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This device is a digital radiography system used in diagnostic X-ray angiography system configuration. This X-ray angiography system is indicated for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower limb blood vessels. It is intended to replace images obtained through the image intensifier technology.

This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography system configuration. This equipment processes, displays, and records digital images obtained from the Fiat Panel Detector, and it replays the recorded images.

The provided document is a 510(k) summary for a Digital Radiography System with Flat Panel Detector (DFP-8000D / FPD). The summary indicates that the device is "substantially equivalent" to a predicate device (DFP-8000D with Image Intensifier, K013608). However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. It primarily focuses on the device's technical specifications and its equivalency to a predicate device.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document states: "TOSHIBA Medical Systems Corporation believes that the new Digital Radiography System, model DFP-8000/FDP is substantially equivalent to the current Digital Radiography System, DFP-800D with Image Intensifier (model RTP16301J-G1E) (K013608) except for the new Flat Panel Detector (FPD)." This means that the device was approved based on its substantial equivalence to a previously approved device, rather than through a direct study demonstrating its meeting of explicit acceptance criteria with performance metrics.

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