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The Med-Lok™ Safety Needle device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Med-Lok™ Safety Needles

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Med-Lok Safety Needle." This document does not contain the kind of information needed to answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based medical device.

The letter confirms substantial equivalence for a physical medical device (a safety needle) based on prior predicate devices, and refers to general controls and regulations. It does not describe any performance studies involving algorithms, AI, or comparative effectiveness with human readers.

Therefore, I cannot provide an answer based on the given input for the following reasons:

• No acceptance criteria for an AI/algorithm: The document does not discuss performance metrics or acceptance thresholds for an AI-powered device.
• No study details: There are no descriptions of a study (clinical or otherwise) that would assess the performance of an algorithm.
• No sample sizes, data provenance, or ground truth information: These details are specific to algorithm validation studies, which are not present in this document.
• No mention of experts or adjudication: These are relevant to establishing ground truth for AI studies, not for the substantial equivalence of a physical needle.
• No MRMC study or standalone performance: These are specific types of studies for AI/algorithm performance that are not mentioned.

The input document is about the regulatory clearance of a physical medical device, not about the validation of an AI/algorithm-based device.

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