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The intensive care ventilator Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight. Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring. Savina 300 is intended for the following environments of use: - In intensive care wards, in recovery rooms and generally for hospital use - During the transfer of ventilated patients within the hospital

Savina 300 is a turbine driven ventilator with a 12.1" color touch screen, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO). Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight in intensive care units, in recovery rooms and generally for hospital use. Savina 300 can also be used during transport of ventilated patients within the hospital. The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides positive pressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes.

Based on the provided text, the device is the Savina 300 intensive care ventilator. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a rigorous clinical trial proving the device meets those criteria, as one might expect for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, many of the requested elements for a study proving acceptance criteria (like specific metrics, sample sizes for training/test sets, expert adjudication details, MRMC studies, and detailed ground truth establishment for AI performance) are not present in this type of submission. This document describes a traditional medical device (a ventilator) and its modifications, with performance demonstrated through non-clinical testing in conformance with recognized standards.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance thresholds for a clinical study, nor does it report specific performance metrics for the device in a clinical context. Instead, it refers to:

• Conformance to FDA recognized standards: This implies that the device's performance meets the requirements outlined in these standards for safety and essential performance.
• Non-clinical testing: "Performance data related to each proposed modification has been tested and evaluated." This suggests bench testing and verification activities.
• Substantial equivalence: The ultimate "performance" goal stated is that the modifications demonstrate the device is substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable/not reported. This was demonstrated through engineering and bench testing, not a clinical study with a patient "test set."
• Data provenance: Not applicable. The "data" comes from engineering tests and measurements, not patient data sets.

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

• Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert image review) is not relevant to the type of testing described for this ventilator. Device performance is evaluated against engineering specifications and standard requirements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. There was no "test set" in the context of clinical data requiring adjudication.

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:

• No. This is not an AI/diagnostic imaging device, and therefore, an MRMC study is not relevant and was not conducted or reported.

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

• Not applicable. This device is a ventilator, a mechanical and electronic medical device, not a standalone algorithm.

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

• The "ground truth" for this device's performance would be the engineering specifications and requirements of the applicable medical device standards (e.g., ISO 80601-2-12 for critical care ventilators), confirmed through bench testing and validation activities. There is no clinical "ground truth" derived from patient data in this submission summary.

8. The sample size for the training set:

• Not applicable. This is a traditional medical device, not a machine learning model, so there is no training set in that context.

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

• Not applicable, as there is no training set.

In summary, this 510(k) submission for the Savina 300 ventilator focuses on demonstrating substantial equivalence through non-clinical testing and adherence to recognized standards for device functionality and safety, rather than a clinical study evaluating diagnostic or interpretive performance.

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Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight.

Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring.

Savina 300 is intended for the following environments of use:

• In intensive care wards, recovery rooms and generally for hospital use

• During the transport of ventilated patients within the hospital

• During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)

• During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)

Savina 300 is a turbine driven ventilator with a 12.1" color touch screen for easy handling, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO).

The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides overpressure ventilation and adjustable oxygen concentration with pressureand volume-controlled automatic and spontaneous breathing modes.

This document is a 510(k) Summary for the Dräger Savina 300 ventilator, claiming substantial equivalence to previously cleared devices. It does not contain a study proving that the device meets specific acceptance criteria in the way a clinical validation study for an AI/ML software device would. Instead, it demonstrates compliance with recognized performance standards to establish substantial equivalence.

Here's an breakdown based on the information provided, and where certain requested information might not be applicable or present for this type of submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of "acceptance criteria" paired with "reported device performance" in the context of specific outcome metrics like sensitivity, specificity, or accuracy for a diagnostic device.

Instead, the "acceptance criteria" are implied by compliance with listed international and national standards relevant to medical electrical equipment, particularly for lung ventilators. The "reported device performance" is demonstrated by the device's design, functional specifications, and its claim of equivalence to existing devices that have already met these standards.

Here's a summarization of the relevant information provided under "List of Performance Testing" and "Comparison of Technological Characteristics":

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

This information is not applicable (N/A) in the context of this 510(k) submission. This document does not describe a clinical validation study involving a "test set" of patient data for evaluating a software algorithm. The "testing" referred to is performance testing against recognized standards for medical devices and a comparison of technical specifications to predicate devices. There is no patient data involved in this type of submission for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is N/A. As explained above, there is no "test set" or "ground truth" establishment in the context of expert review for a diagnostic AI/ML device in this submission. The device is a ventilator, and its performance is assessed against engineering standards and comparison to similar devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is N/A. No adjudication method for a test set is relevant to this 510(k) submission.

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 information is N/A. The device is a ventilator, not a diagnostic imaging device or AI assistance tool for human readers. Therefore, an MRMC study is not relevant to this submission.

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

This information is N/A. The Savina 300 is a physical medical device (ventilator) with integrated software, not a standalone algorithm. Its operation involves continuous interaction with a patient under the supervision of trained medical personnel.

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

This information is N/A. "Ground truth" in the context of diagnostic accuracy is not relevant to this type of device and submission. The "truth" here is compliance with established performance standards and the functional equivalence of its technical characteristics to predicate devices.

8. The sample size for the training set

This information is N/A. As this is a medical device (ventilator) and not an AI/ML software device trained on data, there is no "training set."

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

This information is N/A. No training set exists for this device.

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Long-term ventilator for intensive care. For patients 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. Savina is used in intensive care units, recovery rooms, inter and intra hospital transport and subacute care facilities. LPO means Low-Pressure-Oxygen and allows the supply of oxygen from a low pressure source (such as an oxygen concentrator), independently of high pressure O2 sources. The external low pressure oxygen source is to be provided by the user. The LPO option does not affect the ventilation performance. The only difference between HPO and LPO mode is the supply and monitoring of the O2 concentration. The LPO Option is available for Savina with SW 3.n.

I am sorry but this document does not contain the information requested. This is a 510(k) premarket notification for a ventilator, and it describes the device's intended use and substantial equivalence to previously cleared devices. It does not include information about acceptance criteria or a study that proves the device meets those criteria, as such studies are typically required for more complex or novel devices that pose higher risks.

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Ask a specific question about this device