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The CTU676 is a prescriptive device that includes continuous enhanced circulation therapy of the lower limbs. The CTU676 is intended for use in the following:

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

The CTU676 devices are used for different forms of compression therapy. The system is an air inflatable garment that is controlled by an electrical air pump. The air pump controls the garment so chambers inflate and deflate sequentially over a period of ~ 85 seconds. Patient or staff operated controls with visual and / or audible alarms for low pressure, high pressure, low battery, and system failures. The controls use a power on/off switch on the side of the unit. On the front of the unit are fault indicators. The preset to 52 mmHg. The power on light will flash and stay illuminated when the unit is operating. The charging light will illuminate when batteries are charging.

The provided text focuses on regulatory approval (510(k) summary) for the CTU676 device. It describes the device, its intended use, and states that substantial equivalence was found based on non-clinical design verification and validation tests. However, the document does not contain the specific details required to answer most of your questions about acceptance criteria and a study proving those criteria are met.

Here is what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document only mentions "bench testing and validation that was performed on healthy volunteers" for the new cuff, but no specific number of volunteers is given.
• Data Provenance: The document states "bench testing and validation that was performed on healthy volunteers" for the new cuff. This suggests prospective human data (from healthy volunteers), likely from the manufacturing country (USA, assumed given the FDA submission). However, for the general mechanical performance evaluations and simulated use tests, the provenance of data is not specified beyond "non-clinical design verification and validation tests."

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

• Not Applicable. The described testing largely pertains to engineering and safety performance, not diagnostic accuracy requiring expert interpretation.

4. Adjudication method for the test set

• Not Applicable. As the tests described are primarily engineering and safety evaluations, not diagnostic interpretation, adjudication methods like 2+1 or 3+1 are not relevant.

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. The CTU676 is a physical medical device (compressible limb sleeve and pump), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI is not relevant to this device.

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

• Not Applicable. See point 5. This device is not an algorithm. The "standalone" performance tested would refer to the device's mechanical and electrical functions independently, which is implied by the "mechanical performance evaluations and simulated use tests."

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

• The "ground truth" for the device's performance was established against defined design specifications, safety standards, and functional requirements. For example, pressure profiles were compared to a predicate device (Wiz Air System). For the "healthy volunteers" testing, the ground truth would likely be physiological measurements (e.g., actual pressure exerted, blood flow changes validated by other means) to confirm the device's intended mechanical action.

8. The sample size for the training set

• Not Applicable. This device is hardware with an embedded microprocessor for control, not a machine learning model that requires a "training set" in the conventional AI sense.

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

• Not Applicable. See point 8.

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