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510(k) Data Aggregation
(132 days)
The indications for use of the Paros CRP are for aiding in diagnosis and monitoring of inflammatory diseases. The primary utility is for screening for the presence of inflammatory disease, by measuring CRP on anti-coagulated whole blood samples, and thus eliminating the requirement for sample centrifugation. CRP measurement on serum samples is also possible.
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 inflammatory injury to body tissues.
The Paros CRP is a benchtop C-Reactive Protein Immunological Test System. It is a single parameter instrument (CRP only), with the ability to measure CRP on Whole Blood and Serum samples in-vitro. It employs the same measurement principles as the CRP measurement module of the ABX / Horiba ™MICROS CRP (K002646, October 2000). The Paros CRP does not have a cell counting module.
The CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lyzed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.
Here's an analysis of the Paros CRP device's acceptance criteria and study, based on the provided text:
Acceptance Criteria and Device Performance for Paros CRP
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the document describes performance metrics that demonstrate "good," "excellent," or "no significant" issues. Based on the "Discussion of Performance Data Summary" section, the following can be inferred and presented:
| Performance Metric | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Precision | "Good precision" | Total Imprecision ranged from 0 to 2.6 CV%. |
| Accuracy / Bias | "No evidence of significant bias" | No significant bias reported (assessed by NCCLS EP 9-A). |
| Correlation (Whole Blood) | "Good correlation" with predicate device (Beckman Immage) | R²=0.99 (between Paros CRP and Beckman Immage). |
| Correlation (Serum) | "Excellent correlation" with predicate device (Beckman Immage) | R²=0.98 (between Paros CRP and Beckman Immage). |
| Linearity (Whole Blood) | Supports linearity claim from 0.2 to 10 mg/dL | Demonstrated linearity across tested range (Paros CRP result = 1.05 X Expected Target CRP value, R²=0.99) for 0.2 to 10 mg/dL. |
| Linearity (Serum) | Supports linearity claim from 0.2 to 7 mg/dL | Demonstrated linearity across tested range (Paros CRP result = 0.9 X Expected Target CRP value, R²=0.98) for 0.2 to 7 mg/dL. |
| Sample Stability | Reproducibility of results over 72 hours, with acceptable deviation | Reproducibility over 72 hours. At 0.2 mg/dL, % difference attributed to single decimal point and CRP level. All other results <10% deviation from baseline. |
| Carry-over | Acceptable level of carry-over | Zero % Carry-over. |
| Interfering Substances | Performance acceptable in presence of common interfering conditions and pathologies | Investigated samples with hyperbilirubinemia, hemolysis, hypergammaglobulinemia, hyperlipemia, Multiple Myeloma, Rheumatoid Arthritis, Giant Cell Arteritis, Polymyalgia Rheumatica, Polymyositis, non-specific arthropathies, and somatic carcinomas. (No specific performance values given for these, but implicitly deemed acceptable for bias assessment). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test set in the precision, linearity, stability, carry-over, or correlation studies.
Regarding data provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The concept of "experts" and "ground truth" in the context of diagnostic device validation for CRP measurement typically refers to the reference method or predicate device used for comparison, and samples with known CRP concentrations (e.g., from calibrators or controls). The document refers to:
- Predicate Devices: ABX / Horiba™ MICROS CRP (K002646) and Beckman Coulter Immage IMMUNOCHEMISTRY SYSTEM (K981638). These devices essentially served as the "ground truth" for comparison in the correlation studies.
- Qualified Personnel: The study was "Prepared By: Dr Ian Giles ABX Diagnostics." His qualifications are not explicitly detailed beyond being "ABX Scientific Affairs Manager."
- There is no mention of a panel of human experts (e.g., radiologists) establishing ground truth, as this is an in-vitro diagnostic device for C-reactive protein, not imaging.
4. Adjudication Method for the Test Set
The provided text does not describe an adjudication method (like 2+1 or 3+1) for the test set. Such methods are typically employed in studies where human interpretation of results is involved and discrepancies need to be resolved. For an IVD device measuring a biomarker, the comparison is usually against a reference method or predicate device, not human expert consensus needing adjudication.
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
No MRMC comparative effectiveness study was done or is applicable. This study is for an in-vitro diagnostic device (Paros CRP) that automates the measurement of C-reactive protein. It does not involve human readers interpreting images or data, nor does it involve AI assistance for human interpretation. Therefore, the concept of human readers improving with AI assistance is not relevant to this device's validation.
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 evaluation described for the Paros CRP (precision, linearity, stability, carry-over, and correlation) focuses on the performance of the device itself (the "algorithm only," if you consider the instrument's measurement principles as such) without any human interpretation in the measurement process. The device directly measures CRP levels in samples.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance evaluation primarily consisted of:
- Comparison to a Predicate Device/Reference Method: For accuracy/bias and correlation studies, the Beckman Immage system served as the reference for comparison for whole blood and serum samples. The ABX / Horiba™ MICROS CRP is also listed as substantially equivalent, implying its use as a reference for methodology.
- Expected Target Values: For linearity studies, expected target CRP values were used (likely from calibrators or serially diluted samples with known concentrations).
- Internal Controls and Calibrators: The document mentions "CRP Calibrator: CRPCAL" and "CRP Control: CRPTROL (L, H)" for quality control, suggesting these are part of establishing and verifying ground truth during daily operation and potentially in some validation stages.
8. The Sample Size for the Training Set
The provided text does not mention a "training set" in the context of machine learning or AI. The Paros CRP device is described as an "Immunological Test System" that employs turbidimetric reactions. It is a traditional IVD device, not an AI-based system that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the Paros CRP device as described in the document. The device operates based on established chemical and optical principles, not on learned patterns from a training dataset.
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