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TurbAlign is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with sinus surgery (e.g., endoscopic sinus surgery, FESS). The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.

TurbAlign™ is a bioabsorbable, polydioxanone implant designed to hold the middle turbinate away from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant includes self-anchoring features (e.g., one "distal anchor" and multiple "proximal anchors") which enable attachment to the middle turbinates for short-term fixation of the middle turbinate to the nasal septum.

TurbAlign includes an attached surgical needle which is inserted into the lateral aspect of the middle turbinate. It is then passed through the nasal septum and then through the contralateral middle turbinate. The implant is then pulled through all three structures until the distal anchor feature is embedded in the first middle turbinate at which time the turbinate is medialized to the septum. The contralateral turbinate is then medialized to the opposite side of the septum using a freer or equivalent and held into place via the proximal anchor. The excess portion of the implant is trimmed off.

The sterile, single-use implant is delivered using standard surgical instruments, such as needle drivers. The implant provides temporary fixation and is fully resorbed over 180 days.

This document is a 510(k) Pre-market Notification for a medical device called TurbAlign. It does not describe a study based on analyzing medical images or clinical data for AI/ML device approval. Instead, it describes hardware device attributes and physical performance tests.

Therefore, the requested information regarding acceptance criteria, reported performance for an AI/ML device, sample size for test/training sets, experts, adjudication methods, MRMC studies, or specific types of ground truth cannot be extracted from this document, as it pertains to a different type of medical device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for an intranasal splint based on:

1. Biocompatibility Testing: Ensuring the materials are safe for human contact.
2. Distribution, Packaging, and Shelf-Life Testing: Verifying sterile barrier integrity and device performance over time.
3. Performance Testing – Bench: Evaluating mechanical integrity, anchoring features, and usability by ENT physicians in cadaver specimens.

The closest this document comes to "performance criteria" is the statement that "Mechanical integrity testing of the implant and needle properties was performed and demonstrated that the physical and functional requirements were met" and "Comparative testing... demonstrated equivalent performance of the device's anchoring features in the relevant tissue." For usability, it states that "the physicians graded the turbinate position post-TurbAlign placement and confirmed both turbinates were medialized and did not contact the lateral wall." However, these are not quantitative acceptance criteria in the format requested for an AI/ML study.

Summary of missing information for an AI/ML device:

• Table of acceptance criteria and reported device performance: Not applicable; no AI/ML performance metrics are mentioned.
• Sample size for test set and data provenance: No test set of data (images, etc.) is mentioned.
• Number of experts and qualifications: Experts (ENT physicians) were used for usability testing of the physical implant in cadavers, not for establishing ground truth on a data set.
• Adjudication method: Not applicable.
• Multi Read Multi Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable; this is a physical device.
• Type of ground truth used: Not applicable for an AI/ML context. The closest is the physical observation of turbinate medialization by physicians in cadavers.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

This 510(k) pertains to a traditional, non-AI medical device.

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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 SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.

The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic transnasal sphenoid sinus and skull base surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.

This document describes a 510(k) premarket notification for a medical device called the "SPIWay Endonasal Access Guide." The core of the submission revolves around demonstrating substantial equivalence to a legally marketed predicate device.

Based on the provided text, the device itself (SPIWay Endonasal Access Guide) is a physical, sterile, single-patient-use device, not an AI or software-based medical device. Therefore, the concepts of "acceptance criteria for an AI device," "test set," "number of experts for ground truth," "adjudication methods," "MRMC studies," "standalone performance," "training set," and "ground truth for training set" are not applicable to this physical device submission.

The document explicitly states:

• "Since the subject device is unchanged from the predicate device, repeat design verification and validation testing were not required." (Section 7. Performance Data)
• "Since the subject device is unchanged from the predicate device, repeat biocompatibility testing was not required." (Section 8. Biocompatibility)
• "The subject device is identical to the predicate device." (Section 9. Conclusion)
• "There are no differences in technological characteristics between the subject device and the predicate device." (Section 6. Technological Characteristics)

The only stated change compared to the predicate device is a modification to the "Indications for Use" statement "to more accurately describe use of the SPIWay Endonasal Access Guide in current endoscopic transnasal skull base surgical practice."

Therefore, it is not possible to provide the requested information regarding acceptance criteria and performance studies for an AI/software device, as this submission pertains to a physical, unchanged medical device being cleared based on substantial equivalence to an existing predicate with a minor label change.

