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The CircuFlow 5200 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 5200 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5200 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 text describes a 510(k) premarket notification for the CircuFlow 5200 Sequential Compression Device. This submission focuses on establishing substantial equivalence to existing predicate devices through bench and laboratory testing. It does not present a clinical study or performance data in the way typically seen for AI/ML-driven medical devices.

Therefore, many of the requested categories for AI/ML study details (e.g., sample size for test sets, expert consensus, MRMC studies, ground truth for training data) are not applicable to this submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission defines "Performance Testing" as a set of bench and laboratory tests to assure the product meets its specifications and is substantially similar to predicate devices. Specific acceptance criteria values are not explicitly stated in the provided text, nor are specific quantitative performance results for each test. The document generally states that "Bench and laboratory testing was performed and assures that the product meets its specifications."

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

• Sample Size for Test Set: Not applicable. This was bench and laboratory testing, not a clinical study with patient data.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. Ground truth for clinical cases was not established as this was not a clinical study.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.

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

• MRMC Study: No. This device is a sequential compression device, not an AI/ML diagnostic or assistive tool for human readers.

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

• Standalone Performance: Not applicable. This device is a physical medical device (pneumatic compression) and does not involve an AI algorithm with standalone performance metrics.

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

• Type of Ground Truth: For the "Performance Testing" section, the "ground truth" would be the engineering specifications and recognized electrical/mechanical safety standards (e.g., IEC 60601-1-1, IEC 60601-1-2, UL 60601-1). The device's performance was measured against these predefined engineering and safety requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning, therefore, there is no "training set."

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

• Ground Truth for Training Set: Not applicable.

Summary Explanation:

The K101523 submission for the CircuFlow 5200 is a 510(k) premarket notification for a physical medical device. The focus is on demonstrating substantial equivalence to already legally marketed predicate devices, primarily through bench and laboratory performance testing against engineering specifications and relevant safety standards. It is not an AI/ML device submission, and therefore, the structured questions regarding clinical studies, data provenance, expert labeling, and AI performance metrics are not relevant to this document. The "study" proving the device meets acceptance criteria consists of the listed "Performance Tests" performed in a "bench and laboratory" setting, ensuring the device functions according to its design specifications and electrical safety standards.

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