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The AIROS 6 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema

The device is safe for both home and hospital use.

The AIROS 6 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.

The AIROS 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.

The provided FDA 510(k) summary for the AIROS 6 Sequential Compression Device does not include a study proving device performance against detailed acceptance criteria in the manner typically seen for AI/ML-based diagnostic devices. This document is for a Class II medical device (compressible limb sleeve), which is a mechanical device, not an AI or imaging diagnostic tool. Therefore, the questions related to AI/ML specific aspects (such as AI assistance, human-in-the-loop, training/test set details, expert ground truth, effect size, etc.) are not applicable to this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AIROS 6 Sequential Compression Device K172770 from the same manufacturer) through functional performance testing and adherence to relevant standards.

Here's an analysis based on the provided text, primarily addressing the "functional performance testing" section:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "functional performance testing" categories but does not provide specific numerical acceptance criteria or detailed reported performance values. It states: "Testing was performed and to ensure that the system meets its specifications." This implies that the device did meet its internal specifications, but these specs are not detailed in the public 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as the testing involves the physical device and garments, not a dataset in the context of AI/ML. The "test set" would be the manufactured devices and accompanying garments. The provenance would be the manufacturing site of AIROS Medical, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. "Ground truth" in this context refers to the device's functional specifications, which are established by the manufacturer through engineering design and regulatory requirements, not by external experts adjudicating data.

4. Adjudication Method for the Test Set

Not applicable. The testing appears to be functional and engineering validation, not consensus-based adjudication of interpretations of clinical data.

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 mechanical sequential compression device, not an AI-assisted diagnostic tool.

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

Not applicable. There is no AI algorithm in this device.

7. The Type of Ground Truth Used

The ground truth is the device's design specifications and functional requirements as established by the manufacturer and validated through engineering tests.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

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The AIROS 6 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

• · Lymphedema
• Venous stasis ulcers
• · Venous insufficiency
• · Peripheral edema

The device is safe for both home and hospital use.

The AIROS 6 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.

The AIROS 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.

The provided text is a 510(k) summary for the AIROS 6 Sequential Compression Device. This type of FDA submission is for demonstrating substantial equivalence to a predicate device, primarily through performance testing and adherence to standards, rather than clinical efficacy studies often associated with AI/ML-based devices.

Therefore, the document does not contain specific details regarding:

• Acceptance criteria and reported device performance related to a diagnostic or AI/ML-based task. The performance tests listed are functional and safety tests for a pneumatic compression device, not accuracy metrics for a diagnostic algorithm.
• Sample sizes for a test set or data provenance (e.g., country of origin, retrospective/prospective). The testing described is for engineering validation of the physical device.
• Number of experts and their qualifications for ground truth establishment. Ground truth as defined for diagnostic AI/ML models is not applicable here.
• Adjudication method for a test set. Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this device.
• Standalone (algorithm-only) performance. The device is a physical pneumatic compression system, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.). Not applicable.
• Sample size for the training set or how ground truth for the training set was established. This device does not involve machine learning or a "training set" in the context of AI.

Based on the provided text, here is what can be extracted regarding the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission:

The "acceptance criteria" in this context are the successful completion of various functional and safety performance tests, and compliance with recognized medical device standards, to demonstrate that the AIROS 6 Sequential Compression Device operates as intended and is safe. The "study" refers to the conducted functional performance testing.

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

The document lists "Functional Performance Testing" that was performed to "ensure that the system meets its specifications." While the specific numerical acceptance criteria (e.g., "pressure accuracy within +/- X mmHg") are not detailed, the implication is that the device met these criteria for each test.

Notes:

• The phrase "Testing was performed and to ensure that the system meets its specifications" and the conclusion "AIROS Medical, Inc., believes that the AIROS 6 is substantially equivalent to the predicate device" implicitly state that the device met the acceptance criteria for these tests. The specific quantitative results are not in this summary but would be in the more detailed submission.
• Additionally, compliance with the listed consensus standards (IEC 60601-1, ISO 10993, IEC 61000, ANSI/AAMI ES60601-1, CAN/CSA-C22.2 No. 60601-1) also represents a set of acceptance criteria regarding safety and essential performance.

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 510(k) summary. These details would typically be found in the full test reports submitted to the FDA, not in the public summary. For functional performance tests, a "sample size" often refers to the number of devices or components tested. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical device testing.

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 concept is not applicable to the testing described for this device. Ground truth in the context of diagnostic performance (e.g., image interpretation) is not relevant here. The "ground truth" for these functional tests would be the established engineering specifications and physical measurements.

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

• This concept is not applicable to the testing described for this device. Adjudication methods are used in diagnostic studies to resolve reader discrepancies.

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:

• No. This type of study is for evaluating AI-assisted diagnostic performance, which is not relevant to this pneumatic compression device.

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

• No. This device is a physical medical device, not an algorithm, so a "standalone" algorithmic performance evaluation is not applicable.

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

• This concept is not applicable in the context of this device's functional and safety testing. The "ground truth" for the performance characteristics (e.g., pressure output, cycle time) is based on engineering specifications and direct physical measurement calibrated against known standards.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

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