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For in vitro diagnostic use with the CARESIDE Analyzer™ to measure alkaline phosphatase from anticoagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with diseases of the liver, pancreas, bone, parathyroid, and intestines.

CARESIDE™ ALP cartridges are used with the CARESIDE Analyzer™ to measure alkaline phosphatase activity in anticoagulated whole blood, serum or plasma specimens. The CARESIDE™ ALP cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of alkaline phosphatase activity. The film cartridge (patent pending) contains all reagents necessary to measure alkaline phosphatase activity.

Here's an analysis of the acceptance criteria and study information for the CARESIDE™ ALP device, based on the provided document:

Acceptance Criteria and Device Performance

The core of the study presented here is a demonstration of substantial equivalence to a predicate device (Vitros ALKP DT Slides) rather than meeting predefined numerical acceptance criteria against a gold standard. The performance characteristics of the CARESIDE™ ALP are compared directly to the predicate device.

Table of Performance Characteristics (Acceptance is Implied by Substantial Equivalence):

Note: The document explicitly states: "The nonclinical and clinical data provided demonstrate that the CARESIDE™ ALP product is as safe, effective, and performs as well as or better than the legally marketed predicate device." This statement indicates that "performing as well as or better than the predicate" is the overarching acceptance criterion.

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

• Sample Size: The document does not explicitly state the sample size for the test set used in the comparative performance studies (Accuracy, Precision, Method Comparison, Linearity, Interference).
• Data Provenance: Not specified. It is unclear if the data is retrospective or prospective, or the country of origin.

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

• Not Applicable. This is an in vitro diagnostic device measuring Alkaline Phosphatase activity. The "ground truth" for such devices is typically established through reference methods and calibrated samples, not by expert consensus on visual interpretation as might be the case for imaging devices. The document mentions "IFCC, 1983" as the reference method.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is an in vitro diagnostic device and not relying on subjective interpretation, an adjudication method for a test set based on expert review is not employed. Measurements are quantitative.

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

• No. An MRMC study is not applicable to this type of in vitro diagnostic device, which measures a biochemical analyte. It measures a value directly, and there are no human readers interpreting results in the way an imaging device might require.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, implicitly. The performance data provided (Detection limit, reportable range, accuracy, precision, method comparison, linearity, interference) describes the standalone performance of the CARESIDE™ ALP system (cartridge + Analyzer) without human intervention in the measurement process itself, beyond loading the specimen. It is an automated system.

7. The Type of Ground Truth Used:

• Reference Methods and Quantitative Standards: The ground truth for Alkaline Phosphatase activity measurements is established through well-defined reference methods (e.g., IFCC, 1983, and Bretaudiere, 1977, for the predicate) and traceable calibrators/standards. For the method comparison, other commercial ALP assays (Trace Scientific ALP and Vitros ALKP DT) served as reference points.

8. The Sample Size for the Training Set:

• Not specified. The document does not provide information about a "training set" or its size. For in vitro diagnostic devices, development often involves extensive analytical testing rather than machine learning-style training using large datasets in the same way an AI imaging algorithm would.

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

• Not applicable / Not specified. As no "training set" is mentioned in the context of machine learning, the establishment of its ground truth is not detailed. The device likely relies on established biochemical principles and calibration processes for its internal calculations, not on learned patterns from a large training dataset.

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