(114 days)
The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube.
Conditions for which tympanostomy tubes are indicated include:
Chronic otitis media with effusion (serous, mucoid, or purulent)
Recurrent otitis media that fails to respond to conventional medical treatment
A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
Retraction pocket of the tympanic membrane.
The Tympanostomy Tube Delivery System is a device that penetrates the tympanic membrane and inserts the Acclarent Tympanostomy Tube with a button controlled activation.
The Tympanostomy Tube Delivery System is a mechanical device that can create a myringotomy and deliver the Acclarent Tympanostomy Tube. The Acclarent Tympanostomy Tube is provided pre-loaded in the subject device.
The Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System is a mechanical device designed to create a myringotomy and deliver a preloaded tympanostomy tube.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Success Rate | 94% (95/101 ears) |
| Tube Retention (1 week post-procedure) | 98.95% (94/95 ears) |
| Patient received indicated treatment | 100% (101/101 ears) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 101 ears enrolled from 53 pediatric subjects.
- Data Provenance: The study was a prospective, multi-center, single-arm clinical study conducted across 4 study sites. The country of origin is not specified but implied to be the US given the FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on evaluating the device's technical performance and patient outcomes, rather than diagnostic accuracy requiring expert consensus on a ground truth label. Procedures were performed by 4 investigators (presumably surgeons).
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing a ground truth for the test set, as the study primarily evaluated objective device performance metrics (success rate, tube retention) directly observed during or after surgical procedures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study was a single-arm clinical study evaluating the device's performance directly.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The clinical study evaluated the performance and safety of the Acclarent TTDS device for the placement of the Acclarent Tympanostomy Tube. The success rates and retention rates are standalone performance metrics.
7. Type of Ground Truth Used
The "ground truth" in this context refers to directly observed clinical outcomes and device functionality.
- Device Success: Based on the observed ability of the device to fully deploy tubes across the tympanic membranes. Failures were directly observed (e.g., device not fully deploying the tube).
- Tube Retention: Observed during the one-week post-procedure follow-up.
- Indicated Treatment Received: Direct observation that all enrolled ears received the intended tympanostomy tube placement, even if manual intervention was required after device failure.
8. Sample Size for the Training Set
The document does not mention any "training set" in the context of an algorithm or AI model development. The study described is a clinical performance study of a mechanical device, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML model was utilized.
§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.