(46 days)
Conditions for which tympanostomy tubes are indicated include: Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent otitis media that fails to respond to conventional medical treatment A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus. Retraction pocket of the tympanic membrane.
The Tympanostomy Tube is a silicone tube that is intended to provide ventilation and/or drainage to the middle ear. The Tympanostomy Tube is available in two types: Donaldson and Paparella.
"The provided text contains a 510(k) summary for a Tympanostomy Tube and a letter from the FDA confirming its substantial equivalence. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the format requested. The document states broadly that ""The Tympanostomy Tube met all performance acceptance criteria.""
To answer your request, I will extract relevant information, but please note that some points you asked for, such as the sample size for test and training sets, the number and qualifications of experts, adjudication methods, MRMC study details, and specific ground truth mechanisms, are not explicitly present in the provided text for a performance study. The submission appears to rely on substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria and outcome metrics for the new device.
Here's the information based on the provided text, with explicit notes where information is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The submission states the device met ""all performance acceptance criteria"" without listing them. | The Tympanostomy Tube met all performance acceptance criteria. The device is substantially equivalent to the predicate devices (MicroMedics Otological Ventilation Tube (K830228), Xomed Activent Ventilation Tube (K941407), Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580)) as confirmed through relevant tests. |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "relevant tests" were conducted, but details on the nature or sample size of these tests are not provided.
- Data Provenance: Not specified.
-
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):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
-
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 MRMC or AI-assisted study is mentioned. This device is a physical medical device (Tympanostomy Tube), not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for specific performance acceptance criteria. The basis for safety and effectiveness appears to be substantial equivalence to predicate devices through "relevant tests," which would likely compare physical and material characteristics, and possibly functional performance against established standards for tympanostomy tubes.
-
The sample size for the training set:
- Not applicable/Not specified. This is a physical medical device, not an AI or machine learning algorithm requiring a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable. (See #7).
Summary of the study mentioned (or lack thereof):
The document is a 510(k) premarket notification for a Tympanostomy Tube. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed performance study data in the way one might for a novel diagnostic or AI device. The document explicitly states: "The Tympanostomy Tube met all performance acceptance criteria" and "The Tympanostomy Tube is substantially equivalent to the predicate devices as confirmed through relevant tests."
Therefore, the "study" referred to is likely a set of engineering and bench tests designed to ensure the new device meets the same performance characteristics and safety profile as the predicate devices. These tests would typically cover aspects like material biocompatibility, structural integrity, dimensions, and possibly flow rates or insertion characteristics, rather than diagnostic accuracy or human reader performance. Specific details of these "relevant tests," their methodologies, sample sizes, and expert involvement are not included in this summary document."
§ 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.