To answer the prompt directly, but acknowledging the device type:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Substantial equivalence to the predicate device (SPIWay Endonasal Access Guide K180141) in terms of:
  • Intended use (modified to allow for skull base surgery)
  • Technological characteristics (identical)
  • Design (identical)
  • Function (identical)
  • Basic materials (identical)
  • Biocompatibility (identical, no repeat testing required)
  • Packaging (identical)
  • Sterilization (identical)
• Reported Device Performance: The device performs identically to the predicate because it is the identical device. No new performance data was required or provided as part of this 510(k) submission due to the device being unchanged from its predicate. The change was solely in the Indications for Use statement for clarity regarding current surgical practice.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device requiring a test set for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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The SPIWay® Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.

The SPIWay®Endonasal Access Guide is a temporary working channel sheath for use in endoscopic sphenoid sinus and transsphenoidal surgery. The device consists of a single piece of thermoplastic polymer with a low friction coating, which creates a working channel sheath in the natural orifice of the nose to facilitate visualization of the surgical site and smooth manipulation of introduced instruments during transnasal endoscopic surgery.

The shape of the SPIWay Endonasal Access Guide contains a flared portion at the proximal end of the device which remains outside the nasal passage and a conical body that sits within the nasal cavity. The flared proximal end and conical body act to anchor the device, preventing migration once inserted and allow simple removal. The device has an elliptical shape, and the major axis of the ellipse is oriented vertically with the nostril.

The device is supplied in several lengths that are selected based upon the surgeon's needs. It is provided sterile and for single use in a pack of two, one for each nostril. A pair of devices is sealed in a Tyvek pouch and 5 pouches are placed into a labeled carton.

The provided document is a 510(k) summary for the SPIWay Endonasal Access Guide, which is a Class I medical device. For devices in this class, the regulatory requirements for demonstrating safety and effectiveness are generally less stringent than for higher-risk devices and often rely on substantial equivalence to a predicate device rather than extensive clinical studies.

The document does not contain the detailed information required to fill out all aspects of your request regarding acceptance criteria and performance studies, specifically for an AI/ML-based device or a device involving human readers/ground truth experts. This is because the SPIWay device is a physical, non-AI surgical accessory, and its evaluation focuses on materials, functionality, and biocompatibility, not diagnostic performance or human-AI interaction.

However, I can extract what is available and explain why other sections cannot be completed based on this document.

Acceptance Criteria and Device Performance (Based on available information for a physical medical device)

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SPIWay Endonasal Access Guide, K153686) after modifications were made (coating, material, and size range). The "acceptance criteria" for such a device are typically met through various bench testing and design validation activities to ensure physical and functional requirements are met, rather than a statistical performance study against clinical metrics.

1. Table of Acceptance Criteria and the Reported Device Performance:

Information NOT Available in the Document (and why it's not applicable/expected for this device type):

The following points pertain to AI/ML or diagnostic performance studies, which are not relevant to this physical surgical guide. Therefore, the document does not contain this information.

2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/ML diagnostic. Testing involved bench and cadaver studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device, not an AI/ML diagnostic or image reader.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a diagnostic test with subjective interpretation.

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 device does not involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Performance was likely assessed against engineering specifications and functional success in cadaver models.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary regarding the study proving device meets acceptance criteria:

For the SPIWay Endonasal Access Guide, acceptance was proven through:

• Design verification bench testing: To ensure physical and functional requirements were met.
• Design validation cadaver testing: To demonstrate effectiveness for its intended use.
• Biocompatibility testing (per ISO 10993): To ensure material safety.

The primary "study" proving acceptance was the successful completion of these non-clinical tests, affirming that the modified device performed equivalently to its predicate and met safety standards for a Class I intranasal splint.

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The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention surgery. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.

The subject device is supplied sterile for single use. The composite removable sinus stent provides sinus wall support following functional endoscopic sinus surgery. A delivery system is provided to insert the implant. The system contains the following components: Stent: The stent is balloon expandable and composed of an outer polyurethane and inner Nitinol alloy bodies. The stent is designed to accommodate the size and variability of the post-surgical ethmoid cavity anatomy. Once expanded the stent is designed to support the walls of ethmoid cavity, in order to prevent adhesions and middle turbinate lateralization into the septum. Stent can be removed within 4 weeks by cooling and self-crimping. Delivery System: The delivery system is designed to insert, position and deploy the stent, following functional endoscopic sinus surgery, guided by endoscopic direct vision. The delivery system consists of a water filled syringe connected to high compliance low pressure balloon via rigid shaft. The balloon is supplemented with color marker.

The provided text describes the "Composite Removable Sinus Stent System" and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study results in the format requested for an AI/CADe device.

This document is a 510(k) summary for a physical medical device (a sinus stent), not an AI/CADe (Computer-Aided Detection/Diagnosis) device. Therefore, the questions related to AI/CADe performance, such as sample sizes for test/training sets, expert consensus for ground truth, or MRMC studies, are not applicable to the information provided.

