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Acid Phosphatase is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.

AI/ML Overview

Acceptance Criteria and Device Performance for ACP (Acid Phosphatase) Assay

Metric	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (ACP Assay)
Total Acid Phosphatase
Correlation Coefficient	Acceptable correlation with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer (implicit)	0.995 (with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer)
Slope	Acceptable (implicit)	1.057
Y-intercept	Acceptable (implicit)	0.417 U/L
Total %CV (Level 1)	Acceptable (implicit)	3.9%
Total %CV (Level 2)	Acceptable (implicit)	2.7%
Linearity	Up to 87.90 U/L (implicit, as the "up to" value for the new device is the acceptance itself)	Up to 87.90 U/L
Limit of Quantitation	0.513 U/L (implicit, as the value for the new device is the acceptance itself)	0.513 U/L
Prostatic Acid Phosphatase
Correlation Coefficient	Acceptable correlation with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer (implicit)	0.989 (with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer)
Slope	Acceptable (implicit)	1.062
Y-intercept	Acceptable (implicit)	0.651 U/L
Total %CV (Level 1)	Acceptable (implicit)	4.0%
Total %CV (Level 2)	Acceptable (implicit)	4.0%
Linearity	Up to 77.46 U/L (implicit, as the "up to" value for the new device is the acceptance itself)	Up to 77.46 U/L
Limit of Quantitation	0.674 U/L (implicit, as the value for the new device is the acceptance itself)	0.674 U/L

Study Proving Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria is a comparative performance study demonstrating substantial equivalence to a legally marketed predicate device.

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "comparative performance studies" and "precision studies conducted using two levels of control material," but the precise number of patient samples or runs for method comparison is not provided.
- Data Provenance: Not explicitly stated. However, given the context of a 510(k) submission for a clinical chemistry assay in the US, the data would likely be from prospective studies conducted in a laboratory setting for regulatory submission in the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for this type of in vitro diagnostic assay typically refers to the results obtained from the predicate device (Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer), which itself is a validated and legally marketed device. Expert human interpretation, as found in imaging or pathology studies, is not the primary method for establishing ground truth in clinical chemistry assays measuring analyte concentrations.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement among experts. In this case, the comparison is made between quantitative measurements of two assays.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance, often with and without AI assistance, which is irrelevant for a quantitative clinical chemistry assay where results are generated by an instrument.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study in the sense that it evaluates the instrument and reagent system (the ACP assay) itself. There isn't a "human-in-the-loop" component in the direct measurement process of a clinical chemistry assay in the same way there might be for an AI-assisted diagnostic tool for image interpretation. The performance characteristics (correlation, precision, linearity, sensitivity) are intrinsic to the assay system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for comparative studies in clinical chemistry is typically established by the legally marketed predicate device's performance results. In this case, the Trace® Acid Phosphatase Assay on the Hitachi® 717 Analyzer served as the comparator or "gold standard" against which the new ACP assay's performance was measured for substantial equivalence.
The sample size for the training set:
- Not applicable. This device is an in vitro diagnostic assay, not an AI/ML algorithm that requires a "training set" to learn from data. The performance characteristics are determined by the chemical reagents and instrument design.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

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