(247 days)
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.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.