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The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.

For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.

The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes a Eustachian Tube Balloon Catheter and Guide Catheter designed specifically for use in accessing and dilating the Eustachian Tube. The system is used with the following additional devices: the Acclarent® SE Inflation Device (or Acclarent® Balloon Inflation Device). The Acclarent® SE Inflation Device or Acclarent® Balloon Inflation Device is used to inflate the balloon. All devices are provided sterile for single-patient use. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes is a 6x16mm (inflated diameter x length) flexible Balloon Catheter with an integrated shaft and a nylon balloon at the distal tip. The non-compliant balloon is designed to dilate the cartilaginous portion of the Eustachian tube. The shaft consists of dual lumen tubing with an actuator component that is designed to assist in rotation and advancement of the balloon catheter. The balled catheter tip (aka, “blueberry tip") on the balloon catheter is designed to restrict advancement of the device into the bony portion of the Eustachian tube, known as the isthmus. There is an endoscopic marker placed at the proximal taper of the balloon to aid in positioning under direct endoscopic visualization. The AERA Guide Catheter is anatomically designed to facilitate AERA Balloon Catheter access to the Eustachian tube. The AERA Guide Catheter incorporates an atraumatic distal tip and distal angled tip profile that facilitates access to the Eustachian tube. The Guide Catheter supplied with the ACCLARENT AERA® Eustachian Tube Balloon Dilation System contains a lubricious inner liner to allow smooth passage for the balloon catheter and includes a hypotube for rigidity.

The Acclarent AERA Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for the treatment of persistent Eustachian tube dysfunction. The expanded indication covers patients aged 8-17 years with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and refractory to at least one surgical intervention.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set (for pediatric expansion):

  • Clinical Data: Efficacy data was reported from 20 ears of patients aged 8-17 years with Chronic Otitis Media with Effusion. Safety data encompassed a broader analysis across the expanded pediatric age group (8-17 years), without a specific patient count provided for the 8.2% minor AE rate, but it was derived from real-world evidence.
  • Anatomical Equivalence: "Several articles" based on CT scan reviews were used. No specific number of patients or scans are provided for this.
  • Provenance: "Real-world evidence, with data from published literature and data provided by established physicians" was analyzed. It is retrospective in nature, as it relies on existing published literature and real-world clinical experience. The country of origin of the data is not specified but is generally understood to be diverse given the nature of a systematic literature review and physician-provided data.

• Training Set: The document does not explicitly describe a separate "training set" in the context of an AI/ML algorithm requiring such a set. The performance data for the device (mechanical, biocompatibility, sterilization, etc.) relies on previously submitted bench testing and validations, which are not typically referred to as training sets. The clinical data for the pediatric expansion relies on real-world evidence and a systematic literature review, which also does not fit the typical definition of a training set for an AI/ML model.

3. Number of Experts and Qualifications for Ground Truth:

• For Clinical Data (Pediatric Expansion): The document mentions "data provided by established physicians." It does not specify the number or specific qualifications (e.g., years of experience) of these individual physicians, nor does it detail the experts involved in conducting the systematic literature review.
• For Anatomical Equivalence: Similarly, the CT scan reviews were used as evidence for anatomical equivalence, based on "several articles." The experts performing these CT scan reviews or evaluating the articles are not explicitly identified or qualified.

4. Adjudication Method for the Test Set:

• The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical data or anatomical equivalence evaluations for the pediatric expansion. The data from published literature and physician-provided data likely reflect outcomes as recorded and reported in their respective studies or practices.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a physical medical device for dilation, not an AI or imaging diagnostic software that would typically involve human readers interpreting cases with and without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone (algorithm only) performance study was not done. As noted above, this device is a physical medical device (balloon dilation system), not a software algorithm that would have standalone performance.

7. Type of Ground Truth Used:

• For the pediatric efficacy data, the ground truth was based on:
  • Clinical Outcomes/Measurements: Improvement in tympanometry (an objective measure of middle ear function).
  • Failure-Free Rate: Defined as not requiring further surgery for ETD (e.g., tympanostomy tube insertion or revision ETBD), which is an outcome-based measure.
• For the pediatric safety data, the ground truth was based on:
  • Reported Adverse Events: Classification of events as serious or minor, as observed in real-world clinical practice and literature.
• For anatomical equivalence, the ground truth was based on:
  • CT Scan Reviews: Morphometric analysis of Eustachian tube anatomy as reported in published studies.

