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This device is intended to acquire 2D rotational images and convert them to 3D images.
This device is designed to be used with Toshiba Infinix Angiography X-ray Systems and a 3D Workstation. The image processor receives 2D images and converts the data to 3D images sets that are transmitted to the 3D Workstation for viewing. The device is indicated for imaging both hard and soft tissue, as well as other internal body structures to facilitate diagnosis, surgical planning, interventional procedures and treatment follow-up.

The XIDF-100A/B1 is an image processor that, when used in conjunction with the Toshiba Infinix Angiography System and a 3D Workstation, can acquire 2D images and convert them to 3D images. The system then transmits the 3D images to the 3D Workstation for display and viewing.
This device is a PC based system that has software which is used for image acquisition and transmission.

The provided text (K073259) does not contain information regarding specific acceptance criteria for the XIDF-100A/B1 Image Processor or a study that proves the device meets such criteria.

The 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices (Toshiba XIDF-100A and Siemens DynaCT) based on similar functions, indications for use, technological characteristics, and safety/effectiveness concerns.

Here's an breakdown of why the requested information cannot be found in the provided document:

1. Table of acceptance criteria and reported device performance: This information is not present. The document states "Substantial Equivalence: The XIDF-100A/B1 has similar functions and indications as those of the predicate devices," implying that its performance is considered equivalent to devices already on the market, rather than needing to meet specific new acceptance criteria demonstrated through a study detailed here.

2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set sample size, how training set ground truth was established: None of these details are provided. The submission focuses on regulatory compliance and substantial equivalence, not on a detailed clinical or technical performance study with specific metrics and methodologies.

The document states:

• "This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820."
• "This device is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60950-1."
• "The XIDF-100A/B1 has similar functions and indications as those of the predicate devices: Toshiba XIDF-100A; K002424 Siemens DynaCT; K042646 Therefore this device is substantially equivalent to devices that are already commercialized."

These statements indicate that the device's safety and effectiveness are established through adherence to manufacturing standards, electrical safety standards, and by demonstrating that it is fundamentally similar to legally marketed devices. A full, detailed study with specific performance metrics and acceptance criteria, as one might find for a novel device or a PMA submission requiring clinical trials, is not described in this 510(k) summary.

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