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The disposable safety lancet is used for capillary blood collection. The device has an integral sharps injury prevention feature.

The Disposable Safety Lancets produced is sterile, single use, spring loaded lancets designed for capillary blood sampling. The device intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use. The device is intended to be used by professionals and lay person.

The provided FDA 510(k) summary for the Disposable Safety Lancet by SteriLance Medical (Suzhou) Inc. does not contain the acceptance criteria and study details as requested. This document primarily outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device, rather than detailing a specific performance study against defined acceptance criteria.

The sections for "Performance Data" and "Non-clinical data" briefly mention various tests conducted (Biocompatibility, Appearance, Dimensions, Needle characteristics, Safety), but they do not provide specific acceptance criteria, reported performance values, or any of the detailed study parameters requested in the prompt (e.g., sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information).

Therefore, I cannot populate the requested information from the provided text. The document states that "Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device," but it does not elaborate on the specific results of these tests in the format requested.

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