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EXELINT SecureTouch Safety Hypodermic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.

EXELINT SecureTouch Safety Hypodermic Needle is a sterile, single use, standard luer lock compatible hypodermic needle with a protection shield to enclose the needle after use The device is available in 18 to 30 gauge in length from 10mm to 50mm. The purpose of this submission is to enable Exelint International, Co. to market a line of safety hypodermic needle.

The proposed device is available in EO sterilized sealed in a sterility maintenance package.

The provided text describes the 510(k) premarket notification for the EXELINT SecureTouch Safety Hypodermic Needle. However, it does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is for a physical medical device (hypodermic needle) and describes its physical characteristics, materials, and non-clinical performance tests against established ISO and ASTM standards. There is no mention of an AI/algorithm, a test set, ground truth, expert readers, or MRMC studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner requested, nor can I answer questions about sample sizes, expert involvement, adjudication, or MRMC studies, as these concepts are not applicable to the device described in the provided text.

The closest relevant section is "5. Non-Clinical Test Conclusion," which lists the standards the device complies with and the performance tests performed. These are physical/material tests, not AI model evaluations.

Specifically, the document states:

• "6. Clinical Test Conclusion: No clinical study is included in this submission." This means there are no human subject studies described for this device, which would be essential for an MRMC study or to evaluate human-in-the-loop performance.
• The "Non-Clinical Test Conclusion" section lists various ISO and ASTM standards the device was tested against (e.g., ISO 7864 for sterile hypodermic needles, ISO 10993 for biocompatibility), and specific performance tests like "Test for Tolerance on Length," "Test for Lubricant," "Testing of Force to Activate the Safety Feature," etc. These are the "acceptance criteria" and "reported device performance" for this physical device, but they don't map to the AI-centric questions in the prompt.
• The "510(k) Summary" and "Substantially Equivalent (SE) Comparison" sections compare the proposed device's characteristics and performance to a predicate device (Sol-Care Safety Needle), demonstrating substantial equivalence based on physical and functional attributes.

In summary, the provided text is about a physical medical device and its compliance with established manufacturing and safety standards, not an AI or algorithm-based device.

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