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The Amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the ARCHITECT c System. The Amylase2 assay is to be used primarily as an aid in the diagnosis and treatment of pancreation of the pancreas).

The Amylase2 assay is an automated clinical chemistry assay. The Amylase2 assay is a two-part reaction. Ethylidene-4-NP-G7 (EPS) is hydrolyzed by a-amylase to form 4,6ethylidene-α-(1,4)-D-glucopyranosyl-Gx and 4-nitrophenyl-α-(1,4)-glucopyranosyl-G(7-x). The 4-nitrophenyl-a-(1,4)-glucopyranosyl-G(7-x) is then hydrolyzed into glucose monomers and the assay chromophore (4-nitrophenol) by a-glucosidase. The resulting change in absorbance at 404 nm is proportional to the a-amylase concentration in the sample. Methodology: Enzymatic/Colorimetric. The device is a reagent kit.

Here's a breakdown of the acceptance criteria and the study details for the Amylase2 device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" in a singular table, but rather presents the results of various performance studies. I've extracted the performance metrics and their corresponding observed results to form this table, interpreting the reported successful values as meeting implicit acceptance criteria for substantial equivalence.

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

The document provides details on various studies, each with its own sample size and design:

• Precision (Serum/Plasma & Urine - Within-Laboratory):
  • Sample Size: For each of the controls (2 levels) and panels (3 for serum/plasma, 5 for urine), N=80 data points were collected. This involved testing samples in duplicate, twice per day for 20 days.
  • Provenance: Human serum/plasma and human urine panels were used. No specific country of origin is mentioned, but the context implies an in-vitro diagnostic study conducted under CLSI guidelines, likely in a controlled laboratory setting. It is a prospective study as samples were tested according to a pre-defined protocol.
• System Reproducibility (Serum/Plasma & Urine):
  • Sample Size: For each of the controls (5 for serum/plasma, 4 for urine), N=90 data points were collected. This involved testing samples in a minimum of 3 replicates at 2 separate times per day on 5 different days across 3 instruments and 3 technicians.
  • Provenance: The study used controls, implying commercially prepared materials or pooled biological samples. It is a prospective study.
• Accuracy:
  • Sample Size: Not explicitly stated but implies a set of calibrator materials and potentially patient samples based on "material standardized to the Certified Reference Material IRMM/IFCC-456."
  • Provenance: Relies on certified reference materials and likely patient samples.
• Lower Limits of Measurement (LoB, LoD, LoQ):
  • Sample Size: n ≥ 60 replicates of zero-analyte and low-analyte level samples for each determination (LoB, LoD, LoQ).
  • Provenance: Control materials or spiked biological samples designed to have specific low analyte levels. Prospective.
• Linearity:
  • Sample Size: Not explicitly stated, but typically involves a series of diluted/spiked samples to cover the analytical range.
  • Provenance: Spiked or diluted biological samples. Prospective.
• Potentially Interfering Substances (Serum/Plasma & Urine):
  • Sample Size: Not explicitly stated, but each substance was tested at 2 levels of the analyte (approximately 50 U/L and 200 U/L for serum/plasma; 450 U/L and 1400 U/L for urine). This implies numerous replicates for each interferent and analyte level.
  • Provenance: Biological samples (serum/plasma/urine) spiked with various endogenous and exogenous substances. Prospective.
• Method Comparison:
  • Sample Size: 124 serum samples and 103 urine samples.
  • Provenance: Human serum and urine samples. The description doesn't explicitly state if prospective or retrospective, but typically such studies involve prospectively collected samples from a diverse patient population. No country of origin specified.
• Tube Type:
  • Sample Size: Samples collected from a minimum of 40 donors.
  • Provenance: Human blood samples collected into different tube types. Prospective.
• Dilution Verification:
  • Sample Size: 5 human serum samples and 5 urine samples, each tested in replicates of 5 after automated and manual dilution.
  • Provenance: Human serum and urine samples spiked with α-amylase from porcine pancreas. Prospective.

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

This information is not provided in the document. For an in-vitro diagnostic device, "ground truth" often refers to the true concentration of the analyte, which is usually established by highly precise reference methods, certified reference materials, or by comparison with a well-established predicate device, rather than expert consensus on images or clinical diagnoses. The document indicates standardization against IRMM/IFCC-456, which is a reference material for amylase, and comparison to a predicate device (AMY, K981653). These serve as the "ground truth" or reference for the device's performance.

4. Adjudication Method for the Test Set

This section is not applicable as this is an in-vitro diagnostic (IVD) device for quantitative measurement of amylase. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or subjective evaluations, where multiple experts independently assess data and discrepancies are resolved. For an IVD, the "ground truth" is measured quantitatively against a reference standard or predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided and is not applicable to this device. An Amylase2 assay is an automated clinical chemistry assay, not an AI-powered diagnostic imaging device that requires human "readers" or involves AI assistance in interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Amylase2 assay is an automated clinical chemistry assay, meaning its performance is inherently "standalone" in the sense that it provides a quantitative result without direct human intervention in the measurement process itself, beyond sample loading and general instrument operation. The studies described (precision, accuracy, linearity, interference, method comparison) are all evaluating the algorithm/reagent system's performance independently.

7. The Type of Ground Truth Used

The ground truth for the Amylase2 device's performance studies relies on:

• Reference Materials: For accuracy, the device was compared against "material standardized to the Certified Reference Material IRMM/IFCC-456."
• Predicate Device: For method comparison, the Amylase2 assay was compared to the predicate device, Amylase assay (List Number 7D58), which serves as the established reference standard in this context.
• Spiked Samples: For linearity, lower limits of measurement, interference, and dilution verification, samples were often "spiked" with known concentrations of α-amylase or interfering substances to create samples with a known "true" value.
• Commercial Controls: For precision and reproducibility studies, commercially available controls with known target ranges were used.

8. The Sample Size for the Training Set

The document describes studies for validation and verification purposes (test sets). For an IVD like Amylase2, the "training set" would refer to the data used by the manufacturer during the assay development phase to optimize reagents, calibrate the instrument response, and refine the measurement algorithms. This specific information about the development/training data size is not provided in the 510(k) summary, as the summary focuses on the performance of the final device.

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

Similar to point 8, the specific details on how ground truth was established for any internal "training set" used during development are not provided. Typically, for such IVDs, this would involve a rigorous process of using purified analytes, gravimetric/volumetric standards, certified reference materials, and comparison to established reference methods to assign "true" values to a large panel of samples during the assay's development and optimization.

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