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Cyber BLADE is intended for use under endoscopic visualization and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.

Cyber Blade provides efficient and rapid morcellation under endoscopic visualization. The cutting action is driven by the motor in the handpiece. Cyber Blade comprises: a single use sterile blade fixed to a handpiece where controls are placed, a re-usable internal motor provided with integrated battery pack, an AC powered charger for the battery pack. Cyber blade is also supplied with aspiration tubing and canister for the collection of evacuated tissue.

I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document refers to the Cyber Blade, which is a medical device for morcellation and removal of BPH tissue, but it does not contain information about acceptance criteria or performance studies with human subjects or AI.

The text primarily details:

• The FDA's 510(k) clearance for the Cyber Blade, indicating substantial equivalence to predicate devices.
• Device description, technical specifications, and comparison to predicate devices.
• A list of recognized consensus standards and guidelines that the device complies with (e.g., related to electrical safety, biocompatibility, sterilization, packaging, risk management, and software).
• Additional types of testing performed (morcellation efficiency, suction test, dimensional verification, tensile strength, comparative testing with a specific morcellator, risk analysis on performance tests, and battery testing).

None of these sections provide:

1. A table of acceptance criteria and reported device performance for a study.
2. Sample sizes or data provenance for studies involving performance against acceptance criteria.
3. Details about experts or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size or ground truth establishment for a training set.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical trial data or performance against specific, quantifiable acceptance criteria often seen for novel devices or software with complex performance claims (like AI). The "performance testing" mentioned refers to engineering tests against established standards and product specifications, not clinical outcomes or diagnostic accuracy studies.

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