(80 days)
The Round Window u Cath™ (RWuC) is intended to be used by any board certified otolaryngologist or otologist to irrigate the entire middle ear or the round window area of the middle ear. During the course of the irrigation treatment, it is intended that the vent tube through which the RW (C's dual lumen passes, will aerate the middle ear. The treating physician will choose, based on what hels will be most beneficial for his/her patient, the following: { }) the exact fluids to be delivered through the RWAC; (2) the proper quantities; and (3) the duration and interval of treatment (up to 14 days). It is intended that the physician load the RWuC with the initial fluid to be delivered prior to placement. The RWAC is intended to remain in place for up to 14 days. Neuro-Biometrix, Inc. recommends the physician use only fluids indicated for this use. The physician should refer to the fluid labelling prior to use with the RWC.
The RWAC consists of a double lumen (two parallel and attached Tecoffex 80A (polyurethane) extruded tubes) opening into a common fenestrated reservoir tip on the distal end. The soft, flexible reservoir tip of the RWuC will be available in three sizes: 2mm, 3mm, and 4mm diameters. It is intended that the surgeon will choose an appropriate sized tip to fit the anatomy of the patient. The double lumen is bent at approximately a 60-75 degree angle slightly proximal to the reservoir tip. One lumen is intended to serve as an in-flow and the other an out-flow. The outflow lumen is intended to (1) relieve or avoid a build up of air and/or fluid pressure in the device; and (2) facilitate the removal of fluid from the device. A silicone, paparella-type vent tube will be placed around the RWAC during manufacturing.
The provided text describes a medical device, the Round Window u Cath™ (RWuC), and its intended use, but it does not contain specific acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes.
The "Performance Testing" section outlines what aspects will be tested (pressure vs. flow, bond strength, visual inspection, dimensional compliance) but does not provide the actual results of these tests or explicit acceptance criteria (e.g., "flow rate shall be X ml/minute at Y pressure"). It only states that "Sufficient samples will be used for each test" and that these tests "will be conducted." This indicates a plan for testing, not completed tests with established criteria and results.
Therefore, most of the information requested in your prompt cannot be extracted from this document.
However, I can provide the following based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No performance metrics reported in the provided text. |
| Pressure vs. flow | Testing planned, but no results or specific criteria provided. |
| Distal tip bond strength | Testing planned, but no results or specific criteria provided. |
| Proximal hub bond strength | Testing planned, but no results or specific criteria provided. |
| Workmanship | Visual inspection planned, but no results or specific criteria provided. |
| Dimensional compliance | Visual inspection planned, but no results or specific criteria provided. |
| Biocompatibility | Device materials were subjected to biocompatibility testing, deemed Class VI biocompatible. (Although specific criteria and results are not detailed, this implies meeting some biocompatibility standards.) |
Regarding the study proving the device meets the acceptance criteria, the document states the plan for "Performance Testing" but does not present the study results.
Therefore, the following information is not available in the provided text:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.