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The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, E150, E200, and e500 Newport Ventilators.

The Newport C250 Air Compressor is electric and produces air from the normal environment to supply compressed air for Newport ventilators.

This document appears to be a 510(k) summary for a medical device, the Newport C250 Air Compressor. It details the device's intended use, its substantial equivalence to predicate devices, and the testing performed. However, it does not contain a study that proves the device meets specific acceptance criteria in the format requested.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that comprehensive testing was conducted "in accordance with various industry recognized standards" and that "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." However, it does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table.

The standards mentioned are:

• IEC 60601-1-2:1993
• CSA 22.2 No 601-1-M90
• UL 2601-1
• EN 55011:1998 &A1:1999

These are general safety and electromagnetic compatibility (EMC) standards for medical electrical equipment. They would have specific test limits and pass/fail criteria, but these are not enumerated in the 510(k) summary. The summary only states that the device meets its specifications and is safe/effective, implying it passed the tests against these standards.

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

This type of information is not applicable to this 510(k) submission. The Newport C250 Air Compressor is an electromechanical device, not an AI/software device that processes data in the way typically associated with "test sets" or data provenance (e.g., country of origin for clinical images). Testing would involve a fixed number of physical units of the compressor, often a single unit or a small batch, subjected to rigorous environmental, electrical, and performance tests. The data provenance would be from laboratory testing.

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

This is not applicable to the Newport C250 Air Compressor. "Ground truth" established by experts is relevant for diagnostic or image analysis AI/software, not for a physical air compressor whose performance is measured by objective physical parameters (e.g., pressure, flow, purity, noise, electrical safety).

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in labeling or assessing data, which is not relevant for the testing of this physical device.

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 is a physical medical device (an air compressor), not an AI-assisted diagnostic or image analysis system. Therefore, MRMC studies and "human readers improving with AI" are not relevant to its premarket submission.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The "ground truth" for a device like an air compressor would be its physical specifications and objective measurements of its performance (e.g., pressure output, air purity, noise levels, power consumption) against established engineering and safety standards.

8. The sample size for the training set:

Not applicable. Training sets are used for machine learning models, not for physical electromechanical devices like an air compressor.

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

Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding acceptance and testing:

• Acceptance Criteria (Implied): The device's specifications (e.g., "supply a source of clean, oil-free pressurized air at 42 psig") and compliance with the listed industry standards (IEC 60601-1-2, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011). While not numerically stated here, these standards contain specific, measurable acceptance criteria.
• Study/Testing Information: "Comprehensive testing has been conducted... in accordance with various industry recognized standards." The results of this testing "provides assurance that the device meets its specifications and is safe and effective for its intended use." The 510(k) pathway relies on demonstrating substantial equivalence to a legally marketed predicate, often through a combination of design, performance testing, and comparison of technical characteristics to the predicate. The FDA's clearance implies they were satisfied with the demonstration of compliance with the standards and the device's specifications.

This 510(k) summary is typical for a Class II electromechanical device that does not involve AI or complex data analysis, hence the absence of the detailed information about test sets, experts, or training data that you requested.

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