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The device is a portable air compressor intended to provide compressed air for medical purposes. It is used with a pneumatic nebulizer to administer humidified air or medication to the patient. The device is intended for use on adult and pediatric patients in a home health care or institutional environment. It's not approved for use with ventilators.

The EMG TRITON-COMP. Is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital use. It is capable of servicing nebulizers and humidifiers to produce particle aerosol mist. The EMG TRITON-COMP. Powered by AC current (115V 60Hz) through the wall electric outlet at home, Maximum constant working pressure at 50psi, delivering up to 22LPM of flow (at pressure 10psi) and does not need software to drive. The outlet compressed air pressure of EMG TRITON-COMP. is produced through a built-in compressor. The consist parts include motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve ----etc. When turns on the compressor, motor starts to run and its shaft drives the eccentric crank to actuate the piston connecting rod moving up and down in the cylinder. When the piston is being in the down strike, a vacuum pressure is produced in the cvlinder, then the air will be sucked into the cylinder through an one-way inlet port. When the piston is being in the up strike, it presses out the air through the other outlet port to the atmosphere, these two one-way ports avoid the air being sucked from the atmosphere as well as the air in cylinder being pressed back to the inlet port. When motor keeps running, then the compressed air through outlet port is produced. One set of iron cover with protective earth encloses the compressor and wire harness to protect user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a compressed air pressure regulator, pressure gauge and air outlet port. The pressure regulator connected to the air outlet tube of compressor. The pressure gauge and the compressed air outlet port are connected to the pressure regulator through a three way connector and inner tube. Device's compressed air pressure can be adjusted by tuning the knob of pressure regulator, accuracy within +/-5%. The pressure gauge display the pressure data during operation.

The provided document describes a 510(k) premarket notification for a medical device, the EMG TRITON-COMP. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with AI components. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.

Here's the information that can be extracted or inferred:

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

The document doesn't explicitly state acceptance criteria in a quantitative table format with corresponding performance results in the way one would see for a novel device undergoing clinical trials. Instead, it relies on demonstrating compliance with safety standards and similarity to predicate devices. The "performance validation test" mentioned includes:

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness. The reported performance is that it is the same as the predicate device for the listed validation tests, and it also meets specified safety standards.

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 document. The document refers to "performance validation tests" but does not detail the methodology, sample sizes, or data provenance for these tests. This is typical for a 510(k) summary relying on engineering and bench testing rather than clinical study 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/not provided. The device is an air compressor, and its performance tests would involve measurements of physical parameters (pressure, flow rate, etc.) for which "ground truth" is established by calibrated instruments and engineering specifications, not expert human assessment in a clinical context.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments, typically in clinical studies or human-in-the-loop performance evaluations, which are not described for this 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

An MRMC study was not done. This device is a portable air compressor, not an AI diagnostic tool. Therefore, human reader improvement with or without AI assistance is not applicable.

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

This information is not applicable. The device is a physical air compressor, not an algorithm.

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

The "ground truth" for the device's technical specifications and performance tests would be based on engineering specifications, calibrated measurement systems, and established test protocols for mechanical and electrical devices. For example, pressure gauge accuracy is verified against a master calibrated gauge, and flow rates are measured using calibrated flowmeters. No expert consensus, pathology, or outcomes data are mentioned as ground truth.

8. The sample size for the training set

This information is not applicable/not provided. This device is a mechanical compressor, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.

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

This information is not applicable/not provided as there is no training set mentioned for this device.

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