8. Sample Size for the Training Set:

• As mentioned in section 2, the document does not describe a "training set" in the context of AI/ML. All referred performance data are either previously established bench tests for the device itself or real-world clinical evidence/literature reviews for the expanded indication.

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

• Not applicable, as a conventional "training set" with established ground truth for an AI/ML model is not described in this submission. The "ground truth" for the device's functional and safety characteristics was established through standard engineering bench testing and clinical data collection/review methodologies relevant to medical devices.

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The TruDi® Navigation system is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

The TruDi® Navigation System V3 is intended to be used during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to the targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. The TruDi® Navigation System V3 enables ENT physicians to access sphenoid, frontal, and maxillary sinuses, as well as the skull base, by using the systems magnetic tracking technology, which is the same technology used by the predicate device. The system incorporates a Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Workstation and peripherals. A magnetic field generated by the Emitter Pad induces a current in the magnetic sensor embedded in the tip of the navigated tool, which helps to accurately calculate the tool tip position. A CT or MR image is imported and registered to the patient coordinates and the navigated tool tip icon is displayed on top of the registered image, indicating the position of the tool tip in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the surgical procedure.

Here's a breakdown 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 Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of human data or patient cases. The performance data is derived from non-clinical bench testing and simulated use.

• Bench Location Accuracy: This test compared the TruDi® Navigation System's electromagnetic locations to those provided by a highly accurate robot system over its entire navigation volume. While a sample size of "locations" would have been involved in this measurement, the specific number is not provided.
• Simulated Use Location Accuracy: This involved performing a complete CT image registration and instrument navigation workflow. The specific sample size for "simulated uses" is not provided.

The data provenance is not from human patients; it's from laboratory (bench) and simulated environments. Therefore, country of origin is not applicable in the typical sense.

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

This information is not applicable as the 'test set' for accuracy was based on objective measurements (robot system, simulated workflow) and not on expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established through objective measurement tools and processes (robot system, simulated workflow) rather than human adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary to determine that the subject TruDi® Navigation System V3 performs as intended." This indicates that the evaluation was purely technical and non-clinical.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation of the device's core accuracy functions was done. The "Location Accuracy tests... where the TruDi® Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system" directly assesses the system's inherent accuracy in a controlled, non-human environment. The "Simulated use accuracy test" also falls under this, evaluating the system's accuracy within a simulated workflow.

7. The Type of Ground Truth Used

The ground truth used for accuracy assessments was based on:

• Highly accurate robot system measurements for Location Accuracy tests.
• Known/defined parameters within a simulated use workflow for Simulated Use Location Accuracy tests.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This device is a navigation system primarily relying on electromagnetic tracking technology, not a machine learning model that typically requires a separate training set.

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

This information is not applicable as there is no mention of a training set or its ground truth establishment within the provided document.

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TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:

• · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
• · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
• · Orbital decompression
• · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
• · Access to the sphenoid sinus

The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.

The TruDi® Shaver Blade underwent various performance tests to demonstrate its substantial equivalence to its predicate device. This device is an electromagnetically (EM) navigated instrument intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in incision and removal of soft and hard tissue or bone in various ENT and maxillofacial surgeries.

1. Table of Acceptance Criteria and Reported Device Performance:

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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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TruDi™ Curette is intended for use with the TruDi™ Navigation System to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery.

The subject device, TruDi™ Curette (K201174), is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. The TruDi™ Curette consists of one configuration (straight 0°). The TruDi™ shaft, and a curette cup, which is located at the distal tip and houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Curette in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of the distal shaft as needed.

The TruDi™ Curette incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT/MRI scan to confirm access, and to locate anatomical structures during ENT and ENT skull base surgery.

The provided document is a 510(k) summary for the TruDi™ Curette, which seeks to demonstrate substantial equivalence to a predicate device. While it includes a lot of information about bench testing and design validation, it does not detail a study involving AI performance or human readers. Therefore, several requested sections, particularly those related to AI and human reader studies, cannot be extracted from this document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Design validation testing (simulated use testing) on cadavers" but does not specify the sample size (number of cadavers or test cases) used for this test set nor the detailed provenance beyond "cadavers". It is a prospective study in a simulated clinical setting.

