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Lightin is a needle for injection laryngoplasty with an optical fiber. Lightin Generator is an AC-powered light source including Light Guide which is fiber optic cable that transmits light at the tip of fiber optics embedded within Lightin. Lightin System is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light.

Lightin System consists of Lightin and Lightin Generator. Lightin is a light-guided needle used injection laryngoplasty and Light generator delivers the light energy to Lightin by generating LED light from an AC-powered light source. Lighin consists of injection needle, Y-connector and SMA connector/cable. The light transmitted from the Lightin Generator is emitted from the tip of fiber optics embedded within Lightin. Lightin system used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs.

The provided document is a 510(k) summary for the Solmedix Lightin System, which is a medical device for injection laryngoplasty. This summary primarily focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in a format typical for an AI/ML device.

Here's an analysis based on the information provided, specifically addressing the points requested, while noting that many are not applicable or not explicitly detailed for this type of device submission:

1. Table of acceptance criteria and the reported device performance

For a Class I device seeking 510(k) clearance, the "acceptance criteria" are generally compliance with recognized standards and demonstration that the device performs as intended and is as safe and effective as a predicate device. This document lists the standards the device conforms to and describes various tests performed. It does not provide specific quantitative performance metrics with associated acceptance thresholds in the way an AI/ML device submission often would.

However, based on the non-clinical performance testing sections, we can infer some criteria and reported performance:

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

The document does not specify sample sizes for any of the tests conducted or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or provided in a 510(k) summary for a Class I manual surgical instrument unless specific performance claims necessitate it. The tests listed are primarily engineering, electrical, and biocompatibility tests on device components or finished products, not clinical studies with patient data.

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

This is not applicable. The device is a surgical instrument, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation of data to establish ground truth for training or testing. The "ground truth" for this device relates to its physical performance, safety, and functionality (e.g., biocompatibility, sterility, light output), which are assessed through standardized laboratory and technical tests.

4. Adjudication method for the test set

This is not applicable for the reasons stated in point 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

This is not applicable, as the device is not an AI/ML product designed to assist human readers/interpreters.

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

This is not applicable, as the device is not an AI/ML algorithm. It is a physical medical instrument.

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

The "ground truth" for this device's performance is established through adherence to recognized international and national standards (e.g., ISO, IEC, ASTM, USP) for materials, electrical safety, biocompatibility, sterilization, and basic functionality. For instance, successfully passing a cytotoxicity test per ISO 10993-5 serves as the "ground truth" for non-cytotoxicity. The statement that the system "successfully directs the laryngoplastic injection material to the target area" is a functional performance claim, likely verified through internal testing or benchtop models.

8. The sample size for the training set

This is not applicable, as there is no mention of a training set for an AI/ML model for this device.

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

This is not applicable.

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The VenSure™ Balloon Dilation System is used to access and treat the frontal ostia/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.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian in adult patients using a transnasal approach.
The VenSure™ Nav Balloon Dilation System is additionally intended for use in conjunction with the Cube Navigation System during ENT procedures when surgical navigation or image-guided surgery may be necessary to locate the Eustachian tube or to locate tissue, bone or cartilaginous tissue surrounding the drainage of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The VenSure™ Light Balloon Dilation System is additionally used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.

The VenSure Balloon Dilation Systems combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the Frontal, Maxillary, Sphenoid sinuses, and Eustachian tube using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and the Eustachian tube within the same patient. The devices come in an EO sterilized tray sealed inside of a Tyvek pouch with the bending tool, inflation device, and extension line included in the trav.
All VenSure versions enable a physician to track the device into the sinuses and eustachian tube using endoscopic visualization.
The VenSure™ Nav allows additionally for image-guided visualization when connected to the Cube Navigation System (manufactured by Fiagon). The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "blug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflation device to expand the outflow track of the targeted structure.
The VenSure™ Light additionally allows for LED light confirmation of the VenSure balloon through transillumination across nasal and sinus structures. The VenSure™ Light has an integrated flexible light fiber with battery powered LED light source designed to emit red light from the distal end of the VenSure balloon.
The VenSure™ ET is a 45°- pre-bent configuration of the basic VenSure (with straight balloon tip). The pre-bend to 45°bemt of the VenSure ET facilitates the use of the device when only used for treatment in the eustachian tube. The device however can also be reshaped to fit to the sinuses using the Bending tool.

