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The Velox Nebulizer System is a handheld nebulizer that is to be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 4 years and older who can coordinate breathing through a mouthpiece, and may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The Velox Nebulizer System is a portable, reusable, single-patient use, handheld electronic nebulizer that uses a piezo-driven, micro-perforated vibrating membrane technology to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases. It is to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. it is for prescription use only. It may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile. The device consists of two major components: the nebulizer and a Controller. The nebulizer contains a medication cap, medication reservoir, aerosol head, aerosol chamber, and mouthpiece. The Controller contains a circuit board, USB connector, patient interface (on/off switch), and AA battery housing. The controller's functions are to conduct power pre-processing, supervise aerosol generation through incorporated software, and generate optical and acoustical feedback to the user. The device is powered by connection to a mains power source via an AC Power Supply or disposable/rechargeable AA batteries. Associated accessories include a cleaning aid and an AC Power Supply.

The provided text describes the regulatory clearance of a medical device (Velox Nebulizer System) and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and study details for an AI/ML powered device.

The document is a 510(k) premarket notification for a nebulizer, a physical medical device. The "Software Verification and Validation Testing" section mentions that the software for this device is of a "moderate" level of concern and controls basic functions of the nebulizer (power, aerosol generation, user feedback) but there is no indication that it uses AI or machine learning algorithms for its operation or for diagnostic purposes.

Therefore, I cannot provide the detailed information requested for an AI/ML powered device, such as effect size of human readers improving with AI, standalone performance, or details about ground truth establishment for AI/ML models.

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