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The Thoraguard System is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Thoraguard System is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Thoraguard System is intended for use on patients in appropriate care settings.

The Thoraguard Surgical Drainage System is an AC/DC powered suction pump designed for the aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Thoraguard System offers automated drainage functionality, acquisition and display of drainage information, and safety alarms associated with changes in patient output.

The Thoraguard System consists of the three sub-systems: the Thoraguard Control Module, a reusable electronic device for generating and regulating suction; the Thoraguard Drainage Kit, a disposable drainage canister and dual lumen drainage tubing set; and the Thoraguard Chest Tube Kit, a dual lumen drainage catheter with a passive valve and filter.

Similar to traditional chest drainage systems, the Thoraguard System drains accumulated blood and fluid through the chest tube using regulated suction. The control module facilitates this drainage automatically and works in conjunction with the drainage kit to function as a powered suction pump. The system may be used with any drainage catheter; when used with the Thoraguard Chest Tube Kit, the system provides automated clearance of clogs within the chest tube itself. During normal operation, the control module displays relevant system information via the touchscreen graphical user interface.

The provided text is a 510(k) premarket notification summary for the Thoraguard System, which is a powered suction pump. This document describes the device, its intended use, and performance data supporting its substantial equivalence to a predicate device.

However, the provided text does not contain the specific details required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly presented in a table format, nor are specific quantitative acceptance criteria or detailed device performance metrics (e.g., specific suction rates, pressure ranges with thresholds) provided. The document states that "bench tests qualified its functionality, integrity and performance" and that "all testing requirements" and "all electrical safety and EMC testing requirements" were passed, but it doesn't give the specifics of those requirements or the exact outcomes against them.

2. Sample Size and Data Provenance for Test Set: Not mentioned.

3. Number of Experts and Qualifications for Ground Truth: Not applicable, as no clinical study involving expert assessment or ground truth establishment in this context is described. The performance data primarily refers to bench testing, biocompatibility testing, electrical safety, EMC, software verification, and usability testing.

4. Adjudication Method for Test Set: Not applicable.

5. MRMC Comparative Effectiveness Study: No multi-reader multi-case comparative effectiveness study is mentioned. This device is a medical pump, not an AI diagnostic tool that would typically involve human readers interpreting images.

6. Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device (pump) with integrated software, not a standalone algorithm.

7. Type of Ground Truth Used: For the bench testing, the "ground truth" would be the engineering specifications and reference standards (e.g., ISO 10079-1:2015, EN 1617:1997). For biocompatibility, it refers to ISO 10993-1:2009. These are not "expert consensus, pathology, or outcomes data" in the typical sense applied to diagnostic AI.

8. Sample Size for Training Set: Not applicable. This is a hardware device with software, not a machine learning model that undergoes "training."

9. How Ground Truth for Training Set Was Established: Not applicable.

In summary, the document describes performance testing for a medical device (a pump), focusing on its physical and functional attributes against engineering standards, rather than a diagnostic AI system with expert-defined ground truth and clinical performance metrics.

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