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The ActiveCare DVT and ActiveCare+SFT Systems are prescription devices that induce Continuous Enhanced Circulation Therapy of the lower limbs.

The Systems are intended for use in:

• Preventing Deep Vein Thrombosis (DVT).
• Enhancing blood circulation.
• Diminishing post-operative pain and swelling.
• Reducing wound-healing time.
• Treatment and assistance in healing: stasis dermatitis: venous stasis ulcers: arterial and diabetic leg ulcers.
• Treatment of chronic venous insufficiency.
• Reducing edema.

The ActiveCare DVT and ActiveCare+SFT Systems are prescription, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the ActiveCare DVT and ActiveCare+SFT Systems provide the user with several treatment options: compression of the foot - single or double, compression of the call - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve, The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.

The provided text describes a 510(k) submission for minor modifications to the ActiveCare DVT and ActiveCare+SFT Systems. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size for a "test set" in the context of clinical or performance data for the modified device. The testing described focuses on demonstrating that the modifications themselves do not raise new safety or efficacy concerns, rather than re-proving the device's original clinical effectiveness.

The document indicates "field testing" was performed, but no details on sample size, data provenance (country of origin, retrospective/prospective), or type of data are provided.

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

Not applicable. This submission is for modifications to an existing device, and the testing described does not involve establishing ground truth for a diagnostic or predictive algorithm. There's no mention of experts being used in this capacity.

4. Adjudication method for the test set

Not applicable. As noted above, this type of testing is not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. The submission focuses on demonstrating the safety and equivalence of minor hardware and software modifications.

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

Not applicable. The device is a pneumatic compression system, not an AI or algorithm-based diagnostic tool. The "software updates" mentioned are likely related to the control unit's operational logic, not a standalone diagnostic algorithm.

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

Not applicable. The testing described involves performance, electrical safety, risk analysis, and software validation for the device's functionality, not a diagnostic accuracy assessment against a ground truth.

8. The sample size for the training set

Not applicable. This document pertains to modifications of an existing physical medical device, not a machine learning model that would require a training set.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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Amadeus Adaptive Compression Therapy provides optimized graduated compression in both sustained and intermittent settings for use in::

• Enhancing venous return
• Reducing venous leg ulcer healing time
• Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
  OR
• Treatment of chronic venous insufficiency
• Reducing edema due to venous stasis

AMADEUS Adaptive Compression Therapy has been designed to provide accurate, continuously monitored levels of graduated compression to the foot, ankle and leg.
AMADEUS Adaptive Compression Therapy consists of 4 main parts:

• . The compression sleeve consists of 4 chambers that inflate with air to apply compression to the foot, ankle and leg. Its simple wrap-around design with hook and loop fasteners means the compression sleeve can be fitted to many different shaped legs and can be applied and removed with ease.
• The control unit is a small, compact and portable device that fits into the compression sleeve . making the system ideal for ambulant use. The control unit continuously measures and precisely adjusts the delivery of pneumatic sustained graduated compression and intermittent pneumatic compression according to the physical status of the lower limb.
• The sock is designed to absorb perspiration and moisture away from the skin and has . additional padding in key areas to provide additional comfort. The sock also aids in the support and positioning of the compression sleeve.
• . The AC/DC power adaptor/charger is used to power the device directly (in IPC mode) and to recharge the control unit for ambulant use.
  The device has 2 modes of operation: Sustained Compression mode and Intermittent Pneumatic Compression (IPC) mode. Sustained compression mode enables the control unit to provide accurate and continuously monitored compression levels to the lower limb. Intermittent Pneumatic Compression mode enables a programmed sequence of cyclical pressures to be applied to the lower limb.
  AMADEUS Adaptive Compression Therapy features a compliance monitoring feature. An LCD screen is present on the control unit which displays the number of hours the device has been operational in both Sustained and IPC modes.

The provided text describes a 510(k) submission for the "AMADEUS Adaptive Compression Therapy" device. A 510k submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing acceptance criteria and proving performance through a detailed study in the same way a PMA (Premarket Approval) submission would for a novel device.

Based on the provided text, the following information can be extracted:

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

The document states: "No comparative testing has been performed with either the AMADEUS Adaptive Compression Therapy, Wiz-Air® DVT, Extremity Pump® 7500 or Model SC-3008 Sequential Circulator (as per 807.92(b)(1), (2) & (3)). AMADEUS Adaptive Compression Therapy is substantially equivalent to predicate devices and exempt traditional compression devices in terms of intended use, modes of operation and performance characteristics."

This indicates that specific quantitative 'acceptance criteria' in terms of performance metrics for the AMADEUS device, and corresponding 'reported device performance' against those criteria, are not explicitly defined or presented in a table in this submission. The core "acceptance" for this 510(k) is the demonstration of substantial equivalence to predicate devices, meaning its performance characteristics are deemed similar enough to currently marketed, legally cleared devices.

The text does mention: "A series of laboratory based tests and clinical investigations, with healthy volunteers and subjects with venous insufficiency, were performed with the AMADEUS Adaptive Compression Therapy to demonstrate that there were no safety concerns." However, details of these tests, specific acceptance criteria for safety outcomes, or quantitative performance results from these investigations are not provided in the given excerpt.

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

The text mentions "clinical investigations, with healthy volunteers and subjects with venous insufficiency," but does not specify the sample size for these investigations. It also does not state the country of origin of the data or whether the studies were retrospective or prospective.

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 provided in the document. The device is a "Compressible limb sleeve," and the nature of its function likely relies on physiological measurements rather than expert image interpretation.

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

This information is not provided.

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 is not applicable (N/A). The AMADEUS device is a physical therapeutic device (a compressible limb sleeve), not an AI-powered diagnostic tool, and therefore human reader performance/improvement with AI assistance is not relevant. The document explicitly states: "No comparative testing has been performed with either the AMADEUS Adaptive Compression Therapy, Wiz-Air® DVT, Extremity Pump® 7500 or Model SC-3008 Sequential Circulator".

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

This is not applicable (N/A). The AMADEUS device is a physical therapeutic device, not an algorithm. Its operation is "standalone" in the sense that it performs its function independently once activated, but there's no "algorithm only" performance to evaluate in the context of diagnostic AI.

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

The document mentions "clinical investigations, with healthy volunteers and subjects with venous insufficiency," conducted "to demonstrate that there were no safety concerns." The "ground truth" here would likely refer to established physiological measurements of venous return, edema reduction, or absence of adverse events, assessed using standard clinical methods. Specific details of what constituted "ground truth" (e.g., specific measurement techniques, pathology results for venous ulcers, etc.) are not provided.

8. The sample size for the training set:

This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of typical AI development. Therefore, no sample size for a training set is provided.

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

As above, this is not applicable (N/A) as the device is not an AI/machine learning algorithm.

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