The provided text describes the VenSure™ Balloon Dilation System, including the VenSure™ Light, VenSure™ Nav, and VenSure™ ET variants. These devices are used for balloon dilation of frontal ostial recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula, and the Eustachian tube in adults.

Here's an analysis of the acceptance criteria and the study information as requested:

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)

The document mentions "Bench testing" and "Simulated use testing in clinical model." However, it does not specify sample sizes for the test sets used in performance data. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The reference to "clinical model" suggests a simulated environment rather than actual patient data.

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 in the document. The studies described are primarily bench testing and simulated use, not those requiring expert interpretation of medical images or patient outcomes for ground truth establishment.

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

This information is not provided as the described studies do not involve expert adjudication of results in a clinical context.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device in question is a physical medical device (balloon dilation system) and not an AI/software product requiring human reader performance studies.

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

This refers to an AI/software device. The VenSure™ Balloon Dilation System is a physical medical device. While the VenSure™ Nav includes "image-guided visualization" and "navigation software," the document does not describe "standalone" algorithm-only performance in the context of an FDA-cleared AI/software device. The navigation functionality is an aid for the physician using the physical device.

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

For the bench testing, the "ground truth" implicitly refers to engineering specifications and established physical properties (e.g., "dimensions of the balloon are as specified," "burst pressure at end of lifetime is above the rated in use pressure"). For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-1:2018). For sterilization, the ground truth is sterilization validation standards (ISO 11135-1). For navigation compatibility, it's about functionality and compatibility with the Fiagon Navigation system meeting accuracy ratings of the predicate. This is based on objective, measurable physical and engineering endpoints rather than clinical ground truth (like pathology or expert consensus on a diagnosis).

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI/machine learning model that typically requires a training set.

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

This information is not applicable/not provided as there is no mention of a training set for an AI/machine learning model.

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To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The BB 8 Sinus Dilation Kit is intended to remodel or recreate the sinus outflow tract via transnasal balloon dilation. The device combines features of a curved suction tip and a sinus ostium seeker with the tissue expansion effect of balloon dilation. 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 device also allows the capability to suction and irrigate the surgical field to allow for removal of bodily secretions and to keep the field of view clean for improved visualization. The device includes an LED light with light fiber to locate, illuminate within, and transilluminate across nasal and sinus structures.

In summary, the device includes the following components and accessories:

1. BB 8 Sinus Dilation Kit which incorporates:
   a. shapeable catheter with inflatable balloon
   b. LED light fiber
   c. irrigation line, and
   d. suction line,
2. Inflation syringe,
3. Extension line used for inflation of the balloon (and to provide irrigation, if desired), and
4. A bend template for shaping the catheter tip for treating various sinus anatomy

This document is a 510(k) premarket notification for a medical device called the "BB 8 Sinus Dilation Kit." It does not contain information about studies to prove the device meets acceptance criteria in the way you've described.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, rather than presenting novel clinical study results.

Therefore, many of the items you requested (such as acceptance criteria, specific performance metrics from a study, sample sizes, expert qualifications, and ground truth information) are not applicable or provided in this type of submission.

Here's a breakdown of what information is available based on your request, and what is not:

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

• Not Applicable in the requested format. This document presents a "Table 1: Comparison to Predicate Devices" which outlines technological characteristics and states whether they are "Identical" or "Similar" to predicate devices. It does not provide specific numerical acceptance criteria or performance results from a study designed to meet those criteria. Instead, it relies on the similarities to already cleared devices.

