(114 days)
This device has been designed to allow the safe and effective drainage of fluid from a patient following disruption in the normal anatomical arrangement of the chest or a disturbance of the intrapleural pressure mechanism causing the entry and accumulation of air and or fluid.
This is achieved by a design incorporating safety features to maintain a constant suction pressure, prevent the ingress of air and fluid back into the chest cavity, whilst maintaining an unobstructed drain from the patient.
The provided document (K961287) describes a medical device, the Pleuraseal III Chest Drainage System, and assesses its safety and effectiveness. However, it does not include information about AI or machine learning models. Therefore, it's not possible to extract the requested information related to acceptance criteria for an AI device, study details for AI performance, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document is a traditional premarket notification for a Class II medical device, focusing on its design, function, and substantial equivalence to existing devices. The "safety and effectiveness" claims are based on a year of incident-free use in the UK and general safety features of the device, not on AI performance metrics.
Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluations, which are not present in this document.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.