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

The PathAssist Light Fiber is a flexible instrument that can be connected to a light source to emit light from its distal end. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.5mm (0.020"). The device consists of a flexible illumination fiber, a protective sheath and a light post, with an overall device length of 117cm. The Light Fiber is provided sterile and is for single use only. The Light Fiber is packaged with a commercially available male tuohy borst adapter and a sinus cannula.

This is a submission for a 510(k) premarket notification for a medical device called the "PathAssist™ Light Fiber™." As such, the documentation provided does not contain information about a study designed to prove the device meets acceptance criteria in the manner you've outlined for an AI/algorithm-based device.

The PathAssist™ Light Fiber™ is a manual surgical instrument, specifically a sinus guidewire. Its regulatory pathway relies on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with performance metrics like sensitivity, specificity, etc., typically associated with AI/ML diagnostic tools.

However, I can extract the relevant information available within the provided text to answer your questions where possible, and explicitly state when the requested information is not applicable or not provided.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance (Not applicable in the AI/ML sense)

For this device, "acceptance criteria" are related to demonstrating that the device meets its design specifications and performs its intended function safely and effectively, primarily through engineering and functional testing, and by establishing substantial equivalence to a predicate device.

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

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

• Sample size: Not specified. The testing described is "design verification testing" and "functional testing," which typically involves engineering samples rather than patient data sets characteristic of AI/ML studies.
• Data provenance: Not applicable in the context of patient data. The provenance would be the internal testing facilities of Entellus Medical, Inc.

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

• Not applicable. This device is a physical instrument, not an AI/ML algorithm requiring expert opinion for ground truth. "Ground truth" for this device would be established by engineering specifications and physical measurements.

4. Adjudication method for the test set

• Not applicable. There is no mention of expert adjudication as this is not an AI/ML diagnostic device study.

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. This is not an AI-assisted device. The document states that "animal and clinical data were not submitted."

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; it is not an algorithm and does not operate standalone.

7. The type of ground truth used

• Type of Ground Truth: Design specifications, functional requirements, and physical characteristics. For example, testing light emission, flexibility, and dimensions against pre-defined specifications.

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

• Not applicable. Does not apply to this type of device.

Summary of the Study (as described in the document):

The "study" or "performance data" provided for the PathAssist™ Light Fiber™ consisted solely of design verification testing. This testing included:

• Functional testing: Specifically to support the compatibility of the Light Fiber with LED light sources.
• Confirmation that the device meets its design specifications.
• Verification that the device performs as intended.

The document explicitly states that sterilization, shelf life, packaging testing, biocompatibility, animal, and clinical data were NOT submitted. The conclusion drawn from this performance data was that the device is safe and effective and is substantially equivalent to its predicate device [K111763]. This aligns with the regulatory requirements for Class I devices and the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence.

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

The PathAssist Light Fiber is a flexible instrument that can be connected to a light source to emit light from its distal end. The Light Fiber is provided sterile and is for single use only. It comes with a male tuohy borst adapter, which allows the device to be secured within compatible working lumen instruments. The Light Fiber is also compatible with standard light post adapters and light cables.

The provided document describes the PathAssist Light Fiber, an ENT manual surgical instrument, and its substantial equivalence to a predicate device. It does not detail specific acceptance criteria with numerical targets for device performance or a formal study specifically designed to prove all acceptance criteria.

However, based on the information provided, we can infer some aspects of the "acceptance criteria" and the "study" that supports the device meeting its intended purpose and regulatory requirements.

Here's an interpretation based on the provided text:

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device and meeting general device safety and performance standards through design verification.

Details about the "Study" (Performance Data)

The document refers to "Performance Data" rather than a single, comprehensive "study" with a defined test set and ground truth in the traditional sense of a diagnostic or AI device study. The provided information describes a series of tests:

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

   • The document does not specify a distinct "test set" sample size in terms of patient data or a specific number of devices tested for each performance criterion.
   • The "simulated use in a cadaver model" implies in vitro or ex vivo testing, not human subjects. The number of cadavers or specific trials is not stated.
   • The provenance is not applicable in the sense of country of origin for patient data, as no clinical human data was submitted. The tests were likely conducted in a controlled lab setting by the manufacturer.

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

   • Not applicable as there was no "ground truth" to be established by experts for a diagnostic or AI performance study. The tests are focused on engineering performance criteria (e.g., light output, material integrity, sterility).
   • For the cadaver model, "performance as intended" would likely be assessed by technical staff or medical professionals involved in the simulated use, but these are not explicitly termed "experts establishing ground truth."

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

   • Not applicable. Adjudication methods are typically for clinical endpoints or diagnostic accuracy, which are not part of this device's performance data.

4. 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. This is not an AI device or a diagnostic device. It's a manual surgical instrument.

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

   • Not applicable. This is not an algorithm or AI device. The device itself is a "standalone" physical instrument and its performance was evaluated.

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

   • For engineering tests (biocompatibility, sterilization, mechanical), the "ground truth" is adherence to established standards (e.g., ISO 10993-1, ISO 11135-1) and internal design specifications.
   • For simulated use, the "ground truth" is that the device successfully performs its function (locating, illuminating, transilluminating) in the cadaver model as expected for its indications for use.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable for the same reason as above.

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