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The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.

The SafetiHeel Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a blade encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use. The SafetiHeel Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means. The SafetiHeel device is marketed under model numbers SH-065, SH-100 and SH-150. The device is also marketed under trade names such as MediHeel and Novaplus in the USA market. The models for the MediHeel include model number 1003, 1004, 1005 and 1006. For the Novaplus device, the model numbers are 10041 and 10051.

The document provided describes the SafetiHeel, MediHeel, and Novaplus blood lancets, which are intended for obtaining capillary blood samples from the heel of newborn and neonatal infants. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the "Predicate Device (specification)" column, and the reported device performance is indicated in the "SafetiHeel performance," "MediHeel performance," and "Novaplus performance" columns.

SafetiHeel Device Performance

MediHeel Device Performance

Novaplus Device Performance

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

The document does not specify the exact sample size for the test set beyond stating that "The samples of all the models tested show..." for the Blade Retraction Test, and presenting ranges for Cutting Depth and Trigger Force. This implies that multiple units were tested for each model.

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests described (physical performance tests on the devices themselves), it is highly likely these were prospective laboratory or engineering tests conducted on manufactured devices, rather than clinical studies involving human patients or existing datasets.

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

This information is not applicable to the type of performance testing described. The "ground truth" for these physical performance tests (cutting depth, trigger force, blade retraction) is established by direct measurement against known engineering specifications, not by expert interpretation.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies when establishing ground truth for diagnostic decisions. The tests here are physical measurements of device specifications.

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. The device is a physical blood lancet, not an AI-powered diagnostic or assistance tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical blood lancet, not an algorithm.

7. The type of ground truth used

The ground truth for these performance tests is based on engineering specifications and direct physical measurements. Specifically:

• Cutting Depth: Measured depth of blade protrusion.
• Trigger Force: Measured force required to activate the blade.
• Blade Retraction: Visual and/or mechanical confirmation of the blade returning into the housing.
• Sterility: Adherence to established sterility assurance levels (SAL) based on ISO standards.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an algorithm that requires a training set.

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

This information is not applicable. As stated above, there is no training set for this type of device.

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