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510(k) Data Aggregation
(79 days)
NASAL JACKS MASK
The Nasal Jacks Mask is an accessory to a non-continuous ventilator (respirator), intended for single-patient multiple use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
The Nasal Jacks Mask is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for singlepatient, multi-use and is minimally obtrusive to the user providing a high level of comfort, ease-ofuse and seal. The Nasal Jacks Mask is supported by headgear to allow a seal with the patients nostrils via the nasal cushions, then connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive manner. The Nasal Jacks Mask comes in one frame size and has three nasal cushion sizes.
The provided text describes the 510(k) summary for the Nasal Jacks Mask, a device intended for non-invasive ventilatory support. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device was tested for) | Reported Device Performance (Summary of results) |
|---|---|
| Pressure-flow characteristic | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Functional dead space (CO2 re-breathing) | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Physical dead space | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Flow impedance | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Materials Biocompatibility | Materials either predicate materials or tested to ISO 10993 standards by an independent certified laboratory. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test set or the data provenance (country of origin, retrospective/prospective). It generally states that "Performance testing has been carried out to verify and validate the safety and effectiveness."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily engineering/objective performance testing rather than human expert assessment of outcomes.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method as the studies described are performance tests and biocompatibility tests, not clinical studies requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size.
No, an MRMC comparative effectiveness study was not done. The study described focuses on the physical and material characteristics of the device compared to predicate devices.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
Not applicable. This device is a medical mask, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the performance tests (pressure-flow, dead space, flow impedance), the ground truth was based on objective measurements and comparison to established predicate device performance. For material biocompatibility, the ground truth was based on ISO 10993 standards or the existing approval of predicate materials.
8. The Sample Size for the Training Set
Not applicable. This device is a physical mask and does not involve a "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an algorithm-based device.
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