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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.

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the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen). Federal law restricts this device to sale by or on the order of a physician.

the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen).

The provided document is a 510(k) summary for the Carina™ home ventilator. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in a clinical study report.

The document states: "The results of all verification and validation testing demonstrate that all system and design requirements for the Carina home device have been met. Qualification included hazard analysis, system level qualification and verification / validation tests." However, it does not provide the specifics of these tests in terms of performance metrics, acceptance criteria, sample sizes, or ground truth methods.

Therefore, many of the requested details cannot be extracted from this specific 510(k) summary. I can only provide information that is explicitly stated or can be inferred from the provided text.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance

The document states that "The results of all verification and validation testing demonstrate that all system and design requirements for the Carina home device have been met." However, no specific acceptance criteria or quantitative performance metrics are reported in this summary. For example, it does not provide specific ranges for delivered tidal volume accuracy, respiratory rate accuracy, or pressure control stability that would typically be associated with a ventilator's performance and its acceptance criteria.

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

This information is not provided in the 510(k) summary. The document mentions "verification and validation testing," but it does not specify the sample size of any test sets (e.g., number of patients, test conditions, etc.) or the provenance of the data.

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 not applicable and therefore not provided in the 510(k) summary. This document pertains to a medical device (ventilator) engineering and regulatory submission, not a diagnostic algorithm that requires expert interpretation for ground truth establishment. The "ground truth" for a ventilator would typically relate to its physical performance measurements against established standards, not expert consensus on images or clinical data.

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

This information is not applicable and therefore not provided in the 510(k) summary. As stated above, this is not a diagnostic study requiring adjudication of expert opinions.

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 not applicable and therefore not provided in the 510(k) summary. MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms that assist human readers. The Carina home is a ventilator, not a diagnostic imaging or AI-assisted diagnostic device.

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

This information is not explicitly stated or applicable as described. The device itself is a ventilator, which operates an algorithm for controlling ventilation. Its performance is evaluated intrinsically, not as a standalone diagnostic algorithm in the context of human-in-the-loop performance. The document only mentions "system level qualification and verification / validation tests," which would inherently evaluate the device's algorithmic performance in controlling ventilation.

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

For a ventilator, the "ground truth" would typically be derived from established engineering standards, calibration measurements against highly accurate reference devices, and physiological models. The document does not specify the exact methods for ground truth establishment but implies these through references to "safety testing" and compliance with standards like IEC60601-1, IEC60601-1-2, and ASTM F1246. These standards define the acceptable performance characteristics and testing methodologies for medical devices.

8. The sample size for the training set

This information is not provided and is likely not applicable in the context of this device. Clinical studies for ventilator performance typically involve testing the device on a range of simulated lung models or, in later stages, on a limited number of patients to demonstrate safety and effectiveness. The term "training set" is generally used for machine learning algorithms, which is not the primary focus of this 510(k) for a ventilator.

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

This information is not provided and is not applicable. As mentioned above, the concept of a "training set" with established ground truth is typically associated with machine learning models, which is not the direct subject of this ventilator 510(k) summary. The ventilator's underlying control logic and algorithms are designed based on established physiological principles and engineering requirements, not "trained" on a dataset in the machine learning sense.

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