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The "Wiener lab. ALP 405" test system is an in vitro diagnostic device intended to be used in the quantitative determination of alkaline phosphatase in human serum and heparimized plasmas. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Alkaline phosphatase (ALP or orthophosphoric monoester phosphohydrolase - EC 3.1.3.1.) hvdrolyzes colorless paranitrophenyl phosphate (pNPP) producing phosphate and p-nitrophenol at pH 9.8. The speed at which the p-nitrophenolate anion (yellow) appears, read at 405 nm, is directly proportional to the enzymatic activity of the sample.

The provided document is a 510(k) summary for the "WIENER LAB. ALP 405" test system, which is an in vitro diagnostic device for the quantitative determination of alkaline phosphatase. The document aims to demonstrate substantial equivalence to a predicate device, the RANDOX ALKALINE PHOSPHATASE OPT. test system.

The document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be structured (e.g., with defined sample sizes, ground truth establishment methods, or expert involvement for assessing performance against acceptance criteria). Instead, it relies on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer some "acceptance criteria" by looking at the performance characteristics reported for the WIENER LAB. ALP 405 test system and comparing them to the predicate device, as well as general expectations for such diagnostic systems. The "study" proving the device meets these criteria is the comparison study against the predicate device presented in the 510(k) summary.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but presents performance characteristics of the WIENER LAB. ALP 405 and compares them to the predicate device. For the purpose of this response, "Acceptance Criteria" will be interpreted as the performance characteristics shown to be comparable or superior to the predicate device, as presented in the comparative table.

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

The document does not explicitly state a sample size for a "test set" or provide details on data provenance (e.g., country of origin, retrospective/prospective) for the performance metrics reported.

The data presented (Linearity, Minimum Detection Limit, Expected Values, Within-run precision, Total precision) are likely derived from internal validation studies conducted by Wiener Laboratorios S.A.I.C. for the purpose of demonstrating the device's performance characteristics. This indicates the testing was done by the manufacturer. While the company is based in Argentina, it's not specified if patient samples (for expected values, for instance) or control materials were sourced from specific geographies or if the studies were retrospective or prospective.

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

The concept of "experts" establishing ground truth as typically understood in studies involving image interpretation or complex diagnostic algorithms is not applicable to this type of in vitro diagnostic device (IVD) based on colorimetric enzyme activity measurement.

For IVDs like the ALP 405 test system, the "ground truth" for performance characteristics (e.g., linearity, precision, detection limit) is established through analytical reference methods, certified calibrators, and quality control materials, rather than expert consensus on patient diagnoses.

4. Adjudication Method for the Test Set

Since the "ground truth" for these analytical performance characteristics (precision, linearity, etc.) is established through laboratory methods and reference standards rather than expert interpretation, there is no adjudication method described or necessary in the context of clinical expert review. The data are quantitative measurements derived from laboratory experiments.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices or other human-interpreted diagnostic tools where variability between readers and across cases is a key consideration. The "WIENER LAB. ALP 405" is an automated, quantitative chemical analyzer for a specific analyte and does not involve human "readers" in the diagnostic interpretation in a way that would necessitate an MRMC study.

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

The device itself, being an automated test system for quantitative measurement, inherently operates in a "standalone" manner in terms of its analytic performance. The reported precision, linearity, and detection limit data reflect the device's analytical performance (algorithm/assay only) without human-in-the-loop performance influencing the primary measurement. Human involvement would typically be in sample preparation, loading, and result review, but not in the determination of the ALP level by the device itself.

7. The Type of Ground Truth Used

The ground truth used for performance validation of the WIENER LAB. ALP 405 test system would be based on:

• Reference standards/Calibrators: For linearity and quantitative accuracy.
• Quality control materials: For precision (within-run and total precision).
• Analytically derived values: For minimum detection limit.
• Clinical studies or literature: For establishing expected reference ranges (e.g., 65 - 300 U/l for adults).

It is not based on expert consensus, pathology, or direct patient outcomes data in the same way a diagnostic imaging device might be. For Expected Values, literature references or studies on specific populations would typically be used, but the document doesn't detail this.

8. The Sample Size for the Training Set

The document does not specify a sample size for a "training set." As an in vitro diagnostic device based on a chemical reaction, it does not involve machine learning or AI models that typically require training sets. The "development" of such a system involves chemical and engineering optimization, not algorithmic training on data.

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

Since there is no "training set" in the context of machine learning for this device, the concept of establishing ground truth for a training set does not apply. The performance characteristics are validated through standard analytical chemistry and clinical laboratory procedures.

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