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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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