Search Results

The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Viva Nasal Mask is:
[]To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed. □Intended for single-patient reuse.
The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.
The Numa Full Face Mask is:
□ To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed.
□ Intended for single-patient reuse.

Viva Nasal Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The masks are held in place with adjustable headgear that straps the mask to the face. Viva Nasal Mask has plastic body and silicone seal that touches the face and includes a pad that rests on the forehead.
The Viva Nasal Mask is a prescription device supplied non-sterile.
Numa Full Face Mask provides an interface such that airflow from a positive pressure source is directed to the patient's mouth and nose. The masks are held in place with adjustable headgear that straps the mask to the face. Numa Full Face Mask has plastic body and silicone seal that touches the face and include an adjustable pad that rests on the forehead.
Numa Full Face Mask is a prescription device supplied non-sterile.

The provided document is a 510(k) Summary for medical devices, specifically the Viva Nasal Mask (Model: NM4) and Numa Full Face Mask (Model: BMC-FM2). It describes the devices and compares them to predicate devices to demonstrate substantial equivalence, rather than providing a detailed study of acceptance criteria and performance as typically found in clinical trials for new AI/diagnostic devices.

Therefore, much of the requested information (such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this type of regulatory submission for these specific devices, which are mechanical masks and not AI/diagnostic tools.

However, I can extract the available information regarding their performance and acceptance criteria based on the comparison to predicate devices and non-clinical testing.

Here's the breakdown of what can be inferred or directly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance

For these devices, "acceptance criteria" are not explicitly listed in a quantitative fashion as pass/fail thresholds for specific metrics. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices through technical comparisons and non-clinical performance data. The device performance is reported as being "substantially equivalent" to the predicate devices for various parameters.

Study Details:

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

• Sample Size: The document does not specify a "test set" in the context of patient data. Performance testing was "non-clinical" (bench testing). No patient data samples are mentioned.
• Data Provenance: Not applicable as no patient data was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as no "ground truth" based on expert review of patient data was established for these non-clinical tests. The standard (ISO 17510-2:2007) serves as the benchmark for many parameters.

4. Adjudication method for the test set

• Not applicable as no expert adjudication of patient data was performed.

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. These are mechanical masks, not AI/diagnostic devices that involve human readers.

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

• Not applicable. These are mechanical masks, not algorithms.

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

• For the non-clinical performance tests (like CO2 rebreathing, dead space, resistance), the "ground truth" or acceptance criteria are derived from international standards, specifically ISO 17510-2:2007. The goal was to show that the device performs within acceptable limits set by this standard and is substantially equivalent to predicate devices.

8. The sample size for the training set

• Not applicable as no "training set" in the context of machine learning or patient data was used.

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

• Not applicable as no "training set" was used.

In summary, this 510(k) submission relies on non-clinical bench testing and comparison to legally marketed predicate devices to demonstrate substantial equivalence, rather than clinical trials with patient data, expert review, or AI performance metrics.

Ask a specific question about this device