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NOVEOS™ Immunoassay Analyzer: The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory.
NOVEOS™ Specific IgE (sIgE) Assay: The NOVEOS™ Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS™ Specific IgE Assay is to be used with the NOVEOS™ Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

Device Description

The NOVEOS™ Immunoassay Analyzer is a high-throughput, highly automated immunoassay platform that employs magnetic microbeads as the solid phase. The immunoassay reaction takes place in individual reaction chambers in the reaction rotor, with other rotors containing patient samples and reagents. Liquids are moved by robotic pipettors. The reaction is quantitated by a combination of chemiluminescence and fluorescence measurements compared to a calibration curve, all performed by the analyzer with the NOVEOS software.

AI/ML Overview

This document is a 510(k) summary for the NOVEOS™ Specific IgE (sIgE) Assay and NOVEOS™ Immunoassay Analyzer, specifically for the House Dust Mite D001 allergen. The information provided outlines the device's technical specifications and a study demonstrating its performance compared to a predicate device and clinical diagnosis.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding performance targets for each metric. However, it presents various performance metrics and their measured values. For the purpose of this request, we will infer the implicitly accepted performance based on the presented results and the fact that the device received FDA clearance.

Performance Metric	Implied Acceptance Criterion (Likely based on performance of predicate devices or industry standards)	Reported Device Performance
Precision
Repeatability CV	Should be within acceptable limits for a quantitative immunoassay, implying low variability in repeated measurements. (Typically, lower CV% is better)
- Sample 1	N/A (not explicitly stated, but <10% is generally good for low concentrations, and <5% for higher)	8.4% (at 0.17 kU/L)
- Sample 2	N/A	4.4% (at 79.98 kU/L)
- Sample 3	N/A	6.6% (at 0.32 kU/L)
- Sample 4	N/A	4.0% (at 1.70 kU/L)
- Sample 5	N/A	5.2% (at 9.20 kU/L)
- Sample 6	N/A	3.4% (at 0.50 kU/L)
- Sample 7	N/A	5.3% (at 0.47 kU/L)
- Sample 8	N/A	6.0% (at 15.05 kU/L)
Within-Lab Precision CV	Should be within acceptable limits for a quantitative immunoassay, implying low variability within a single laboratory over time. (Typically, lower CV% is better)
- Sample 1	N/A	19.7% (at 0.17 kU/L)
- Sample 2	N/A	7.7% (at 79.98 kU/L)
- Sample 3	N/A	9.8% (at 0.32 kU/L)
- Sample 4	N/A	7.0% (at 1.70 kU/L)
- Sample 5	N/A	6.5% (at 9.20 kU/L)
- Sample 6	N/A	7.3% (at 0.50 kU/L)
- Sample 7	N/A	8.7% (at 0.47 kU/L)
- Sample 8	N/A	9.3% (at 15.05 kU/L)
Detection Limits
Limit of Blank (LoB)	Should be low to allow for accurate detection of low concentrations.	0.03 kU/L
Limit of Detection (LoD)	Should be low to allow for accurate detection of low concentrations.	0.08 kU/L
Limit of Quantitation (LoQ)	Defined as the lowest concentration with a within-lab precision ≤ 20%CV.	0.17 kU/L
Linearity	R-squared (r²) value close to 1, slope close to 1, and intercept close to 0, indicating accurate measurement across the measuring range.	r² = 1.00, Regression: y = 1.01x + 0.18, Slope (95% CI): 0.99 to 1.04, Intercept (95% CI): -0.82 to 1.19
Comparison to Predicate Device (ImmunoCAP - based on 0.35 kU/L cutoff)	High agreement (e.g., >90-95%) with the legally marketed predicate device.
Positive Percent Agreement (PPA)	N/A (but typically high, e.g., >90%)	91.5% (95% CI: 84.1% to 95.6%)
Negative Percent Agreement (NPA)	N/A (but typically high, e.g., >95%)	98.6% (95% CI: 94.4% to 99.6%)
Total Percent Agreement	N/A (but typically high, e.g., >95%)	95.7% (95% CI: 92.3% to 97.7%)
Clinical Performance (based on 0.35 kU/L cutoff)	High sensitivity and specificity to correctly identify allergic and non-allergic individuals.
Clinical Sensitivity	N/A (but typically as high as possible, e.g., >70-80%)	77% (95% CI 69% to 84%)
Clinical Specificity	N/A (but typically as high as possible, e.g., >90%)	100% (95% CI 97% to 100%)

