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510(k) Data Aggregation
(29 days)
The Hospital Nasal Mask is an accessory to a non-continuous ventilator (Respirator) intended for single patient, multi-use for adults prescribed continuous positive airway pressure (CPAP) or Bilevel therapy in hospitals or clinics.
This is a disposable mask. It is intended to be used for the short-term (7 days) treatment of a single patient only, then discarded.
The Hospital Nasal Mask is a respirator mask covering the nose. It is a patient interface accessory to CPAP and bilevel devices for use in hospitals and clinics. The Hospital Nasal Mask is strapped to the patient's face covering the nose. It is connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way. The Hospital Nasal Mask is a single patient multiple-use medical accessory. The mask will be marketed to clinics and hospitals for short-term use.
The provided text describes a 510(k) premarket notification for a medical device, the ResMed Hospital Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance metrics. As such, the information typically found in a clinical study report or performance evaluation regarding acceptance criteria and detailed device performance metrics (e.g., sensitivity, specificity for diagnostic devices, or specific quantitative performance targets) for a new algorithm or diagnostic system will not be present in this type of document.
The document primarily states that the Hospital Nasal Mask is a modified version of an existing predicate device (Modular Mask, K961783) and that its safety and effectiveness are established by showing substantial equivalence through design input requirements, risk analysis, and materials biocompatibility testing.
Therefore, the following information, if applicable, would be derived from the provided text as best as possible, with many points being "Not Applicable" or "Not Provided" due to the nature of a 510(k) for a physical medical device like a mask:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from risk analysis and design inputs) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Materials Biocompatibility (compliant with ISO 10993 or predicate materials) | Materials used are either predicate materials or compliant with ISO 10993 standards. |
| Safety and Effectiveness substantially equivalent to predicate device | Performance data and materials biocompatibility testing show substantial equivalence with the unmodified predicate mask. |
| Design Input Requirements Met (derived from risk analysis) | Performance testing derived from the risk analysis is provided to ensure design input requirements have been met. |
| Intended Use: accessory to CPAP/bilevel devices, single patient multiple-use, short-term (7 days) | Device description and Indications for Use confirm these parameters. |
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: Not explicitly stated for performance testing. Given it's a physical device (mask), testing would likely involve bench testing, material testing, and potentially limited user perception studies, rather than a clinical trial with a "test set" in the sense of a diagnostic algorithm.
- Data Provenance: Not specified. likely internal lab testing/bench testing.
- Retrospective/Prospective: Not specified, but generally refers to internal engineering/ biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like a nasal mask, "ground truth" as it applies to diagnostic algorithms (e.g., expert consensus on an image) is not relevant. Performance is assessed against engineering specifications, biocompatibility standards, and equivalence to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically for subjective assessments in clinical trials or for establishing ground truth in diagnostic studies. This is not described for the performance evaluation of a 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 device is a nasal mask, not an AI-powered diagnostic tool. MRMC studies are not relevant for its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the traditional sense. The "ground truth" for this device's evaluation is primarily based on:
- Compliance with ISO 10993 standards for biocompatibility.
- Verification against design input requirements (which are engineering specifications and user needs).
- Demonstration of substantial equivalence to the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI-powered device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it.
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