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The device is indicated for use in patients requiring supplemental oxygenation, patients requiring capnographic monitoring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.

The subject device is a non-sterile, single-use airway support system that is intended to support airway patency, aid in supplemental oxygen delivery and assist in respiratory gas sample collection for capnogrpahy. The device consists of an airway tube, accessory tubes, and in some versions a magnetic securement system.

The provided text does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria. The document is a 510(k) premarket notification approval letter for the IntelAir Nasal Airway Support System, indicating that the device is substantially equivalent to a predicate device. While it mentions performance data related to biocompatibility and mechanical testing, it does not describe specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) against which the device's functional performance was measured.

The "Performance Data" section briefly lists the types of tests performed (biocompatibility and mechanical testing) but does not provide results, acceptance thresholds, or details about how these tests "prove" the device meets specific performance criteria relevant to its intended function (supplemental oxygenation, capnographic monitoring, airway support).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number/qualifications of experts, or adjudication method for a test set.
3. Information on MRMC comparative effectiveness studies or standalone performance.
4. Details about the type, sample size, or establishment of ground truth for training data.

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The AirPort is indicated for use in patients requiring supplemental oxygenation, patients requiring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.

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I am sorry, but the provided text does not contain the detailed information required to answer the request about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for the "AirPort" device, which is a Carbon Dioxide Gas Analyzer. It states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use.

However, it does not include:

1. A table of acceptance criteria or reported device performance.
2. Details on sample sizes for test or training sets, nor data provenance.
3. Information on the number or qualifications of experts, or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
5. Whether a standalone algorithm-only performance study was done.
6. The type of ground truth used.
7. How the ground truth for any training set was established.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device