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510(k) Data Aggregation
(30 days)
DRAGER OXYLOG 2000
The Oxylog 2000 is a time cycled, volume constant transport and emergency ventilator for patients with tidal volumes starting at 100 mL. With applications in: mobile emergency and primary care of emergency patients, patient transports in emergency rescue vehicles or by helicopter, patient transfers by road or air, inner hospital transport of ventilated patients, emergency room, secondary transports between hospitals.
The device is a software controlled and time cycled transport and emergency ventilator. It can be equipped with an external power supply for stationary operation in hospitals and is equipped with a NiCd Battery Pack for the during transport. The Oxylog 2000 has 5 rotary knobs for the adjustment of the ventilator rate, tidal volume, I:E ratio, inspiratory pressure limitation and peep.
The provided text describes a Special 510(k) submission for the Oxylog 2000 SW 3.n ventilator. It does not contain information about a study proving the device meets specific acceptance criteria in the way typically seen for AI/ML-enabled devices involving performance metrics like sensitivity, specificity, or F1-score.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device through a software change, asserting that "no questions regarding safety and effectiveness arose." The "study" mentioned is a laboratory test to show functional equivalence, not a statistical performance study against predefined metrics.
Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to the evaluation of AI/ML diagnostic or prognostic devices, which this ventilator is not.
Here's an attempt to extract and interpret the requested information based on the provided text, with explicit notes where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the submission) |
|---|---|
| Maintain intended use of predicate device | "exactly the same intended use like the predicate device" |
| Software change conforms to design control procedures | "carried out in accordance with Dräger's internal design control procedure and no questions regarding safety and effectiveness arose" |
| Technology for additional monitoring/ventilation mode is same as predecessor | "The technology...is the same as already used with the predecessor." |
| Control mechanism, energy type, materials are same as predecessor | "The control mechanism, the energy type and the materials used are exactly the same." |
| Breathing modes and possibilities are substantially equivalent to predecessor | "It was shown in laboratory tests that the breathing modes and the possibilities of the breathing modes are substantial equivalent." |
| Monitoring and alarm functions are comparable to predecessor | "The monitoring and alarm functions...are also comparable...There were no elementary deviation between the different possibilities..." |
| Device fulfills the same standards as the predecessor | "The device fulfils the same standards as the predecessor." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not specified. The "laboratory tests" mentioned are functional tests, not a statistical study on a patient-based test set.
- Data Provenance: Not applicable. The nature of the "tests" implies internal validation against functional specifications rather than data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for functional equivalence of a ventilator is typically established through engineering specifications, standards, and functional testing by qualified engineers and technicians, not through expert clinical consensus in the way a diagnostic AI would be evaluated.
4. Adjudication method for the test set
- Not applicable. This device's evaluation did not involve human-interpreted outputs 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 a ventilator, not an AI-assisted diagnostic device. 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
- Not applicable in the context of AI/ML. The device itself operates in a "standalone" fashion (as a ventilator), and its software changes were validated as part of its integral function.
7. The type of ground truth used
- Ground Truth: Functional specifications, engineering standards, and the performance characteristics of the predicate device. The "laboratory tests" would have validated the software's ability to maintain these specified operational parameters (e.g., ventilator rate, tidal volume, I:E ratio, inspiratory pressure limitation, PEEP, as well as monitoring and alarm functions).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that undergoes "training" on a dataset in the conventional sense. The software, while controlling the device, is likely based on deterministic control logic and algorithms developed through engineering principles, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable. No "training set" in the context of AI/ML.
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