Search Results

AMC replacement non-invasive blood pressure cuffs, interface hoses and adapters are accessories for noninvasive blood pressure systems with manual or automated noninvasive sphygmomanometers. The cuffs, interface hoses and adapters are supplied non-sterile and may be reused. The NIBP Cuffs and interface cables are supplied in adult, pediatric, infant and neonatal sizes. The cuffs, interface hoses and adapters are not designed, sold or intended for use except as indicated.

The Advantage Cuff, NIBP Hose and Adapters are accessories for noninvasive blood pressure systems. Cuff: The cuff is comprised of an air tight bladder enclosed in an inelastic sleeve with one or two tubes and the appropriate connectors for the type device required. The Advantage Cuffs come in a range of sizes, each marked with the appropriate limb circumference for which the cuff is intended. Hose: The hose is comprised of single or dual tubing, in various lengths as required by the customer or application, with the appropriate connectors attached to each end of the tubing. Adapters: The adapters are comprised of short pieces of tubing in a "Y" configuration primarily to adapt a single tube cuff to a dual tube hose or a dual tube cuff to a single tube hose as required by the customer.

The provided document does not describe a study involving a device that uses artificial intelligence (AI) and therefore does not contain information about acceptance criteria or specific performance metrics in the way typically expected for AI-driven medical devices.

This document is a 510(k) premarket notification for a traditional medical device: Advantage Cuff, NIBP Hose, and NIBP Adapter, which are accessories for non-invasive blood pressure systems. The submission seeks to prove substantial equivalence to a legally marketed predicate device (Sensa®-Cuff by GE® Medical Systems, K022482).

The 'Testing' section mentions that the Advantage Cuffs were tested according to applicable sections of the following standards:

• AAMI SP-10:2002 & 2002/A1:2003 Manual, electronic or automated Sphygmomanometers
• BS EN 1060 Non-Invasive Sphygmomanometers
• ISO 10993 Biological Evaluation of Medical Devices

These standards specify performance requirements and testing methods for blood pressure cuffs. However, the document does not report the specific acceptance criteria defined by Advantage Medical Cables, Inc. or the quantitative performance metrics achieved by their device against those criteria. It only states that the device was tested according to these standards and concludes that it is "equivalent in safety and usage to the legally marketed predicated devices."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance using the information given in the document.

In summary, none of the requested information regarding AI device performance can be extracted from this document, as it pertains to a non-AI medical accessory.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The compatible Medical Cables, Inc. SpO2 Finger Probe has the same intended use as the predicate probes, i.e. recommended for use in short term continuous noninvasive SpO2 saturation and pulse rate monitoring on patients weighing greater than 40kg. The intended environment of use of the Medical Cables SpO2 Finger Probe is the same as the predicate probe, i.e. in a medical or clinical environment under the direction of a physician.

SpO2 Finger Probe Models P856RA, P861RA, P862RA, P867RA, and P876RA

I cannot provide information about the acceptance criteria and study as the provided text is a 510(k) clearance letter for a medical device and does not contain the details of acceptance criteria or the study that proves the device meets those criteria. The letter primarily states that the device has been reviewed and determined to be substantially equivalent to previously marketed devices.

To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the performance data and the methods used to establish substantial equivalence.

Ask a specific question about this device