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The Aria sequential circulator is a programmable sequential, pneumatic compression device intended for use by medical professionals and patients at home, for the treatment of the following conditions:

• Chronic edema
• Lymphedema
• Venous insufficiency
• Wound healing

The Aria system consists of two main components: A flow generator and a garment. The garment is to be wrapped around the limb, providing a comfortable fit. The garment has seven (7) chambers that are filled with air by the flow generator to provide compression on the extremity. The Aria system uses a compressand-release massage action, similar to the predicate, in order to stimulate lymphatic vessels in the treated area and encourage fluid clearance.

The Aria system retains similar hardware and performance features of the predicate device. Key features include flow generator, valves, A/C plug pack, lower limb garment, tubing, no-LCD User Interface and ON/OFF button. The Aria System contains a microprocessor-controlled flow generator/blower system that generates pressure from 0-45 mmHG to provide for effective treatment of the conditions described in the IFU.

The Aria flow generator has no control settings and delivers one pre-programmed therapy mode.

This document describes the Inova Labs Aria System, a programmable sequential, pneumatic compression device. It is intended for the treatment of chronic edema, lymphedema, venous insufficiency, and wound healing. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which the device performance is reported with specific numerical targets. Instead, it describes "bench testing" which included performance comparisons to a predicate device. The results of this testing are stated to "demonstrate that the Aria system raises no new safety or effectiveness concerns and is substantially equivalent to the predicate device."

Here's a summary of the characteristics compared with the predicate device (Entre Model PD08-U, K143185):

The "bench testing" areas mentioned for the Aria System were:

• Pressure stability
• Sleeve burst test
• Sleeve leakage test
• Sleeve integrity test
• Pressure accuracy test
• Chamber filling cycle time testing
• Total therapy time

The report generally states that the Aria system "met the Aria System Specification when compared to the predicate device" for these tests, implying that the performance was either equivalent or acceptable relative to the predicate. Specific numerical values for acceptance criteria or detailed results are not provided in this summary.

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

The document primarily discusses non-clinical bench testing. There is no "test set" in the context of patient data described for evaluating device performance. The testing involved physical device units. The provenance of the device units used for bench testing (e.g., country of manufacture) is not specified.

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 question is not applicable as there was no clinical test set requiring expert ground truth establishment. The evaluation was based on bench testing against engineering specifications and comparison to a predicate device.

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

This question is not applicable as there was no clinical 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

This question is not applicable. The Aria System is a pneumatic compression device, not an AI-assisted diagnostic or interpretative device that would involve human "readers." No MRMC study was performed.

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

This question is not applicable. The Aria System itself is a standalone medical device (hardware) that delivers therapy; it's not an algorithm whose performance needs to be assessed independently. While it contains a microprocessor and potentially firmware/software for control, the evaluation focuses on the overall device's physical and functional performance through bench testing.

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

For the non-clinical testing, the "ground truth" or reference for evaluating performance was based on engineering specifications for the Aria System and the performance characteristics of the legally marketed predicate device (Entre Model PD08-U, K143185). For example, pressure accuracy would be compared to a calibrated standard.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning.

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

This question is not applicable as there was no training set.

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