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

Not specified in the provided document. The document mentions "evaluators" for assessing packaging and instructions for use, but not for establishing ground truth regarding clinical performance.

4. Adjudication method for the test set

Not specified in the provided document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The TruDi™ Curette is a physical surgical instrument, not an AI or imaging diagnostic device that would involve human readers or AI assistance in the way typically assessed by MRMC studies.

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

Not applicable. The TruDi™ Curette is a physical surgical instrument, not an algorithm. Its navigation capability is part of the TruDi™ Navigation System, which has a stated accuracy of ≤ 2mm RMS. This accuracy is a standalone measurement of the system's ability to track the instrument's tip.

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

For the navigational location accuracy, the ground truth would typically be established through precise metrological measurements using a known standard or reference system. For the simulated use testing on cadavers, the "ground truth" or successful performance would be based on the device functioning as intended in manipulating, dissecting, and/or removing tissue, cartilage, and bone, as verified by the evaluators. Specific methods for establishing this ground truth (e.g., expert observation, quantitative assessment of tissue removal) are not detailed.

8. The sample size for the training set

Not applicable. The TruDi™ Curette is a physical device, and the document describes performance testing and design validation, not the development or training of an AI algorithm.

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

Not applicable. There is no mention of a training set or AI model in the context of this device.

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The TruDi™ Probe is intended for use with the TruDi™ Navigation System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.

The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.

The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed.

The TruDi™ Probe incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT scan to confirm access and locate anatomical structures during ENT surgery.

The document describes the Acclarent TruDi™ Probe, a single-use electromagnetically (EM) navigated instrument for locating anatomical structures during ENT and ENT skull base surgery. The device is intended for use with the TruDi™ Navigation System.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data from various non-clinical tests. Since specific quantified acceptance criteria are not presented in a direct table format alongside the reported performance values, I will infer them from the descriptions.

2. Sample Size for Test Set and Data Provenance:

The document mentions "bench testing" and "simulated use testing on cadavers." However, specific sample sizes for these tests are not provided. The provenance of the data is implied to be from the manufacturer's internal testing as part of their 510(k) submission, and it is retrospective (performed before the submission). There is no mention of country of origin for the data; it is assumed to be part of the manufacturer's internal development and testing.

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

The document describes "simulated use testing on cadavers" where "packaging and instructions for use were also successfully assessed by evaluators." However, the number of experts and their qualifications used to establish ground truth for these tests are not mentioned.

4. Adjudication Method:

The document does not specify an adjudication method for the "simulated use testing" or any other performance evaluation involving human assessment.

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

A MRMC comparative effectiveness study was not conducted or reported. The submission explicitly states "Clinical data was not necessary for the TruDi™ Probe. The performance data demonstrated that the device performs as intended." This indicates no study was done to assess human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only):

The document describes the standalone performance of the device concerning its navigational accuracy:

• A mean bench accuracy of 0.43 mm (Standard deviation 0.15 mm) was measured for the device.
• With 95% confidence, measured devices have a location accuracy of ≤ 2 mm RMS over the entire navigation volume.
  This indicates algorithm-only performance testing for its core functionality (localization).

7. Type of Ground Truth Used (for standalone performance):

For the navigational accuracy, the ground truth would have been established by a highly precise engineering and metrology setup (e.g., using a known reference system or precision measurement tools) to determine the true position, against which the device's reported position was compared. This is typical for such electromagnetic navigation systems.

8. Sample Size for the Training Set:

The TruDi™ Probe is an electromagnetic navigation instrument, not an AI or machine learning algorithm in the typical sense that would require a "training set" of data to learn from. Its performance is based on physical principles and sensor technology. Therefore, a training set size is not applicable in this context.

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

As mentioned above, the concept of a "training set" and associated ground truth is not applicable to this device, which relies on direct physical measurement and not a learning algorithm.

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The TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.

The subject device, TruDi™ NAV Wire, is a single-use electromagnetically (EM) navigated, flexible guidewire, which is compatible for use with the TruDi™ Navigation System to provide access and confirmation of placement in patient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.

