(86 days)
The Hummingbird® Tympanostomy Tube System (HTTS) 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 months and older.
The Hummingbird® Tympanostomy Tube System (HTTS), which includes 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 surgeon 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.
The provided text does not describe an AI/ML device but rather a medical device called the "Hummingbird® Tympanostomy Tube System (HTTS)". Therefore, the information requested regarding acceptance criteria and study proving device meets acceptance criteria, specifically for an AI/ML device, cannot be extracted from this document.
However, I can extract the information relevant to the clinical performance of the HTTS device itself, based on the provided text, using the structure you've requested. Please note that terms like "test set," "training set," "experts," and "ground truth" are typical for AI/ML studies and may not perfectly align with how a traditional medical device's clinical study is described, but I will interpret them to the best of my ability based on the provided clinical data.
Device: Hummingbird® Tympanostomy Tube System (HTTS)
Device Type: Medical Device (Tympanostomy Tube Inserter with pre-loaded ventilation tube) - Not an AI/ML device.
Acceptance Criteria (Interpreted as Clinical Performance Endpoints) and Reported Device Performance:
| Acceptance Criteria (Clinical Endpoint) | Reported Device Performance (2-17 years old study) | Pediatric Office Study, 6-24 months (K200952, for comparison) |
|---|---|---|
| Successful procedure completion in-office | 95.8% | 98.9% |
| Efficacy endpoint (HTTS delivery of tube) | 97.3% | 96.9% |
| Safety endpoint (procedural AE rate) | 0.0% | 0.56% |
Study Proving Device Meets Acceptance Criteria:
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Sample Size and Data Provenance:
- Test Set (Clinical Study Population): A total of 48 children (74 ears) for the "2-17 years old" study.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be a multi-site study in an ENT office setting.
- Retrospective or Prospective: Implied to be prospective, as it describes a multi-site study where procedures were performed and results collected.
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Number of Experts and Qualifications:
- The study involved ENT specialists performing the procedures and evaluating outcomes. Specific numbers or detailed qualifications (e.g., years of experience) beyond "ENT" are not provided. The recovery of the child was evaluated by the "ENT and staff."
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Adjudication Method for the Test Set:
- No formal adjudication method (like 2+1 or 3+1 used in imaging studies) is described. Clinical outcomes were presumably determined by the treating ENT and staff, and adverse events were recorded.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done, as this is not an AI/ML diagnostic or assistive device. The study evaluates the effectiveness and safety of a surgical device performed by human operators.
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Standalone Performance:
- This concept is not directly applicable. The device (HTTS) is a manual surgical instrument. Its "performance" is inherently tied to its use by a human operator. The study provides data on its performance when used in a clinical setting by an ENT.
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Type of Ground Truth Used:
- The "ground truth" for clinical outcomes (successful procedure completion, efficacy of tube delivery, safety/AEs) was established through direct observation, medical records, and clinical assessment by the treating physicians and staff during and after the procedure. Parent surveys were also collected for satisfaction.
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Sample Size for the Training Set:
- This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device design and previous predicate device (K200952) serve as the foundation for this iteration.
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How Ground Truth for the Training Set Was Established:
- Not applicable, as there is no AI/ML training set. The device's design and previous version (K200952) are based on traditional engineering and medical device development processes, which include preclinical testing and clinical data from previous iterations. The present study for K221254 uses clinical data from the identical device (as the predicate) to demonstrate substantial equivalence for an expanded age group.
§ 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.