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For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.

The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use system that is an integrated device with a handle, rail, balloon catheter, and sinus illumination system with an illuminated ball tip. The packaged device contains the sinus balloon catheter an angle selection tool to enable angular bends for multiple sinus access (sphenoid, frontal, maxillary). The device may be used to access the sinus space and the balloon inflated with sterile water or sterile or saline to dilate the sinus ostia and infandibulum. The inflation device is provided separately. The device may be used in Operating Room and physician office settings.

Here's a breakdown of the acceptance criteria and the study information for the Relieva Scout™ Multi-Sinus Dilation System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical (bench) testing. Therefore, much of the information typically found in clinical studies (like specific sample sizes for test sets, number of experts for ground truth, or MRMC studies) is not present because it was not required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent based on non-clinical performance data. Specific numerical acceptance criteria are not detailed in this summary, but the general categories and outcomes are listed below:

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

• Sample Size for Test Set: Not specified. This documentation focuses on non-clinical (bench) testing, where specific "sample sizes" like those for patient data are not typically reported in this format. The testing would have involved multiple units of the device for each test (e.g., multiple balloons for burst testing).
• Data Provenance: The data is from non-clinical (bench) testing conducted by the manufacturer, Acclarent, Inc., based in Menlo Park, California, USA. It is inherently "prospective" in the sense that the tests were designed and conducted specifically for this submission.

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

Not applicable. For non-clinical bench testing, "ground truth" is established by adherence to predefined engineering specifications, standardized test methods (e.g., ISO, AAMI, ASTM standards), and regulatory requirements. There are no "experts" establishing ground truth in the clinical interpretation sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies involving human interpretation or uncertain outcomes. For bench testing, results are typically objective measurements against a standard.

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 done. The document explicitly states: "Clinical data was not necessary for the Relieva Scout™ Multi-Sinus Dilation System." This type of study would be for evaluating the effectiveness of the device in a clinical setting, often involving human readers/interpreters, which was not performed for this 510(k) submission.

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

Not applicable. This device is a manual surgical instrument, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was established by:

• Predefined Engineering Specifications: The device's design and manufacturing specifications.
• Standardized Test Methods: Adherence to international and national standards such as ISO 10993-1, AAMI ANSI ISO 10993-1:2009/(R) 2013 for biocompatibility; AAMI/ANSI/ISO 11135-1:2007 for sterilization; ISO 10993-7:2008 for ethylene oxide residuals; and ASTM F1980-07 for packaging shelf life.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

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

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

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The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used 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; or
• locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical quidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The NuVent™ EM Sinus Dilation System comprises sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape and angle that allows for entry into the sinus outflow tract. The inflator consists of a plunger, barrel and extension tube.

Each sinus seeker is intended for use in conjunction with the Fusion software on a Medtronic computer-assisted surgery system. Inside each sinus seeker is an EM tracker. The emitter on the EM Computer-Assisted Surgery System generates a low-energy magnetic field to locate the tracker mounted inside of the sinus seeker. The software displays the location of the sinus seeker's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seekers balloon can be inflated with saline solution by using the inflator to expand the outflow of the targeted sinus.

The provided text describes a 510(k) premarket notification for the NuVent EM Sinus Dilation System. This device is an ear, nose, and throat (ENT) manual surgical instrument used in conjunction with a computer-assisted surgery system for sinus procedures. The submission seeks to expand the indications for use to include procedures on scarred, granulated, or previously surgically altered tissue, and also to explicitly state facilitating "dilation of the sinus ostia" in the indications.

The submission does not contain acceptance criteria for specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be expected for a diagnostic or AI-driven device. This is primarily because the device is a surgical instrument for physical manipulation and guidance, not a diagnostic tool that produces classification or quantitative results.

The "study" described is a clinical study to support the expanded indications, focusing on the safe and intended performance of the device in a specific patient population, not on meeting predefined statistical performance thresholds for an AI algorithm.

