Search Results

The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.

The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.

MasterScreen Paed - Baby Body is a pediatrics device providing following characteristics:

• Mains operation .
• Trolley for device and Baby Body box .
• Personal Computer System .
• Graphic user interface Windows XP Professional .
• Powerful database for storing patient- and test data .
• Tidal Breathing Analysis .
• Baby-Body Plethysmography .
• Baby Resistance / Compliance .
• Rapid Thoracic Compression (RTC) .
• Raised Volume Rapid Thoracic Compression (RV-RTC) .
• Spirometry / Flow Volume / MVV for children and adolescents ◆
• Airway Resistance (R Occlusion) for children and adolescents .
• P.01 / PImax / PEmax for children and adolescents .

The provided 510(k) summary for the MasterScreen Paed - Baby Body (K081823) does not describe a clinical study comparing the device's performance against specific acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, patient population, performance (measurements), software, device specifications, and accessories.

The summary highlights that the new options for the device were developed in accordance with VIASYS's standard operating procedures (Design Control), and that risk analysis (FMEA), safety test procedures, software development (IEC 601-1-4), and EMC testing (EN 60601-2) were performed. However, these are general compliance and engineering validation activities, not a detailed clinical study with performance metrics and acceptance criteria as typically found in a comparative effectiveness or standalone performance study for an AI/CADx device.

Therefore, the specific information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as such a study is not described.

The comparison tables provided in the document indicate that the new features offer "Identical" performance to the predicate devices in terms of specific measurement capabilities, but they do not define numerical acceptance criteria or present data from a study to prove these criteria were met.

In summary, the 510(k) relies on demonstrating equivalency to existing, legally marketed devices and adherence to relevant standards for design, safety, software, and EMC, rather than presenting a novel clinical study with explicit acceptance criteria for device performance.

Ask a specific question about this device