(217 days)
These patient cables and leadwires are intended to be used with ECG, EKG, Sp02 and Blood Pressure monitoring devices.
Advantage Medical Cables are produced using purchased 5 conductor cable and single conductor leadwire, both shielded and un-shielded, which is cut to various lengths, terminated with the appropriate type terminals and housed in a protective covering made from different types of FDA Grade thermoplastic elastomers, (polypropylene and TPR), using an injection molding process and custom built molds to achieve the desired shape and size. The cito-toxticity test results are in Attachment J1.
The most common cable configuration is of a three or five conductor cable with a metal or plastic connector terminated on one end by crimp or solder method, using various keyway configurations depending on the make and model of the monitor, for connection to the monitoring device, and the three or five conductors terminated into a yoke assembly for the leadwires to attach on the other end. The leadwires may be permanently attached to the yoke or terminated on one end with a .060 diameter pin and over molded with the mating DIN style connector and a snap or pinch type connector on the other end for connection to the patient electrodes. The leadwires may be shielded or unshielded construction. See Attachment E2-1 Patient Cable Drawing CB-71330R, and Illustration E1.
Advantage Medical Cables and leadwires are used in conjunction with various patient monitoring equipment such as ECG, EKG, SpO2 and Blood Pressure equipment for short term diagnostic monitoring. They are not intended to be used in any manner other than as the connection between the monitoring equipment and the electrode pads to monitor the signals between the patient and the transmitter/receiver.
The provided text is a 510(k) summary for patient monitoring cables and leadwires, and it does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML medical device.
The document discusses patient monitoring cables (ECG, EKG, SpO2, Blood Pressure) and their manufacturing process. It focuses on demonstrating substantial equivalence to predicate devices, but it references performance testing in Attachment K, which is not provided in the input.
Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving device performance, as the provided text pertains to a hardware device (cables) and lacks the specific information you're asking for regarding AI/ML device validation.
If you can provide the relevant Attachment K or a document describing the performance study for an AI/ML device, I would be happy to analyze it according to your requested categories.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).