The provided text describes the "TruDi™ NAV Wire," an electromagnetically navigable guidewire. Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and the device's reported performance against those targets in a readily digestible format for certain tests. Instead, it states that "Bench testing has been performed and met all acceptance criteria for attributes..." and then lists the attributes. For sterility, it mentions a specific level.

Here's a table based on the provided text, outlining the tests performed and the general statement of performance:

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

The document does not specify the sample size used for the test set for any of the bench tests (simulated use, durability, etc.).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. Since these are bench tests, they are typically conducted in a laboratory setting.

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

This information is not applicable as the studies described are bench tests on the device's physical and functional properties, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication in the way clinical studies with ground truth establishment would. The tests would likely have pre-defined pass/fail criteria.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Wire." The studies described are non-clinical bench tests.

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

This question is not directly applicable as the TruDi™ NAV Wire is a physical medical device, not an algorithm, and its performance relies on interaction with a navigation system. The "Location Accuracy (Sensor Sensitivity)" test implicitly assesses the standalone performance of the guidewire's electromagnetic tracking capability, but it's not an algorithm in the typical sense of AI.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be established by engineering specifications, industry standards (e.g., ISO, ASTM), and design requirements. For example, a specified durability threshold or a precise dimensional measurement.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical guidewire and the studies described are bench tests, not machine learning studies that require a training set.

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

This information is not applicable as there is no training set for a machine learning model.

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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 RELIEVA TRACT™ Balloon Dilation System 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 RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17 years or older.

The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile device, which is 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. The RELIEVA TRACT™ Balloon Dilation System is composed of:

• A RELIEVA TRACT™ Balloon Catheter, which consists of an integrated shaft system and a high-pressure balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the balloon with sterile water or saline via the ACCLARENT® Balloon Inflation Device (K090660). The inner lumen permits the use of the RELIEVA TRACT™ Stylet to facilitate advancement of the balloon catheter to the target location, such as the nasal passage in the region of the inferior turbinate and nasal septum. The proximal end of the RELIEVA TRACT™ Balloon Catheter consists of a luer that is used for inflation of the balloon and a secondary luer that is used for stylet access. The balloon is inflated by injecting sterile water or saline through the inflation luer.
• A RELIEVA TRACT™ Stylet, which is an optional accessory and intended to facilitate advancement of the Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.

This document is a 510(k) Summary for a medical device, the RELIEVA TRACT™ Balloon Dilation System. The request is to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data validation (e.g., test set, experts, ground truth).

However, this document does not contain information about the performance of a software or AI-based medical device, nor does it detail a study involving a test set, expert consensus for ground truth, or MRMC studies.

This 510(k) is for a physical medical device (a balloon dilation system) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (e.g., sterilization validation, biocompatibility, simulated use testing on cadavers).

Therefore, many of the requested bullet points, which are typically relevant for the validation of AI/software medical devices, cannot be answered from the provided text. The document explicitly states:

• "Clinical data was not necessary for the RELIEVA TRACT™ Balloon Dilation System." (Page 6)

Below is an attempt to answer the questions based on the available information, highlighting where the requested details are not present in the document.

Acceptance Criteria and Device Performance Study (RELIEVA TRACT™ Balloon Dilation System)

This 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance and simulated use testing, rather than a clinical study or a study specifically validating a data-driven AI/software component with a test set and ground truth.

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

The document broadly states that the device "met all performance acceptance criteria," and then lists types of testing performed. Specific numerical acceptance criteria for each test are not detailed in this summary.

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

• Sample Size: Not specified. The document mentions "simulated use testing on cadavers." The number of cadavers or specific test instances is not provided.
• Data Provenance: "Cadavers" are mentioned for simulated use testing. No information on country of origin or whether the testing was retrospective or prospective. Given it's simulated use, it would typically be prospective for the purpose of the study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The simulated use testing included "evaluators" who assessed the packaging and instructions for use, but their number and qualifications (e.g., medical professionals, engineers) are not detailed.

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

• Adjudication Method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, this type of study was not performed. This device is a physical medical instrument, not an AI/software. The document explicitly states "Clinical data was not necessary."

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

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

• For the simulated use testing, the "ground truth" would implicitly be the successful navigation, deployment, and dilation of the device as per its design specifications and intended use in the cadaveric model. This would likely be assessed by professional evaluators (e.g., engineers, medical device specialists, or potentially clinicians), but the specific method (e.g., visual inspection, measurement, functional assessment against a defined standard) is not detailed, nor is it based on expert consensus in the sense of diagnostic image interpretation.

