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This device is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Well-life™ Safety Pen Needles and Well-life™ Pen Needles are single use, sterile, disposable medical devices intended to be used with compatible insulin pen injectors. The pen needles are intended for use by adults and pediatrics in a home, clinical, or hospital environment. The devices are sterilized by Ethylene Oxide (EO) to a sterility assurance level of 10 °. The Well-life™ Pen Needles consist of a Needle, Hub, Needle Cap, and Sterile Cap. The Well-life™ Safety Pen Needles consist of a Needle, Hub, Needle Cap, Sterile Cap, Guide, Safety Cap, and Spring. To use the devices, the Needle Hub is screwed onto a compatible pen injector. The Well-life™ Safety Pen Needle (i.e., S type) is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin, the Needle Cap will retract. After the injection is completed and needle is removed from the skin, the safety cap will automatically extend to cover the needle. Once the pen needle is locked out, it can no longer be used.

The provided text describes the 510(k) premarket notification for "Well-life™ Pen Needles" and "Well-life™ Safety Pen Needles." This submission focuses on establishing substantial equivalence to legally marketed predicate devices through performance data (bench testing and biocompatibility) and a comparison of device characteristics.

However, the provided document DOES NOT describe an AI/ML-driven medical device. Therefore, it is not possible to extract information related to:

• Acceptance criteria for an AI/ML model
• A study proving an AI/ML device meets acceptance criteria
• Sample size for a test set or its provenance for an AI/ML model
• Number of experts for ground truth establishment for an AI/ML model
• Adjudication methods for an AI/ML model's test set
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance
• Standalone performance of an algorithm (AI only)
• Type of ground truth used for an AI/ML model
• Sample size for the training set of an AI/ML model
• How ground truth for the training set was established for an AI/ML model

The document details the physical and biological testing of the pen needles to ensure they meet established standards and are substantially equivalent to the predicate devices. The "performance data" section (page {5}) lists various tests and their requirements, predominantly referencing ISO standards for physical characteristics, material properties, and sterility. The "biocompatibility" section (page {5} - {6}) lists tests related to the device's interaction with the human body. These are physical device performance evaluations, not AI/ML model performance evaluations.

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