(258 days)
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.
The Solo+ Tympanostomy Tube Device TTD (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.
To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.
The provided text describes the Solo+ Tympanostomy Tube Device (TTD) and its substantial equivalence determination. However, it does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance, as typically seen in submissions for AI-powered devices. The device described, the Solo+ TTD, is a physical medical device for placing tympanostomy tubes, not an AI/software device.
Therefore, many of the requested points in your prompt are not applicable to the provided document. I can, however, extract the relevant information regarding the clinical study performed to demonstrate the device's safety and effectiveness compared to a predicate device.
Here's the closest possible answer based on the provided text, focusing on the clinical study conducted for the physical device:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The study conducted for the Solo+ Tympanostomy Tube Device (TTD) was a multi-site clinical study designed to demonstrate substantial equivalence to its predicate device, the Preceptis Hummingbird TTS, for in-office tympanostomy procedures in pediatric patients.
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents the "acceptance criteria" (though not explicitly labeled as such, these are the primary outcomes measured for comparison of substantial equivalence) as clinical outcomes compared between the Solo+ TTD and the predicate device.
| Clinical Outcome | Acceptance Criteria (Predicate Device Performance - Hummingbird TTS, K200952) | Reported Device Performance (Solo+ TTD) |
|---|---|---|
| Successful Placement of the Device without need for an operating room procedure | 98.9% | 100% (20/20 patients) |
| Delivery Success (placed without the need for additional instruments to aid in placement of the device) | 96.9% | 87.5% (35/40 ears) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: A total of 20 patients (40 ears).
- Data Provenance: Conducted in a multi-site study across 2 sites. The country of origin is not explicitly stated, but the applicant company is based in Ireland. The study was a clinical study, implying a prospective design for the purpose of demonstrating substantial equivalence.
3. Number of Experts and Qualifications: Not applicable. This was a clinical study involving patients and the mechanical placement of a device, not an AI/image-based diagnosis requiring expert readers for ground truth establishment.
4. Adjudication Method: Not applicable. (See #3)
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This was not a study evaluating human reader performance with or without AI assistance but rather the performance of a physical surgical device.
6. Standalone (Algorithm Only) Performance: Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used: The "ground truth" for this study was the observed clinical outcome of the tympanostomy tube placement (i.e., whether the tube was successfully placed and if additional instruments were needed). This is essentially outcomes data directly observed during the procedure and initial follow-up.
8. Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How Ground Truth for Training Set was Established: Not applicable. (See #8)
§ 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.