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The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Alkaline Phosphatase is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.

Here's an analysis of the acceptance criteria and study information for the K981806 device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to the predicate device, the Boehringer Mannheim® Alkaline Phosphatase/AMP assay (K823213) on the Hitachi® 717 Analyzer. The study aims to show that the new Abbott AlkP assay performs similarly to the predicate.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated. The document mentions "comparative performance studies" and "precision studies" using "two levels of control material" but does not specify the number of patient samples or replicates used for these tests.
   • Data provenance: Not explicitly stated, though it's an in vitro diagnostic assay for human serum or plasma. The country of origin is not mentioned, and it is a prospective study as these are performance characteristics being evaluated for a new device.

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

   • Not applicable. For an in vitro diagnostic assay like Alkaline Phosphatase, ground truth is typically established by reference methods or validated calibrated instruments/materials, not by expert interpretation in the same way it would be for imaging diagnostics. The comparison is against a legally marketed predicate device (Boehringer Mannheim Alkaline Phosphatase/AMP assay).

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

   • Not applicable. This is a quantitative chemical assay, not an interpretation task requiring adjudication.

4. 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:

   • Not applicable. This is an in vitro diagnostic assay and does not involve human readers for interpretation.

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

   • Yes, this study represents a standalone performance evaluation of the Abbott AlkP assay on the AEROSET™ System. There is no human-in-the-loop component mentioned; it's an automated quantitative assay.

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

   • The "ground truth" for demonstrating substantial equivalence is the performance of the predicate device (Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer). The new device's results are compared directly to this established method. For precision, the ground truth is often tied to certified reference materials or internal quality control materials with known target values.

7. The sample size for the training set:

   • Not applicable. This is a chemical assay, not an algorithm that requires a "training set" in the machine learning sense. The device is likely calibrated using standardized calibrators, but these are not referred to as a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there's no "training set" in the context of this device. Calibrators for such assays are typically prepared using gravimetric or volumetric methods with highly pure chemical substances, and their ground truth concentrations are established through analytical chemistry techniques.

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Measurement of BAP is intended for use as an aid in the:

management of postmenopausal osteoporosis and Paget's disease.

monitoring of postmenopausal women on hormonal or bisphosphonate therapy

prediction of skeletal response to hormonal therapy in postmenopausal women.

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for the Alkphase-B® Assay Kit does not contain information about the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA letter granting substantial equivalence, not a detailed study report. Therefore, I cannot generate the requested table and paragraphs based on this input.

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