The document discusses various tests for the sinus stent, including:

• Bench Testing: Covered aspects like stent integrity, dimensions, functional tests, crush resistance, radial strength, corrosion resistance, delivery system integrity, dimensional verification, repeat inflation, crossing profile, and simulated use. It states, "Bench testing met all acceptance criteria of the Design Verification tests and complied with 311001 Composite Removable Stent System Specifications." However, the specific acceptance criteria values and the reported device performance values are not detailed in a table.
• Biocompatibility Testing: Conducted according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, and chemical characterization. It concludes the device is biocompatible.
• Animal Study (GLP): Involved 5 sheep with 10 implanted stents and 10 control sites. Evaluated safety and feasibility through macroscopic and histological analysis after 4 and 6 weeks. Concluded no adverse local tissue effects and safe implantation for up to 28 days.
• First in Man Clinical Study: Involved 15 patients with 29 successfully implanted and removed stents. Evaluated complications, adverse events, inflammatory reaction, healing, adhesion/restenosis rate, pain, discomfort, and SNOT-20 scores. Concluded no complications, lower inflammation, faster healing, lower adhesion/restenosis, and improved patient experience compared to standard of care.
• Sterilization & Shelf Life: Validated according to ISO 11135;2014 for sterilization (SAL 10-6), tested ethylene oxide residuals (met ISO 10993-7:2008), and met Bacterial Endotoxin Test (USP 85). Packaging shelf life established per various ASTM and ISO standards.

Therefore, I cannot populate the requested table or answer the specific AI/CADe related questions based on the provided text. The document focuses on the safety and effectiveness of a physical medical device through traditional engineering and biological evaluations.

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The Chitogel Endoscopic Sinus Surgery Kit is indicated 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 and minimize ostial stenosis following endoscopic sinus surgery
• 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
  The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.

The Chitogel Endoscopic Sinus Surgery Kit consists of the following components:

• Sealed vial containing 300mg Dextran Aldehyde Powder
• Sealed vial containing 10ml Sodium Phosphate Buffer Solution
• Sealed vial containing 10ml Chitosan Succinaamide Solution
• 12cc control syringe
• Fluid dispensing connector
• Two (2) mixing cannulae
• Malleable cannula
  The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre- measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing.
  All components are provide sterile and are for single use only.

The provided text describes a medical device (Chitogel Endoscopic Sinus Surgery Kit) and its comparison to a predicate device (Novashield Injectable Nasal Packing and Stent) for FDA 510(k) clearance. This document is a Summary of Substantial Equivalence, not a detailed study report with all the specific information requested.

Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, and ground truth establishment, particularly for a device with an AI/algorithm component, is not present in this document because this device is a physical medical product, not an AI/software device.

However, I can extract and infer some relevant information based on the typical content of such documents for medical devices:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it focuses on qualitative equivalency to a predicate device and safety testing for a physical product.

The "acceptance criteria" here refer to meeting standards for biological safety, physical properties, and functional performance as demonstrated through various tests. The "reported device performance" is essentially that the device passed all these tests and met their respective acceptance criteria.

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

• Test Set Sample Size: Not explicitly stated for specific tests.
  • For biological testing (cytotoxicity, etc.), it would typically involve an adequate number of samples as per ISO standards, but no specific count is given.
  • For non-clinical physical testing (viscosity, gel time, etc.), "All samples" passed, but the quantity of "samples" is not provided.
  • For animal testing, it mentions "an animal model" (singular imply a single type of animal study, not necessarily a single animal), but no specific number of animals is provided.
  • For "Clinical Experience", it refers to "Several clinical studies" and "randomized controlled studies," but the specific number of participants in these studies (i.e., the sample size of the test set) is not provided in this summary.
• Data Provenance:
  • Clinical Experience: References multiple published journal articles involving "randomized controlled studies." While specific countries are not mentioned, one of the authors, "Wormald, PJ," is associated with the University of Adelaide, Australia, suggesting at least some data might originate from Australia. The company itself is based in New Zealand.
  • Retrospective/Prospective: The description "randomized controlled studies" indicates these were prospective clinical trials.

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)

This information is not provided as the device is a physical product, not an AI system requiring expert labeling for ground truth. Clinical "observations were documented" and confirmed in studies, likely by the treating physicians and study investigators, but their specific qualifications or number for "ground truth establishment" in an AI context are not relevant here and thus not stated.

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

This information is not provided and is generally not applicable for a physical medical device submission like this. Adjudication methods are typically relevant for complex subjective assessments in AI studies or clinical trials where multiple readers/assessors need to reach a consensus on ground truth or outcomes. For this device, the outcomes are observed clinical effects (e.g., bleeding control, adhesion prevention).