8. The sample size for the training set:

• Training Set: Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

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TruDi™ NAV Suction Instruments are intended for use with the TruDi™ Navigation System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments.

TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.

TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically- navigated reusable devices intended to be used in conjunction with the TruDi™ Navigation System. When used with the TruDi™ Navigation System, the TruDi™ NAV Suction Instruments provide navigation of the devices to targeted anatomy and evacuate gases, liquids, and fragments. The TruDi™ Navigation System is the trade name for the ACCLARENT® ENT Navigation System cleared in K173628.

TruDi™ NAV Suction Instrument Set consists a 0° suction instrument, 70° suction instrument, 90° suction instrument, and a single-use sterile cable called the TruDi™ NAV Cable. The TruDi™ NAV Cable may be used to connect the suction instruments to the TruDi™ Navigation System.

The TruDi™ NAV Suction Instruments include an EM trackable single axis sensor, which is integrated at the distal tip of the device. The TruDi™ Navigation System acquires the position and orientation of the distal tip of the device and displays it in real-time view over the patient's pre-operative CT scan to confirm access of target anatomy. Following confirmation, the physician operates the surgical instrument at the target anatomical structure.

The provided text is a 510(k) Premarket Notification for the TruDi™ NAV Suction Instruments. It outlines the regulatory process, device description, comparison to predicate devices, and non-clinical performance data.

However, it does not contain information related to a study proving the device meets acceptance criteria regarding clinical performance or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or details about the training and test sets as typically found in submissions for AI/ML-based medical devices.

The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Suction Instruments." and "The performance data demonstrated that the device performs as intended." This indicates that substantial equivalence was primarily established through non-clinical testing and comparison to predicate devices, rather than a clinical trial involving human performance assessment with the device.

Therefore, many of the requested details, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC study results, and specifics on AI algorithm ground truth establishment, are not present in the provided text because the device is a navigation suction instrument and not an AI/ML diagnostic tool.

I can, however, extract the acceptance criteria related to the device's physical and functional performance, along with the reported outcomes from the non-clinical tests.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Here's an analysis of the requested information based on the provided document, highlighting what is not applicable (N/A) given the nature of the device and the submission:

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

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

   • Test Set Sample Size: Not explicitly stated for specific non-clinical tests (e.g., number of instruments tested for accuracy, deflection, etc.). The mention of "simulated use testing with ENT surgeons and support staff" doesn't provide the number of participants or simulated cases.
   • Data Provenance: Not specified. As these are non-clinical tests, country of origin is less relevant than for clinical data. This was a premarket notification (510(k)) based on non-clinical performance and substantial equivalence.

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):

   • N/A. Ground truth in the context of AI/ML diagnostic devices (e.g., disease presence/absence) is not relevant here. For the "simulated use testing," the "experts" were "ENT surgeons and support staff," who were evaluating the device's functional and mechanical performance, not establishing a diagnostic ground truth. No specific number or qualifications beyond "ENT surgeons and support staff" are provided.

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

   • N/A. Adjudication methods are typically used to resolve discrepancies in expert labeling a dataset for AI/ML ground truth. This is not applicable to the non-clinical and simulated use testing 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. The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Suction Instruments." This means no MRMC study was conducted. This device is a surgical instrument, not an AI-based diagnostic tool.

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

   • N/A. There is no standalone AI algorithm discussed for this device. The device itself is an instrument that works with a navigation system. Its "performance" (accuracy) is a standalone measurement of the physical system (instrument + navigation system), but this is not an AI algorithm's standalone performance in the typical sense.

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

   • N/A. For the non-clinical tests, "ground truth" was established through engineering measurements, validated test methods (e.g., AAMI/ANSI/ISO for sterility, ASTM for packaging), and design specifications. For "clinical accuracy" in simulated use, it implies the device performed as expected by the ENT surgeons and support staff based on its design and intended function, not against a medical ground truth (like a biopsy result or patient outcome).

8. The sample size for the training set:

   • N/A. This device does not involve a training set for an AI/ML algorithm.

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

   • N/A. This device does not involve a training set for an AI/ML algorithm.

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