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The FastPack® Total Testosterone Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of testosterone in human serum.

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The provided document is a 510(k) summary for the FastPack® Testosterone Calibrator. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive performance studies with specific acceptance criteria in the way you've outlined for diagnostic algorithms.

Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, and training set sample sizes) is not present in this document because it describes a calibrator, not a diagnostic algorithm.

However, I can extract information related to the acceptance criteria for a calibrator and the general comparison made to the predicate device.

Here's the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

For a calibrator, "acceptance criteria" and "device performance" are typically related to how well it functions within the assay system to yield accurate results, and how its characteristics compare to a predicate calibrator. The document doesn't explicitly state quantitative acceptance criteria for performance metrics like accuracy or precision of the calibrator itself but rather details its features and intended use in comparison to the predicate.

Study that proves the device meets the acceptance criteria:

The document doesn't describe a detailed performance study with quantitative results to prove specific acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device, the Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA Kit (K844423) Calibrator component. The 510(k) process for calibrators primarily involves showing that the new device has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.

The "study" in this context is the submission of information to the FDA demonstrating that the FastPack® Testosterone Calibrator is sufficiently similar to the predicate device to be considered safe and effective for its stated intended use. This is supported by the "Comparison to Predicate Device" table provided in the document.

Missing Information (Not Applicable or Not Provided in this Document):

The following information is either not applicable to a calibrator's 510(k) submission as directly as it would be for a diagnostic algorithm, or it is simply not detailed in this specific document:

• 2. Sample size used for the test set and the data provenance: Not provided, as there isn't a "test set" in the sense of patient data for evaluating an algorithm's diagnostic performance. The comparison is between the calibrators' intrinsic properties and use.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant for a calibrator.
• 4. Adjudication method for the test set: Not applicable.
• 5. 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, as this is a calibrator, not an AI-powered diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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