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The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.

Dropper A1c Controls are supplied in two levels, 4 bottles total, 2 x 2 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.

This document is a 510(k) premarket notification for a medical device called "Dropper A1c Diabetes Control" by Quantimetrix Corporation. This device is a quality control material intended for laboratory procedures to quantify HbA1c (Hemoglobin A1c).

The document is a regulatory submission, not a study report demonstrating the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this type of document.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance metrics against established acceptance criteria.

Here's how the provided information relates to your request:

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

• Not Applicable. This document does not present acceptance criteria for device performance nor does it report specific numerical performance data against such criteria. The submission aims to demonstrate substantial equivalence, not to quantify performance against pre-defined thresholds.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document does not describe a "test set" in the context of device performance evaluation. The "assayed values are determined from in-house data," but no details on sample size, provenance, or study design are provided for this internal data generation.

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)

• Not Applicable. Ground truth, in the context of device performance evaluation by experts, is not relevant to this submission. The "assayed values" for the control are internally determined, likely through a validated process using reference methods, but not by a panel of external experts establishing a "ground truth" for a test set.

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

• Not Applicable. There is no "test set" and no expert adjudication described in this regulatory submission.

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. This device is a quality control material, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness is irrelevant.

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

• Not Applicable. This device is a physical control material, not a standalone algorithm.

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

• The "ground truth" for the assayed values of the control material (i.e., what the HbA1c levels should be) would be established by in-house data using validated methods, likely traceable to a recognized reference measurement procedure for HbA1c. The document states "Assayed values are determined from in-house data."

8. The sample size for the training set

• Not Applicable. This device is a quality control material, not a machine learning algorithm requiring a training set.

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

• Not Applicable. As there is no training set for an algorithm, this question is not applicable.

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