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Sterile, single use medical devices intended for capillary blood sampling.

DropSafe/droplet Safety Lancets are sterile, single use medical devices intended for capillary blood sampling. The devices have similar design and are gamma sterilized. DropSafe/droplet Safety Lancets comprise needle or blade and are offered with different gages and lengths (different skin penetration depths after puncture). DropSafe/droplet Safety Lancets are sterile until protective cap is removed. DropSafe/droplet Safety Lancets are push-button activated or activated by pressing the device against the puncture site (contact activation). Regardless of the activation mechanism, the devices are designed to minimize the risk form accidental needle/blade sticks with a used needle/blade by application sharps prevention feature. Following use, the needle/blade retracts into the housing which prevents reuse and accidental sticks. The devices are packed in various quantities in boxes. DropSafe/droplet Safety Lancets share the same technological design and principle of operation. The selected models comprise a needle or a blade. The only differences relate to the shape of the outer housing of the devices and the method of their activation.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets them.

The document is an FDA 510(k) clearance letter and summary for a medical device (safety lancets). While it discusses safety and effectiveness studies, it does not provide:

• A table of acceptance criteria with reported device performance.
• Sample sizes for test sets, data provenance, number of experts, expert qualifications, or adjudication methods for test sets.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
• Information about standalone (algorithm-only) performance.
• The specific type of ground truth used (beyond implying it relates to sharps injury prevention and compliance with product specifications).
• Sample size for the training set or how ground truth for the training set was established.

The non-clinical performance data section mentions internal quality control tests and compliance with established requirements as per product specifications, but it doesn't detail the acceptance criteria for these specific tests. It also mentions biocompatibility, sterilization, and transport tests, which likely have acceptance criteria based on relevant standards, but these are not explicitly stated in the provided text.

The clinical performance data section mentions simulated clinical use studies for sharps injury prevention features conducted in the USA between 2018 and 2019, referencing an FDA guidance document. It states that "all of tested types of the DropSafe/droplet Safety Lancets passed the sharps injury prevention study." However, it does not provide the specific acceptance criterion used to determine "passed" or the detailed results.

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