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LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only.

The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva.

The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine.

LabOne Micro-Plate Cotinine EIA is a solid phase competitive enzyme immunoassay for the qualitative and semi-quantitative analysis of cotinine in oral fluid specimens collected with the OraSure® Oral Specimen Collection Device.

The provided text describes a 510(k) summary for the LabOne Micro-Plate Cotinine EIA, which is a device for detecting cotinine in oral fluid. However, the document does NOT contain detailed information about specific acceptance criteria and the comprehensive study results to "prove" the device meets them in the way described by the requested table and points.

Specifically, the document states:
"Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the LabOne Micro-Plate Cotinine EIA is substantially equivalent to the OraSure Micro-Plate Cotinine EIA."
And:
"Results tested from self-claimed patient specimens and diluted samples with both the LabOne Micro-Plate Cotinine EIA and the OraSure Micro-Plate Cotinine EIA also showed that the sample results from this two test systems are substantially equivalent when using self-claimed specimen results and urine results as references."

This indicates that studies were performed, but the actual acceptance criteria (e.g., minimum sensitivity, specificity, or precision values) and the specific reported device performance values for these criteria are not provided in the summary. The core of the submission is to demonstrate "substantial equivalence" to a predicate device (OraSure Micro-Plate Cotinine EIA, K974234), rather than proving it meets standalone, predefined performance metrics with detailed study data.

Therefore, many of your requested points cannot be directly extracted from the provided text.

Here's an attempt to answer what can be inferred from the document, along with explanations for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document focuses on declaring substantial equivalence to the predicate device, K974234. It states that "performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the LabOne Micro-Plate Cotinine EIA is substantially equivalent" and that "sample results from this two test systems are substantially equivalent when using self-claimed specimen results and urine results as references." However, the specific quantitative acceptance criteria (e.g., "precision CV < X%") and the actual performance metrics achieved (e.g., "precision CV was Y%") are not reported in this summary.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The document mentions "self-claimed patient specimens and diluted samples" were tested, but the number of these samples is not provided.
• Data Provenance: Not explicitly stated. However, given the context of a US FDA submission, it's highly likely the data would be derived from studies relevant to the US regulatory environment. The terms "self-claimed patient specimens" suggest human biological samples, but their origin (country, etc.) is not specified.
• Retrospective or Prospective: Not explicitly stated.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Explanation: For an in vitro diagnostic (IVD) device like this, ground truth would typically be established through a reference method or clinical status, rather than expert interpretation of images or other subjective data. So, the concept of "experts" in the context of radiologists, for example, is not applicable here.

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

• Adjudication Method: Not applicable/not mentioned. This type of adjudication is typically for subjective assessments (e.g., reading medical images). For an IVD like this, ground truth is usually objectively determined via a reference standard or clinical outcome.

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

• MRMC Study: No. This is an in vitro diagnostic device, not an imaging device requiring human reader interpretation in the same way. The device's performance is compared to a predicate device and reference methods, not human readers.
• Effect size of human readers improvement: Not applicable.

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

• Standalone Performance: Yes, in essence. The device itself (LabOne Micro-Plate Cotinine EIA) is a diagnostic test kit that measures cotinine. Its "performance" refers to how accurately it detects or quantifies cotinine, irrespective of human interpretation in the loop in the way AI applications are often discussed. The comparison data described ("Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity") are effectively standalone performance evaluations against established analytical standards and the predicate device.

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

• Type of Ground Truth: The document mentions "using self-claimed specimen results and urine results as references." This implies that the presence or absence of cotinine, or its concentration, was established using:
  • Self-claimed patient information: Patients' own statements about tobacco use.
  • Urine results: Testing of urine samples (likely using a validated reference method for cotinine) as an independent corroborator.
  • Additionally, the "performance characteristic studies" would rely on controlled samples with known cotinine concentrations or known interfering substances, which serve as a form of ground truth for analytical validity.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not mentioned. For a traditional immunoassay kit like this, there isn't a "training set" in the sense of machine learning algorithms. The device's components (reagents, antibodies, etc.) are developed and optimized, but not "trained" on data in the same way.

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

• Ground Truth for Training Set: Not applicable, as there isn't a "training set" in this context. The development of such a kit would involve significant R&D to select and optimize reagents that provide the desired biochemical specificity and sensitivity. The "ground truth" during this development would be the known concentration of cotinine (or other analytes) in characterization samples.

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