(48 days)
The Access Unconjugated Estriol Calibrators set is a device intended for medical purposes for use in the Access Immunoassay System, to establish points of reference that are used in the determination of values in the measurement of estriol levels in human serum.
The Access® Unconjugated Estriol Calibrators are liquid Calibrators to be used with the Access Immunoassay System.
This document outlines the 510(k) summary for the Beckman Coulter Access® Unconjugated Estriol Calibrators. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, many of the requested sections (Table of Acceptance Criteria, Sample Size for Test Set, Number of Experts, Adjudication Method, MRMC study, Standalone study, Type of Ground Truth, Training Set Size, and Training Set Ground Truth establishment) cannot be directly extracted from the provided text.
Based on the information provided, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document states, "Data is presented to demonstrate substantial equivalence to the predicate." And "Calibrators support the stability claim of a minimum of 24 months." However, specific quantitative acceptance criteria (e.g., precision, accuracy, linearity targets) and their corresponding performance values are not detailed in the provided text. The submission focuses on demonstrating substantial equivalence to a previously marketed device rather than providing a new performance study against pre-defined acceptance criteria for a novel device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing or the data provenance. It generally refers to "data in the Premarket Notification on safety and effectiveness."
3. 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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable as the device is a set of calibrators for an immunoassay system, not an AI-powered diagnostic tool requiring human reader intervention or improvement analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a set of calibrators, not an algorithm. However, calibration performance would be assessed in a "standalone" sense of the calibrator's ability to accurately define the reference points for the immunoassay system. The document states, "Data is presented to demonstrate substantial equivalence to the predicate." which implies performance testing was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For calibrators, the "ground truth" would typically be derived from highly accurate reference methods or certified reference materials used to assign values to the calibrator levels. This specific detail is not explicitly stated in the provided text.
8. The sample size for the training set
This is not applicable as the device is a set of calibrators, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.