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The Facet 28G Universal Lancet is a sterile, disposable single used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.

The Facet 28G Universal Lancet) is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients. The lancets consist of a 28G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.

This document is a 510(k) summary for the Facet 28G Universal Lancet, a medical device. It does not describe an AI/ML-enabled device, nor does it contain information about clinical studies with human participants, expert ground truth establishment, or multi-reader multi-case (MRMC) studies. Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML devices cannot be answered from this document.

However, I can extract the acceptance criteria and performance related to the non-clinical bench testing for this physical device.

Device: Facet 28G Universal Lancet

Nature of the Device: This is a physical medical device (blood lancet), not an AI/ML software device. The acceptance criteria and performance data presented are for physical and material properties, and compatibility, not for diagnostic accuracy or algorithmic performance.

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes non-clinical bench testing, which serves as the "study" to prove the device meets pre-determined criteria. The reported performance is not explicitly given in numerical terms for all tests, but rather stated that "predetermined criteria were met" and "risks were appropriately managed." However, the acceptance criteria (requirements) are provided.

Note: The document only states that the criteria were "met" or that the performance was "same" as the predicate. Specific numerical results of the tests (e.g., the exact bond strength measured) are not provided in this summary.

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

• Sample Size: The document does not specify the numerical sample sizes for each non-clinical test (e.g., how many lancets were tested for bond strength or cap torque). It broadly states that "non-clinical bench testing was performed."
• Data Provenance: This is not applicable in the context of clinical data for an AI/ML device. For this physical device, the data provenance is from internal non-clinical bench testing performed by Facet Technologies, LLC. The testing ensures the device meets specified engineering and biocompatibility requirements.

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

• Not applicable. This device is a physical lancet, not an AI/ML system requiring expert interpretation of data. The "ground truth" here is objective measurement of physical properties (e.g., force, torque) and standard biocompatibility testing.

4. Adjudication Method for the Test Set

• Not applicable. There is no human interpretation or adjudication required for the physical property tests or biocompatibility assessments described.

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. This is not an AI-enabled device and no MRMC studies were performed or are relevant.

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

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

• For physical properties (Bond Strength, Cap Torque): The ground truth is established by objective physical measurements against engineering specifications.
• For Biocompatibility: The ground truth is established by standardized international (ISO 10993 series) and FDA-recognized test methods performed in a laboratory setting.
• For Compatibility: The ground truth is established via simulated use with commercially available lancing devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set." The focus is on verifying compliance with design specifications and regulatory standards.

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

• Not applicable. There is no training set as this is not an AI/ML device.

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