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The Sentinel Pancreatic Amylase is used for the quantitation of pancreatic amylase levels in human serum or plasma. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). For In Vitro use only.

The Sentinel Pancreatic Amylase is an in vitro diagnostic assay for the quantitative determination of pancreatic amylase in serum or plasma. The Sentinel Pancreatic Amylase is a two-reagent format that is carried out in two successive steps. In the first incubation step, the activity of the human salivary alpha-amylase is inhibited using two different monoclonal antibodies with no effect on the pancreatic alpha-amylase. In the second reaction step, the pancreatic alpha-amylase catalyses the hydrolysis of the EPS substrate (Ethylidene Protected Substrate) p-nitrophenyl-maltoheptaoside 4,6ethylidene-blocked (Ethylidene-G7PNP) forming 2 ethylidene-G4 + 2 G3PNP + ethylidene-G3 + G4PNP. The a-glycosidase hydrolyses all fragments of G2PNP. G3PNP, and G4PNP into p-nitro phenol (PNP) and glucose (G). The increase of absorbance, due to PNP formation, is proportional to the activity of pancreatic alphaamylase in the examined sample.

The Sentinel Pancreatic Amylase is an in vitro diagnostic assay for the quantitative determination of pancreatic amylase in serum or plasma. The study conducted aimed to demonstrate substantial equivalence to the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

• Correlation Coefficient: 0.9994
• Slope: 0.965
• Y-intercept: 3.843
  ARCHITECT c8000 vs. Sentinel Pancreatic Amylase (AEROSET):
• Correlation Coefficient: 0.9998
• Slope: 1.011
• Y-intercept: -0.796 |
  | Precision | Acceptable within-run, between-run, and between-day variability. (Specific %CV targets likely defined internally, comparable to the predicate device) | AEROSET Analyzer:
• Total %CV for Level 1: 3.99%
• Total %CV for Level 2: 1.64%
• Total %CV for Level 3: 1.11%
  ARCHITECT c8000 Analyzer:
• Total %CV for Level 1: 1.50%
• Total %CV for Level 2: 0.60% |
  | Linearity | Linear range comparable to or exceeding the predicate device. | Up to 2200 U/L |
  | Limit of Detection (Sensitivity) | Limit of detection comparable to or better than the predicate device. | 1 U/L |

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

• Method Comparison (AEROSET vs. Roche): Samples ranged from 5 to 2428 U/L. The exact number of individual samples is not explicitly stated, but the range indicates a broad spectrum of pancreatic amylase levels were tested.
• Method Comparison (ARCHITECT c8000 vs. AEROSET): Samples ranged from 4 to 2290 U/L. The exact number of individual samples is not explicitly stated.
• Precision Studies: Three levels of control material for the AEROSET and two levels of control material for the ARCHITECT c8000. For each level, within-run, between-run, and between-day studies were performed, implying multiple replicates were run over several days. The exact number of replicates is not specified.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's an in vitro diagnostic assay, the samples would typically be human serum or plasma originating from patients, and the study would be conducted prospectively (collecting samples and running tests according to a defined protocol).

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

This section is not applicable to this type of in vitro diagnostic assay. For quantitive chemical assays like the Pancreatic Amylase test, "ground truth" is established by the highly accurate and precise measurements from a reference method (the predicate device in this case, and potentially higher-order reference methods for calibration), not by expert consensus or interpretation of images.

4. Adjudication method for the test set

This is not applicable for a quantitative chemical assay. Adjudication methods like "2+1" or "3+1" are typically used in clinical imaging or pathology studies where there's subjectivity in interpretation by multiple experts. For this device, the comparison is directly between numerical results from two different assays.

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. An MRMC study is relevant for diagnostic imaging or pathology, specifically to assess the impact of a device (often AI-powered) on the performance of human readers. The Sentinel Pancreatic Amylase is a fully automated in vitro diagnostic assay that provides a quantitative numerical result; it does not involve human "readers" in the diagnostic interpretation process that an AI might assist.

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

Yes, the studies described are standalone performance studies (algorithm only). The Sentinel Pancreatic Amylase is an automated instrument-based assay, and its performance characteristics (precision, linearity, limit of detection, and method comparison) are evaluated based on the analytical measurements produced by the device itself, without human intervention in the diagnostic interpretation. The comparison is made against another standalone diagnostic assay (the predicate).

7. The type of ground truth used

The "ground truth" for the test set was essentially the measurements obtained from the legally marketed predicate device, the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer (and Hitachi 911 Analyzer). For precision, linearity, and limit of detection, the ground truth is established by the inherent analytical capabilities of the assay and potentially by preparing reference materials with known concentrations. The goal of the study was to show substantial equivalence to this established method.

8. The sample size for the training set

This is not applicable in the context of this 510(k) summary for an in vitro diagnostic reagent kit. "Training set" refers to data used to develop and optimize a model or algorithm, typically for AI/machine learning applications. For a chemical assay like this, there isn't an "algorithm" in the same sense that requires a training set. The assay's performance is based on its chemical reactions and instrument calibration, which are developed through R&D and analytical validation, not by training on a data set.

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

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of device submission. The chemical and enzymatic reactions, as well as the measurement principles, are based on established scientific principles and analytical chemistry, not on machine learning from a training data set.

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