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To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.

The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").

The PathAssist LED Light Fiber is packaged alone or may be packaged with XprESS (LoProfile suction tip).

This document describes the PathAssist LED Light Fiber, a device intended to locate, illuminate within, and transilluminate across nasal and sinus structures. The document is a 510(k) summary submitted to the FDA, indicating a claim of substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria. Therefore, the information provided focuses on demonstrating equivalence to an existing device rather than presenting detailed acceptance criteria and a study proving the device meets them in a conventional sense.

Here's a breakdown based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for novel performance metrics are not explicitly stated in this document. Instead, the focus is on meeting "design specifications" and performing "as intended," which is implicitly tied to the performance of the predicate device.

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

The document states: "Performance testing of the PathAssist LED Light Fiber consisted of design verification testing to support the device modifications." It does not specify a "test set" in the context of clinical or large-scale comparative studies. The testing described is primarily benchtop design verification.

• Sample Size: Not specified for individual tests.
• Data Provenance: Not applicable in the context of clinical data. It's internal company design verification data. This is retrospective in the sense that it evaluates the modified device's adherence to design specifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable as the document describes design verification testing, not a clinical study involving human readers or expert ground truth panels.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" in the context of expert review or clinical trial adjudication. Design verification results are typically evaluated against established engineering specifications.

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

A MRMC comparative effectiveness study was not done. The document explicitly states: "animal and clinical data were not submitted."

6. Standalone Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done in the clinical sense. The "performance data" refers to "design verification testing" (functional, mechanical, compatibility, thermal safety), which assesses the device's physical and operational characteristics, not its clinical efficacy in a standalone context.

7. Type of Ground Truth Used

The "ground truth" for the design verification testing would be the engineering design specifications and established quality control parameters for the device's physical and functional attributes.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

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

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To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.

The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.5mm (0.020").

The provided text describes the Entellus Medical PathAssist LED Light Fiber, a flexible instrument emitting light from its distal end for locating, illuminating, and transilluminating nasal and sinus structures.

Based on the information provided, the acceptance criteria and the study proving the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a numerical sample size for the test set used in the performance testing.
The testing appears to be primarily laboratory-based and simulated use (cadaver model). Data provenance would be from internal testing conducted by Entellus Medical, Inc.

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

The document does not mention the involvement of experts for establishing ground truth, as the testing described is primarily focused on engineering and performance validation rather than clinical ground truth (e.g., diagnosis of a condition). The simulated use in a cadaver model would likely be evaluated by internal engineers or potentially medical professionals involved in the simulated use, but specific numbers or qualifications are not provided.

4. Adjudication method for the test set:

The document does not describe any adjudication method like 2+1 or 3+1. Given the nature of the described performance tests (e.g., EMC, electrical safety, mechanical, functional, cadaver simulation), it's highly probable that pass/fail criteria based on predefined specifications were used, rather than an adjudication process involving multiple reviewers.

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

No, an MRMC comparative effectiveness study was not done. This device is a manual surgical instrument (light fiber), not an AI-assisted diagnostic tool. Therefore, there is no discussion of human readers or AI assistance.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an algorithm or AI.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on engineering design specifications, industry standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety), and the intended functional performance (e.g., light emission, physical dimensions, ability to transilluminate in a cadaver). There is no mention of pathology or clinical outcomes data being used for ground truth in this submission.

8. The sample size for the training set:

The document does not mention a training set. This device is a physical instrument and does not involve AI or machine learning algorithms that would typically require a training set.

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

As there is no training set, this question is not applicable.

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