(93 days)
The Biowy Tym Tube products are indicated for 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 text describes the Biowy Tym Tube, a tympanostomy tube, and its 510(k) summary for substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets clinical acceptance criteria in the context of an AI/ML device.
The provided information focuses on engineering and biocompatibility testing for a physical medical device, not a software or AI/ML product. Therefore, I cannot extract the requested details relevant to AI/ML device performance or clinical studies using AI models.
To answer your request, here's an analysis based solely on the information provided, which is limited to the physical device's characteristics and safety testing:
Based on the provided document, the "device" in question is the Biowy Tym Tube, a physical tympanostomy tube, not an AI/ML software device. The acceptance criteria and "study" described pertain to the physical properties, sterility, and biocompatibility of this physical device.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Sterility: Appropriate sterilization and shelf-life validation. | Met requirements (submission supported by appropriate validation). |
| Pyrogenicity: Device labeled non-pyrogenic. Validated for LAL Endotoxin testing using the Kinetic-Chromogenic test method using three production lots. | Met requirements (labeled non-pyrogenic, tested successfully). |
| Bench Testing - Visual Inspection: No visual defects. | Met requirements |
| Bench Testing - Compression: Comparable to predicate. | Met requirements |
| Bench Testing - Tensile: Higher than that needed for placement and removal. | Met requirements |
| Biocompatibility: According to ISO 10993. | Shown to be safe, non-toxic, and biocompatible. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set:
- Pyrogenicity: "Three production lots of the test article identified as Biowy Tym Tube" were validated.
- Bench Testing (Visual, Compression, Tensile): Not explicitly stated, but typically involves a sample size representative of production for such physical tests.
- Biocompatibility: Not explicitly stated, but ISO 10993 testing requires specific sample sizes depending on the test.
- Data Provenance: Not specified. This type of testing is typically performed by internal or contract labs and is generally considered part of the manufacturing quality control and design verification process, not clinical data.
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):
This information is not applicable and not provided in the document. The tests performed are engineering, chemical, and biological safety tests, not clinical evaluations requiring expert interpretation (like a radiologist establishing ground truth for image analysis).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or expert reviews of complex data (e.g., medical images, clinical outcomes) to resolve discrepancies. The described tests are objective measurements against defined standards.
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:
This information is not applicable and not provided. An MRMC study is relevant for evaluating the clinical performance of diagnostic or assistive AI/ML devices involving human readers. The Biowy Tym Tube is a physical medical device, not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This concept applies to standalone AI/ML algorithms. The described device is a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests mentioned are:
- Sterility: Absence of microorganisms (verified through validated sterilization processes).
- Pyrogenicity: Absence of pyrogens/endotoxins (quantified via LAL test).
- Visual Inspection: Conformance to manufacturing specifications (e.g., no cracks, burrs, malformations).
- Compression/Tensile: Objective physical measurements against defined engineering specifications and comparison to the predicate device.
- Biocompatibility: Absence of adverse biological reactions (measured via ISO 10993 tests for cytotoxicity, sensitization, irritation, etc.).
These are objective, measurable standards for a physical product, not clinical "ground truth" derived from patient data or expert interpretation.
8. The sample size for the training set:
This information is not applicable and not provided. A "training set" is relevant for AI/ML models. This document describes a physical medical device.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. This concept is for AI/ML models.
§ 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.