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VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: Total prostate-specific antigen (PSA) and free prostate-specific antigen (fPSA) on automated systems.

Quality control material (assayed and un-assayed)*
Each VALIDATE® PSA Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

This document describes the VALIDATE® PSA Calibration Verification / Linearity Test Kit, a device intended for in vitro diagnostic use to verify calibration and linearity of automated systems for measuring Total Prostate-Specific Antigen (PSA) and free Prostate-Specific Antigen (fPSA).

Here's an analysis of the provided information relating to acceptance criteria and the study:

Acceptance Criteria and Device Performance

The provided document describes the device as behaving "in a manner suitable for the evaluation of calibration, verification of reportable range, and the linear response of the listed analytes over the ranges tested when compared to the predicate device." However, specific numerical acceptance criteria (e.g., % bias, correlation coefficients, or specific ranges of linearity) are not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed quantitative acceptance criteria for its own performance.

Therefore, the table below reflects what can be inferred.

Study Details

The provided text is a 510(k) summary, which often focuses on demonstrating substantial equivalence rather than providing a detailed study report. As such, many of the requested details about the study are not explicitly present in the provided document.

Here's what can be extracted or inferred:

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

   • Sample Size: Not explicitly stated. The description mentions "Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes." This suggests that a series of concentrations were tested, but the number of replicates or distinct samples is not specified.
   • Data Provenance: Not explicitly stated, but given that it's a submission to the FDA by a US company (Maine Standards Company), it implies the study was likely conducted with data relevant to the U.S. market. The study is retrospective in the sense that the results were generated and then submitted to the FDA.

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

   • Not applicable / Not stated. For calibration verification kits, "ground truth" is typically established by the known concentrations of the analytes in the manufactured control materials, rather than expert interpretation of a biological sample. The accuracy of these known concentrations would be verified through reference methods and quality control procedures during manufacturing.

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

   • Not applicable / Not stated. Adjudication methods are typically relevant for studies where subjective interpretation (e.g., medical imaging) forms the basis of ground truth. For a linearity/calibration verification kit, the assessment is based on quantifiable measurements against expected values.

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:

   • No. This type of study is completely irrelevant for a calibration verification/linearity test kit. MRMC studies are used for evaluating diagnostic aids, often involving human interpretation of images or other data with and without AI assistance. This device is a quality control material.

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

   • Not applicable / Not stated in these terms. The "performance" of this device is its inherent chemical and physical stability and its ability to provide accurate and linear responses across different analytes when measured by automated systems. The study likely involves running the kit on various automated systems and comparing the results to expected values and to the predicate device's performance. It's an "algorithm only" in the sense that the automated systems are the "algorithms" that process the kit, but the kit itself isn't an algorithm.

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

   • The "ground truth" for this type of device is the assigned target values/concentrations for each analyte at each level of the kit, established during the manufacturing process through precise analytical methods and verified against reference standards (e.g., gravimetric measurements, certified reference materials).

7. The sample size for the training set:

   • Not applicable / Not stated. This device is not an AI algorithm that requires a "training set." It is a physical chemical product.

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

   • Not applicable / Not stated. As above, it's not an AI algorithm requiring a training set. The "ground truth" for the device's performance is tied to the manufacturing and characterization of the control material itself.

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