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The WHF-314 (POWER Q1000) device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema

WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration, pressure, cycle time and gradient setting Power unit features visual operation status and fault indicators

The provided 510(k) summary for the WONJIN MULSAN Co., Ltd. WHF-314 (POWER Q1000) device does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a submission for substantial equivalence to a predicate device, focusing on regulatory information, intended use, device description, and a comparison with the predicate. There is no mention of a performance study, clinical trial, or any data presented to establish device performance against predefined acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document primarily focuses on establishing substantial equivalence based on the device's design, intended use, and comparison to existing devices, rather than presenting new performance data. The section "Performance Characteristics (If/when applicable)" explicitly states "See the Exhibits," but these exhibits are not included in the provided text.

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