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To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.

The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation.

The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.

This document is a 510(k) premarket notification for a medical device called the "XprESS Multi-Sinus Dilation Tool". It is a submission to the FDA seeking clearance to market the device, claiming substantial equivalence to a previously cleared predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a typical format. Instead, it discusses the outcomes of various tests. Based on the "Performance Data" section (Page 4), the implicit acceptance criteria are that the device meets design specifications and performs as intended.

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

• The document mentions "simulated use in a cadaver model." However, it does not specify the sample size (e.g., number of cadavers or number of procedures performed).
• The data provenance is retrospective/simulated, as it was done in a cadaver model, not live patients. The country of origin for the cadaver model data is not explicitly stated.

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

• The document does not provide information regarding the number of experts or their qualifications for establishing ground truth in the simulated use testing. For a device like this, ground truth would likely be based on successful access, dilation, and lack of damage in the cadaveric sinuses, assessed by qualified medical professionals (e.g., ENT surgeons).

4. Adjudication Method for the Test Set

• The document does not describe any formal adjudication method for the simulated use testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The device is a surgical tool, not an AI diagnostic imaging device that would typically involve human readers interpreting images. The evaluation primarily focuses on the device's physical performance, safety, and functionality.

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

• This question is not applicable to the XprESS Multi-Sinus Dilation Tool. This is a manual surgical instrument, not an AI algorithm. Its performance is always with a human (surgeon) in the loop.

7. The Type of Ground Truth Used

• The ground truth for the performance testing (e.g., in the cadaver model) would have been based on direct observation and assessment of the physical outcomes (e.g., successful dilation, structural integrity, absence of damage) within the simulated environment by qualified personnel. It's a functional ground truth rather than a diagnostic one like pathology or expert consensus on an image. For biocompatibility, the ground truth is established by standardized testing protocols for material safety.

8. The Sample Size for the Training Set

• This question is not applicable. The XprESS Multi-Sinus Dilation Tool is a mechanical surgical instrument, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

• This question is not applicable as there is no training set for a mechanical surgical instrument.

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To access and treat the frontal recesses. sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium secker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria for the "XprESS Multi-Sinus Dilation Tool". The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Therefore, I cannot fulfill your request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Infusion Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only. The items packaged with the XprESS Multi-Sinus Dilation Tool include the Inflation Device, Bending Tool and two Infusion Lines.

The provided text describes the XprESS Multi-Sinus Dilation Tool, a medical device, and its 510(k) submission (K121943) for clearance. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device.

Therefore, many of the requested categories related to acceptance criteria, detailed study design, ground truth establishment, expert involvement, and comparative effectiveness studies are not explicitly present in the provided text. The submission is primarily about demonstrating that the new device is as safe and effective as an already marketed predicate device, relying on design verification and simulated use rather than extensive clinical trials or AI performance evaluations.

Here's an analysis based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, quantified acceptance criteria. Instead, it makes a general statement about meeting design specifications.

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

• Test Set Sample Size: Not specified. The text mentions "simulated use in a cadaver model," but the number of cadavers or specific tests performed is not detailed.
• Data Provenance: The simulated use was conducted in a "cadaver model." This implies an ex vivo setting, likely in the country where the company (Entellus Medical, Inc. - Plymouth, MN, USA) is based. The data would be considered prospective for the purpose of this submission, as it was generated specifically for the device verification.

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

Not applicable/Not specified. The simulated use involved a cadaver model to test mechanical performance and the ability of the device, not to establish a "ground truth" for diagnostic or AI-related outcomes. The "ground truth" in this context would be related to the device's mechanical integrity and functionality, which is evaluated against engineering specifications, not expert diagnostic consensus.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Since this is not a study requiring expert interpretation or consensus for a diagnostic outcome, there is no mention of an adjudication method.

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 MRMC study was done.
• No AI component or human-in-the-loop performance evaluation is mentioned. The device is a surgical tool, not an AI-assisted diagnostic or therapeutic system.

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

Not applicable. The device is a physical surgical tool; there is no "algorithm" in the sense of an AI or diagnostic algorithm being tested in standalone mode.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on engineering specifications and functional performance in a simulated environment. For example, the device must withstand a certain number of inflations without failure, or the balloon must dilate to a specific diameter. These are objective measurements against predefined design requirements.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and testing are based on traditional engineering principles.

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

Not applicable, as there is no training set for this type of device.

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To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Infusion Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only. The items packaged with the XprESS Multi-Sinus Dilation Tool include the Inflation Device, Bending Tool and two Infusion Lines. XprESS is available in the following balloon sizes: 5 mm diameter, 18 mm length; 6 mm diameter, 8 mm length; 6 mm diameter, 18 mm length; 7 mm diameter, 18 mm length.

