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510(k) Data Aggregation
(51 days)
The Wako L-type Amylase test is an in vitro diagnostic assay for the quantitative determination of amylase activity in serum. Determination of a-amylase activity is largely of use in the diagnosis of pancreatic diseases, but is also of value in detecting nonpancreatic disorders such as renal insufficiency, salivary gland lesions, macroamylasemia, and intra-abdominal diseases.
The Wako L-type Amylase is a kinetic assay employing a defined-substrate, p-nitrophenzy-a-maltopentaoside (BG5P), with glucoamylase and a-glucosidase as coupling enzymes. When a sample is allowed to react with the BG5P, BG3 and p-nitrophenyl-a-maltoside (PNP-G2) are formed by the action of a-amylase in the sample. The PNP-G2 produced is hydrolyzed to p-nitrophenol by the reactions of glucoamylase and a-glucosidase. By measuring the increase in absorbance of p-nirophenol at the optimum wavelength of 405 nm, a - amylase activity in the sample is determined.
The provided text describes the Wako L-type Amylase test, an in vitro diagnostic assay for determining amylase activity in serum. The submission focuses on establishing substantial equivalency to a predicate device, the Sigma Amylse test, rather than setting specific acceptance criteria for performance metrics like sensitivity or specificity.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalency | To be substantially equivalent to the legally marketed predicate device (Sigma Amylse test). | Demonstrated substantial equivalency to the Sigma Amylse test. |
| Precision | Acceptable values on a day-to-day basis. (Specific numerical criteria not provided) | Precision studies indicate acceptable values can be obtained on a day to day basis. |
| Minimum Detectable Level (MDL) | Not explicitly stated as an acceptance criterion, but a low MDL is generally desired. | Estimated to be 1.0 IU/L. |
| Linearity | Not explicitly stated as an acceptance criterion, but linearity over a clinically relevant range is desired. | Determined to be linear to 3000 IU/L. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "Precision studies" and "The Wako L-type Amylase assay had determined to be linear," but does not provide details on the number of samples or data points.
The data provenance is not specified. It is not clear if the data was retrospective or prospective, nor the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of experts to establish ground truth for this device. The evaluation method described is a comparison to a predicate device, not an assessment against an expert-derived ground truth for diagnostic accuracy.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
No adjudication method is mentioned, as the study does not involve expert review or consensus for establishing ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study was done. This type of study is typically performed for imaging or qualitative diagnostic devices where human readers interpret results, and the goal is to assess improvements in reader performance with AI assistance. The Wako L-type Amylase test is a quantitative, automated assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance described (precision, MDL, linearity) is the standalone performance of the assay, as it's an automated in vitro diagnostic test without direct human interpretation of the assay's output for diagnosis. The "algorithm" in this context is the chemical reaction and measurement process.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is implicitly the performance and results obtained from the predicate device, the Sigma Amylse test. The study's objective was to demonstrate substantial equivalency to this existing, legally marketed device, not to establish a new gold standard.
8. The Sample Size for the Training Set
The document does not mention a "training set." For an in vitro diagnostic assay, development and validation typically refer to optimization of reagents and protocols, followed by performance verification runs. The concept of a distinct "training set" is more common for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the context of machine learning, there is no information on how its ground truth was established. For the development and verification of the assay's chemical and measurement process, the "ground truth" would have been established through standard analytical chemistry practices, including the use of reference materials, calibrators, and known-concentration samples to optimize the reaction and detection parameters. However, specific details are not provided in this 510(k) summary.
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