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The Round Window E-Cath™ is indicated for irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials.

The RW E-Cath™ is an accessory to a tympanostomy tube. The RW E-Cath™ consists of a single triple-lumen tube opening into a hollow fenestrated reservoir tip on the distal end. Two lumcns are empty and are intended to allow fluid inflow and outflow. The third lumen encases the electrode wire lead and insulates it from the other two lumens. The atraumatic blunt distal tip of the electrode is the only part of the electrode that is exposed. The exposed distal tip of the electrode is located on the outside edge of the distal tip where it is intended to come into contact with the floor of the bony round window niche. The proximal end of the electrode contains a lead connector which the treating physician or audiologist can attach to a standard evoked potential recording instrument.

The provided text describes a medical device called the "RW E-Cath™" and its performance testing, but it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, detailed sample sizes, expert involvement, or comparative effectiveness studies.

The document is a 510(k) Summary submission to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria against specific performance targets.

Here's a breakdown of what is available and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Missing. The document states: "A bench test protocol was developed to assess the performance of the RW E-Cath™ in terms of pressure vs. flow, distal tip bond strength, tensile strength of the catheter body, proximal hub bond strength, and clectrode integrity." However, it does not provide the specific acceptance criteria (e.g., "pressure vs. flow must be X to Y") nor the reported performance values from these tests. It only mentions that "All tests will be conducted on final sterile product" and "Sufficient samples will be used for each test."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Missing. The document states, "Sufficient samples will be used for each test." No specific sample sizes, data provenance, or study design (retrospective/prospective) are mentioned. The testing described is "bench testing," 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):

• Not applicable. The described testing is bench testing of physical properties (pressure vs. flow, bond strength, tensile strength, electrode integrity). This type of testing does not involve establishing ground truth from experts in the way an imaging or diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. As above, bench testing of physical properties does not typically involve expert adjudication for a "test set" in the context of clinical or diagnostic performance.

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 device is a medical catheter with an electrode, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is hardware (a catheter with an electrode) used for irrigation and electrophysiological potential recording. It does not operate as a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable / Missing. For the bench tests ("pressure vs. flow, distal tip bond strength, tensile strength of the catheter body, proximal hub bond strength, and clectrode integrity"), the "ground truth" would be the objective measurements obtained from standardized testing methods against pre-defined engineering specifications. These specifications and the results are not provided.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is a hardware device undergoing bench testing, not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set or machine learning model is discussed.

In summary, the provided document focuses on the description, intended use, principles of operation, technological characteristics, and a high-level overview of bench performance testing for a medical device submitted for 510(k) clearance. It lacks the detailed information about acceptance criteria, specific test results, sample sizes, expert involvement, and study designs typical of performance claims for diagnostic or AI-driven devices.

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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

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.

Ask a specific question about this device