Based on the provided text, here is the information requested, with "N/A" where the information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a surgical instrument and not an AI or diagnostic device, the "acceptance criteria" discussed are related to the broader concepts of "substantial equivalence," "performance as intended," and "no new safety concerns." There are no quantitative performance metrics like sensitivity or specificity.

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

• Sample Size (Test Set): Not explicitly stated as a number of "subjects." The text mentions "subjects with scarred, granulated or previously surgically altered tissue were enrolled and treated in at least one frontal, sphenoid, or maxillary sinus." The exact number of subjects is not provided in this excerpt.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Prospective.

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. This is a study to demonstrate the performance and safety of a surgical instrument in a clinical setting, not a study involving expert-derived ground truth for diagnostic accuracy. The "truth" is whether the device could be used as intended without issue and without new safety concerns, as observed by the operating surgeons. Though not called out explicitly regarding "ground truth," the study involved "surgeons" performing procedures.

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

N/A. This type of adjudication is not applicable to a clinical study evaluating the performance and safety of a surgical instrument. The study was described as "non-randomized, non-blinded, single arm."

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

N/A. This device is a surgical instrument assisted by a computer navigation system, not an AI-assisted diagnostic imaging interpretation tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.

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

N/A. The device is a physical surgical instrument that functions "in conjunction with the Medtronic Computer-Assisted Surgery System." It is inherently a "human-in-the-loop" device as it aids the surgeon, rather than performing tasks autonomously.

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

The "ground truth" implicitly assessed was clinical outcome and observed safety/performance during live surgical procedures. The clinical study evaluated whether the device "performed as intended and did not raise new safety concerns" in patients with the expanded indications.

8. The sample size for the training set

N/A. This submission describes a modification to an existing surgical device. There is no mention of an algorithm or AI model that would require a "training set."

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

N/A. As there is no training set for an algorithm, this question is not applicable.

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the XprESS Multi-Sinus Dilation System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document doesn't explicitly state quantitative acceptance criteria in a typical tabular format with specific thresholds to be met (e.g., "Success Rate > 90%"). Instead, the performance claims are presented as achieved outcomes.

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

• Sample Size (Test Set): 50 subjects (with 157 attempted sinus dilations).
• Data Provenance: Prospective, multicenter, single-arm study conducted in the United States.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on procedural success and complication rates, which were likely determined by the treating physicians and reported in the clinical study. It's not a diagnostic AI device where external expert review of outputs for ground truth is typically required.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given it's a procedural device study focusing on success and complications, data would typically be collected and reported by the clinical sites and then aggregated and analyzed.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or AI-assisted interpretation devices to compare human performance with and without AI assistance. The XprESS device is a surgical instrument.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No, a standalone (algorithm only) performance study was not done. The XprESS Multi-Sinus Dilation System is a physical medical device, not an algorithm or AI. Its performance is tied to its physical use.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the outcomes measured in the clinical study:

• Procedural Technical Success: This would be determined by direct observation during the procedure by the treating physician(s) – i.e., whether the dilation was successfully completed.
• Complication Rate: Recorded by clinical staff and physicians based on adverse events occurring during or after the procedure.

8. The Sample Size for the Training Set

Not applicable. The XprESS Multi-Sinus Dilation System is a physical medical device, not an AI or algorithm that requires a training set.

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

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

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For patients aged 18 and older, the Relieva Scout ™ Sinus Dilation System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.

The Relieva Scout Sinus Dilation System is an integrated device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and an ergonomic handle. The sinus balloon may be inflated to dilate the frontal recess, frontal sinus ostia, and spaces within the frontal sinus cavity.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/algorithm based technology. The document describes a "Relieva Scout™ Sinus Dilation System", which is a manual surgical instrument, not an AI or algorithm-based device.

The "Performance Data" section (on page 1) mentions:

• Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, balloon burst, and bond separation.
• Testing also showed that the Scout Balloon Sinuplasty System is biocompatible.
• The sterilization process was validated per AAMI/ANSI/ISO 11135-1:2007.
• Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements.
• Packaging shelf life was established via accelerated aging per ASTM F1980-07.

