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Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use in patients suffering from anterior epistaxis to:

• Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation;

• 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.

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The Novapak Nasal Sinus Packing and Stent is intended for use in patients undergoing nasal/sinus surgery as a space occupying packing to:

• · Separate tissue or structures compromised by surgical trauma.
• · Separate and prevent adhesions between mucosal surfaces in the nasal cavity.
• · Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption, and platelet aggregation.
• · Act as an adjunct to aid in the natural healing process.

Novapak is indicated for use as a nasal packing to treat epistaxis.

Novapak™ is a single use, nasal packing and stent for use following sinus surgery to prevent adhesions, control mild bleeding and provide a level of antibacterial effectiveness. Novapak™ is composed of formulated chitosan and cellulose ingredients in a sponge can be compressed for insertion into anatomy and can be cut to size.

Novapak™ hydrates with sterile saline and forms a gel. The sponge dissolves within the nasal cavity with daily irrigation and natural mucus flow over several days. Residence time is typically 7-14 days with adequate irrigation. Alternately, the dressing may be removed through gentle aspiration at the discretion of the physician.

This FDA 510(k) summary describes the Novapak™ Nasal Sinus Packing and Stent and its substantial equivalence to a predicate device. The information provided heavily focuses on the physical and biological performance of the device rather than a clinical study with human readers or AI performance. Therefore, many of the requested categories related to AI performance, multi-reader studies, and expert ground truth cannot be answered from this document.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify exact sample sizes for each test ("all samples passed testing"). The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but all testing was conducted on the device itself (sterile final product) and its packaging in a laboratory setting. This is therefore prospective laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical medical device (nasal packing and stent), not a diagnostic AI system requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for its performance is derived from laboratory tests and established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human reader interpretation or clinical adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission concerns a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established through internationally recognized standards (e.g., ISO 10993 for biocompatibility) and laboratory tests. For example:

• Biocompatibility: Adherence to ISO 10993 guidelines.
• Sterilization: Meeting a validated sterility assurance level of 10-6.
• Absorption, degradation, compression, hemolysis, platelet activation, bacterial log reduction, bacterial barrier: Measured outcomes against internal specifications and relevant test methods.
• Shelf life and packaging integrity: Measured outcomes against internal specifications and relevant test methods, potentially following ASTM or other packaging standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for a physical device like this.

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