(105 days)
Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml.
Savina is a long term ventilator unit designed for patients with a tidal volume of 50 ml or more and is used in the intensive care areas, recovery rooms, inter and intra hospital transport and subacute care facilities. NIV means Non-Invasive Ventilation and supports the mask application mode. The NIV Option is available for Savina with SW 2.0. The NIV Option for Savina expands the range of available ventilation strategies to include Non-Invasive Ventilation. NIV is not a new ventilation mode but a different format to deliver ventilation to the patient. With the NIV Option activated, the user can switch the ventilator during preparation of the machine into one of two application modes: a) "Tube" application mode, b) "Mask" application mode. The "Tube" application mode corresponds to the reqular behavior of the device if the NIV option is not activated. If the "Mask" application mode is selected, the user gains the option to configure parts of the device integrated monitoring to adapt the specific need of the mask ventilated patient.
The provided text describes the "NIV Option for Savina" device, which is an enhancement to the Savina ventilator to include Non-Invasive Ventilation (NIV) capabilities. However, the document does NOT contain information about specific acceptance criteria or a study that details device performance against such criteria in the manner requested (e.g., accuracy, sensitivity, specificity, or objective metrics typically found in performance studies).
The document is a 510(k) Summary and a clearance letter, primarily focused on establishing substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria through a detailed study with objective metrics.
Therefore, most of the requested information cannot be extracted directly from the provided text.
Here is a summary of what information can be gathered and what is missing:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document focuses on "substantial equivalence" and safety/effectiveness for its intended use, rather than specific performance metrics (e.g., accuracy, reliability, latency) that would typically have acceptance criteria. | Not specified in the document. There are no quantitative performance metrics or results of a specific study to report against acceptance criteria. The document states that the device "meets its specifications and is safe and effective for its intended use," but no details on how this was measured are provided. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified. The document only states that "Design, development and verification of the device was performed in accordance with FDA guidance and company internal standards" and "The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective." This implies testing was done, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This type of information is typically related to diagnostic or interpretive devices, which this ventilator option is not. Ground truth for a ventilator would generally relate to its physical performance, safety features, and accuracy of delivered parameters, which are usually measured against physical standards or reference devices, not expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. (See point 3 above).
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 ventilator option, not an AI-assisted diagnostic or interpretive system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical medical device (ventilator option), not an algorithm in the sense of AI or image analysis. Its "performance" would be assessed through engineering and clinical validation rather than standalone algorithm testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified directly. For a ventilator, ground truth would typically refer to established engineering standards, physiological models, or direct measurements against calibrated equipment to verify the accuracy of delivered gas volumes, pressures, flow rates, alarm functionality, and safety features. Clinical outcomes might be considered for overall effectiveness but are not usually the "ground truth" for individual performance metrics.
8. The sample size for the training set:
- Not applicable/Not specified. This term is typically used for AI/machine learning models. While the device underwent "design, development, and verification," the concept of a "training set" in the context of machine learning is not relevant here.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. (See point 8 above).
In summary: The provided document is a regulatory submission for 510(k) clearance, which focuses on demonstrating substantial equivalence to existing devices. It confirms that the device meets specifications and is safe and effective, but it does not provide the detailed performance study data, acceptance criteria, or specific methodologies (like sample sizes, ground truth establishment, or expert involvement) that would be found in a comprehensive clinical or performance validation study report.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).