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Sterile Syringe with Fixed Safety Needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.

Sterile Syringe with Fixed Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe and fixed needle with a safety mechanism. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The proposed device is available in a variety combination of syringe volume and needle size.

This document is a 510(k) Premarket Notification from Gemtier Medical (Shanghai) Inc. for a "Sterile Syringe with Fixed Safety Needle for Single Use." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about an AI/ML-driven medical device. The acceptance criteria and study described are for a physical medical device (syringe and safety needle), focusing on its mechanical, material, and safety performance, rather than an AI algorithm's performance on data.

Therefore, I cannot provide the detailed information requested in the prompt, as it pertains to AI/ML acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types).

The document specifically mentions:

• No clinical study is included in this submission. (Page 10)
• The studies performed are non-clinical tests verifying the physical device's specifications, such as needle performance according to ISO standards, syringe performance, sharp injury protection, simulated clinical study for the safety feature, biocompatibility testing, sterility, shipping, and shelf-life. (Pages 8-9)

Because the provided text is about a physical medical device and not an AI/ML product, the questions related to AI/ML device performance and evaluation methodologies are not applicable.

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