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The CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack to be used in combination with the CEDIA® Folate (No Boil) Assay is a homogeneous enzyme binding assay for the quantitation of folate in red blood cells.

The CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack to be used in combination with the CEDIA® Folate (No Boil) Assay is an in-vitro homogeneous enzyme immunoassay used for the quantitative determination of folate in red blood cells. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. Folate specific binding protein, by binding to folate on the enzyme donor will inhibit enzyme reassociation thereby regulating the level of β-galactosidase formed. Folate present in the sample wil compete with the folate bound to the enzyme donor subunit for the limited number of specific binding sites further regulating the level of active enzyme formed. Concentrations of folate are directly proportional to the amount of enzyme formed as monitored by the hydrolysis of the substrate o-nitrophenyl-β-D-galactopyranoside (ONPG).

The provided text describes a 510(k) summary for the CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with defined acceptance criteria and extensive performance data typical of a novel device.

However, I can extract the relevant performance data and present them in a way that aligns with your request for acceptance criteria and device performance, interpreting "acceptance criteria" as implicitly set by the predicate device's performance that the new device aims to match or exceed.

Here's an attempt to structure the information based on your prompt, with the understanding that this is a comparative summary rather than a full standalone study report:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for demonstrating substantial equivalence, the "acceptance criteria" can be inferred from the performance metrics presented for the predicate device and the new device's performance relative to those. The document implicitly asserts "substantial equivalence" based on these comparisons.

2. Sample Size and Data Provenance

• Test Set Sample Size (for Method Comparison): 96 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a medical device submission, it's highly likely to be prospective data collected within a clinical laboratory setting for validation purposes. The samples are referred to as "Patient Samples" for precision testing, implying human biological samples.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This document describes the performance of an in vitro diagnostic (IVD) assay for quantitative determination of folate. The "ground truth" for such assays is typically established by reference methods or validated comparative assays, rather than expert interpretation of images or clinical data. There were no experts mentioned for establishing ground truth in the context you described (e.g., radiologists interpreting images).

4. Adjudication Method

• Not Applicable. As described above, this is an IVD assay, not a device relying on human interpretation or adjudication. The performance is assessed by comparing quantitative results from different methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is relevant for devices where human readers interpret data (e.g., medical images). This document describes an automated laboratory assay for measuring a biomarker. There are no human readers involved in directly interpreting the assay's output in a way that an MRMC study would measure.

6. Standalone Performance

• Yes, implicitly. The precision data (Within-Run %CV) and the method comparison data represent the standalone performance of the CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack. The assay generates quantitative results directly without human-in-the-loop intervention in the measurement process itself.

7. Type of Ground Truth Used

• The "ground truth" for the method comparison appears to be the results obtained from another established Folate assay (specifically, another "CEDIA B12/Folate Assay"). For precision, the "ground truth" is the statistically derived mean of repeated measurements on patient samples at different concentrations. This is a common approach for validating quantitative IVD assays by comparing them to a predicate or established method.

8. Sample Size for Training Set

• Not explicitly stated and likely not applicable in the traditional sense. For a homogeneous enzyme immunoassay like CEDIA, the "training set" doesn't typically involve machine learning model training with labeled data. The assay's performance characteristics (e.g., linearity, detection limits, precision) are established through extensive analytical validation studies using controls, spiked samples, and patient samples. The document highlights parameters of the assay itself (e.g., dilution, incubation, reagents) that were likely optimized during development, but it doesn't refer to a "training set" in the context of AI.

9. How Ground Truth for Training Set was Established

• Not applicable as per #8. The development and optimization of such an assay would involve internal analytical tests and performance verification against known standards and other established methods.

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