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The TM Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TM Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

The TM Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.

The provided document is a 510(k) summary for the ThinkMed Medical Technology Co., Ltd. TM Safety Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of a device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies cannot be extracted from this document.

The document only states that "Non clinical tests were conducted to verify that the subject device met all design specifications and was substantially equivalent to the predicate devices" and "The non-clinical test results demonstrated that the subject device complies with the following standards: ISO 7864, ISO 9626, ISO 23908."

To answer your questions accurately, a detailed test report or a full submission document with specific study methodologies and results would be required.

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