(148 days)
The Invia Foam Dressing Kit is intended to be used in conjunction with the Invia Liberty NPWT Systems to deliver negative pressure wound therapy to the wound. The Invia Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound of excess exudates, infectious material and tissue debris ..
Invia Foam Dressing Kit is appropriate for use on the following wounds:
- Pressure Ulcers
- Diabetic/Neuropathic Ulcers
- Venous Insufficiency Ulcers
- Traumatic Wounds
- Post-operative and Dehisced Surgical Wounds
- Skin Flaps and Grafts
The Invia Foam Dressing Kit consists of a Foam Pad, a Connection Tube including a Ported Pad and Thin Film Drapes (1-3 pieces depending on the Kit size). The Foam Pad is manufactured using a reticulated flexible polyester and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Pouch which is sterilized using EtO, Ethylene Oxide.
This document is a 510(k) Summary for the Medela AG Invia Foam Dressing Kit (K151261). It does not contain information about an AI/ML device or a study structured to evaluate acceptance criteria for such a device.
The document describes a medical device (a foam dressing kit for negative pressure wound therapy) and its substantial equivalence to a predicate device based on non-clinical performance data and comparative bench testing. There is no mention of an AI/ML component or involvement in this device or its evaluation.
Therefore, I cannot provide the requested information, which pertains specifically to acceptance criteria and studies for an AI-powered device. The questions you've asked (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are relevant to AI/ML device evaluations, but they are not addressed in this regulatory submission for a physical medical device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.