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Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVIII concentrates. For in vitro diagnostic use.

Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVII concentrates.

This device is a Factor Deficiency Test, specifically for Factor VIII. The provided text describes a 510(k) summary for the Coatest SP FVIII, demonstrating its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement: "the slopes and correlation coefficients (r) obtained for Coatest SP FVIII versus the following reference methods showed statistically similar performances." While no explicit numerical thresholds for acceptance are given (e.g., "slope must be between X and Y"), the reported values are presented as evidence of meeting this general criterion of "statistically similar performances."

*Note: The 'n' for precision is "multiple runs (n=80)", implying 80 runs were conducted for the precision assessment, though the specific number of unique samples contributing to each CV% is not detailed.

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

• Method Comparison Test Set (Manual Method vs. Coatest FVIII (K833892)): n = 181
• Method Comparison Test Set (ACL 9000 vs. Coamatic FVIII (K981038)): n = 90
• Precision Test Set: "multiple runs (n=80)" for both normal and abnormal samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is retrospective in the sense that existing samples are being tested and compared to established methods, but the text doesn't specify if these were newly collected prospective samples or archived retrospective samples.

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

Not applicable. This device is a diagnostic assay for quantitative measurement of Factor VIII activity. Ground truth is established by the results of the reference methods (predicate device and another similar device), not by expert human interpretation of images or other subjective data.

4. Adjudication Method for the Test Set

Not applicable. Ground truth is based on reference assay results, not on expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where multiple human readers assess cases. This device is a quantitative assay.

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

Yes, this is essentially a standalone (algorithm only) performance study. The device, Coatest SP FVIII, is a reagent kit and associated photometric measurement system that performs automated/semi-automated quantitative measurements. Its performance is evaluated independently against established reference methods. Human involvement is in running the test and interpreting the numerical output, but the analytical performance described (slopes, correlation, precision) is intrinsic to the device system itself.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established by reference methods (predicate device: Coatest Factor VIII (K833892) and another established method: Coamatic FVIII (K981038)) which are considered clinical standards for Factor VIII activity determination.

8. The Sample Size for the Training Set

Not applicable. This is a traditional in-vitro diagnostic (IVD) device, not an AI/Machine Learning algorithm that typically requires a distinct "training set." The system is based on an enzymatic reaction and photometric measurement, not on a learned model.

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

Not applicable, as there is no specific "training set" in the context of an AI/ML algorithm for this type of IVD device. The reagents and assay parameters are developed and optimized through standard biochemical and analytical chemistry principles.

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