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The Powerpress Unit Sequential Circulator is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.

Powerpress Unit is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components: Pneumatic Manual Pump and Limb Sleeve or garment composes of 4 chambers. Powerpress Unit enables different treatment pressure (30 ~ 100mmHg). Treatment pressure and time should be used according to physician prescription. When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable - pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chamber 2, 3 & 4 are individually lowered according to the default factory setting. Gradient: appx 7%, example: Foot 60mmHg - Ankle 56mmHg - Calf 52mmHg -Thigh 48mmHg Cycle Time: Inflation 36 sec / Deflation 24 sec Inflation time each chamber : 1st chamber(foot) - 36 sec, 2nd chamber(ankle) - 27 sec, 3rd chamber - 18 sec, 4th chamber(thigh) - 9 sec. A calibrated dial gauge displays pressure in the range of 0 ~ 160 mmHg.

The provided text describes the 510(k) summary for the Powerpress Unit Sequential Circulator, which is a medical device intended for pneumatic compression therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "Bench testing and side by side comparisons were done with predicate devices to assure equivalence in performance." However, it does not explicitly list quantitative acceptance criteria for attributes like pressure accuracy, inflation/deflation timings, or gradient percentages, nor does it provide detailed performance results against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The reported performance characteristics of the Powerpress Unit are:

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

The document does not specify any sample sizes for a test set. It mentions "bench testing and side by side comparisons," but details on the number of devices tested, the number of cycles performed, or any specific test parameters are absent. The concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a clinical study involving patient data.

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

This information is not provided. The assessment appears to be a technical comparison, not one requiring expert human interpretation of medical data.

4. Adjudication Method for the Test Set:

An "adjudication method" is not applicable here as there is no mention of a test set requiring expert review or consensus for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. Without AI Assistance:

An MRMC study was not done. The device is a pneumatic compression unit, not an AI-assisted diagnostic or therapeutic tool with human-in-the-loop performance. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant to this device.

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

The device is not an algorithm or AI system. It's a mechanical and pneumatic device. Therefore, the concept of "standalone performance" in this context is not applicable in the way it's typically understood for AI/algorithm-based devices. Its performance is assessed as a standalone physical product.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance assessment appears to be based on direct physical measurements and observation of its operational characteristics (e.g., pressure output, timing) compared to the known characteristics of the predicate device. It's essentially a comparison against established functional standards of similar devices, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable as this is not a machine learning or AI device.

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

This question is not applicable for the same reason as point 8.

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