and assessing its internal variability. The device is designed for automated quantitative determination, so human "interpretation" is minimal beyond loading samples and reviewing numerical results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Method Comparison: The "ground truth" or reference standard for comparison was the IMMAGE System C-Reactive Protein (CRP) Reagent (the predicate device), which is an existing, legally marketed diagnostic system. The output of the new device was compared to the output of the predicate device for the same samples.
- Imprecision: The "ground truth" for imprecision is the true concentration of CRP in the control samples, with the study assessing the variability around this true concentration.
8. The sample size for the training set
Not Applicable. This device is a reagent for an in vitro diagnostic system, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such systems involves rigorous assay development, calibration, and optimization using control materials and sometimes characterized clinical samples, but not a "training set" like an AI model.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).