(113 days)
Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include the hands (gloves) and feet (socks).It is intended for adult patients.
Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.
The provided text is a 510(k) premarket notification letter from the FDA regarding "Wrap accessory electrodes." This document is a regulatory clearance for a medical device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI/ML-based medical device performance study.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This determination of substantial equivalence for a Class II medical device like electrodes is primarily based on performance testing and comparison to existing devices, not on the type of clinical performance study (like an MRMC study or standalone AI performance study) typically performed for AI/ML-based diagnostic devices.
Therefore, I cannot fulfill your request using the provided text. The questions you've asked are relevant for AI/ML medical devices where performance metrics like sensitivity, specificity, or AUC are established, and clinical studies are conducted to demonstrate their effectiveness, often involving human readers and ground truth data.
To answer your questions, I would need a document that describes the clinical performance assessment of an AI/ML device, including study design, results, and ground truth establishment.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).