Search Results

The Evita 4 with the Software version 3.0 is a time cycled, constant volume ventilator The Evita + with the Oct.ware is microprocessor controlled and provides the following ventilation modes:

CMV/assist
SIMV
MMV
SB
CPAP
ASB/PSV
PCV+
APRV
Apnea Ventilation
ILV

AI/ML Overview

This is a regulatory submission for a medical device (ventilator) and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in a clinical study report or a 510(k) submission for a diagnostic AI/ML device.

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific clinical acceptance criteria through a dedicated study with experts establishing ground truth.

Therefore, many of the requested fields cannot be extracted directly from this document. I will fill in what can be inferred or stated as "Not applicable/Provided" based on the content.

Here's an analysis based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative manner as one would expect for a diagnostic device. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The "performance" is implicitly deemed acceptable if it is equivalent to the legally marketed predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary of Equivalence)
Classification: Intensive Care Ventilator	Yes
Operating Principle: Time cycled, volume constant, pressure controlled	Yes
Software controlled	Yes
Gas delivery system: Fast "High Pressure Servo Valve", microprocessor controlled	Yes
Intended Use: For adults and children with body weight >= 3 kg	Identical to predicate Evita 4 (K 961687)
Modes of Ventilation	Identical to predicate Evita 4 (K 961687)
Ventilator Settings	Identical to predicate Evita 4 (K 961687)
Flow Trigger Sensitivity	Identical to predicate Evita 4 (K 961687)
Parameter setting	Identical to predicate Evita 4 (K 961687)
Monitors/Indicators	Identical to predicate Evita 4 (K 961687)
Pressure Limitation	Identical to predicate Evita 4 (K 961687)
Alarm Functions	Identical to predicate Evita 4 (K 961687)
Displayed Values	Identical to predicate Evita 4 (K 961687)
Displayed Curves	Identical to predicate Evita 4 (K 961687)
Intermittent PEEP	Identical with Evita 2 dura (K 970165)
Inspiration Hold	Identical with Evita 2 dura (K 970165)
Apnea Ventilation	Identical with Evita 2 dura (K 970165)
Nebulization	Identical with Evita 2 dura (K 970165)
Nebulization in pediatric mode	Identical with Evita 2 dura (K 970165)
Suction Help Mode	Identical with Evita 2 dura (K 970165)
Switch over function	Identical with Evita 2 dura (K 970165)
Leak-Compensation	Identical with Evita 2 dura (K 970165)
Minute Volume-Leak	Identical with Evita 4 (K 961687)
Overall Safety and Efficiency	Substantially equivalent to predicate devices

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

Sample Size: Not applicable/Provided. This document does not describe a clinical study with a "test set" in the context of diagnostic performance evaluation. The substantial equivalence claim is based on comparing technical specifications and intended use.
Data Provenance: Not applicable/Provided. No specific "data" in terms of patient results is discussed. The device is manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany, and sold in the United States.

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)

Number of experts: Not applicable/Provided. This document does not pertain to an AI/ML diagnostic device requiring expert-established ground truth.
Qualifications of experts: Not applicable/Provided.

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

Adjudication method: Not applicable/Provided.

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

MRMC study: No. This is a ventilator, not an AI-assisted diagnostic device for human readers.
Effect size: Not applicable.

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

Standalone performance: Not applicable in the context of an AI/ML algorithm. This device is a ventilator, designed to be used by trained medical professionals. Its "performance" refers to its mechanical and software functions meeting specifications, not an algorithm's diagnostic output.

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

Type of ground truth: Not applicable in the traditional sense of diagnostic device evaluation. The "ground truth" for a ventilator's performance would be its adherence to established electrical, mechanical, and software specifications, and its ability to safely and effectively deliver ventilation as intended, as demonstrated through engineering tests and comparison to legally marketed predicate devices.

8. The sample size for the training set

Sample size for training set: Not applicable/Provided. This document does not describe an AI/ML device that undergoes training on a dataset.

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

Ground truth for training set: Not applicable/Provided.

Ask a Question

Ask a specific question about this device

Page 1 of 1