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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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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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The Sinusway Dilation System is intended to access and treat the frontal, maxillary and sphenoid sinuses in sinus procedures in adults using a trans-nasal approach, by dilation and displacement of the anatomic structures along the sinus drainage pathways.

Sinusway Dilation System combines the tissue expansion effect of balloon dilation with the features of a curved sinus seeker, and by that allows the user to track the dilation device into the sinus drainage pathways. The shape of the distal end of the dilation system can be changed by inserting pre-shaped seekers into it. The system includes:

1. A Dilation Kit (Single use, provided sterile) consists of the following components:
   a. A Dilation Device includes an inflatable balloon at its distal end and connects to the inflation device at its proximal end.
   b. Three interchangeable pre-shaped Seekers (also referred to as stylets).
   c. An Inflation Device connects to the dilation device and inflates it while providing visual and tactile pressure indication.
   All Dilation Kit components are disposed of at the end of the procedure.
2. A Holder (re-processible and auto-clavable) - holds the components of the Dilation Kit in place and locks them, allowing the user to operate the dilation tool.

The provided document is a 510(k) premarket notification for the Sinusway Dilation System. The information required in the request pertains to the performance criteria and studies for a device, typically AI/ML-based software. However, the Sinusway Dilation System is a physical surgical instrument (Ear, Nose, And Throat Manual Surgical Instrument). Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "sample size for the training set," are not applicable to this type of medical device.

The document focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and bench testing, rather than clinical performance metrics typically associated with AI/ML devices.

Nevertheless, I will extract the available information related to acceptance criteria and device performance based on the provided text, while explicitly noting when requested information is not applicable.

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

The document states that "All tests met the predefined acceptance criteria," but it does not explicitly list the acceptance criteria or the specific numerical performance results for each test. Instead, it lists the types of bench tests performed.

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

For the bench testing, the document does not specify sample sizes for each test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "tests" being performed.

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

Not applicable. This device is a physical surgical instrument, and its performance was evaluated through bench testing and compliance with standards, not through comparison against expert-established ground truth in a diagnostic context.

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

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of diagnostic results, which is not the case for this device's performance evaluation.

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 is a physical 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 a physical device, not an algorithm. Its functionality is dependent on human use during surgery.

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

The "ground truth" for the device's acceptable performance was established by adherence to recognized international standards (e.g., ISO 14971:2012 for risk analysis, ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization) and internal predefined acceptance criteria for bench tests. These are engineering and safety standards, rather than clinical "ground truth" for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a physical device. The concept of a "training set" is relevant for AI/ML models.

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

Not applicable. As above, this is a physical device.

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MESIRE™ - Balloon Sinus Dilatation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic 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.

The MESIRE™ - Balloon Sinus Dilatation System consists of following components. It is available as an integrated system or individual components.

• MESIRE™ Sinus Balloon Catheter
• MESIRE™ Guide - Sinus Guide Catheter
• MESIRE™ Illuminus Sinus Light Wire
• MESIRE™ Latch Catheter Holding System

The MESIRE™ - Balloon Sinus Dilatation System is a Class I device and the provided documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with specific performance metrics against acceptance criteria that are typically seen for higher-risk devices or software.

Based on the provided text, the acceptance criteria and the study demonstrating the device meets them can be summarized as follows:

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

The document does not explicitly state numerical acceptance criteria or reported device performance in a comparative table format. Instead, it states that "The following testing demonstrated that Mesire™ Balloon Sinus dilatation System effectively dilated the sinus." It then lists various mechanical tests, biocompatibility tests, sterilization validation, and packaging/shelf life studies. The results are generally described as "demonstrated" or "complies with/meets requirements", implying successful achievement of pre-defined criteria for each test.

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

The document does not specify the sample sizes used for the mechanical tests, biocompatibility tests, sterilization validation, or packaging/shelf life studies. It mentions "Simulated use testing was performed" for mechanical tests, implying lab-based testing. There is no information provided regarding the provenance (country of origin, retrospective or prospective) of any data beyond what's implied by the tests being conducted by Meril Life Sciences Private Limited in India.

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

This information is not applicable and therefore not provided in the document. The device is a physical surgical instrument, not an AI/ML-driven diagnostic or image analysis tool that would require expert-established ground truth for its performance evaluation. The "ground truth" here would be established by physical measurements and compliance with engineering and biological standards.

4. Adjudication method for the test set

This information is not applicable and therefore not provided in the document 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

No such study was done or reported. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.

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

This information is not applicable and therefore not provided in the document, as the device is a physical surgical instrument and does not involve AI algorithms.

