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For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.

The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.

Here's a breakdown of the acceptance criteria and study information for the Pantex AM/PM Salivary Cortisol EIA Kit, based on the provided text:

The provided text focuses on the analytical performance of the Pantex AM/PM Salivary Cortisol EIA Kit and its equivalence to a predicate device. It demonstrates the device's ability to accurately and reliably measure salivary cortisol levels.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Precision/Reproducibility:
  • Intra-assay: 20 replicates for low, medium, and high samples.
  • Inter-assay: Mean of average duplicates for 12 separate assays.
  • Inter-lot: Duplicate measurements of 5 saliva pools and 3 saliva controls using 3 different lots.
  • Repeatability: 3 saliva pools tested over 20 days (2 assays/day).
• Linearity: 10 sample concentrations (dilutions).
• Recovery: 10 saliva samples.
• Expected Reference Values (for establishing normal range): 152 male saliva samples and 152 female saliva samples (Total 304 samples).
• Detection Limits (LoB, LoD, LoQ): 120 measurements of "cortisol free free salvia" (clarified as cortisol-free saliva) and low-level cortisol samples.
• Analytical Specificity/Cross Reactivity: Each compound tested at 10,000 ng/mL (or 1000 ng/mL for some) in an unspecified number of samples.
• Method Comparison: 160 samples compared between the new device and the predicate device.
• Interferences Studies: 3 levels of Cortisol (low, medium, high) spiked with high concentrations of 5 interfering substances (alcohol, caffeine, nicotine, food, gum extracts). The number of individual replicates per interferent is detailed in the tables (typically 4 levels of interferent tested with each of the 3 cortisol pools).

Data Provenance: The document does not explicitly state the country of origin of the data or whether the samples were retrospective or prospective, except for the "Expected Reference Values" study which collected 304 samples (presumably from individuals) to establish a new reference range. Given the context of a 510(k) submission, these studies are typically conducted internally or by contract research organizations (CROs) for the device manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The device is an in-vitro diagnostic (IVD) assay for quantitative measurement of salivary cortisol. The "ground truth" for such devices is typically established through:

• Reference materials: Calibrators and controls are traced to NIST cortisol.
• Known concentrations: For linearity, recovery, and interference studies, known concentrations of cortisol or interferents are added to samples.
• Comparison to a legally marketed predicate device: This is a key method for demonstrating substantial equivalence.

Therefore, for the analytical performance studies, no external human experts were used to establish "ground truth" in the way a radiologist would read an image. The ground truth relies on laboratory standards, analytical methods, and comparison to an established device.

4. Adjudication Method for the Test Set

Not applicable. This is an in-vitro diagnostic test, not a subjective interpretation task requiring adjudication by human readers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a quantitative immunoassay, not an AI-assisted diagnostic intended for human reader interpretation.

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

Yes, the studies presented are standalone performance evaluations of the assay itself. The Pantex AM/PM Salivary Cortisol EIA Kit is an automated/semi-automated laboratory test using an enzyme immunoassay principle; its performance is determined by the output of the instrument reading the optical density, not by human interpretation of individual cases. It functions as an "algorithm only" in the sense that it provides a quantitative result based on chemical reactions and optical measurement, without human clinical interpretation being part of the device's performance claim.

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies primarily relied on:

• Known concentrations/reference standards: For precision, linearity, recovery, detection limits, and analytical specificity, the accuracy is determined against samples with known, carefully prepared concentrations or certified reference materials (e.g., NIST cortisol).
• Comparison to a predicate device: For method comparison, the reference is the performance of the legally marketed predicate device (Salimetrics HS Salivary Cortisol EIA Kit).
• Spiked samples: For recovery and interference studies, known amounts of analyte or interferents were spiked into samples.

8. The Sample Size for the Training Set

Not applicable in the context of an enzyme immunoassay kit. There is no machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a device refers to its development and optimization based on chemical and biological principles, using reagents, controls, and calibration curves as part of its design for accurate measurement.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, there isn't a "training set" for an EIA kit in the machine learning context. The "ground truth" during the development and optimization of the kit would be based on fundamental analytical chemistry principles, known concentrations of cortisol, and established practices for immunoassay development and validation.

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