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It is intended to be used with disposable sterile lancets to collect capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. It is for single patient use only.

The lancing device is a mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The lancing device is used with commercially available, sterile, standard square shaft blood lancets.

The lancing device is for use only on a single patient.

I am sorry, but the provided text from the FDA 510(k) notification for the Verifine® Ease Lancing Device, Verifine® Lancing Device does not contain the type of detailed performance criteria and study results you are requesting for a device that typically involves AI or image analysis.

The document describes a lancing device, which is a mechanical tool for collecting blood. It focuses on demonstrating substantial equivalence to a predicate device (Genteel Lancing Device K153670) based on technological characteristics, intended use, and general performance aspects such as:

• Materials: Primarily made from medical-grade plastics.
• Puncture Depth Settings: Comparisons of adjustable depth ranges.
• Reusability: Both are reusable for single-patient use.
• Sterility: Both are non-sterile.
• Shipping and Shelf-Life: Verification of integrity after transportation testing (ASTM D4169) and validation of a 5-year shelf-life / 3000 uses (ASTM F1980-16).

The document explicitly states that the device is a "mechanical blood lancet holder" and its purpose is to "collect capillary blood". There is no mention of AI, image analysis, diagnostic capabilities, or a study involving human readers or expert ground truth adjudication related to disease detection or image interpretation.

Therefore, I cannot provide the information you asked for, such as:

1. A table of acceptance criteria and reported device performance (for AI/image analysis): Not applicable, as this is a mechanical lancing device.
2. Sample size used for the test set and data provenance: No such test set is described for AI performance.
3. Number of experts used to establish ground truth & qualifications: No image-based ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable for AI/image analysis.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The performance testing mentioned in the 510(k) summary is limited to verifying mechanical aspects, shipping integrity, and shelf-life, which are typical for this type of medical device.

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