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

• Not provided. No clinical "test set" in the context of an accuracy or performance study is mentioned. The verification testing listed is engineering and bench testing, not human clinical trials or performance assessments that would involve a test set of data.

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. No expert ground truth establishment for a test set is mentioned.

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

• Not applicable. No adjudication method for a test set is mentioned.

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 or therapeutic device that would involve human "readers" or AI assistance.

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

• Not applicable. This is a manual surgical instrument, not an algorithm.

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

• Not applicable. No ground truth for clinical performance is mentioned. The "ground truth" here is the established safety and efficacy of the predicate devices.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model, so there is no "training set."

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

• Not applicable. As above, no training set.

Summary of what the document does provide regarding device evaluation:

The document lists "Verification testing performed for the subject device" on page 5, which includes:

• Visual Testing
• Dimensional Testing
• Functional Testing (e.g., Bend Radius, Suction Force, Irrigation Rate, Balloon Inflation/Deflation Time, Balloon Burst Pressure, LED Visibility, LED Battery Life, Joint Strengths, Torque Value)
• Electrical Safety and EMC Testing
• Biocompatibility Testing
• Sterilization, Packaging, and Shelf-Life Testing

These are engineering and laboratory tests to ensure the device meets its design specifications and relevant standards, and that its characteristics are comparable to the predicates, not a clinical study to establish performance against specific acceptance criteria as you might see for an AI algorithm or a novel therapeutic with clinical outcomes. The "comparison of devices" table (Table 1) provides the rationale for how these tests demonstrate substantial equivalence.

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The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.

VenSure™ LightGuide is a sterile, single-use device designed to emit light from the distal end. The device is an accessory to the VenSure™ Balloon device and used to locate, illuminate within and transilluminate across nasal and sinus structures. The device consists of a flexible light fiber, a protective sheath and an integrated battery-powered LED light source. When activated, the light fiber will emit red light from the distal tip for two (2) hours. It has a fiber nominal working length of 20mm (0.79 inch) with an outer diameter of 0.5mm (0.02 inch). The VenSure™ LightGuide is packaged separately.

The provided text describes the VenSure™ LightGuide, a manual surgical instrument for ear, nose, and throat procedures. However, the document does not contain any information about an AI/algorithm component or a study involving human readers or expert ground truth for diagnostic purposes. The device described is a physical medical tool (a light guide), not an AI-powered diagnostic or assistive tool.

Therefore, I cannot provide details on:

• Acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
• Any study data related to AI performance, human reader improvement with AI assistance, or standalone algorithm performance.
• Sample sizes for test or training sets related to AI.
• Number/qualifications of experts, adjudication methods, or types of ground truth for an AI study.

The document focuses on the substantial equivalence of the VenSure™ LightGuide to a predicate device (PathAssist LED Light Fiber) based on:

• Intended use
• Technological characteristics
• Bench testing (mechanical integrity, light output, electrical safety, etc.)
• Biocompatibility
• Sterilization & Stability
• Electromagnetic compatibility and Electrical Safety

It states that "All tests met the predefined acceptance criteria" for these engineering and safety-related characteristics, but it does not specify what those numerical acceptance criteria were for each test.

Summary of what CAN be extracted (related to the physical device, not AI):

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All tests met the predefined acceptance criteria" for various bench tests, biocompatibility, sterilization, and electrical safety. However, specific numeric acceptance criteria (e.g., minimum light output in lumens, specific force in Newtons, etc.) and the exact measured performance values are not provided in this regulatory summary.

2. Sample size and Data Provenance: Not applicable to an AI study, and specific sample sizes for the engineering tests mentioned (e.g., how many devices were tested for light output) are not disclosed in this summary. The data provenance is a regulatory submission to the FDA for a medical device cleared in the US.

