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The RedDrop ONE is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

The RedDrop ONE Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The device is adhered to the skin in the selected position on the upper arm. The device is actuated by sliding the actuator causing an energized spring to release and deploy the lancet array. The lancet array is deployed to a maximum depth of 2 mm to access capillaries. The lancet array is then automatically retracted to a safe position that prevents sharps injury and re-activation. Sliding the actuator also releases two spring loaded pistons that create a gentle vacuum to the skin to facilitate the emergence of capillary blood from the sample site.

The RedDrop ONE (One) device, a single-use blood lancing device, underwent clinical testing to demonstrate its performance and meet acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample size for the test set is not explicitly stated as a number of participants. However, the summary mentions that "Subjects produced their blood samples following the instructions for use."

The data provenance is prospective, as indicated by the "actual-use study" and subjects actively producing blood samples. The country of origin for the data is not specified in the provided text.

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

This information is not provided in the document. The study focuses on the device's ability to produce blood samples rather than a diagnostic interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (producing blood samples), adjudication by experts for ground truth is unlikely in the same way it would be for an AI diagnostic device. The "success" was likely objectively measured based on whether a blood sample was successfully produced.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study involving human readers and AI assistance was not conducted. This device is a lancing device for obtaining blood samples, not an AI diagnostic algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The RedDrop ONE is a physical medical device, not an algorithm. Its performance inherently involves a "human-in-the-loop" to operate it.

7. Type of Ground Truth Used

The ground truth used was the ability of the device to "produce blood samples from the upper arm of human subjects according to the device labeling." This implies an objective measurement of whether a sufficient micro-liter capillary whole blood sample was successfully obtained after using the device as instructed.

8. Sample Size for the Training Set

Not applicable. This device is a physical lancing device and does not involve AI algorithms that require a training set.

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

Not applicable, as no training set was used for this physical medical device.

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