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The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment.

The mask ClassicStar NV, with standard elbow is disposable and for single patient use.

The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.

The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure.

A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.

The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory.

All noninvasive ventilation masks are available in three different sizes (S, M, L),

The provided text is a 510(k) summary for non-invasive ventilation masks. It is a regulatory submission to the FDA for market clearance, not a scientific study reporting device performance against acceptance criteria in the way a research paper would. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth details) is not typically found in this type of summary.

Instead, a 510(k) summary focuses on demonstrating "substantial equivalence" to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate. The "acceptance criteria" here are essentially the regulatory requirements for substantial equivalence, and the "study" is the overall 510(k) submission process itself, where testing (e.g., biocompatibility, materials testing, performance under simulated conditions) is conducted to ensure the device meets recognized standards and performs similarly to its predicates.

Given this context, here's an attempt to answer your questions based on the provided text, recognizing the limitations:

Acceptance Criteria and Device Performance (Based on 510(k) Submission)

The "acceptance criteria" in a 510(k) context are primarily demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is not quantified in the typical sense of a human-AI study but rather implied through comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Additional Requested Information:

Since this is a 510(k) summary for a physical medical device (masks) and not an AI/software device, many of your specific questions related to AI study design are not applicable.

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

   • Not applicable for this type of device and document. A 510(k) for a physical device like a mask does not typically involve "test sets" of data in the AI/machine learning sense. Performance is generally assessed through engineering testing (e.g., airflow resistance, dead space, seal integrity, materials biocompatibility, pressure drop) and clinical use data collection, if necessary, to demonstrate equivalence. Specific sample sizes for such tests are not detailed in this summary.
   • Data Provenance: The applicant is Dräger Medical AG & Co. KG from Lübeck, Germany. Any internal testing data would likely originate from their facilities.

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. Ground truth for a physical medical device like a mask is established through objective engineering measurements, adherence to recognized standards, and, if applicable, clinical validation (though not usually required for 510(k) unless a new significant performance claim is made or equivalence is challenged). There are no "experts establishing ground truth" in the diagnostic context.

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

   • Not applicable. This relates to diagnostic interpretation consensus, which is not relevant for a respiratory mask.

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

   • Not applicable. This is a physical medical device, not an AI or diagnostic tool. MRMC studies are not relevant.

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

   • Not applicable. This is a physical mask, not an algorithm.

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

   • Not applicable in the AI/diagnostic sense. The "ground truth" for a non-invasive ventilation mask would be derived from:
     • Engineering specifications and standards: Adherence to ISO, ASTM, or other recognized standards for breathing devices (e.g., dead space, flow resistance, pressure integrity).
     • Biocompatibility testing: Ensuring materials are safe for human contact.
     • Bench testing: Actual performance measurements in a laboratory setting.
     • Clinical experience/literature: Supporting the general safety and effectiveness of non-invasive ventilation masks of similar design.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device.

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

   • Not applicable. This is not an AI/machine learning device.

In summary: The provided document is a regulatory submission aiming for market clearance based on substantial equivalence to existing devices. It demonstrates this equivalence through a comparison of intended use and technological characteristics, implicitly supported by internal testing and adherence to recognized standards by the manufacturer. It does not provide the detailed scientific study results typically found for AI/diagnostic devices.

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