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

No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is specifically designed for evaluating diagnostic AI systems where human readers' performance (e.g., radiologists, pathologists) is compared with and without AI assistance across multiple cases. This device is a physical surgical implant, not a diagnostic AI tool.

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

Not applicable. This question pertains to AI algorithms. The Chitogel device is a physical kit that forms a gel used by a surgeon. There is no "algorithm" to perform in a standalone capacity.

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

For the clinical effectiveness discussed, the "ground truth" was based on clinical observations and outcomes data from prospective randomized controlled trials. These include:

• Direct observation of tissue separation.
• Assessment of adhesion prevention.
• Measurement/assessment of bleeding control.
• Observation of the natural healing process.
• Histopathological analysis (implied by "wound healing" studies, potentially at a microscopic level in animal or human biopsies, but not explicitly stated as the primary ground truth source here).

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI/machine learning, thus there is no "training set."

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

Not applicable. See point 8.

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The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.

The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic sphenoid sinus or transsphenoidal surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.

The provided text is a 510(k) summary for the SPIWay Endonasal Access Guide, a Class I medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed AI algorithm study. Therefore, most of the requested information about acceptance criteria, detailed study design, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.

However, based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document mentions "design verification bench testing" and "design validation cadaver testing" were performed. It states: "Performance testing showed the device meets design specifications and performed as intended." However, specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary for direct comparison in a table.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "cadaver testing," implying a set of cadavers were used, but the number is not specified.
• Data Provenance: "Cadaver testing" implies the data would be from human cadavers. The country of origin is not mentioned. It would be considered prospective for the specific tests conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For a physical device like this, the "ground truth" would likely be the successful physical manipulation and visualization during the cadaveric procedures, observed by the study conductor(s), rather than an expert consensus on interpretative outputs.

4. Adjudication method for the test set:

This information is not provided. Given it's a physical device validation, formal adjudication methods like "2+1" typically used for interpretation tasks (e.g., image reading) are unlikely to apply. The assessment would likely be direct observation by the study conductor(s) or surgeon(s) performing the cadaveric tests.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices. The SPIWay Endonasal Access Guide is a physical surgical guide.
• Effect Size: Not applicable as no such study was conducted.

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

• No, a standalone algorithm-only performance study was not done. This device is not an AI algorithm. It's a physical guide intended for human-in-the-loop use during surgery.

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

The document implies the "ground truth" for the cadaveric testing was the successful physical functionality and visualization during the procedures. This would likely be assessed by the surgical team performing the testing, confirming the device "performed as intended" and "demonstrate[d] effectiveness for its intended use." It's not expert consensus on an interpretation, pathology, or outcomes data in the usual sense for diagnostic AI.

8. The sample size for the training set:

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

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HEMOPORE® is intended for use in patients undergoing nasal/simus surgery as a temporary wound dressing.

HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation.

It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.

HEMOPORE® is a sterile fragmentable nasal dressing of 8 cm composed of poly(DL-lactide-cos-caprolactone) urethane and blended with a chitosan derivate and a violet color additive.

After insertion of HEMOPORE®in the nasal cavity, fluids will be absorbed by the dressing, which helps to control bleeding after surgery.

The dressing fragments within several days by hydrolyzing ester bonds, whereafter it is drained from the nasal cavity via the natural mucus flow.

The HEMOPORE® is sterilized in a blister package. The device is single-use, cannot be resterilized, and is a prescription product.

This document is a 510(k) Pre-market Notification for the HEMOPORE® device. The provided text describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results with reported device performance metrics against those criteria, or information regarding sample sizes, data provenance, expert involvement, or MRMC studies that would be typically found in a clinical study report or a more comprehensive technical document.

Therefore, many of the requested items cannot be extracted from this document.

Here's what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not provided. The document mentions "in vitro testing" and "biocompatibility testing" but does not specify the number of samples used for these tests.
• Data provenance: Not provided. The type of study (e.g., retrospective or prospective) is not mentioned beyond "in vitro 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/Not provided. The testing described (biocompatibility, degradation, shelf-life, absorption, thrombogenicity) appears to be laboratory-based physical and chemical performance testing, not human-read clinical data that would require expert ground truth establishment.

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

• Not applicable/Not provided, for the same reasons as item 3.

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

• No. This is not an AI/imaging device. No MRMC study was conducted or mentioned.

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

• Not applicable. This is a medical device (intranasal splint/dressing), not an algorithm.

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

• For the performance testing mentioned (biocompatibility, degradation, shelf-life, absorption, thrombogenicity), the "ground truth" would be established by standardized laboratory methods, physical/chemical measurements, and potentially comparison to predicate devices' known performance characteristics. There is no mention of clinical ground truth such as pathology or outcomes data in this summary.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable. (See item 8).

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