3. Number of experts and Qualifications: Not applicable, as this is not an AI diagnostic study.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable.

6. Standalone Algorithm Performance: Not applicable.

7. Type of Ground Truth Used: Not applicable. The "ground truth" for this device would be defined by engineering specifications, material standards, and safety standards, not clinical diagnostic accuracy based on expert consensus or pathology.

8. Sample size for training set: Not applicable.

9. How the ground truth for training set was established: Not applicable.

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The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297.

A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal.

Mounted near the distal end of the balloon handpiece is a flexible balloon section. Once the balloon section is advanced into the target Eustachian tube the 6mm diameter/16 mm long rigid balloon is inflated using the separate NuVent™ inflator, expanding the Eustachian tube canal tissue and cartilage.

The provided text is a 510(k) Summary for the NuVent Eustachian Tube Dilation Balloon. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. The information supplied in this document focuses on mechanical and functional performance testing to prove substantial equivalence, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes in the way a diagnostic AI device might be.

Therefore, many of the requested items (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance, training set details) are not applicable to this type of device and the information provided in this 510(k) summary.

However, I can extract the acceptance criteria and performance data for the mechanical and functional tests that were performed to support the device's substantial equivalence.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "All samples passed testing and met acceptance criteria." While the specific numerical acceptance criteria for each test are not explicitly detailed (e.g., "tensile strength must be > X N"), the general statement indicates that the device met pre-defined requirements for these performance characteristics. The table below lists the performance tests conducted, implying that the acceptance criterion for each was successful completion without failure, demonstrating performance comparable to or better than the predicate devices and ensuring safety and effectiveness.

Study Information Specifics:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document states "All samples passed testing," but does not specify the sample size (N) used for each of the performance tests.
   • The data provenance is from non-clinical tests conducted by Medtronic Xomed, Inc. This testing is typically done in a lab setting, not on human subjects.
   • The data is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

   • N/A. This device's testing involves mechanical and functional performance, not diagnostic interpretation requiring expert ground truth in the context of a medical imaging or AI study. The ground truth for these tests is based on engineering specifications and physical measurements/observations of device performance against predefined criteria.

3. Adjudication Method for the Test Set:

   • N/A. Since this involves mechanical/functional tests against engineering specifications, there is no "adjudication" in the sense of reconciling human expert opinions. Test results are objectively measured or observed.

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:

   • N/A. This device (Eustachian Tube Dilation Balloon) is not an AI-powered diagnostic tool, nor does it assist human readers in interpreting medical images. It is a surgical device.

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

   • N/A. This device does not have an "algorithm-only" performance component. It is a physical medical device.

6. The Type of Ground Truth Used:

   • The ground truth used for this type of device relies on engineering specifications, physical measurements, and adherence to established performance standards (e.g., ISO, ASTM, internal Medtronic criteria). For example, a "passed" result for tensile strength means it met a minimum force before breaking, or "passed" for inflation means it inflated to the specified dimensions without bursting within a given pressure range.

7. The Sample Size for the Training Set:

   • N/A. There is no "training set" in the context of this device's mechanical and functional testing, as it is not an AI/machine learning model.

8. How the Ground Truth for the Training Set was Established:

   • N/A. This question pertains to AI/machine learning model development, which is not relevant to the type of device and testing described in this 510(k) summary.

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Use a single dilation device by transnasal approach to access and treat an individual anatomical location as follows:

· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Maxillary ostialethmoid infundibula in patients 2 years and older;

· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Frontal ostialrecesses in patients 12 years and older: may be used with LED Light fiber to locate, illuminate across nasal and sinus structures;

· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Sphenoid sinus ostia in patients 12 years and older;

• Dilation of the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older.

