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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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The Amylase EPS Reagent is used for the quantitative determination of a-Amylase (1,4-α-D-glucan glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/ LX ® Systems. a-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.

Amylase EPS Reagent

The provided text is a 510(k) premarket notification letter from the FDA to Thermo Fisher Scientific regarding the "Amylase EPS Reagent." This document confirms the substantial equivalence of the device to a legally marketed predicate device.

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval letter, not a scientific study report.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and mentions the intended use of the reagent (quantitative determination of α-Amylase in human serum, plasma, or urine for diagnosis of acute pancreatitis), but it does not detail any performance metrics, study designs, sample sizes, or ground truth methodologies.

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For the quantitative determination of Amylase in human serum and urine. Amylase measurements are used primarily for the diagnostics and treatment of pancreatitis.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Amylase Liquid Reagent" by TECO Diagnostics. It is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets those criteria, nor any of the other requested details about a study.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

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This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.

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The document provided is a premarket notification (510(k)) letter from the FDA to Pointe Scientific, Inc. regarding their Amylase EPS-G7 (Liquid) Reagent Set. This type of document declares "substantial equivalence" to a predicate device, which allows the product to be marketed, but does not typically include detailed studies proving performance against acceptance criteria in the way a clinical trial for a novel AI device would.

Therefore, many of the specific details requested in the prompt, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies, are not applicable to this 510(k) submission for an in vitro diagnostic reagent kit.

However, I can extract the relevant information about the device and its intended use, and explain why other sections are not present:

1. A table of acceptance criteria and the reported device performance

This document (a 510(k) clearance letter) does not typically contain a table of detailed performance characteristics and acceptance criteria in the way a clinical study report for an AI device might. For in-vitro diagnostic products like this, the demonstration of "substantial equivalence" to a legally marketed predicate device is the primary regulatory hurdle. This means the device is shown to perform as well as, or comparably to, an existing device on the market.

While the letter doesn't explicitly state "acceptance criteria," the intended performance of the device is for the "quantitative determination of amylase in human serum" for the "diagnosis and treatment of diseases of the pancreas." Substantial equivalence implies that its performance (e.g., sensitivity, specificity, accuracy, precision, linearity, interfering substances) is comparable to, and not worse than, the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) clearance letter. For in vitro diagnostic reagents, performance studies are conducted, but their detailed results (including sample sizes, study design, and data provenance) are typically submitted to the FDA in a separate dossier and summarized or referenced in the 510(k) submission, rather than being fully reproduced in the publicly available clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided in this context. For a reagent test determining a quantitative analyte (amylase), the "ground truth" is typically established by reference methods, standard assays, or certified reference materials, not by expert consensus in the way a diagnostic imaging interpretation would be.

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

This information is not applicable/provided. Adjudication methods are relevant for subjective interpretations (like radiology reads) where multiple experts might disagree. For quantitative assays, the "ground truth" is determined by objective laboratory measurements, not expert consensus requiring adjudication.

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

This is not applicable. This device is a reagent set for laboratory testing, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.

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

This is not applicable. This is a laboratory reagent kit, not an algorithm. Its performance is inherent to the chemical reaction and analytical equipment, not an AI algorithm.

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

For an amylase reagent test, the "ground truth" would typically be established through:

• Reference methods: Highly accurate and validated analytical methods.
• Standardized calibrators: Materials with known, certified concentrations of amylase.
• Interlaboratory comparisons: Performance against other established and trusted assays.

The specific type of ground truth used is not detailed in this 510(k) clearance letter.

8. The sample size for the training set

This information is not applicable/provided. This device is a chemical reagent, not a machine learning model, so there is no "training set" in the AI sense. Performance validation involves testing the reagent's characteristics (e.g., linearity, precision, accuracy, reproducibility) across a range of samples and conditions, but this is distinct from training an AI model.

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

This information is not applicable/provided for the reasons stated in point 8.

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The Amylase Reagent is to be used in the assessment of pancreatitis.

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The provided text is related to a 510(k) clearance letter for an Amylase Reagent, an in vitro diagnostic device used for the assessment of pancreatitis. This type of document, particularly a 510(k) summary (which is not fully provided here but implied by the clearance letter), typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description with acceptance criteria and device performance results as would be found in a clinical study report or a more comprehensive premarket approval (PMA) application.

Therefore, the requested information elements related to detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided document. The document states "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This implies that the device's performance was compared to a legally marketed predicate device, and the specifics of that comparison, including the criteria and results, would be in the full 510(k) submission, not typically summarized in the clearance letter itself.

Given this, I cannot fill out the requested table and answer the specific questions about acceptance criteria and study details.

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For the quantitative determination of a-amylase in serum. For IN VITRO diagnostic use.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document is an FDA 510(k) clearance letter for the "a-Amylase-SL Assay," indicating that the device is substantially equivalent to a predicate device and can be marketed. It states the indications for use and general regulatory information but does not include any performance study details or acceptance criteria.

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Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis.

"This Amylase test system is a device intended to measure the activity of the enzyme amylase in serum, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)". , CFR 862.1070

TRACE Amylase - DST Reagent

The provided documents are a 510(k) premarket notification letter from the FDA for a device called "TRACE Amylase - DST Reagent." This is not a study report or clinical trial document for a medical AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and the study proving the device meets them.

The 510(k) letter confirms that the device is "substantially equivalent" to predicate devices already on the market, meaning it has similar indications for use and technological characteristics. It does not elaborate on specific performance data or studies beyond stating that a review was conducted.

To answer your questions, I would need a document that describes a clinical or analytical study performed to evaluate the performance of an AI/ML medical device, including acceptance criteria and results.

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Ask a specific question about this device

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