This information refers to engineering and material-based performance, not the kind of AI-driven performance (like sensitivity, specificity, or reader improvement) that would require the specific details you've asked for (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance).

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The Vent-Os™ Sinus Dilation System is an instrument intended to provide a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

The Vent-OsTM Sinus Dilation System is an osmotically driven device that dilates maxillary sinus ostia and associated spaces. The Vent-Os™ Sinus Dilation System is comprised of a Dilation Device preloaded on a Placement Instrument. The Placement Instrument accesses the target site through the nasal passageway and delivers the Dilation Device. The Vent-Os™ Sinus Dilation Device then expands and remodels the target tissues and then is removed.

Here's a breakdown of the acceptance criteria and the study details for the Vent-Os™ Sinus Dilation System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary focuses on demonstrating "substantial equivalence" rather than providing explicit numeric acceptance criteria for each test. Instead, it reports "Passed" or specific outcomes that are compared to a literature control for clinical efficacy.

Study That Proves the Device Meets Acceptance Criteria:

The 510(k) submission details several studies to demonstrate safety and effectiveness for substantial equivalence:

• Biocompatibility Studies: In compliance with EN ISO 10993 requirements (ISO 10993-5:2009 and ISO 10993-10:2010).
• In Vitro Bench Evaluation: Performance testing was completed on various physical and mechanical attributes of the device.
• Transportation, Sterilization, and Shelf-life Testing: Sterilization compliant with ANSI/AAMI/ISO 11137-2. Transportation and packaging validation included transit testing, sterile barrier integrity, packaging/system visual inspection, and pouch seal testing.
• Animal Studies: Four (4) Dilation Devices were deployed into four (4) separate sheep maxillary sinuses to confirm safe placement and dilation.
• Cadaver Testing: Performed by multiple users (investigators) using two (2) adult cadaveric head specimens. The device was placed four (4) times into each target site.
• Clinical Trial: A prospective, non-randomized, single-arm, open-label study was conducted.

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

• Clinical Trial Test Set Sample Size:
  • Patients: 34 patients
  • Maxillary Ostia Treated: 57 maxillary ostia
  • Data Provenance: The study was conducted at five (5) clinical sites. The summary does not specify the country of origin, but given the applicant is a US company (Palo Alto, CA) and the FDA submission is for the US market, it's highly probable the study was conducted in the United States.
  • Retrospective or Prospective: Prospective.

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

• The summary states that five (5) investigators conducted the clinical trial at five (5) clinical sites.
• Their specific qualifications are not explicitly stated beyond being "investigators," but for a study involving sinus dilation, they would typically be Ear, Nose, and Throat (ENT) specialists or Otolaryngologists. Their years of experience are not mentioned.
• The "ground truth" for the clinical trial was likely established by these investigators through post-procedure assessments of ostia patency, potentially using endoscopy or other clinical evaluation methods.

4. Adjudication Method for the Test Set

• The information provided does not specify an explicit adjudication method (e.g., 2+1, 3+1). For a single-arm, open-label study, it's common for the treating physician/investigator to evaluate the outcome. There is no mention of independent reviewers or a consensus process for the clinical trial results presented in the table.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a surgical instrument, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a manual surgical instrument, not an algorithm, so a standalone algorithmic performance study was not performed.

7. Type of Ground Truth Used

• Biocompatibility: Standardized laboratory test results based on established ISO guidelines.
• In Vitro Bench: Quantitative measurements and qualitative assessments ("Passed") against pre-defined performance specifications.
• Animal Studies: Direct observation and assessment of safe placement and dilation in sheep maxillary sinuses by qualified personnel.
• Cadaver Testing: Endoscopic delivery and placement of the device confirmed by investigators.
• Clinical Trial: Clinical assessment of maxillary ostia patency at acute and 3-month follow-ups, likely by the treating investigators based on clinical examination (e.g., endoscopy). This falls under expert clinical assessment/outcomes data.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/Machine Learning algorithm, so there is no "training set" in the computational sense. The "training" for the device would involve manufacturing process controls, design iterations, and perhaps early prototype testing, none of which are detailed as a formal "training set" in this context.