The SINUSPRIME Dilation System is intended to remodel or recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. Each packaged SINUSPRIME System includes a balloon device configured for a specific anatomy (frontal, sphenoid, maxillary, or Eustachian tube (ET) configuration) and an inflation device. The SINUSPRIME Dilation System combines features of an ostium seeker with the tissue expansion effect of balloon dilation. The SINUSPRIME Dilation System is provided sterile and for single use only. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. The SINUSPRIME LED Light Fiber consists of a flexible illumination fiber that allow physicians to locate, illuminate within, and trans-illuminate across nasal and sinus structures. The SINUSPRIME LED Light Fiber is optional and available packaged and pre-loaded only on the SINUSPRIME Frontal with LED model.

The provided text is a 510(k) summary for the Stryker ENT SINUSPRIME Dilation System. It outlines the device, its indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, study design, or ground truth establishment for an AI-based device.

The document discusses "Performance Data" but only states: "Performance testing involved biocompatibility, design verification (dimensional, strength, HFE/UE verification testing), packaging, shelf life and design validation with physicians (HFE/UE). Performance testing showed that the device meets design specifications and performs as intended." This refers to engineering and human factors testing for a physical medical device, not a study involving AI algorithm performance with a test set, expert readers, or ground truth in the context of diagnostic or prognostic capabilities.

Therefore, I cannot provide the requested information from this document. The SINUSPRIME Dilation System is a physical medical device (balloon catheter for dilation), not an AI/ML-based diagnostic or imaging device. The questions you've asked are typically relevant for AI/ML medical devices where performance metrics like sensitivity, specificity, AUC, or reader agreement are crucial for regulatory submission.

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The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnoutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the NGB Balloon System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.

The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.

The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.

The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.

The Next Generation Balloon Dilation System (NGB) is an integrated balloon sinuplasty (BSP) and Eustachian tube (ET) dilation device, that will be available in light fiber and navigation guidewire configurations for compatibility with illumination and navigation technology. The system includes a handle with several integrated features to allow for single-handed use. The adjustable gripping feature allows for ergonomic handling. The directable guide tip enables access (i.e. manipulating/separating/dividing tissue) and placement near the targeted anatomy. There are four preset approximate positions: Sphenoid (straight), Eustachian tube (55°), Frontal (70°), Maxillary (110°). The directable guide knob allows for positioning of the balloon tip towards the target anatomy. The wire slider and spinner are used to advance, retract, and rotate the guidewire. The balloon slider is used advance and retract the balloon. The Next Generation Balloon Dilation System also allows for suction and irrigation in and around the target anatomy.

Here's a breakdown of the acceptance criteria and the study information for the Acclarent Next Generation Balloon Dilation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, rather than specific acceptance criteria in terms of performance metrics with pre-defined thresholds, the document outlines the types of non-clinical tests performed and states that the device "met all acceptance criteria" and "passed all tests in accordance with appropriate test criteria and standards."

2. Sample Size for Test Set and Data Provenance

The document explicitly states: "Clinical data was not necessary to determine that the subject Next Generation Balloon Dilation System performs as intended." This indicates that no clinical "test set" was used as part of this submission for performance evaluation against specific clinical acceptance criteria. The performance data is derived solely from non-clinical bench testing. The provenance of this data is therefore internal laboratory testing rather than patient data from a specific country or retrospective/prospective study.

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

Not applicable, as no clinical test set was used to establish ground truth with expert review.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission is based on demonstrating substantial equivalence through non-clinical testing.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device, not an algorithm, and its performance is evaluated in relation to its physical and functional characteristics.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be the engineering specifications, industry standards (e.g., AAMI/ANSI/ISO for sterilization, ASTM for shelf life), and validated internal test methods that define acceptable performance.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device effectively comes from its design and manufacturing processes, guided by engineering principles and regulatory standards.

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

Not applicable, as no training set was used.

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The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used 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 VenSure™ Nav Balloon Device is intended for use in conjunction with the Fiagon Navigation System during sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.

