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The intended use of this device is for newborn babies of any ethnicity where a blood sample is desired, and a self-retracting safety feature is desired to protect the clinician performing the blood sampling.

The gentleheel® is designed to be an easy to use, safe, one handed heel incision device for acquiring blood samples from the heels of newborns. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with an infant's foot. The user is instructed to remove the trigger lock. When the gentleheel is placed against the infant's heel and the user presses the trigger mechanism it automatically makes the incision by starting the blade in a continuous motion from inside the housing, into the infant's heel, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The gentleheel comes in models for Newborn (NGH), Preemie (PGH), Micro-Preemie (MPGH), and Toddler (TGH). The models are differentiated by the styles and colors of the housing (see following definitions).

The provided text describes a 510(k) summary for the "gentleheel" device, which is an infant heel stick lancet. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study. Therefore, much of the requested information regarding specific acceptance criteria metrics, detailed study design, and statistical results from a primary clinical study is not available in the provided document.

However, I can extract information related to the device's characteristics and the types of testing performed to support its safety and substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement. Instead, it details that performance and safety testing was completed for the gentleheel®.

The categories of performance and safety tests mentioned are:

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

The document does not describe a clinical "test set" in the context of typical AI/diagnostic device studies. The testing described is primarily mechanical, biocompatibility, and simulated-use testing. Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), or ground truth establishment based on patient data is not applicable or provided.

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

Not applicable, as the provided document does not detail a clinical study with a "test set" requiring expert ground truth establishment for a diagnostic output. The device is a manual surgical instrument, not an AI diagnostic tool.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. The gentleheel is a manual surgical instrument, not a device that involves human readers or an AI assistance component in its primary function that would necessitate an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable, as the device does not employ an algorithm or AI.

7. The Type of Ground Truth Used:

For the performance and safety testing mentioned, the "ground truth" would be established by:

• Biocompatibility: Adherence to ISO 10993-1 standards and laboratory test results.
• Functionality (Cutting Profile, Trigger Force, Reverse Safety): Engineering specifications and mechanical measurements.
• Durability (Drop Testing): Pre-defined physical integrity standards.
• Sharps Prevention Feature: Mechanical operational verification against design requirements and FDA guidance.

8. Sample Size for the Training Set:

Not applicable, as the device does not involve training of an algorithm or AI model.

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

Not applicable, as the device does not involve training of an algorithm or AI model.

Summary of the Document's Focus:

The document is a 510(k) summary demonstrating substantial equivalence for the gentleheel® device to previously cleared predicate devices (K172712 and K883968/K911997). The core argument is that the proposed device:

• Has the "same principles of operation, intended use, and technological characteristics" as the predicates.
• Maintains the "same" materials (medical grade stainless steel, plastics), dimensions, cut profiles, and safety features (single-use, integral sharps injury prevention, automatic blade retraction).
• Has undergone biocompatibility, cutting profile, trigger force/reverse safety, drop testing, and simulated use testing to demonstrate its continued safety and performance against established standards and its prior clearance.

The "testing" mentioned is to confirm these characteristics and ensure they are maintained or are equivalent to the predicate devices, not to establish novel performance metrics against a clinical ground truth for a new diagnostic capability.

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