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Tenderfoot is a sterile incision device intended to initiate capillary blood flow via a heel stick with infants and toddlers. For medical device use. For healthcare professional use, prescription only.

Tenderfoot is an automated skin incision device used to collect capillary blood from infants and toddlers by heel stick. The device produces an arc-like incision at a controlled depth to provide blood flow for obtaining a blood sample. The incision is made by a surgical blade that is completely enclosed in a plastic housing and deployed by pressing a trigger. Following deployment, the blade permanently retracts within the housing, rendering the device inoperable for further use. Tenderfoot is provided as a sterile, single-use disposable device intended for use by healthcare professionals only. Sterilization is achieved by gamma irradiation. Tenderfoot is offered in four models covering a range of incision depths sized for different infant populations: Micro-Preemie, Preemie, Newborn, and Toddler.

The provided text is a 510(k) summary for a medical device called "Tenderfoot". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict acceptance criteria through a clinical or algorithmic performance study in the way one might for a novel AI/ML device.

Therefore, the information requested in the prompt, particularly regarding MRMC studies, standalone performance, ground truth establishment for test/training sets, and expert adjudication, is not present in this document. This typically applies to AI/ML software as a medical device (SaMD) where performance is measured against reference standards. The Tenderfoot device is a physical, mechanical blood lancet.

However, I can extract the information that is available about the "performance data" provided.

Understanding the Context

The Tenderfoot device is a physical medical device (a heel incision device/lancet), not a software or AI/ML product. The "performance data" referred to in Section VII of the 510(k) summary are non-clinical bench testing and biocompatibility/sterilization/packaging validation, relevant for mechanical devices and their safety, not for evaluating algorithmic performance or diagnostic accuracy.

The FDA's review for this type of device (a Class II blood lancet, product code FMK) primarily focuses on demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate. This often involves comparing technological characteristics and validating that the device meets relevant performance standards (e.g., incision depth/length accuracy, sharps injury prevention features, sterility, biocompatibility).

What Can Be Extracted from the Provided Text:

Given the nature of the device and the document, the acceptance criteria and supporting study details will pertain to physical performance and safety, not diagnostic accuracy or AI/ML performance.

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

The document states: "Nonclinical bench testing was performed for cut depth, cut length, trigger activation, and blade retraction before and after stress conditions, such as simulated distribution and aging. The testing met all acceptance criteria."

While the specific numerical acceptance criteria and reported numerical performance values are not detailed in this summary, the statement confirms that the device did meet predefined standards for these physical aspects.

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

• Sample Size: Not explicitly stated for each test. The summary only mentions "Nonclinical bench testing was performed..." without specifying the number of units tested.
• Data Provenance: Not applicable in terms of "country of origin of the data" or "retrospective/prospective" for this type of physical device testing. The tests are bench tests performed on the manufactured devices.

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

• This is not applicable as the device is a physical lancet, not an AI/ML diagnostic or image interpretation device that requires human expert-established ground truth. The "ground truth" for physical properties like cut depth/length would be measured directly by instruments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for this type of device and testing. Adjudication methods are typically used for establishing ground truth in clinical image or data analysis.

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:

• No, an MRMC study was not done. This type of study is specifically for evaluating the performance of diagnostic devices, often AI-assisted, where human readers interpret medical images or data. The Tenderfoot device is a physical instrument for blood collection.

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

• No, a "standalone" study in the context of an algorithm was not done because the Tenderfoot is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For physical attributes like incision depth and length, the "ground truth" would be direct physical measurement using appropriate metrology tools, not expert consensus or pathology. For biocompatibility and sterilization, the ground truth is established by validated laboratory assays and standards (e.g., ISO 10993, ISO 11137).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As there is no training set (for AI/ML), there is no ground truth establishment for it.

Summary of missing information and reasons:

The prompt's questions are largely tailored to the evaluation of AI/ML-based medical devices or diagnostic software. The provided document is a 510(k) summary for a physical, mechanical blood lancet. Therefore, many of the requested details (especially those regarding AI performance, human reader studies, and expert ground truth establishment for data sets) are fundamentally not applicable to this type of device or the regulatory pathway it followed. The performance validation documented here pertains to the physical and safety characteristics of the device, demonstrated through bench testing and compliance with recognized standards.

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