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PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:

• Separate tissue or structures compromised by surgical trauma;
• Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
• Help control minimal bleeding following surgery or trauma;
• Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
• Act as an adjunct to aid in the natural healing process

PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® X BAM is placed in the nasal cavity after sinus surgery to prevent adhesions, control mild bleeding, and provide a level of protection against bacteria and fungi. PosiSep X BAM is supplied as a compressed foam, and it quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. Upon hydration, PosiSep® X BAM expands to contact and conform to the surrounding anatomy.

PosiSep X BAM is comprised of N, O-Carboxymethyl Chitosan derived from non-shell fish based Chitosan, modified Cellulose, and antimicrobial agents.

PosiSep® X BAM is fragmentable and eliminated from the site of application by natural excretion through the action of cilia.

The provided text is a 510(k) summary for a medical device called PosiSep® X BAM Hemostatic Dressing/Intranasal Splint. It describes the device, its intended use, and how its substantial equivalence to a predicate device (Hydrofera Bacteriostatic Nasal Dressing) was demonstrated. However, this is NOT a study that evaluates an AI/ML powered device, nor does it contain acceptance criteria or study results for such a device.

The information you requested (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are typically found in the clinical study report or performance evaluation section of an AI/ML device submission. This document does not contain any of that information.

The document describes performance bench testing for antimicrobial activity of the PosiSep® X BAM device, but this is a physical/chemical performance test of a traditional medical device, not an evaluation of an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot provide the requested information from the given text because it is not relevant to an AI/ML device.

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PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.

This document describes the PosiSep® EAR Fragmentable Ear Dressing, a medical device, and its acceptance criteria as demonstrated through a substantial equivalence submission to the FDA. The information provided focuses on comparing the device to a predicate device (NasoPore® Ear) and reference devices (PosiSep/PosiSep X) rather than detailing a specific clinical study with granular data on acceptance criteria and performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and corresponding reported device performance. Instead, substantial equivalence is claimed based on comparable characteristics to predicate devices. The key "acceptance criteria" are implied through the comparison parameters.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily relies on non-clinical performance data, specifically biocompatibility testing and performance bench testing. It does not mention a "test set" in the context of clinical data or patient samples for evaluating device performance against the specified indications. The evaluation appears to be based on:

• Biocompatibility testing: Performed internally, demonstrating compliance with ISO 10993 and FDA guidelines.
• Performance bench testing: Performed internally to demonstrate physical and functional requirements were met.
• Comparison to predicate devices: The primary data provenance is the established safety and effectiveness of the legally marketed predicate devices (NasoPore® Ear, PosiSep/PosiSep X).

The document does not specify a sample size for these non-clinical tests. As it's a 510(k) submission, the focus is on demonstrating "substantial equivalence" rather than conducting a de novo clinical trial with a large patient sample.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided because the submission primarily relies on non-clinical data and comparisons to predicate devices for demonstrating substantial equivalence, not on a clinical test set with human expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with expert adjudication is described.

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. The device described is a physical ear dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as the device is a physical medical dressing, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by standardized biological tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 guidelines, where "ground truth" means the objective results of these tests (e.g., non-cytotoxic). For performance, the "ground truth" relates to the physical and functional properties of the device meeting predetermined engineering specifications during bench testing.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as the device is not an AI/ML algorithm.

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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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Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:

• Separate tissue or structures compromised by surgical trauma
• Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity
• Help control minimal bleeding following surgery or trauma
• Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation
• Act as an adjunct to aid in the natural healing process

Indicated for use as a nasal hemostat to treat epistaxis.

Intended for use under the direction of a licensed healthcare provider.

Intranasal splints are utilized to stop nasal hemorrhage and for the prevention of tissue adhesion in the nasal and/or sinus cavities. It is often used after FESS, nasal/sinus surgery, or surgical trauma in the event of excessive epistaxis. Splints are gently inserted into the nasal cavity. The device is designed to swell within the nasal cavity in order to exert pressure on the bleeding sites.

The splint material is dissolvable. Splints can also be used following sinus surgery in order to hold cartilage and membranes in their proper places during healing following surgerv.

The Chitosan Intranasal Splint is made from Carboxymethyl Chitosan, mixed with Methyl Cellulose, and Hydroxyethyl Cellulose to make an absorbent porous sponge that is flexible and dissolvable. The device acts as a nasal splint and temporary spacer.

The provided text describes a 510(k) premarket notification for a medical device called "ChitoZolve," an intranasal splint. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, specifically concerning an AI/ML-driven device.

The document focuses on demonstrating that ChitoZolve is substantially equivalent to a predicate device (Hemostasis PosiSep / PosiSep X). The performance testing described is for the physical and biological characteristics of the splint itself, such as:

• Reconstitution (volume)
• Expansion (dimensional height)
• Dissolution time (In vitro)
• Platelet adhesion, whole blood coagulation
• Firmness
• Pliability
• Thickness
• pH
• Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity)
• Stability/Shelf life

It explicitly states: "No animal or clinical testing was conducted. The use of the device type has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device, a sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the non-AI/ML device described in the document.

The document is a regulatory submission for a physical medical device and not an AI/ML diagnostic or therapeutic system.

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