(57 days)
The Hummingbird® Tympanostomy Tube System (HTTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic of the patient and is indicated to be used in office settings for children 6-24 months old.
The Hummingbird® Tympanostomy Tube System (HTTS), which includes a preloaded ventilation tube, is a single-use, sterile manual surgical instrument. The HTTS is used to create a myringotomy in the tympanic membrane and place a ventilation tube. The surgeon manually advances the sharpened sheath to create a myringotomy and simultaneously positions the ventilation tube within the myringotomy, always under direct visualization. The surgeon 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.
The provided text describes the Hummingbird® Tympanostomy Tube System (HTTS) and its performance data, particularly in an office setting for children. Here's a breakdown based on the categories you provided:
1. A table of acceptance criteria and the reported device performance
While the document doesn't explicitly list "acceptance criteria" in a separate table, it presents several performance metrics from a clinical study, implicitly serving as the basis for evaluating the device's acceptability for its intended use. The comparison to a predicate device's performance also highlights what might be considered acceptable thresholds.
| Clinical Metric | Reported Device Performance (HTTS Pediatric Office Study) | Implicit Acceptance Criteria (based on predicate or good clinical outcome) |
|---|---|---|
| Successful rate in office or under sedation | 98.9% | High success rate (e.g., >88.3% of predicate) |
| Efficacy endpoint (HTTS delivery of tube) | 96.9% | High efficacy (e.g., >92% of predicate) |
| Safety endpoint (procedural Adverse Event rate) | 0.56% (2/360 ears) | Low procedural AE rate (ideally comparable to or lower than predicate, though predicate reported 0.0%) |
| % ears completed in one surgical pass | 84.5% | High percentage of single-pass completion (e.g., >82% of predicate) |
| Child's tolerance of procedure (clinician review) | "In all 18 cases, each of the reviewers deemed that the child tolerated the procedure acceptably." | Acceptable tolerance by child in office setting. |
| Parent satisfaction (alternative to GA) | 93.1% strongly agree/agree | High parent satisfaction. |
| Parent recommendation | 93.1% strongly agree/agree | High parent recommendation. |
| Bi-lateral procedure time | Median 5:00 (range 2:00-15:32) | Efficient procedure time for office setting. |
| Recovery (calm/no inappropriate crying before leaving) | 98.3% (177/180 children) | High rate of calm recovery. |
| Tube delivery using additional instruments | 7 ears | Minimal need for additional instruments. |
| Passes required: >2 passes | 2.3% | Low rate of multiple passes. |
| Early extrusion rate | 3.0% | Comparable to or lower than predicate (predicate 3.2%). |
| Plugging rate | 11.3% | Comparable to or lower than predicate (predicate 12.3%). |
2. Sample size used for the test set and the data provenance
- Sample Size: 180 children (360 ears) underwent tympanostomy procedures in an ENT office using the HTTS.
- Data Provenance: The study was a "multi-site clinical study." While specific countries are not mentioned, the FDA clearance suggests it was likely
conducted, at least in part, within the United States. The data is prospective, collected specifically for this clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: The document states "A committee of clinicians with ENT and/or pediatric specialty independently reviewed 18 procedure videos". The exact number of clinicians on this committee is not specified, but it was more than one due to the phrasing "each of the reviewers".
- Qualifications of Experts: Clinicians with "ENT and/or pediatric specialty". No specific years of experience are mentioned.
4. Adjudication method for the test set
- For the video review of child tolerance, it appears experts reviewed independently, and the aggregated results (bar graph tabulation) indicate a consensus was reached, as "In all 18 cases, each of the reviewers deemed that the child tolerated the procedure acceptably." This suggests either unanimous agreement or a very strong majority for acceptability. No specific formal adjudication such as 2+1 or 3+1 is detailed for the video review, but the reported outcome implies a high level of agreement.
- For the core clinical endpoints (success rate, AE rate), these are typically based on observed events and objective measures, not multi-reader adjudication of images.
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, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance for human readers was not done. The device is a surgical instrument (Tympanostomy Tube System), not an AI-powered diagnostic or assistive tool for human interpretation of data. The study focuses on the device's performance outcomes (efficacy, safety, procedural characteristics) during its use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical surgical instrument, not an algorithm. Its performance is inherently tied to its use by a human operator (surgeon) in real-world clinical settings, making "standalone" algorithm-only performance irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance relies on several types of data:
- Clinical Outcomes Data: This includes direct measurements of success rates (tube delivery, completion in office), adverse event rates, procedure times, early extrusion rates, and plugging rates.
- Expert Observational Consensus: For the child's tolerance during the procedure, a committee of ENT/pediatric clinicians reviewed videos and made judgments (see point 3 & 4).
- Patient/Parent Reported Outcomes: Parent surveys provided data on satisfaction and willingness to recommend.
8. The sample size for the training set
- This question is not applicable to the information provided. The "training set" concept is relevant for machine learning algorithms. This document describes the clinical evaluation of a medical device (surgical instrument), not an AI system. The study described is a clinical validation study, not a dataset for training.
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as point 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.