(63 days)
Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use in patients suffering from anterior epistaxis to:
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Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation;
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Act as an adjunct to aid in the natural healing process.
Epi-Stop™ Nasal Gel/Epistaxis Pack is indicated for use as a nasal packing to treat anterior epistaxis.
Epi-Stop™ Nasal Gel/Epistaxis Pack is intended for use under the direction of a licensed healthcare provider.
Epi-Stop™ Nasal Gel/Epistaxis Pack is a single use, hemostatic, and injectable gel, made of crosslinked gelatin and hyaluronic acid, indicated for the treatment of anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack creates a moist environment for healing and the ability of absorbing and stopping nose bleeding within minutes. Due to its viscoelasticity and low extrusion force, Epi-Stop™ Nasal Gel/Epistaxis Pack can be injected into the anterior nasal cavity and the gel must be left in the nose for at least 72 hours. Afterwards, the gel can be removed by using safe water for gentle irrigation (either sterile or boiled water) or using safe lukewarm water.
The provided document is a 510(k) summary for a medical device (Epi-Stop™ Nasal Gel/Epistaxis Pack), not a clinical study report for an AI/ML device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving an AI/ML device meets them.
The document discusses the substantial equivalence of the Epi-Stop™ Nasal Gel/Epistaxis Pack to a predicate device (Chitogel® Endoscopic Sinus Surgery Kit) based on biocompatibility testing and performance testing of the physical properties of the gel. It also mentions an in-vivo animal study to verify the device's ability to stay at the placement site and its hemostatic capabilities.
Here's why the document cannot answer your specific questions about AI/ML device acceptance criteria and study:
- Device Type: The Epi-Stop™ Nasal Gel/Epistaxis Pack is a physical medical device (nasal gel/packing) designed to treat anterior epistaxis (nosebleeds). It is not an AI/ML software or algorithm.
- Study Design: The studies described (biocompatibility, physical performance tests like absorption, occlusion, viscosity, extrusion force, pH, and an in-vivo animal study) are all related to the physical and biological characteristics of the gel itself, not to the performance of an AI/ML model.
- Ground Truth/Experts: The concept of "ground truth" established by experts, multi-reader multi-case (MRMC) studies, or training/test sets is specific to the validation of AI/ML algorithms, particularly in image analysis or diagnostic applications. These concepts are not applicable to the evaluation of a physical product like a nasal gel.
Therefore, it is not possible to extract the requested information regarding AI/ML device acceptance criteria and study design from this document.
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.