Search Results

The Accu-Chek FastClix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm. upper arm, and the forearm. Six sterile, sincets are in a drum. The lancet drum is to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The Accu-Chek FastClix Lancing Device uses compatible Accu-Chek FastClix Lancets to obtain a drop of blood from a fingertip or alternative sites. The Accu-Chek FastClix Blood Lancing System consists of three components: 1. Accu-Chek FastClix Lancing Device 2. Accu-Chek FastClix Lancets 3. Accu-Chek FastClix Alternative Site Testing (AST) Cap

This document is a 510(k) premarket notification decision letter from the FDA for the Accu-Chek FastClix Blood Lancing System. It declares the device substantially equivalent to a predicate device.

The provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI/ML powered device. The device described is a mechanical blood lancing system for capillary blood collection, not an AI/ML system.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (for an AI/ML system).
• Sample size and data provenance for a test set (for an AI/ML system).
• Number and qualifications of experts for ground truth (for an AI/ML system).
• Adjudication method (for an AI/ML system).
• MRMC comparative effectiveness study details (for an AI/ML system).
• Standalone performance details (for an AI/ML system).
• Type of ground truth used (for an AI/ML system).
• Sample size for the training set (for an AI/ML system).
• How ground truth for the training set was established (for an AI/ML system).

The document explicitly states: "Clinical Testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately." This further confirms that no clinical study, of the type relevant to AI/ML device performance validation, was conducted or required for this mechanical device.

The "Nonclinical bench testing" mentioned refers to mechanical and validation testing related to sharps injury prevention and mechanical functions, not AI/ML performance.

Ask a specific question about this device