7. The type of ground truth used

The "ground truth" for this device's evaluation is primarily based on:

• Engineering specifications and standards: For mechanical tests (e.g., measurements, burst pressure, material properties).
• Biological standards: For biocompatibility (e.g., ISO 10993 series).
• Sterilization standards: For sterility assurance (e.g., AAMI/ANSI/ISO 11135).
• Packaging and shelf-life standards: For integrity and stability (e.g., ISO 11607).

These are established scientific and regulatory benchmarks, rather than expert consensus, pathology, or outcomes data in the context of clinical decision-making.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of this traditional manual surgical instrument.

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

This information is not applicable as there is no "training set" for this device.

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The Relieva SpinPlus Nav™ Balloon Sinuplasty 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 diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the Relieva SpinPlus Nav™ Balloon Sinuplasty 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; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

The Relieva SpinPlus Nav™ Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT® ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy

The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is packaged with a handle with integrated flexible balloon catheter and Sinus Navigation Guidewire, and three RELIEVA® Spin Sinus Guide Catheter Tips. The system features a handle with an integrated flexible balloon catheter. Features of the handle include a sinus guide tip release button, a suction system, a balloon guard, and several gripping features to grip the device. The guide tip release button must be depressed to separate the sinus guide catheter tip from the handle system. The suction system consists of a suction line and a suction port. Suction may be used to clear the field of fluids and/or blood. The suction line is attached to the proximal end of the handle system and may be removed if desired. The suction port may be covered by the user's finger to increase the suction flow rate. A clear balloon guard is connected to the distal end of the handle system and protects the sinus balloon during sinus guide catheter tip exchanges. The Handle features a wire slider, wire spinner, balloon slider, sinus balloon, handle markers, and proximal connections. The wire slider allows the user to advance, retract and spin the sinus navigation guidewire with a single hand while simultaneously supporting the handle. The balloon slider allows the user to advance and retract the sinus balloon catheter to the target sinus ostia and outflow tract, to enable dilation. The integrated connector enables the device to be interfaced to the ACCLARENT ENT™ Navigation System to facilitate EM navigation. The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT ENT™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy via electromagnetic navigation.

This document describes the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System. The information provided focuses on technical characteristics and non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria in patient outcomes. Therefore, some of the requested information, specifically regarding sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth establishment for training, is not available from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of a patient cohort. The performance evaluation relies on non-clinical bench testing and simulated use testing with ENT surgeons. The number of instances or items tested for each bench test is not provided (e.g., how many balloons were burst tested, how many times was the device used in simulated use).
• Data Provenance: The data is primarily from non-clinical, laboratory-based testing (bench tests, accelerated aging, biocompatibility, sterilization validation) and simulated use testing performed with ENT surgeons. There is no mention of data from human patients or a specific country of origin in the context of a clinical study.

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

• Number of Experts: For the "simulated use testing," ENT surgeons were involved. The exact "number of experts" is not specified (e.g., "ENT surgeons" could imply more than one, but no specific count is given).
• Qualifications of Experts: The experts are identified as "ENT surgeons," indicating their medical specialty relevant to the device's use. No further details on their experience (e.g., "10 years of experience") are provided.
• Ground Truth: In the context of simulated use, the "ground truth" would be the successful procedural outcome as observed and judged by these ENT surgeons in a simulated environment (i.e., effective access and dilation).

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the simulated use testing or any other part of the performance evaluation. The results are presented as having "demonstrated" specific outcomes.

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

• No, a "multi reader multi case (MRMC) comparative effectiveness study" was not conducted. The document states, "Clinical data was not necessary for the RELIEVA SPINPLUS™ NAV Balloon Sinuplasty System." The evaluation was based on non-clinical performance and simulated use data to establish substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

• This device is a physical medical instrument (a balloon sinuplasty system) and does not involve an "algorithm" or AI in the traditional sense of image analysis or decision support for diagnostics. It is used in conjunction with an "ACCLARENT ENT™ Navigation System," which is a separate system (K161701 for its navigation accuracy testing). The performance reviewed here is an instrument that aids surgeons, not a standalone AI algorithm. While navigation accuracy was tested for the combined system, it's not an "algorithm only" performance evaluation.

7. The Type of Ground Truth Used

• The "ground truth" for the various non-clinical tests was based on engineering specifications, industry standards, and established metrics for material properties, mechanical integrity, and biological safety (e.g., burst pressure limits, sterility assurance levels, biocompatibility standards).
• For the simulated use testing, the "ground truth" was established by expert observation and judgment of ENT surgeons regarding the device's ability to effectively access and dilate paranasal sinuses in a simulated environment.

8. The Sample Size for the Training Set

• The document describes a device approval process based on substantial equivalence to predicate devices through non-clinical and simulated use testing. It does not mention a "training set" as would be relevant for machine learning algorithms or for establishing a new clinical efficacy profile.

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

• As no "training set" for an algorithm or new clinical efficacy was described, this information is not applicable and not present in the document.

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