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

• Not applicable, as there is no training set for an algorithm. The "ground truth" during device development and manufacturing would be established through engineering specifications, material standards, and quality control metrics.

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The EM Sinus Dilation System is intended for use in 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 the frontal, maxillary, and sphenoid sinuses.

The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The EM Sinus Dilation System composes of sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilatation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape with the appropriate angle that allow for entry into the scarred sinus outflow tract. The inflator consists of a plunger, barrel and extension tube.

Each sinus dilation instrument is intended to be used in conjunction with the Fusion software on a Medtronic computer-assisted surgery system.

Inside of each sinus seeker is an EM tracker. The emitter on the Fusion System generates a low-energy magnetic field to locate the tracker mounted on the sinus seeker. Then, the software displays the location of the sinus dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seeker's balloon can be inflated with saline solution, using the inflator to expand the outflow track of the targeted sinus.

The provided 510(k) summary for the Medtronic EM Sinus Dilation System (K132297) focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and intended use. It does not include a detailed study proving the device meets specific performance acceptance criteria in the way a diagnostic AI device summary might.

The submission is for a surgical instrument with electromagnetic tracking, rather than an AI/ML-driven diagnostic tool. Therefore, the typical acceptance criteria and study designs (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) for AI-powered devices are not applicable or detailed in this document.

However, based on the information provided, I can extract what is stated regarding performance testing and how it relates to ensuring "acceptable navigational accuracy."

Here's a breakdown of the available information in the requested format, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Test samples" but does not quantify them or describe the nature of these samples (e.g., physical phantoms, cadaveric models, clinical data).
• Data Provenance: The testing was "Benchtop and simulated environment." There is no mention of country of origin for data, nor whether it was retrospective or prospective, as it appears to be primarily lab-based testing.

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 because the device is a surgical instrument with navigation capabilities, not a diagnostic tool requiring expert interpretation of images or clinical data for ground truth establishment. The "ground truth" for navigational accuracy would likely be established by known physical measurements in the simulated environment.

4. Adjudication Method for the Test Set

• Not applicable/Not described. Given the nature of the device and testing, expert adjudication in the context of diagnostic performance is not relevant here. Navigational accuracy would typically be objectively measured against known spatial references.

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

• No. An MRMC study was not done. This type of study is relevant for evaluating human reader performance, particularly with diagnostic imaging tools where human interpretation is a key component. This device is a surgical instrument, and its performance is evaluated in terms of its physical function and navigational accuracy rather than diagnostic reader performance.

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

• Yes, effectively. The "System Accuracy Method" is described as "Benchtop and simulated environment." This indicates that the functional and navigational accuracy of the device, likely using its electromagnetic tracking algorithm, was evaluated in a controlled setting without a human surgeon performing a full procedure. The document states the system "displays the location of the sinus dilation instrument's tip," implying an objective measurement of this display accuracy.

7. The Type of Ground Truth Used

• Implied objective measurements in a simulated environment. While not explicitly stated with details like "pathology" or "outcomes data," the "Benchtop and simulated environment" testing for "System Accuracy" and "navigational accuracy" suggests that the "ground truth" would be precisely known physical positions or measurements within the controlled test setup. For example, a known target position versus the device's reported position.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is a mechanical surgical instrument with electromagnetic tracking. It does not refer to an AI/ML algorithm that would typically require a "training set" in the conventional sense (e.g., for image recognition or predictive modeling). The "Fusion software" mentioned is likely a deterministic navigation system rather than a machine learning model that undergoes training.

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

• Not applicable/Not provided. As there is no explicit mention of a "training set" or an AI/ML model being trained with data in this submission, the method for establishing ground truth for such a set is not discussed.

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Intended Use: The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
Indications for Use: The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

The Sinus Dilation System with Cannulated Instrument consists of a disposable balloon which is mounted on a reusable cannulated delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic guidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to guide the device to the sinus ostium using endoscopic visualization. The instrument cannulation provides a working channel for suction, irrigation, etc.

