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The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.

Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.

The OR table is suitable for interventional and surgical procedures.

The intended use and indications for use are unchanged from the predicate device.

GE HealthCare IGS interventional x-ray systems are designed to perform monoplane fluoroscopic x-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures (standard configuration).

Additionally, in the OR configuration (with an OR Table), these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room.

Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR are monoplane GE HealthCare IGS interventional X-Ray system product models. Each product model is designed with a set of components that are combined into different configurations for providing specialized interventional x-ray systems. GE HealthCare IGS interventional x-ray system consists of a C-arm positioner, an x-ray table or the interface to the radiologic table, an x-ray tube assembly, an x-ray power unit with its exposure control unit, an x-ray imaging chain (including a digital detector and an image processing unit).

Allia IGS 5 is a monoplane system (C-arm positioner with L-shaped gantry) and is proposed in IGS 530 configuration with a square digital detector of 31cm (also called 30 cm configuration) or in IGS 520 configuration with a square digital detector of 20.5cm (also called 20 cm configuration). These product configurations are available in Standard configuration with Omega V table or Omega IV table (IGS 520 configuration only); or in OR configuration with Innova-IQ GE HealthCare OR table.

Allia IGS 3 is a monoplane system (C-arm positioner with L-shaped gantry) and is proposed with a square digital detector of 31cm. This product is available in Standard configuration with Omega V table. Allia IGS 7 is a monoplane system (C-arm with mobile AGV gantry) and is proposed in IGS 730 configuration with a square 31cm digital detector (also called 30 cm configuration). This product configuration is described in sub configurations: Standard or OR configuration. The Innova-IQ table in the OR configuration is the GE HealthCare OR table. Allia IGS 7 OR is a monoplane system (C-arm positioner with mobile AGV gantry) and is proposed in IGS 730 OR configuration with a square 31cm digital detector configuration. This is the product model compatible with a qualified configuration of the Maquet Magnus OR table system. This product model is provided with a table integration kit. The Magnus OR table configuration compatible with Allia IGS 7 OR includes flat table top configurations for Interventional X-Ray imaging and surgery procedures, an optional universal table top (table top with articulated joints) to enable expansion to surgical procedures requiring advanced patient positioning and with X-Ray imaging capabilities. A set of Magnus OR table accessories is included in the compatible configuration.

The purpose of this Premarket Notification is for the re-design of the x-ray source assembly.

Allia IGS 3, Allia IGS 5 in IGS 520 and IGS 530 configurations, Allia IGS 7 in IGS 730 configuration, and Allia IGS 7 OR in IGS 730 OR configuration will be improved and will be marketed as Allia IGS 3 Pulse, Allia IGS 5 Pulse, Allia IGS 7 Pulse, and Allia IGS 7 OR Pulse. All these four models may also be designated with the marketing name Allia IGS Pulse.

The provided text does not contain specific acceptance criteria and detailed device performance results relevant to AI/ML software. The document is an FDA 510(k) clearance letter for an interventional fluoroscopic x-ray system (Allia IGS 3, IGS 5, IGS 7, IGS 7 OR). It describes changes to hardware components (e.g., x-ray tube, cooling unit, generator), lists applicable regulatory standards, and generally states that the device successfully completed verification and validation testing, including risk management, software V&V, image quality, and dose performance using standard IQ metrics and QA phantoms. It also mentions "additional engineering bench testing... to substantiate the quantitative performance claims related to the new x-ray source assembly" and "testing... to demonstrate the overall imaging performance... using a wide variety of anthropomorphic phantoms."

However, none of this information is presented in the format of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for an AI/ML algorithm or detailed device performance metrics against those criteria. Furthermore, there is no mention of a study involving human readers, comparative effectiveness studies with or without AI, or the collection of ground truth data for a specific diagnostic task relevant to an AI/ML component.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets them in the context of AI/ML software performance based on the provided text. The document refers to the overall system's compliance with safety and performance standards for an X-ray system, not the performance of an AI/ML component.

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