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The babyLance® is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLance® has a sharps prevention feature to protect the user from a sharps injury.

The MediPurpose babyLance® Heel Incision Device is 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 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, 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.

The babyLance® comes in two models, preemie and newborn. The preemie model is to be used on pre term neonates, while the newborn model is for full term neonates. The two models are differentiated by color.

The provided text describes a Special 510(k) submission for the MediPurpose babyLance® Heel Incision Device. This type of submission is typically used for modifications to a legally marketed device that do not significantly alter its safety or effectiveness. The information focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria as would be common for novel AI/ML devices or higher-risk devices.

Therefore, the document does not present a table of acceptance criteria with reported device performance in the manner you specified for AI/ML or diagnostic devices. Instead, it details why the modified device is substantially equivalent to its predicate.

Here's an analysis based on the information provided, addressing your points where possible:

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

The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC that would be typical for an AI/ML device. For this device (a manual surgical instrument), the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, focusing on maintaining or improving safety and effectiveness.

The document states:

• "Testing results support the determination of substantial equivalence with the results demonstrating that the babyLance® Heel Incision Device (Version 2, proposed device) has equivalent or in some cases improved results than the first version of the babyLance Heel Incision Device (predicate device)."

The "performance" is described qualitatively as:

• "same basic technology characteristics"
• "retains the sharps injury prevention features"
• "intended for piercing the heel skin of a preemie or newborn, as the predicate device"
• "indications for use are the same"
• "materials are the same except as noted under differences"
• "blades using the same medical grade stainless steel"
• "housings made of the same plastics"
• "redesigned with a flat surface against the heel for better stability"
• "trigger activation was modified with the addition of a spring to prevent the possibility of variable incisions"
• "added non patient contacting spring is medical grade stainless steel"
• "trigger plastic was changed to Nylon"
• "All the materials are known biocompatible materials"

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

The document mentions "product drop tests, cut profiles with comparisons to the predicate device, and simulated use." However, it does not specify the sample size for these tests or the data provenance (e.g., number of devices tested, number of simulated uses, origin of data).

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

This information is not provided in the document. The type of testing performed (mechanical and simulated use) for a lancet typically does not involve human expert adjudication in the same way an AI/ML diagnostic device would.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. The testing described (drop tests, cut profiles, simulated use) does not involve human readers or a consensus process.

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 as the device is a manual surgical instrument (lancet), not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used

For this device, "ground truth" would relate to the physical performance and safety characteristics. The document implies the "ground truth" was established by engineering tests and evaluation of material properties:

• "product drop tests"
• "cut profiles with comparisons to the predicate device"
• "simulated use"
• Evaluation against "FDA's guidance document" for sharps prevention.
• Confirmation that "All the materials are known biocompatible materials."

8. The sample size for the training set

This is not applicable as the device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

This is not applicable (see point 8).

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