Fiagon's VenSure™ Balloon Device and VenSure™ Nav Balloon Device are sterile, singleuse devices designed to remodel the bony structures within the sinuses. The device comes in two versions a navigation ready version (VenSure™ Nav) that is compatible with the Fiagon electromagnetic navigation system, and a basic non-navigation ready version (VenSure™).

The VenSure™ and VenSure™ Nav devices, combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the frontal, maxillary, and sphenoid sinuses using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.

Both versions enable a physician to track the device into the sinuses using endoscopic visualization; while the VenSure™ Nav allows for image-guided visualization when connected to the Fiagon Navigation System. The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "plug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the sinus dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflator to expand the outflow track of the targeted sinus.

A suction tube may be connected directly to the proximal luer fitting of the basic VenSure™ balloon dilation device to provide active suction. Alternately, an Extension Line connected to a syringe may be connected directly to the proximal luer fitting to provide irrigation. Suction and irrigation are not possible on the VenSure™ Nav.

The provided text describes a 510(k) premarket notification for the VenSure™ Balloon Device and VenSure™ Nav Balloon Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as might be seen for novel devices or PMAs.

Therefore, the information requested, particularly regarding acceptance criteria, specific study designs (like MRMC), expert consensus, and detailed ground truth establishment, is largely not present in the provided document, as it falls outside the scope of a typical 510(k) submission for this type of device.

However, I can extract the information that is available:

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests met the predefined acceptance criteria." and "All tests successfully met the required acceptance criteria". However, the specific quantitative acceptance criteria values themselves are not provided in the text. Only the categories of tests performed are mentioned.

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

The document specifies "Bench testing" and "Biocompatibility testing" were conducted. It does not provide specific sample sizes for these tests (e.g., number of balloons tested for dimensional integrity).

• Data Provenance: Bench testing would be conducted in a laboratory setting. Biocompatibility testing involved laboratory assays. The document does not specify a country of origin for the test data, but the submitter (Fiagon GmbH) is based in Germany. The tests are described as prospective in the sense that they were conducted specifically for this submission.

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. The tests described are largely objective laboratory and engineering tests (e.g., measuring balloon dimensions, pressure). For biocompatibility, the ground truth would be established by the results of standardized biological assays, not expert consensus in the clinical sense.

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

• This information is not provided and is generally not applicable to the types of bench and biocompatibility tests 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

• No, an MRMC comparative effectiveness study was not done. The devices described are physical surgical instruments (balloon dilation devices and their navigation-compatible versions), not AI/software intended for diagnostic interpretation or aiding human "readers" (e.g., radiologists). Therefore, this type of study is not relevant to this device.

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

• Not applicable. These are physical medical devices, not algorithms.

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

• For bench testing, the ground truth would be engineering specifications, material properties, and functionality requirements (e.g., specific dimensions, pressure resistance, inflation/deflation times).
• For biocompatibility testing, the ground truth would be the defined acceptable limits and criteria for cytotoxicity, irritation, sensitization, and acute systemic toxicity as per ISO 10993-1 and related sub-standards.
• For sterilization and shelf-life, the ground truth is established by the specified standards (e.g., ISO 11135 for sterilization, ASTM F1980 for accelerated aging, ISO 11607-1 for packaging).

8. The sample size for the training set

• Not applicable. These are physical medical devices, not machine learning algorithms that require training sets. The document describes pre-market testing for device safety and performance, not AI model development.

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

• Not applicable. As above, this concept refers to AI/ML development and is not relevant to this device submission.

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The Dillard Nasal Balloon (DNB) Catheter is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.

The Dillard Nasal Balloon (DNB) Catheter is intended for use in ages 17 years or older.

The Dillard Nasal Balloon (DNB) Catheter has a total length of either 25cm or 100cm and is available in balloon diameters from 5mm to 12mm and balloon lengths of 20mm and 40mm. The balloon component of the catheter has radiopaque markers to assist with radiographic positioning (as applicable). The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends through the central lumen back to the proximal hub and through the distal tip. All catheters and accessories are supplied sterile and intended for single use.

