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For In Vitro Diagnostic Use Only. The LeadCare® II Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The Leadcare® II System is suitable for use in a physician's office laboratory environment (POL).

The LeadCare® II Blood Lead Testing System is an instrumented assay utilizing electrochemistry and a unique sensor to be used for the quantitation of lead in whole human blood. Testing can be performed on venous or capillary samples. The system is comprised of an analyzer, sensor (single use, disposable), reagent vial (filled with a measured amount of Treatment Reagent) and a calibration button. The system is powered by 4 AA batteries or AC Adapter. A built in self test checks the electronic functions of the analyzer cach time it is turned on. Blood lead controls are available to monitor the precision and accuracy of the system. The methodology of the system is Anodic Stripping Voltammetry (ASV). Most lead is carried in red blood cells. When a sample of whole blood is mixed with Treatment Reagent, the lead in the red blood cells is released and made available for detection. During the Pb test, the analyzer causes the lead to collect on the sensor. After a specified time, the analyzer removes the lead accumulated on the sensor. The current response (a peak shaped curve) is baseline corrected, quantified and converted to a blood Pb value. The analyzer displays the blood Pb level in units of µg/dL. The test electrode is covered by a thin layer of colloidal gold in an inert polymer matrix. The treatment reagent contains a dilute hydrochloric acid solution in water.

Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria but rather demonstrates substantial equivalence to a predicate device by comparing performance metrics. The key performance indicator measured is bias from the reference method (GFAAS).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 108 human samples. Of these, 22 were spiked samples, and 86 were unspiked.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it involves samples that were then run on the devices and compared to a reference method.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth was established using a gold standard laboratory method, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established using an objective laboratory method (GFAAS), not subjective expert judgment.

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 blood lead testing system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

Yes, the device's performance was evaluated in standalone mode. The study compared the LeadCare II system's measurements directly against the GFAAS reference method.

7. The Type of Ground Truth Used

The ground truth was established using a laboratory reference method: Graphite Furnace Atomic Absorption Spectroscopy (GFAAS).

8. The Sample Size for the Training Set

Not applicable. This document describes the performance of a medical device (a blood lead testing system), not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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