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The Access Folate Calibrators are intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.

The Access Folate Calibrators are a six level calibrator set intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay System. The calibrator set provides calibrators at six levels - zero and approximately 1.2. 3.1. 6.2, 12.4 and 24.8 ng/mL (2.8, 7.0, 14.0, 28.1, and 56.2 nmol/L). The calibrators are contained in 4.0 mL vials. The calibrator vials are intended for storage at -20°C or colder.

Calibration cards are provided with each calibrator kit. Calibration cards contain bar codes that are encrypted with the individual calibrator concentrations for each calibrator level.

Folate Calibrator S0 is intended for use with Access Folate assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator. Folate Calibrator S0 is a buffered matrix with human serum albumin (HSA) surfactant, < 0.1% sodium azide, and 0.25% ProClin 300. Contains 0.0 ng/mL (nmol/L) folate.

The provided text describes a 510(k) submission for "Access Folate Calibrators" and compares the new calibrators to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K060774) based on modifications not affecting the intended use or fundamental scientific technology. The "acceptance criteria" discussed are largely in the context of device specifications and the conclusion that the modified device "meets product claims specifications."

Therefore, I cannot fulfill all parts of your request as the information about a dedicated study meeting acceptance criteria, sample sizes for test/training sets, expert involvement, MRMC studies, or specific ground truth methodologies in the context of a performance study is not present.

However, I can extract the available information related to the device characteristics and comparisons.

Here's a breakdown of what can be extracted:

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

The document doesn't present "acceptance criteria" in the typical sense of a target performance metric (e.g., sensitivity, specificity) derived from a clinical study. Instead, the comparison table acts as a set of specifications for the device, which the new device is stated to meet or be equivalent to.

Note: The "reported device performance" in this context refers to the specifications of the new re-standardized calibrator, which are compared against the predicate's specifications to demonstrate equivalence despite some numerical changes in calibrator levels and range. The document states: "Based on the results of the product performance characteristics testing, these calibrators meet product claims specifications."

2. Sample sized used for the test set and the data provenance:

This information is not provided in the document. The submission focuses on device parameters and comparison to a predicate, not a clinical performance study with a distinct test set of patient samples.

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

This information is not provided. This type of detail would be relevant for a diagnostic device performance study using expert labels, but not for a calibrator's 510(k) submission based on equivalence.

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

This information is not provided. This is not applicable to the type of device and submission described.

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 information is not provided. An MRMC study is completely irrelevant to a calibrator device.

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

This information is not provided. This is not applicable to a calibrator device.

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

This information is not provided in the context of clinical "ground truth." For a calibrator, the "truth" lies in its ability to accurately establish a known concentration for a specific analyte. The document implies that "product performance characteristics testing" was conducted to confirm the calibrators meet their specifications, but the specifics of this testing or any "ground truth" derived from patient samples are not detailed.

8. The sample size for the training set:

This information is not provided. This is not applicable to a calibrator device in the context of machine learning.

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

This information is not provided. This is not applicable.

In summary: The provided document is a 510(k) premarket notification for a calibrator device. Its primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving diagnostic performance against a clinical "ground truth" through a large-scale clinical study involving patient samples and expert interpretation, which is typical for a diagnostic AI/CAD device. Therefore, many of the requested details are not present as they are not relevant to this type of device submission. The "acceptance criteria" are implied by the comparison to the predicate's specifications and the assertion that "product performance characteristics testing" confirmed the new calibrators meet their claims.

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