(25 days)
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)
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Meets Specification | The device meets design specifications. |
| Intended Use | Performed as intended. |
| Biocompatibility | Meets biocompatibility standards. |
| Sterility | Meets sterility standards. |
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.
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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.
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- N/A. This is not an AI device, so there is no "training set."
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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.
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.