(50 days)
The intended purpose of the I-neb Insight AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the acute care, nursing home, sub-acute institution, or hospital environment.
The I-neb Insight AAD System is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (Vibrating Thesh) nebuilder System for inhalation by the patient in the approved for ass mursing home, sub-acute institution, or hospital environment. I-neb insight has a monitoring function and it provides feedback to both patient and clinician regarding different aspects of inhaled aerosol therapy. The I-neb insight is designed to be used by the clinician to display a patients THE I Theo InSight is adaly. And it can be used to aid the teaching of optimized breathing. It may also be used by the clinician to interrogate the I-Neb AAD AND AND AND AND Andress (RLC) which can provide the clinician with de breathing. It Thay also be used by the clinician provide the clinician with device System Patient Logging System (1 ES) Which can provide we was and the make information that they need to
The provided document is a 510(k) Premarket Notification for the I-neb Insight AAD System. It states that "Design verification tests were performed on the I-neb Insight AAD System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria, confirming the safety and effectiveness of the device." However, the document does not provide a table of acceptance criteria nor the reported device performance for these tests. It also does not detail a specific study that proves the device meets acceptance criteria in the manner requested (e.g., with detailed statistics, sample sizes, ground truth establishment, etc.).
Based on the provided information, I can address the following points:
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A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only generally states that "All tests were verified to meet the required acceptance criteria."
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Sample size used for the test set and the data provenance: This information is not provided in the document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
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Adjudication method for the test set: This information is not provided in the document.
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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 provided in the document. The device is a nebulizer system, and the document focuses on its mechanical and software aspects, not on AI-driven diagnostic or interpretative capabilities that would typically be evaluated in an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided in the document.
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The type of ground truth used: This information is not provided in the document.
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The sample size for the training set: This information is not provided in the document.
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How the ground truth for the training set was established: This information is not provided in the document.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on:
- Same intended use.
- Same operating principle.
- Same technology.
- Same manufacturing process.
It also notes compliance with "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," indicating some level of software verification was conducted, but the specifics of that verification (e.g., acceptance criteria, test results) are not included in this summary.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).