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510(k) Data Aggregation
(216 days)
The OPTIGEN assay is an in vitro test, which provides a semi quantitative measurement of circulating allergen specific IgE antibodies in human serum. The OPTIGEN assay is intended to assist in the clinical diagnosis of IgE-mediated allergic disorders. This device is designed for use in clinical laboratories.
The OPTIGEN® Allergen-Specific IgE Assay is a solid phase in vitro test used for the semi quantitative determination of circulating allergen-specific IgE antibodies to multiple allergens simultaneously in human serum.
Here's a breakdown of the acceptance criteria and the study details for the Hitachi Chemical Diagnostics OPTIGEN Allergen-Specific IgE Assay System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing performance metrics. The implicit acceptance criterion is that the new device's performance should be comparable to the predicate device.
| Performance Metric | Acceptance Criteria (Implicit - based on predicate device) | Reported Device Performance (OPTIGEN) |
|---|---|---|
| Positive Percent Agreement (PPA) | High agreement with Pharmacia CAP Specific IgE Assay | 89.3% |
| Negative Percent Agreement (NPA) | High agreement with Pharmacia CAP Specific IgE Assay | 92.2% |
| Overall Agreement | High agreement with Pharmacia CAP Specific IgE Assay | 91% |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: A total of 1753 determination points for 20 allergens.
- Data Provenance: The three performance comparison studies were done in France, Germany, and the USA. The data is retrospective, as it's a comparison study to an already existing legally marketed device.
3. Number of Experts and Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth.
4. Adjudication Method
The document does not specify an adjudication method. The study involved a direct comparison of the OPTIGEN assay to the Pharmacia CAP Specific IgE Assay, which served as the reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, this was not an MRMC study. It was a comparison study between two assay systems, not an evaluation of human readers with and without AI assistance.
- Effect Size: Not applicable, as it was not an MRMC study.
6. Standalone (Algorithm Only) Performance
- Was it done? Yes, this was a standalone performance study. The OPTIGEN assay system, being an in vitro diagnostic device, operates independently to generate results. Its performance was compared directly to another in vitro diagnostic device.
7. Type of Ground Truth Used
The ground truth was established by comparison to a legally marketed predicate device, the Pharmacia CAP Specific IgE Assay. The results from this predicate device served as the reference for determining agreement.
8. Sample Size for the Training Set
The document does not specify a training set or its sample size. This type of submission (510(k) for an in vitro diagnostic assay) typically focuses on validation and comparison to a predicate, rather than an AI/machine learning model that would require distinct training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a specific training set is not mentioned in the context of this device submission. The focus is on validation against an established predicate device.
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