Search Results

The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upwards.

The Oxylog 2000 p/us is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 ml. upwards. The device is intended for use by and under the supervision of trained healthcare professionals. The device is intended for use in the following environments:

• Mobile use for emergency patients, in both outdoor and indoor environments;
• During transport in ambulances or aircraft, including helicopters;
• In accident and emergency departments;
• When moving ventilated patients around the hospital;
• In the recovery room.

This document concerns the 510(k) Notification for the Dräger Oxylog 2000 plus ventilator. The submission primarily focuses on establishing substantial equivalence to previously marketed devices rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive standalone performance testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not contain a table of specific, quantitative acceptance criteria (e.g., accuracy, precision for ventilation parameters) for the Oxylog 2000 plus. Instead, it states:

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

The document does not describe a test set in the context of clinical or performance data for the Oxylog 2000 plus as one might expect for an AI/diagnostic device. The "testing" mentioned is related to engineering verification and validation of the device's design against safety and system requirements, not patient data or clinical outcomes. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.

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

This information is not applicable as the submission does not describe a test set requiring expert-established ground truth related to clinical performance or diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable as there is no described test set 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

An MRMC comparative effectiveness study is not applicable here. The Oxylog 2000 plus is a ventilator, not a diagnostic device that assists human readers.

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

A "standalone" performance study in the context of an algorithm's performance is not applicable to this device. The document describes engineering verification and validation of the device itself (hardware and software combined), not an isolated algorithm. The device's performance is inherently "standalone" in its function as a ventilator, but this is not the typical meaning in the context of AI/diagnostic device submissions.

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

The "ground truth" used in the context of the described testing is related to engineering specifications, regulatory standards (like IEC60601 series), and internal design requirements. For example, the "ground truth" for electrical safety would be defined by the limits set in IEC60601-1-2. There is no mention of clinical ground truth (e.g., patient outcomes, expert consensus on a diagnosis) because this is not a diagnostic device.

8. The sample size for the training set

This information is not applicable. The device is a ventilator, and there is no mention of an AI model being "trained" in the sense of machine learning using a distinct training set of data. Its performance is based on its engineered design and programming, not a learning algorithm developed from a training dataset.

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

This information is not applicable, as there is no described training set.

Summary of the Study:

The study described is not a clinical trial or a performance study comparing the device against human performance or a diagnostic gold standard. Instead, it is an engineering verification and validation process executed to demonstrate that the Oxylog 2000 plus ventilator meets its design requirements and complies with relevant safety standards (IEC60601-1, IEC60601-1-2). This type of testing is typical for medical devices that are primarily hardware-based and perform a functional role (like a ventilator) rather than an interpretative or diagnostic role. The FDA's 510(k) clearance for this device, based on "substantial equivalence" to predicate devices (Oxylog 2000 and Oxylog 3000), relies on this engineering evidence and the comparison of specifications and intended use.

Ask a specific question about this device

Ask a specific question about this device