(87 days)
The CanGaroo® Envelope is intended to securely hold a cardiac implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
The CanGaroo Envelope is a sterile device intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator device to create a stable environment when implanted in the body. It is for single use in a single patient. The cardiac devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices; the implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
The CanGaroo Envelope is constructed from two perforated, multi-laminate sheets (4- ply) of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa. The perforations are spaced evenly to allow exit of any exudate. The ECM is assembled into pouch form using violet 5-0 polydioxanone (PDS) suture.
The provided text is a 510(k) premarket notification letter and summary for a medical device called the CanGaroo® Envelope. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about an AI/ML-driven medical device, nor does it describe an acceptance criterion or a study that proves a device meets an acceptance criterion related to AI/ML performance.
The document details the device's physical properties (decellularized porcine small intestinal submucosa, polydioxanone suture), its purpose (securely holding implanted cardiac or neurostimulator devices), and the non-clinical testing performed (seam strength testing) to demonstrate its biomechanical properties.
Therefore, I cannot answer your request based on the provided input. The request asks for details about acceptance criteria and a study proving an AI/ML device meets those criteria, including specifics like sample sizes for test/training sets, expert qualifications for ground truth establishment, MRMC studies, and standalone algorithm performance. This information is completely absent from the provided text, which pertains to a physical surgical mesh envelope.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.