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The babyLance safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.

The babyLance™ safety heelstick is a sterile, single-use device designed to be a one-handed, automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests.

The babyLance™ is constructed with a Nylon housing which holds the stainless-steel cutting blade and deployment mechanism. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury. It is supplied in a sterile polypropylene tray with a Tyvek™ lid.

The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. The user breaks off the trigger lock from the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision. Once the blade has been triggered, the blade is automatically retracted within the housing. The device is discarded in a sharps container after use.

I am sorry, but the provided text, while being an FDA 510(k) clearance letter and summary for a medical device (babyLance Safety Heelstick), does not contain any information about acceptance criteria or a study proving the device meets such criteria in terms of algorithmic performance, AI assistance, human reader improvement, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Indications for Use: The device is a single-use incision device for obtaining blood samples from the heel of neonates or infants, with a sharps prevention feature.
• Technological Characteristics: Comparison of various design elements, materials, mechanical specifications (e.g., cut profile), safety features (sharps injury prevention, automatic retraction, reuse prevention), sterilization, and biocompatibility with the predicate device.
• Physical Characterization: Mention of tests conducted like biocompatibility, shelf-life, shipping, usability, simulated use, and user validation, but no specific performance metrics or acceptance criteria for an AI/algorithm component are presented.

The device described is a mechanical blood lancet, not an AI-powered diagnostic or imaging device. Therefore, the questions related to AI performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this document.

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