(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.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for Rocketmedical. The logo consists of a black circle with a white "R" inside, along with a white cross and two white lines. Below the logo, the word "Rocketmedical" is written in black font.
JUL 26 1996
Summary of Safety and Effectiveness
Pleuraseal III Chest Drainage System
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.
This is a class II device, registered by Rocket Medical (Establishment number: 8010022/9610632). This device is substantially equivalent to a medical device which is currently in commerce and has been submitted to the FDA, marketed by Atrium.
The device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness for over 1 year, without incident in the UK.
Rocket Medical continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
27th March 1996
Date
Signature
Signed by Leslie Todd Quality Assurance Manager Rocket Medical Wear Industrial Estate, Washington Tyne & Wear, England. NE37 1NE
.
(
§ 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.