The provided document K131709 describes a "Sinus Dilation System with Cannulated Instrument." The submission is a Special 510(k) notice for a modification to a previously cleared device (ENTrigue® Sinus Dilation System, K121351).

This type of device is classified as a Class I medical device (exempt from 510(k) requirements) under 21 C.F.R. § 874.4420, an "Ear, Nose, and Throat manual Surgical Instrument" with product code LRC. Due to its classification and the nature of the submission (Special 510(k) for a modification), the regulatory requirements for showing effectiveness through clinical studies involving human patients, as would be expected for AI/diagnosis devices, are not applicable here.

The "acceptance criteria" and "device performance" in this context refer to engineering and biocompatibility testing rather than diagnostic performance metrics like sensitivity, specificity, or AUC which are typical for AI/CADe devices.

Here's an analysis based on the provided text, indicating what information is present and absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of units tested) for the bench tests (fatigue life, human factors, articulation/lock, cleaning/sterilization). It only states that "Bench testing was conducted."
• Data Provenance: The data is from "Bench testing," meaning it was conducted in a laboratory or manufacturing environment. There is no mention of country of origin for the data or whether it was retrospective or prospective, as this is laboratory testing, not clinical data from patients.

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

• This question is not applicable to this type of device and study. The "ground truth" for a mechanical device's performance (like articulating, locking, or fatigue life) is generally based on engineering specifications and validated testing protocols, not expert clinical interpretation of data. Human factors verification might involve users (physicians or other healthcare personnel), but their number or qualifications as "experts to establish ground truth" in the diagnostic sense is not relevant here and not specified.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers when establishing ground truth for diagnostic decisions. Since this is a submission for a mechanical device based on bench testing, such methods are not relevant or described.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant to diagnostic devices, particularly AI-driven ones where human readers' performance is compared with and without AI assistance. This submission is for a mechanical surgical instrument.

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

• No, a standalone performance study was not done. This concept is only applicable to AI/algorithm-based diagnostic devices. The device in question is a physical surgical instrument; its performance is always "human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering specifications and validated test protocols. For example, a successful fatigue life test means the device withstood a specified number of cycles without failure, as per its design requirements. Successful cleaning and sterilization validation means it met established standards for those processes. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a physical surgical instrument modification. Training sets are relevant for machine learning algorithms.

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

• This question is not applicable for the same reason as point 8.

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The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.

The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

The ENTrigue® Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic quidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to quide the device to the sinus ostium using endoscopic visualization.

The ENTrigue® Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures.

The provided text describes a 510(k) submission for the ENTrigue® Sinus Dilation System, focusing on its substantial equivalence to a predicate device. The information available pertains to the device's technical characteristics and the claim of equivalence, rather than a detailed clinical study with specific acceptance criteria and performance metrics typically found in efficacy trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) for the ENTrigue® Sinus Dilation System in a typical clinical study format. Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool.

The primary "acceptance criterion" in this context is that the ENTrigue® Sinus Dilation System is "as safe and effective" as the predicate device. The performance data presented are qualitative and based on comparing technological characteristics and intended use.

Acceptance Criteria (Implicit for Substantial Equivalence):

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

• Sample Size: The document mentions "Bench and cadaveric testing, featuring multiple users." It does not specify the exact number of cadavers or the number of components tested for bench testing. It also doesn't specify the number of "users" (presumably surgeons) involved.
• Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) is not specified. It is likely prospective testing specifically conducted for this 510(k) submission, given the nature of bench and cadaveric studies.

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

• The document refers to "multiple users" for the cadaveric testing. It does not specify the number or qualifications of these users/experts. It can be inferred that these would be medical professionals (e.g., ENT surgeons) experienced in sinus dilation procedures, as the testing was to validate "user requirements."

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method. The testing appears to be functional validation and comparison, rather than a scenario requiring multiple expert opinions for ground truth establishment. The focus is on the device's operational performance.

