(235 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit quantitative acceptance criteria for clinical performance are listed. The submission states the device "meets specification" and "performed as intended." | Safety and Performance: "The device performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets specification, is biocompatible and meets sterility standards. Performance testing included dimensional verification, bench testing, and simulated use testing and showed that the device meets design specification and performed as intended." |
| Biocompatibility | Met |
| Sterility Standards | Met |
| Design Specification | Met |
| Intent to Perform | Performed as intended |
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.
§ 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.