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510(k) Data Aggregation
(217 days)
Vapotherm Aerosol Adapter AAA-2
The Vapotherm Aerosol Adapter AAA-2 is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT 2.0 and the Aerogen Solo Nebulizer.
The Vapotherm Aerosol Adapter AAA-2 is an accessory that is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT® 2.0, cleared under K203357, and the Aerogen Aeroneb® Solo Nebulizer System, cleared under K133360, and more recently with K143719. which is intended to aerosolize solutions for inhalation. The AAA-2 facilitates the connection between the noted devices, and therefore aerosolization use is dictated by the Aerogen Aeroneb Solo Nebulizer System labeling.
The provided text describes the Vapotherm Aerosol Adapter AAA-2 (subject device) and its equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specific numerical results of a study that directly proves the device meets those criteria in a tabular format as requested.
Instead, the document outlines the types of non-clinical performance testing conducted and generally states that the device passed these tests or demonstrated similar performance to the predicate device.
Here's an attempt to extract and infer the information based solely on the provided text, while noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing descriptions) | Reported Device Performance (as stated or inferred) |
|---|---|
| Delivery of aerosolized solution confirmed (utilizing laser) | Confirmed delivery with nasal cannula and trach adapter. |
| Achievable flow rates (8, 20, 45 L/min with various cannula sizes) | Set flows were achieved. |
| Occlusion detection and alarm (at various L/min for different cannulas) | Passed occlusion testing (implied by "Occlusion testing with associated alarm included running..." without negative result). |
| Maximum rain-out of 5 mL not exceeded | System passed; maximum of 5 mL of rain-out was not exceeded in worst-case orientation. |
| Physical connections integrity under varying conditions | All connection points challenged and implied to be sufficient. 22mm female port compliant to ISO 5356-1. |
| No component/material degradation during continuous use | No signs of component or material degradation. |
| Similar aerosolization performance (particle size, respirable dose) to predicate | Demonstrated similar performance for both AAA-2 and Aeroneb Solo Adapter with Aeroneb Solo Nebulizer System, and did not interfere with expected performance. |
| Acceptable biocompatibility risk | Determined to possess acceptable biocompatibility risk. |
| Usability/Human Factors: no identified potential use errors, close calls, or difficulties with critical tasks. | Results support a substantial equivalence determination (implied successful). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the individual tests. The text describes "testing" and "running" the device but doesn't quantify the number of units or repetitions.
- Data Provenance: Not explicitly stated. The tests were performed by Vapotherm Inc. or a contracted lab. It's bench testing, not clinical data, so country of origin of data (patients) is not applicable. This is retrospective bench testing on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. This document describes physical and performance bench testing of a medical device accessory, not an AI or diagnostic system that requires expert consensus for ground truth. Biocompatibility and performance standards (like ISO 10993-1, ISO 18562-1, ISO 5356-1) serve as the "ground truth" or accepted standards that the device performance is measured against.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, especially in AI studies, to establish ground truth. As this is bench testing against established engineering and material standards, such methods are not used. The device's performance is either within the specified limits or it is not.
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
This section is not applicable. This document describes an accessory product (an adapter for a nebulizer) and its bench testing, not an AI system, diagnostic tool, or a product that interacts with human readers/interpretations. Therefore, an MRMC study and AI-assisted human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a hardware accessory; it does not involve any algorithm or AI component.
7. The type of ground truth used
The ground truth for the various tests described is based on:
- Established engineering specifications and performance limits for flow rates, rain-out, connection integrity.
- International standards for medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, ISO 18562-1 for breathing gas pathways, ISO 5356-1 for connections).
- The performance of the predicate device (Aeroneb Solo Adapter) for aerosolization comparison.
8. The sample size for the training set
This section is not applicable. The device is a hardware accessory and does not involve AI/machine learning, so there is no training set.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for an AI/ML algorithm, the establishment of ground truth for such a set is not relevant.
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