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The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Nichols Advantage® Bio-Intact PTH (1-84) assay is a fluorescence immunometric assay for quantifying PTH in human serum or plasma.

The provided text describes a Special 510(k) submission for the "Nichols Advantage Bio-Intact PTH (1-84)" immunoassay. This submission focuses on
labeling changes and new clinical performance data rather than establishing new acceptance criteria or presenting a comprehensive study of the device meeting pre-defined acceptance criteria.

The submission outlines changes to the "Expected Values section" in the labeling and includes a reference range study. It also details a new clinical performance study. However, it does not explicitly state acceptance criteria in numerical or qualitative terms, nor does it present a formal study demonstrating the device meets such criteria with specific performance metrics against those criteria.

Therefore, the requested information elements related to specific acceptance criteria and a study proving the device meets them cannot be directly extracted from the provided text in the typical format you might expect for a pre-market submission focused on efficacy.

However, I can provide the available information from the text, interpreting the clinical performance study as the closest equivalent to a study demonstrating device performance.

Here's the breakdown of what can be extracted, and where information is not available:

Acceptance Criteria and Device Performance

Since specific acceptance criteria are not explicitly stated in the provided text, I will interpret the outcomes of the clinical performance study as the "reported device performance." The purpose of this study was to provide clinicians and laboratories with new information to interpret PTH results, particularly for establishing a local reference range.

Study Details (Clinical Performance Study)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: n=63 patients with surgically confirmed primary hyperparathyroidism, n=6 patients with hypoparathyroidism, n=3 patients with hypercalcemia due to malignancy, and n=276 normal individuals.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text refers to it as a "Study was performed," suggesting it could be prospective, but this is not explicitly stated.

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

   • This information is not provided in the text. The ground truth for the patient groups (e.g., "surgically confirmed primary hyperparathyroidism") is implied to be clinical diagnosis, but the involvement of specific experts in establishing this for the test set is not detailed.

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

   • This information is not provided in the text.

4. 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:

   • This device is an in vitro diagnostic immunoassay (a laboratory test for measuring PTH levels), not an AI/imaging device that would typically involve human "readers" or an MRMC study comparing human performance with and without AI assistance. Therefore, this type of study was not applicable and not performed.

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

   • This device is an in vitro diagnostic immunoassay. Its "performance" is inherently standalone in the sense that the assay itself measures the analyte. Human involvement comes in collecting samples, running the assay, and interpreting the raw result in a clinical context. The clinical performance study described assesses the device's ability to differentiate patient populations based on its PTH measurements, which is effectively its standalone performance in that context.

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

   • The ground truth for the patient cohorts appears to be clinical diagnosis, with some explicitly stated as "surgically confirmed." For "normal individuals," the ground truth would be the absence of relevant disease or symptoms.

7. The sample size for the training set:

   • This submission describes a clinical performance study on specific patient cohorts intended to provide data for interpretation, particularly for developing local reference ranges. It does not mention a "training set" in the context of machine learning model development. The data appears to be for characterizing performance across specific clinical conditions, not for training a predictive algorithm.

8. How the ground truth for the training set was established:

   • As there is no mention of a "training set" in this context, this information is not applicable.

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