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The CircuFlow 5208 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema
  The device is intended for home and hospital use.

The CircuFlow 5208 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5208 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, 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 each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.

The provided document describes a 510(k) summary for the CircuFlow 5208 Sequential Compression Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria related to a disease outcome. Therefore, the information provided primarily pertains to performance testing designed to ensure the device operates according to its specifications and is safe, rather than a study proving clinical effectiveness against defined acceptance criteria for a medical outcome.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not explicitly state quantitative acceptance criteria or their corresponding reported device performance values. The general statement is that "Bench and laboratory testing was performed and assures that the product meets its specifications."

• Leakage Current Test: Performed. (Implicitly met standards, but no data provided.) |
  | Pressure Control | - Pressure Calibration for Pressure Sensor: Performed. (Implicitly met specifications, but no data provided.)
• Pressure Gradient Performance: Performed. (Implicitly met specifications, but no data provided.) |
  | Timing Accuracy | - Inflation & Deflation Time Performance: Performed. (Implicitly met specifications, but no data provided.)
• Treatment Time Performance: Performed. (Implicitly met specifications, but no data provided.) |
  | Biocompatibility | - ISO 10993-5 (in vitro cytotoxicity): Conforms to standard.
• ISO 10993-10 (irritation and delayed-type hypersensitivity): Conforms to standard. |
  | Risk Management | - ISO 14971 (risk management): Conforms to standard. |
  | General Safety & Performance | - IEC 60601-1 / AAMI ES 60601-1 (general requirements for basic safety and essential performance): Conforms to standards. |
  | Electromagnetic Compatibility | - IEC 60601-1-2 (collateral standard for EMC): Conforms to standard. |

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

The document describes bench and laboratory testing, not a clinical study on human subjects. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) and sample size for human subjects does not apply. The tests mentioned are likely conducted on a limited number of device units in a controlled lab environment.

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

This question is not applicable as the testing described is technical product performance testing, not a study requiring expert clinical ground truth assessment on a test set.

4. Adjudication Method for the Test Set:

Not applicable, as this was not a clinical study requiring human adjudications.

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 is a medical device, not an AI diagnostic or assistive tool, and no MRMC study was conducted or referenced.

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

Not applicable. This is a physical medical device, not an algorithm. The device operates independently according to its programmed functions.

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

For the performance testing, the "ground truth" would be established engineering and safety standards (e.g., IEC 60601-1, ISO 10993) and the device's own internal design specifications. The tests verify that the device's performance aligns with these predefined technical requirements.

8. The sample size for the training set:

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not described here.

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

Not applicable, as there is no training set mentioned for this device.

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