The provided text describes a medical device, the XprESS Multi-Sinus Dilation Tool, and its regulatory submission. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and performance as would be expected for a novel device.

Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device meeting these criteria (especially for AI/standalone performance, multi-reader multi-case studies, and ground truth establishment methods) is not present in the document, as it pertains to a different type of regulatory submission and device evaluation.

However, I can extract the information that is available:

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

The document states: "Performance testing showed that the device meets design specifications and performed as intended." Specific quantitative acceptance criteria are not detailed in this summary, nor are specific quantitative performance metrics published. The focus is on demonstrating equivalence to the predicate device.

2. Sample sized 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 explicitly stated as a numerical sample size. The document mentions "simulated use in a cadaver model to support the additional balloon size." This implies one or more cadavers were used for testing.
• Data Provenance: The cadaver model is a simulated use environment. Country of origin for this testing is not specified but would likely be the US given the submission to the FDA. The nature of cadaver testing is generally considered prospective for the purposes of evaluating the device in a controlled environment.

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 mentioned. The testing described (mechanical testing, simulated cadaver use) does not involve expert interpretation for ground truth establishment in the context of diagnostic accuracy, which is what this question typically pertains to. The "ground truth" here is mechanical integrity and functionality, established through engineering tests.

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

Not applicable/Not mentioned. Adjudication methods are typically for resolving discrepancies in expert interpretation, which is not the type of testing described here.

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 is a manual surgical instrument, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

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

The ground truth for the performance testing (design verification and simulated use) was based on engineering specifications and the observable functional performance of the device (e.g., successful dilation, withstand multiple inflations).

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI models that require a training set.

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

Not applicable (as above).

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To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia / ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. XprESS is offered in three balloon sizes: 5mm, 6mm and 7mm diameter balloons. The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated. The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Infusion Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only. The items packaged with the Xpress Multi-Sinus Dilation Tool include the Inflation Device and Infusion Line.

This 510(k) summary describes a medical device, the XprESS Multi-Sinus Dilation Tool, and its performance data. However, it does not contain the detailed information typically found in studies designed to establish acceptance criteria for AI/ML devices or studies that directly "prove" a device meets those criteria with specific statistical metrics.

The provided document is for a manual surgical instrument and the performance data presented is for design verification and simulated use in a cadaver model, not for an AI/ML algorithm.

Therefore, many of the requested categories (like MRMC studies, standalone algorithm performance, training/test set sizes, expert ground truth for AI, etc.) are not applicable to this specific device and the information provided.

However, I can extract the acceptance criteria for the design verification and the reported device performance from the provided text:

Acceptance Criteria and Reported Device Performance

Due to the nature of the device (a manual surgical instrument, not an AI/ML system), most of the subsequent questions are not directly applicable. However, I will answer them based on what can be inferred from the provided text for completeness, noting where the information is not present or relevant to AI/ML.

Additional Information (Contextualized for a Non-AI Device)

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

   • Test Set Description: The "test set" for this device consisted of "simulated use in a cadaver model" and "design verification" which included dimensional, functional, and simulated use testing.
   • Sample Size: Not explicitly stated for the cadaver model or other tests. The durability test mentions "all 6 sinus ostia" being dilated in a surgical case, implying at least one full cadaver head or simulated model.
   • Data Provenance: Not specified, but implied to be from laboratory testing and potentially cadaver labs, likely within the US where the company is based (Maple Grove, MN). It is "prospective" in the sense that tests were conducted specifically for this submission.

2. 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):

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified, but implied that the testing was overseen by product engineers, clinical experts, and regulatory personnel familiar with surgical instrument performance and medical device standards. Given the nature of a manual surgical instrument, "ground truth" is typically established by engineering specifications, validated test methods, and clinical assessment of usability/effectiveness by surgeons.

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

   • Not applicable in the context of this type of device testing. Performance is measured against engineering specifications and functional benchmarks, not through expert adjudication of output.

4. 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 study was not done. This is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic device that involves human "readers" or "AI assistance" in the sense of an algorithm.

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

   • No, a standalone algorithm performance test was not done. This device is a manual surgical instrument.

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

   • The "ground truth" for this device's performance is established by engineering design specifications, industry standards (e.g., ISO 10993 for biocompatibility), and functional benchmarks observed during simulated use (e.g., ability to withstand a certain number of inflations, proper fluid flow, physical dimensions).

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is a non-AI manual surgical instrument. Device design and validation are based on engineering principles and performance testing, not machine learning.

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

   • Not applicable. No training set; therefore, no ground truth needed to be established for it.

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