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Morce Scope Set 8970:
The Morce Scope Set, in conjunction with a morcellation probe, and with its sheaths and obturators, is used in the cutting (morcellation) and continuous removal of large detached tissue masses.
In combination with intracorporeal lithotriptors, e.g. operated pneumatically, by ultrasound, electro-hydraulically or by laser under endoscopic control, it can be used as a nephroscope in the disintegration and removal/aspiration of kidney and bladder stones and the removal of detached tumors from the bladder.

Power Control 2303:
The POWER CONTROL 2303 in conjunction with POWER STICK M4 serves to drive WOLF morcellators for the continuous removal of ablated tissue in endoscopic operations.

Suction Pump 2207:
The SUCTION PUMP is used for aspirating irrigation fluid in conjunction with a resectoscope or a morcellator following laser TURP.

Indication and Field of Use:
When used as a Morce Scope: for therapy via the transurethral passage after a TURP (TransUrethral Resection of the Prostate) procedure.
When used as a nephroscope: for diagnosis and therapy of urolithiasis.
In both cases the product must be used in conjunction with endoscopic accessories. The product may only be applied by adequately qualified and trained medical personnel.

The Morce Scope Set 8970, is a morcellation set that consist of a Morce endoscope, rotary blade, sheaths, obturators and an optional sieve. The rotary blade is designed to be inserted through the Morce endoscope, requiring one incision. The rotary blades are driven by the motor on the Power Controlled by the Power Control Generator 2303. The suction pump 2207 removes the morcellated tissue.

This is a 510(k) premarket notification for a medical device (Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207), not an AI/ML device, and therefore the provided document does not contain information on acceptance criteria or a study proving that an AI/ML device meets those criteria. The information requested (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to AI/ML device evaluations and is not relevant to this traditional medical device submission.

The document indicates that "No clinical tests performed" were conducted for this device. The performance data section states that "The devices are designed to meet the standards IEC601-11 1988 and A1 + A2 and IEC601-1-2." This refers to electrical safety and electromagnetic compatibility standards, not to clinical performance or accuracy in the context of AI/ML.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other questions as they pertain to AI/ML device studies.

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