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To access and treat the sinus and its outflow tract with a trans-antral approach in adults. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinuses.

The Entellus Medical FinESS Sinus Treatment allows for trans-antral access of the maxillary sinus, placement of the balloon catheter with endoscopic guidance at the ostium and infundibulum. The ostium and infundibulum is widened by balloon dilated using saline.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Entellus Medical FinESS Sinus Treatment device:

Important Note: The provided text is a 510(k) summary and FDA clearance letter. It outlines the regulatory process for demonstrating substantial equivalence to a predicate device. It does not contain a detailed report of a clinical study or performance study with specific acceptance criteria, sample sizes, or ground truth methodologies for a diagnostic or AI-based device. The device described is a surgical instrument (a balloon catheter system for sinus treatment), not a diagnostic device or one that incorporates AI. Therefore, many of the requested points related to AI, ground truth, and reader studies are not applicable to this document.

Acceptance Criteria and Device Performance (Based on provided text)

Study Information (Based on provided text)

Since this is a surgical instrument and not an AI-powered diagnostic device, the following points are largely not applicable (N/A) based on the provided 510(k) summary. The "study" mentioned is a general performance test for mechanical, biological, and sterility aspects, typical for medical devices.

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

   • Sample Size: Not specified in the provided summary. The summary mentions "dimensional verification, bench testing, and simulated use testing," which would involve samples of the device, but the number is not given.
   • Data Provenance: Not specified. This would typically be from the device manufacturer's internal testing.

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

   • N/A. This device does not have a "ground truth" established by human experts in the way a diagnostic AI device would. Its performance is assessed against engineering specifications, biocompatibility standards, and sterility standards.

3. Adjudication method for the test set:

   • N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, typically involving human interpretation of data. This is not reported for mechanical or biological performance tests.

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:

   • N/A. This is a surgical device, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

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

   • N/A. This is a mechanical surgical device; it does not have an algorithm operating in a standalone capacity.

6. The type of ground truth used:

   • For mechanical performance: Engineering specifications and benchmarks (e.g., burst pressure, tensile strength, dimensions).
   • For biocompatibility: ISO standards for medical devices (e.g., cytotoxicity, irritation, sensitization).
   • For sterility: Sterility assurance levels (SALs) defined by international standards.
   • No "expert consensus," "pathology," or "outcomes data" are presented as the primary ground truth for device function in this type of submission. Outcomes data would be relevant for clinical efficacy, which is usually demonstrated in larger post-market studies or more extensive clinical trials, not typically fully detailed in a 510(k) summary focused on substantial equivalence.

7. The sample size for the training set:

   • N/A. This is not an AI device, so there is no "training set."

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

   • N/A. As it's not an AI device, there's no training set or corresponding ground truth establishment process in this context.

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To access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The Entellus Medical RS Series system allows for trans-mucocutaneous access of the sinus, placement of the balloon catheter with endoscopic guidance and the displacement of the tissue and bony structures by balloon catheter dilation.

This 510(k) submission (K072302) for the Entellus Medical RS Series System primarily focuses on demonstrating substantial equivalence to predicate devices and provides general statements about performance testing. It does not contain the type of detailed acceptance criteria and study information typically associated with AI/ML device evaluations. The device described is a physical medical device (a trans-antral sinus access and dilation catheter system), not an AI-powered diagnostic or therapeutic tool.

Therefore, many of the requested fields cannot be directly extracted from the provided text because the study design and reporting requirements for this type of device are different than for AI/ML devices.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

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

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

• Not Applicable / Not Provided: The submission describes performance data from "bench testing and simulated use testing," but does not mention a clinical test set in the context of human data or AI model evaluation. It's for a physical medical device, not an AI artifact.
• The data provenance, if human clinical data were used, is not specified.

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)

• Not Applicable / Not Provided: This information is not relevant to the type of device and testing described. Ground truth in the context of AI/ML evaluation is not applicable here.

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

• Not Applicable / Not Provided: No adjudication method is mentioned as this is not a study involving expert review of diagnostic outputs.

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: No MRMC study was conducted or mentioned. This is a physical surgical device, not an AI assistance tool for human readers.

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

• Not Applicable / No: This is not an algorithm, but a physical device. Standalone performance as described for AI is not relevant.

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

• Not Applicable: For this physical device, "ground truth" would relate to its physical properties (e.g., balloon pressure, material strength, dimensional accuracy) and the ability to perform its intended mechanical function, rather than diagnostic accuracy against a clinical reference standard. The text mentions meeting "design specification" as the standard.

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI/ML device, so there is no "training set."

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

• Not Applicable / Not Provided: This is not an AI/ML device, so there is no "training set" or ground truth establishment for an algorithm.

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