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Babyleo TN500 is intended for use with premature babies and neonates and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally requlated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: Temperature; Humidity; Oxygen (option).

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer. Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates. The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray tray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package. The subject of this submission is the addition of the optional Touch time function, which can be activated in order to stabilize the thermal environment in the patient compartment when the hand ports are opened. It supports users during routine tasks (e.g. changing diapers, washing the baby, checking sensors). Additionally, the scale resolution is changed from 5q to 10g.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Babyleo TN500 (Neonatal Incubator and Radiant Warmer)
Reason for Submission: Addition of optional "Touch time" function and change in scale resolution.

Acceptance Criteria and Reported Device Performance

Since this 510(k) submission is for modifications to an already cleared device (K162821), the core performance specifications of the Babyleo TN500 remain unchanged and are considered the acceptance criteria based on the predicate device. The changes are specifically for the "Touch time" feature and the scale resolution.

The table below focuses on the elements changed or directly impacted by the submission. For other parameters, the document states "Identical" meaning the performance meets the existing criteria from the predicate device (K162821).

Study Information

The provided document describes a verification and validation (V&V) testing approach for the modifications, not a typical clinical study with patient data, ground truth establishment, or human reader involvement. This is common for modifications that do not significantly alter the intended use or fundamental technological characteristics of a device.

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

   • Test Set Size: Not explicitly stated as individual "samples" in terms of patient data. The testing was focused on the device's functionality and safety regarding the "Touch time" feature and scale resolution. This likely involved engineering bench testing or simulated use cases.
   • Data Provenance: Not specified. Given the nature of V&V testing for a medical device modification, it would be laboratory-based data generated during manufacturing and development, likely in Germany (Drägerwerk AG & Co. KGaA is in Luebeck, Germany) with adherence to international standards. It is prospective testing specific to the modifications.

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

   • Not applicable as this was not a study requiring expert-established ground truth in the clinical sense (e.g., diagnosis). The ground truth for device performance features like temperature regulation, alarm functionality, and scale accuracy is typically against engineering specifications and validated test equipment.

3. Adjudication method for the test set:

   • Not applicable. The V&V testing would involve comparing device performance against predetermined engineering specifications and international standards, rather than expert adjudication of clinical outcomes.

4. 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-assisted device and therefore no MRMC study was conducted.

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

   • Not applicable. This device is not an algorithm-only device. The V&V testing evaluated the functional performance of the device and its new feature.

6. The type of ground truth used:

   • Engineering Specifications and International Standards: The performance of the device and its new features were evaluated against established engineering specifications for the device and compliance with recognized international standards (IEC 60601-1-2, 60601-2-19, and 60601-2-21). This is the "ground truth" for demonstrating safety and effectiveness of device functions.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable for the same reason as above.

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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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