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The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

The PathAssist™ Light Seeker™ is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm - 3.5mm light guides (cables).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Entellus Medical PathAssist™ Light Seeker™:

This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" discussed are primarily related to design specifications, safety, and equivalence to the predicate, not clinical performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of clinical performance data. The performance testing focused on design verification, biocompatibility, and packaging. These tests would have involved specific units of the device or its components for each test (e.g., a certain number of devices for dimensional checks, samples of materials for biocompatibility, packaged units for shipping tests), but the exact sample sizes are not specified in this summary.

Data Provenance: The data is generated internally by Entellus Medical, Inc. based on their design, manufacturing, and testing processes. No external data provenance (e.g., country of origin, retrospective/prospective) is applicable in the sense of clinical data.

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

Not applicable. This submission does not involve a clinical "test set" requiring expert ground truth in the way a diagnostic AI device would. The "ground truth" for design verification tests would be established by engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication.

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

Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical, manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the engineering and safety tests performed:

• Design Verification (Dimensional, Thermal Safety): Ground truth is established by the device's own engineering design specifications, industry standards, and test protocols.
• Biocompatibility: Ground truth is established by the criteria and methods outlined in ISO 10993-1.
• Packaging: Ground truth is established by the specified standards in ASTM D4169-09.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

The PathAssist™ Light Seeker™ is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm light guides (cables).

The provided 510(k) summary for the PathAssist™ Light Seeker™ (K113522) focuses on demonstrating substantial equivalence to a predicate device (K110158), rather than a detailed clinical study proving specific performance metrics against pre-defined acceptance criteria for a novel device. As such, many of the requested elements (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with explicit metrics, and ground truth establishment for novel algorithms) are not applicable or not reported in this type of submission.

The "acceptance criteria" in this context are primarily related to maintaining functionality and safety after reprocessing, aligning with the predicate device's performance, and meeting design specifications.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Not applicable/Not reported. This submission describes design verification testing and reprocessing validation, not a clinical study on patient data with a "test set" in the sense of an algorithm. The testing involved repetitive reprocessing cycling of the device itself.
   • The document implies laboratory/engineering testing rather than patient-based data.

2. 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)

   • Not applicable. No ground truth in the context of clinical expert review of diagnostic output is established or mentioned, as this is a surgical instrument, not an interpretive diagnostic device.

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

   • Not applicable. No clinical test set requiring adjudication is described.

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 a Class I manual surgical instrument. No MRMC comparative effectiveness study was performed or is relevant to this device type. There is no AI component.

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

   • No. This is a manual surgical instrument. There is no standalone algorithm.

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

   • The "ground truth" for the performance testing of this surgical instrument would be its adherence to engineering specifications and demonstrated functionality (e.g., light output, structural integrity, cleanability, sterilizability) after simulated use and reprocessing cycles. This is based on design specifications and engineering validation.

7. The sample size for the training set

   • Not applicable. No training set for an algorithm is described.

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

   • Not applicable. No training set for an algorithm is described.

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