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The NeatNick Heel Safety Lancet is a single use device with a sterile blade that is used by medical professionals to obtain a blood sample from the heel of neonates and infants for subsequent diagnostic testing.

The NeatNick Heel Safety Lancet is a single use, blood sampling device with a sterile blade that are used by medical professionals to obtain a blood sample from the feet of neonates and infants for diagnostic purposes. The NeatNick Lancet incorporates an integral sharps injury prevention feature that also prevents reuse of the lancet.

The NeatNick Lancet has been in commercial distribution since 2006.

NeatNick Lancets are available in two configurations (Preemie and Full Term) are intended to be used by medical professionals to obtain a blood sample for diagnostic testing. The lancets consist of a stainless steel blade overmolded with low density polyethylene (LDPE) which protects the blade until use and functions as a sterile barrier. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-6.

Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility. The lancet is classified as Class II.

The lancet is currently in commercial distribution in the United States and Canada. Since commercial distribution of the current lancets began, there have been no design changes.

The provided text is a 510(k) Pre-Market Notification for the NeatNick Heel Safety Lancet. This type of FDA submission focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than proving general safety and effectiveness through extensive clinical trials with specific acceptance criteria and detailed study results.

Therefore, the document does not contain the detailed information typically associated with a study proving a device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would. It explicitly states, "Clinical testing is not applicable as the risk analysis confirmed that all identified risks were addressed and mitigated appropriately."

However, based on the non-clinical testing mentioned and the comparison table, here's what can be inferred and what information is missing:

1. Table of acceptance criteria and the reported device performance:

The document describes "predetermined criteria" being met for non-clinical bench testing and satisfaction of "special controls (21 CFR 878.4850)". The comparison table (Table 1) essentially serves as a performance comparison against the predicate device, where "Same" for the subject device implies it meets or performs comparably to the predicate for those characteristics.

Missing Information:

• Specific quantitative acceptance limits for the "mechanical design verification and validation testing" are not provided. The document only states these tests were performed and criteria were met.
• Actual measured values for the subject device's Trigger actuation force, Length of cut, and Depth of cut are not provided, only that they are "Same" as the predicate, which also presents a range.

The following questions cannot be answered from the provided document as it describes a 510(k) submission for a physical medical device (lancet), not an AI/software device or a study involving human readers or ground truth derived from expert consensus/pathology. The document explicitly states "Clinical testing is not applicable".

2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable/Not Provided: This type of information is relevant for clinical or algorithm performance studies, which were not conducted for this 510(k) submission. Non-clinical bench testing was performed, but sample sizes for these tests are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable/Not Provided: This information pertains to studies where ground truth is established by experts (e.g., in imagery or diagnostic tasks). This submission relies on engineering specifications and bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not Provided: This is relevant for expert-based ground truth establishment or clinical trial adjudication, neither of which occurred.

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
Not Applicable/Not Provided: This is specific to AI-assisted diagnostic tools and human reader performance studies. The device is a physical lancet.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Not Provided: This is specific to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable/Not Provided (in the context of clinical "ground truth"): For the non-clinical testing, the "ground truth" would be the engineering specifications and established test standards (e.g., ISO 10993-1 for biocompatibility, SAL of 10^-6 for sterility, and the specified ranges for cut length/depth and actuation force).

8. The sample size for the training set
Not Applicable/Not Provided: This is specific to machine learning/AI models.

9. How the ground truth for the training set was established
Not Applicable/Not Provided: This is specific to machine learning/AI models.

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