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Precision Test Set: Not explicitly stated as a separate "test set" in the context of clinical validation, but for precision determination:
- Quantitative Samples: 8 samples were used.
- Replicates: 80 replicates per sample (duplicate replicates, 2 runs/day for 20 days).
- Provenance: Not specified (country/retrospective/prospective).
Detection Limits (LoB, LoD, LoQ) Test Set:
- LoB: 60 replicates of analyte-free samples.
- LoD: 300 replicates of low IgE samples.
- LoQ: A panel of low analyte samples, 80 replicates per sample (duplicate replicates, 2 runs/day for 20 days).
- Provenance: Not specified (country/retrospective/prospective).
Linearity Test Set:
- Samples: Dilutions of D001 specific IgE samples. Number of distinct samples used for the dilutions not explicitly stated, but covers a concentration range of 0.03 to 133 kU/L.
- Provenance: Not specified (country/retrospective/prospective).
Predicate Device Comparison Test Set:
- Sample Size: 234 clinical samples.
- Provenance: Not specified (country/retrospective/prospective).
Clinical Performance Study Test Set:
- Sample Size: n=236 samples from patients.
- Sub-groups: 117 samples identified as allergic positive (atopic), 119 samples from apparently healthy, non-atopic subjects.
- Provenance: Not specified (country/retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts in establishing the ground truth for any of the quantitative performance studies (precision, detection limits, linearity).

For the clinical performance study, the "allergic status" (atopic vs. non-atopic) was established as ground truth.

The status of 117 samples identified as allergic positive (atopic) was confirmed by skin-prick testing.
The other 119 samples were from "apparently healthy, non-atopic subjects with no reported allergy."
Number of Experts: Not specified.
Qualifications of Experts: Not specified. The skin-prick testing implies evaluation by a clinician, likely an allergist, but no details are provided about the number or qualifications of the personnel performing or interpreting these tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

There is no mention of any adjudication method for the test sets. The ground truth for the comparison study is the output of the predicate ImmunoCAP system, and for the clinical study, it's based on skin-prick testing and reported allergy status. This is not a human-reader based AI study, so standard adjudication methods (like 2+1 or 3+1) would not apply.

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, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device (NOVEOS™ Specific IgE Assay on the NOVEOS™ Immunoassay Analyzer) operates in a standalone manner without human intervention for the assay's execution and result generation. The performance data presented (precision, linearity, detection limits, agreement with predicate, and clinical performance) are intrinsic to the device's automated function.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For comparison to predicate device: The ground truth was implicitly the results obtained from the Phadia ImmunoCAP system, which is the legally marketed predicate device. This serves as a reference for substantial equivalence.
For clinical performance study: The ground truth for individual patient samples was their clinical allergic status, determined by a combination of skin-prick testing confirmation for atopic individuals and reported non-allergic status for non-atopic subjects. This is a form of clinical outcomes/diagnosis data.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. This is an immunoassay system, and its development typically involves extensive analytical validation (precision, linearity, etc.) and clinical validation, rather than a distinct "training set" as understood in AI/ML. The development of such assays often involves optimization stages to establish reagents and protocols, but this isn't typically referred to as a "training set" in the same way as for AI.

9. How the ground truth for the training set was established

As there's no mention of a "training set" in the AI/ML sense, this question is not directly applicable. For the development of the assay (which could be analogized to training, though not in the AI sense), the ground truth for calibrators and controls would be established through a rigorous process of standardization and traceability, often to international reference materials (e.g., WHO reference reagent serum Immunoglobulin E (IgE) 11/234, as mentioned for the standard curve traceability).

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