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Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a LCD, a console and 6 channels of electrode cables with alligator type connectors. Only 3 channels at most could work together on single patient. The console has the operating elements of Channel selecting button, Setting button, Operation suspending switch button, Wave-selecting button, On/off switch, Mute button, Therapy time adjusting button, Output frequency adjusting button, Intensity adjust knobs, and Output indicator light. Needle Stimulator (Model: RJNS6-1) does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.40mm and insertion depth of 16mm) for use.

The provided text describes the 510(k) submission for the "Needle Stimulator (Model: RJNS6-1)" and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop diagnostic system.

The device in question is an electro-acupuncture stimulator, and the FDA's review focuses on its electrical safety, performance parameters, and substantial equivalence to a legally marketed predicate device (K202861). The testing mentioned is related to electrical safety and electromagnetic compatibility (e.g., IEC 60601 standards), not diagnostic performance or AI assistance.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth establishment as these concepts are not applicable or mentioned in the context of this specific device's 510(k) submission as provided.

The document confirms the following:

• Device Name: Needle Stimulator (Model: RJNS6-1)
• Intended Use: An electro-acupuncture stimulator indicated for use in the practice of acupuncture by qualified practitioners.
• Regulatory Pathway: 510(k) Premarket Notification.
• Predicate Device: Needle Stimulator (Model: CMNS6-2), K202861.
• Performance Evaluation: Substantial equivalence based on non-clinical tests (electrical safety, EMC, etc.) according to recognized standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).

In summary, the provided text does not contain the specific information requested about acceptance criteria and a study proving an AI-powered device meets them. The evaluation described is for a non-AI medical device and focuses on electrical and functional equivalence.

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