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

• No, an MRMC comparative effectiveness study was not done as described in the provided text. The submission focuses on substantial equivalence through bench and cadaveric testing, not a clinical trial comparing human reader performance with and without AI assistance. This device is a surgical instrument, not an AI diagnostic tool.

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

• This question is not applicable as the ENTrigue® Sinus Dilation System is a physical surgical instrument, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that it is the device itself being evaluated for its physical function, guided by a human surgeon.

7. The Type of Ground Truth Used:

• For the bench testing, the "ground truth" would be engineering specifications and expected functional performance.
• For the cadaveric testing, the "ground truth" would be the successful and safe execution of the intended surgical procedures (e.g., successful dilation of ostia as observed by the "multiple users" for meeting "user requirements"), demonstrating physical interaction with anatomical structures. This is essentially expert observation and assessment of procedural success and device functionality in a simulated environment.

8. The Sample Size for the Training Set:

• This question is not applicable. The ENTrigue® Sinus Dilation System is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI models. This type of device is developed and validated through engineering design, material science, and functional testing, not through data-driven training.

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

• This question is not applicable for the same reason as point 8.

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The Relieva Spin Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The Relieva Spins Sinus Dilation System is comprised of three components: Handle System, Sinus Guide Catheter Tip, and Sinus Balloon Catheter. The Handle System unites the various components into one device. A suction line is embedded in the Handle System which can be actuated by the user covering the suction port. The Sinu Guide Catheter Tip is a sinus guide catheter that is available in three shapes and attaches to the Handle System on the distal end. The Sinus Balloon Catheter is a flexible catheter with a balloon on the distal tip; one lumen is used for inflation of the sinus balloon and the second permits passage of a sinus guidewire. A hypotube is incorporated on the proximal end of the device to provide rigidity as the Sinus Balloon Catheter is advanced and retracted in the Handle System. There are several markers placed along the Sinus Balloon Catheter to aid in positioning under direct endoscopic visualization. A sinus guidewire is packaged with the Relieva Spin Sinus Dilation System.

This document describes the Relieva Spin Sinus Dilation System, a medical device, and its acceptance criteria as presented in a 510(k) summary. The information provided is for a device submission, not an AI or algorithm-based product. Therefore, several of the requested categories related to AI performance, such as MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for AI, are not applicable.

Here's an analysis based on the provided text for the medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing, meaning the "test set" refers to the manufactured device units subjected to various physical and chemical tests. The sample sizes for these specific bench tests are not explicitly stated in the provided text.

• Data Provenance: The tests are conducted on manufactured devices in a laboratory setting, not patient data. The country of origin of the data is implicitly where Acclarent, Inc. conducts its testing, which is likely the USA given their address. All data is prospective as it's generated through controlled testing of the device.

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

This question is not applicable as the "ground truth" for a physical medical device in bench testing is defined by engineering specifications, material science standards, and established regulatory guidelines (e.g., ISO, ASTM standards). It does not involve expert clinicians establishing ground truth on medical images or patient outcomes. The "experts" would be the engineers and scientists conducting and interpreting the tests, ensuring compliance with the defined standards.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for resolving discrepancies in expert interpretations of clinical data, especially in AI studies. For bench testing of a physical device, results are objectively measured against predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. This device is a physical medical instrument (sinus dilation system), not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This question is not applicable. This device is a physical medical instrument; there is no algorithm for standalone performance.

7. The Type of Ground Truth Used

For this physical medical device, the "ground truth" is based on:

• Engineering Specifications: Pre-defined design parameters for dimensions, material properties, and performance limits.
• International and National Standards: Adherence to established standards like AAMI/ANSI/ISO 11135-1:2007 for sterilization, ISO 10993-7:2008 for EtO residuals, and ASTM/ISTA standards for packaging.
• Bench Testing Results: Objective measurements from physical tests (e.g., burst pressure, fatigue cycles, dimensional measurements).

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI system that requires a "training set" of data. Its performance is verified through physical bench testing on manufactured units.

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

This question is not applicable for the same reason as point 8.

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