The Dillard Nasal Balloon Catheter (DNB) is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. It is intended for use in ages 17 years or older.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The provided document does not explicitly present a table of "acceptance criteria" with numerical targets and the device's reported performance against those targets in the context of an algorithmic or AI-driven device. Instead, it lists various performance tests conducted to demonstrate substantial equivalence to a predicate device. The "reported device performance" is generally stated as the device performing "as intended" and being "as safe and as effective as the predicate device."

Here's an interpretation of relevant performance characteristics and implicitly met criteria:

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of an AI/algorithmic evaluation. The performance tests mentioned include:
  • Simulated use in cadavers: The sample size for cadavers is not specified.
  • Other performance tests (dimensional, strength, burst pressure, etc.): These typically involve a statistically relevant number of manufactured devices, but the specific quantity is not disclosed.
• Data Provenance: Not applicable in the context of typical AI data provenance (country of origin, retrospective/prospective). The data comes from direct physical testing of the device and its components.

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

This device is a physical medical instrument, not an AI/algorithmic device requiring an expert-established "ground truth" in the way an image analysis algorithm would. The "ground truth" for its performance is established through engineering and biological testing standards and clinical observation (in cadavers). There is no mention of external experts establishing ground truth for the test set.

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

Not applicable. This is not an AI/algorithmic device where adjudication of interpretations would be necessary. The performance tests yield objective physical measurements or observations.

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 not an AI-assisted diagnostic or interpretative tool, so an MRMC study and effect size in improving human reader performance is not relevant.

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

Not applicable. This is a physical medical instrument, not an algorithm.

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

The "ground truth" for the Dillard Nasal Balloon Catheter's performance is established through:

• Engineering specifications and standards: For dimensional, strength, pressure, and fatigue tests.
• Biological testing standards (ISO 10993): For biocompatibility.
• Sterilization and packaging standards (ISO 11135, ISO 11607, ISTA 2A, ASTM F1980): For sterility, integrity, and shelf life.
• Simulated use in cadavers: Provides a realistic anatomical environment for evaluation, implicitly using the cadaver anatomy as "ground truth" for device interaction.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithmic device that uses training data.

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

Not applicable. As above, this is not an AI/algorithmic device requiring a training set with established ground truth.

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The RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

The RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT intended to irrigate from within a target sinus for therapeutic procedures nor to facilitate diagnostic procedures with TruDi™ NAV Wire.

The RELIEVA ULTIRRA® Sinus Balloon Catheter is a flexible catheter that is intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of an electromagnetic navigable sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document states, "Clinical data was not necessary for the RELIEVA ULTIRRA® Sinus Balloon Catheter." This indicates that no clinical test set was used, and therefore no sample size or data provenance for a clinical test set is applicable. The evaluation was based on non-clinical performance testing.

3. Number of Experts and Qualifications for Ground Truth

Since no clinical data or human-in-the-loop performance was performed for this 510(k) submission, the concept of "experts used to establish ground truth" is not applicable in the context of evaluating diagnostic accuracy or clinical decision-making. The ground truth for the non-clinical performance tests would be the established engineering and materials standards and specifications. Engineers and technicians with expertise in medical device testing would have established and verified these.

4. Adjudication Method for Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission explicitly states "Clinical data was not necessary."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a manual surgical instrument (catheter), not an algorithm or AI system. The performance studies conducted were non-clinical, evaluating the physical and mechanical properties of the device.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance data was based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO, ASTM standards) for medical device performance (e.g., burst pressure, fatigue, biocompatibility, sterilization).

8. Sample Size for Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The device's design and manufacturing processes are developed and refined through engineering principles and iterative testing, not through data-driven training sets as understood in AI systems.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set in this context. The "ground truth" for the device's development and manufacturing would be its intended function, design specifications, and relevant industry standards.

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