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The TITAN 11 is a diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. This device is not intended for mammography.

TITAN 11, the high frequency inverter type of Radiographic system is operated by the built-in operation program. TITAN 11 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the SSXI detector, X-ray Generator, X-ray Collimator, PC, Detector Stand, Tube Stand, Mobile Table, PU-30(Power Supply) and viewing software. Optional devices include AEC, DAP, Hand or Foot Exposure Switch.

The provided text describes a 510(k) premarket notification for the TITAN 11 Stationary X-ray System, asserting its substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-driven medical device.

The document discusses performance testing, but this is primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance acceptance criteria for a novel AI/ML application. The performance testing includes non-clinical tests (e.g., electromagnetic compatibility, software validation) and a limited clinical review by a radiologist.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria, detailed study design, and quantitative performance results for an AI/ML device. The document primarily focuses on regulatory compliance and substantial equivalence for a traditional x-ray system.

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