(122 days)
STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.
The STA® - Free PS Calibrator kit is a set of lyophilized human plasmas used to create the calibration curve on an IVD instrument performing the immunoturbidimetric method for free protein S assays, STA® - Liatest® Free PS. Such IVD instruments being the STA® product line of medical device analyzers such as STA-R® and STA Compact®.
In the lyophilized state and uncompromised primary packaging, the product calibrator plasmas remain stable for a period of 18 months from the date of manufacture when stored at 2 - 8°C. In the reconstituted state, STA® - Free PS Calibrator have demonstrated to be stable for 4 hours on board STA-R® and STA Compact®.
The provided text describes the 510(k) premarket notification for the STA® - Free PS Calibrator. While it details the device's intended use, technological characteristics, and substantial equivalence to a predicate device, it does not include a specific study or detailed data proving the device meets acceptance criteria.
The text states, "performance data enclosed in this notice further demonstrates suitability for the intended use," but this data is not present in the provided excerpts. As such, I cannot create a table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, ground truth establishment, or specific study types.
However, based on the available information, I can address some of the requested points if such a study were described:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present in the provided text.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided text.
- 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: This is a calibrator for an in-vitro diagnostic test, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable to this device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a calibrator, not an algorithm. Therefore, a standalone performance study in the context of "algorithm only" is not applicable. However, the text mentions "performance data enclosed in this notice further demonstrates suitability for the intended use," which would imply standalone performance data for the calibrator itself, likely focusing on its ability to establish a correct calibration curve and maintain stability. The specifics of this performance data are not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a calibrator, the "ground truth" typically involves reference values or certified reference materials against which the calibrator's assigned values are validated. The text does not explicitly state how the ground truth for the performance data (mentioned but not included) was established, but it would involve comparing the calibrator's output to known, highly accurate reference standards.
- The sample size for the training set: This is a calibrator device, not a machine learning algorithm that requires a "training set" in the conventional sense. Performance evaluation would involve evaluating the calibrator's characteristics (e.g., linearity, stability, accuracy of assigned values) using multiple lots, instruments, and potentially comparison to established reference methods or predicate devices. The relevant "sample size" for such an evaluation is not provided.
- How the ground truth for the training set was established: As mentioned in point 8, a "training set" in the AI/ML context is not applicable. For a calibrator, its "ground truth" (i.e., its assigned values and performance characteristics) would be established through a rigorous process of metrological traceability, often involving primary reference materials or international standards for free protein S. The text does not detail this process for the STA® - Free PS Calibrator.
In summary, while the document confirms the device's intended use and the FDA's substantial equivalence determination, it does not provide the specific performance data or a detailed study description that would allow for the complete fulfillment of your request regarding acceptance criteria and their proof.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.