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ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of a pneumothorax 5 mm or larger; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of cases suspected of containing a pneumothorax is not for diagnostic use beyond notification. ClearRead Xray Pneumothorax is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. The device does not replace review and diagnosis of the Xrays by trained professionals. The device is not intended to be used with plain film X-ray.

ClearRead Xray Pneumothorax is comprised of a computer assisted triaging tool, designed to prioritize chest X-rays based on the suspected presence of a pneumothorax (PTX) 5mm or larger. ClearRead Xray Pneumothorax requires both lungs to be in the field of view. ClearRead Xray Pneumothorax provides adjunctive information and is not intended to be used for diagnosis. ClearRead Xray Pneumothorax receives images according to the DICOM® protocol (via a standard IEEE 802.3 network connection), processes the image, and delivers the resulting information through the same DICOM network interface. Image inputs are limited to adult, digital frontal chest radiographs. The output results are sent to facilitate prioritization of chest Xrays for radiologist review on one or more devices that conform to the ClearRead Xray Pneumothorax DICOM Conformance Statement. ClearRead Xray Pneumothorax does not support printing or DICOM media.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: ClearRead Xray Pneumothorax (K213566)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" per se. However, it indicates key performance metrics that were measured and met through the clinical evaluation. The primary objective was to demonstrate the device meets or exceeds expected performance. The specific metrics, measured on an independent test set, and their reported values are:

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