(242 days)
The Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.
The Preceptis Tympanostomy Tube System (TTS) which includes a tympanostomy tube inserter (TTI) with a preloaded ventilation tube, is a single-use, sterile manual surgical instrument which is used to create a myringotomy in the tympanic membrane and place a ventilation tube. The TTI comprises a handle with one or more tip assemblies which contain a sterile tympanostomy tube. Each tip assembly can be removably attached to the handle and includes a positioning rod and a ventilation tube pre-loaded inside the distal end of a sharpened sheath. Attaching the tip assembly to the handle also connects the sheath and actuator, allowing the user to retract the sheath by manually scrolling an actuator located on the handle. The user manually advances the sharpened sheath to create a myringotomy and simultaneously positions the ventilation tube within the myringotomy, always under direct visualization. The user then manually retracts the sharpened sheath away from the myringotomy using the manual actuator located on the handle. The retraction of the sheath releases the tube within the myringotomy. A first tip assembly can then be removed from the handle and replaced with a second preloaded tip assembly for bilateral procedures.
Here's a breakdown of the acceptance criteria and study details for the Preceptis Tympanostomy Tube System (TTS), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: No safety issues associated with the TTS. | An independent otolaryngologist reviewed the results of the trial and determined that there were no safety issues associated with the TTS. There was one case of recurrent infection not associated with the TTS and three occluded tubes, but these were not deemed safety issues directly attributable to the device. |
| Performance (Success Rate): 100% success rate in performing tympanostomy procedures. | The success rate in performing the tympanostomy procedures was 100%. Tympanostomy tubes were successfully delivered in all 25 patients (50 ears). |
| Performance (Use of TTI): TTI used as the sole instrument for the tympanostomy procedure. | In 40/50 ears (80%), only the TTI was used for the tympanostomy procedure. In 10/50 ears (20%), either a pick or alligator clip was used for additional adjustment of the tympanostomy tube. In all cases, only a single TTI was used for each ear. |
| Performance (Tube Retention): 100% tube retention at follow-up (15-60 days post-surgery). | At follow-up, between 15 and 60 days post-surgery, tube retention was 100%. |
The document explicitly states: "The Preceptis TTS met the study safety and performance criteria."
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: 25 pediatric patients, involving a total of 50 ears.
- Data Provenance: Prospective, treatment-only multicenter clinical study. The document does not explicitly state the country of origin, but given the FDA submission and the language used, it's highly likely to be the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 1
- Qualifications of Experts: An independent otolaryngologist. No specific years of experience are provided, but the title suggests a qualified medical professional specializing in ear, nose, and throat.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The evaluation appears to be based on direct observation during the procedures by the 6 investigators, and the post-procedure safety review by a single independent otolaryngologist.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study solely evaluated the performance and safety of the TTS device in a treatment-only context. It did not compare the device's performance against human readers or assess improvement with AI assistance (as the device itself is a manual surgical instrument, not an AI diagnostic tool).
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance study was not done. The device is a manual surgical instrument, not an algorithm, and its performance is inherently tied to its use by a human surgeon.
7. Type of Ground Truth Used
The ground truth used was primarily clinical observation and outcomes data:
- Procedure Success: Directly observed by the 6 investigators during the surgery (whether the tympanostomy tube was successfully delivered and positioned).
- Safety: Evaluated by an independent otolaryngologist based on clinical results and adverse events.
- Tube Retention: Assessed at follow-up clinical visits.
8. Sample Size for the Training Set
The document does not mention a training set as this is a clinical study for a medical device (surgical instrument), not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/machine learning model.
§ 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.