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The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.

The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet. The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.

The provided documentation describes the One Drop Lancing Device, which is intended for collecting capillary blood from the fingertip for testing purposes in a home setting. The document confirms that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document explicitly states that "Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied." It also mentions "mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the device continued to meet the specified requirements."

While the document indicates that these criteria were met, it does not provide a specific table detailing the acceptance criteria values and the device's measured performance against each. It only lists the types of tests conducted.

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

The document does not specify the sample sizes used for the non-clinical bench tests. It also does not provide information on data provenance (e.g., country of origin of the data, retrospective or prospective) as the testing described is non-clinical bench testing, not clinical human studies.

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

Since the testing described is non-clinical bench testing of a mechanical device, the concept of "experts used to establish the ground truth" in the context of clinical interpretation (like radiologists for imaging) is not applicable. The "ground truth" would be the engineering specifications and regulatory requirements, and the tests were performed by engineers/technicians in a lab setting.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical bench testing against engineering specifications, not a clinical study requiring adjudicated interpretations.

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 to the One Drop Lancing Device. This device is a mechanical lancing device, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

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

This is not applicable to the One Drop Lancing Device, as it is a mechanical device without an algorithm.

7. The type of ground truth used:

The ground truth for the non-clinical testing of the One Drop Lancing Device can be inferred as:

• Engineering specifications and design requirements: For dimensional measurements, function reliability, piercing depth, and cock force.
• International standards (ISO 10993-1): For biocompatibility.
• Regulatory Special Controls (21 CFR 878.4850): For overall regulatory compliance.

8. The sample size for the training set:

Not applicable, as there is no "training set" for a mechanical lancing device; it does not involve machine learning or AI.

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

Not applicable, as there is no "training set."

Summary of the Study:

The study was a series of non-clinical bench tests conducted to evaluate the mechanical performance, safety, and compatibility of the One Drop Lancing Device. These tests aimed to ensure the device met predetermined engineering specifications, international standards (ISO 10993-1 for biocompatibility), and regulatory special controls (21 CFR 878.4850). The tests included:

• Dimensional measurements
• Function reliability drop test
• Piercing depth test
• Cock force test
• Biocompatibility testing
• Compatibility with One Drop branded Lancets (by reference to K221383)

The document concludes that "The intended use, technology, non-clinical testing, and functionality of the One Drop Lancing Device demonstrate a substantially equivalent safety and effectiveness profile to the predicate device."

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