Search Results

The Ombra® Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.

The Ombra* Table Top Compressor provides a source of compressed air for use with jet nebulizers. The device is a motor-driven compressor, housed in a plastic case with rubber skids. It operates from 120V/60Hz. It is supplied with several replaceable air filters. The Ombra* Table Top Compressor is intended for adult, child and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The Ombra* Table Top Compressor is a medical device designed to provide compressed air for use with jet nebulizers. The provided text details the device's characteristics and its comparison to predicate devices, but it does not describe a study involving acceptance criteria in the traditional sense of clinical performance or algorithm evaluation.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and comparison of technological characteristics. This is a common pathway for medical devices seeking 510(k) clearance, where direct clinical trials or extensive performance studies with acceptance criteria based on patient outcomes are often not required if the new device is sufficiently similar to a predicate.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in this context.

Here's the information that can be extracted from the provided text, framed within the substantial equivalence approach:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are typically defined by demonstrating that the new device's parameters are comparable to or within acceptable limits relative to the predicate devices, and that it complies with relevant safety and performance standards.

The "study" that proves the device meets these criteria is the "Non-Clinical Test Summary."

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

• Sample size: Not specified as a "sample size" in the context of patient data. The testing involved one unit of the Ombra* Table Top Compressor to characterize its operating parameters.
• Data provenance: Not applicable in the context of clinical data. The tests were conducted internally to characterize the device's physical and electrical properties.

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

• Not applicable. Ground truth in this context refers to objective measurements of the device's physical and electrical performance, not expert clinical interpretation.

4. Adjudication method for the test set:

• Not applicable. There was no human interpretation or adjudication involved in the objective measurements.

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:

• Not applicable. This device is a compressor, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a standalone hardware component. Its performance is measured directly, not via an algorithm.

7. The type of ground truth used:

• Objective physical and electrical measurements of the device's operating parameters (e.g., pressure, flow rate, current, sound level, temperature ranges) and compliance with recognized safety and EMC standards. Comparisons were made against the specifications of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. As there is no training set, this question is irrelevant.

In summary, the Ombra Table Top Compressor gained clearance through a 510(k) submission based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing and adherence to recognized electrical and electromagnetic compatibility standards.* The "acceptance criteria" were met by showing that its technical specifications were comparable to predicates and that it complied with relevant safety standards, raising no new safety or effectiveness concerns. No clinical performance studies or AI-related evaluations were conducted or required for this type of device.

Ask a specific question about this device