(130 days)
To access and treat the frontal recesses and sphenoid sinus ostia in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
The Entellus Medical Balloon Device is shaped like a sinus ostium seeker, or a curved suction tube, with a dilatation balloon. It is placed trans-nasally under endoscopic guidance. The position of the device may be verified with fluoroscopy. The size of the device lumen is similar to a 5F suction tube and can be used to aspirate thin liquids from the sinus. The device is provided sterile and is available either in the standard model or the shapeable model.
The provided text describes a medical device, the Entellus Medical Balloon Device, and its 510(k) submission to the FDA. However, it does not include information about acceptance criteria, a detailed study proving device performance against those criteria, or a multi-reader multi-case (MRMC) comparative effectiveness study, which are typically associated with performance evaluation of diagnostic or AI-driven medical devices.
The information provided focuses on the substantial equivalence to predicate devices, safety, biocompatibility, and functional testing. Therefore, I cannot fully answer all aspects of your request based on the given text.
Here's what I can extract and address:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it mentions that the device "meets design specification" and "performed as intended" based on bench testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of quantitative metrics suitable for AI/diagnostic device performance like sensitivity/specificity) | - Biocompatible |
| - Sterility assured through sterilization validation | |
| - Meets design specification | |
| - Performed as intended (functional tests) | |
| - Can be safely positioned within sinus structures (cadaver studies) | |
| - Easily visible using fluoroscopy (fluoroscopy imaging) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing" and "Cadaver studies." It does not specify the sample size for these tests, nor does it provide information about the country of origin or whether the data was retrospective or prospective.
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)
This information is not provided in the document. The "ground truth" here seems to be inherent in the engineering and medical testing (e.g., successful balloon inflation, correct positioning in cadavers), rather than expert interpretation of medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or conducted for this device based on the provided text. This type of study is typically relevant for diagnostic devices, especially those incorporating AI, where human interpretation is a key component. The Entellus Medical Balloon Device is a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the Entellus Medical Balloon Device, as it is a manual surgical instrument. There is no AI algorithm or standalone performance. The "human-in-the-loop" is the surgeon using the instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific tests mentioned:
- Bench testing: Ground truth would be engineered specifications and direct measurement/observation of physical properties (e.g., burst pressure, inflation time, material strength).
- Biocompatibility: Ground truth is established through adherence to ISO standards or similar guidelines for material interactions with biological systems.
- Sterilization validation: Ground truth is the absence of microbial contamination, validated by standard microbiological tests.
- Cadaver studies: Ground truth is the physical observation of the device's ability to be safely and correctly positioned within anatomical structures (e.g., successful navigation, absence of trauma).
8. The sample size for the training set
This is not applicable as the device is a manual surgical instrument and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.