(77 days)
Indicated where chronic Eustachian tube dysfunction does not respond to conventional therapy.
The tympanostomy tube is a silicone tube that is intended to provide ventilation and drainage to the middle ear.
The provided document is a 510(k) summary for the Preceptis Medical Hummingbird Tympanostomy Tube. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not available in this document. The document explicitly states: "The tympanostomy tube met all performance acceptance criteria," but it does not elaborate on what those criteria were or how they were met beyond general statements about equivalence to the predicate device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | The tympanostomy tube met all performance acceptance criteria. (General statement; no specific metrics provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document does not describe a clinical study or a test set involving human subjects. The evaluation appears to be based on an engineering comparison and material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not available. No human experts are mentioned as establishing ground truth for a test set in this 510(k) submission, as there is no described clinical or performance study with such a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. No test set or adjudication method is described.
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. This is a medical device for implantation, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available. For the "Performance Data" stated as "The tympanostomy tube met all performance acceptance criteria," the document implies that the ground truth for performance was likely established through engineering tests and material characterization to demonstrate that the device meets its design specifications and characteristics similar to the predicate device. No clinical outcomes data or pathology is referenced as ground truth for this submission, which focuses on substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; therefore, there is no training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. See 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.