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It is intended for capillary blood sampling.

The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through irradiation. The product has a shelf life of 3 years.

The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling.

The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.

The provided document is a 510(k) Premarket Notification for medical devices, specifically blood lancets. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets novel acceptance criteria.

Therefore, the information typically requested in your prompt regarding acceptance criteria, performance reports, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable or directly available in this specific document.

This document primarily compares the technical specifications and non-clinical test results of the new devices (Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus) to a legally marketed predicate device (VeriFine Safety Lancet, VeriFine Mini-Safety Lancet, and Promisemed Blood Lancet, K221368) to establish that they are "substantially equivalent."

Here's a breakdown of why some of your requested information isn't present:

• Acceptance Criteria and Performance Report (Table 1): The document doesn't provide a table of novel acceptance criteria for a new device and its performance against those. Instead, it compares features of the submitted devices to a predicate device and states that non-clinical tests (sterilization, shelf-life, biocompatibility, and performance testing) were conducted and met regulatory requirements and safety standards.
• Sample Size for Test Set and Data Provenance: The document explicitly states "Clinical performance testing was not deemed necessary as the non-clinical testing was sufficient to demonstrate substantial equivalence." Therefore, there is no clinical "test set" in the context of human data. The non-clinical tests (sterilization, shelf-life, biocompatibility, and performance) would have their own sample sizes, but these are not detailed in the summary.
• Number of Experts, Qualifications, and Adjudication Method: Since no clinical data or image-based studies are presented, these details are irrelevant.
• MRMC Comparative Effectiveness Study: Not applicable, as no clinical study comparing human readers with and without AI assistance was conducted or described.
• Standalone Performance: While non-clinical performance tests were done on the devices themselves, this is not "standalone performance" in the context of an AI algorithm operating without human intervention.
• Type of Ground Truth Used: Not applicable. There's no clinical "ground truth" established as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established standards and specifications for performance, sterility, etc.
• Sample Size for Training Set and How Ground Truth was Established (for Training Set): Not applicable, as this is related to AI/machine learning models, which are not described in this submission for blood lancets.

In summary, the provided document focuses on demonstrating substantial equivalence of a physical medical device (blood lancet) through comparison to a predicate device and non-clinical bench testing, not on clinical performance studies involving human data or AI algorithms.

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