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Dayspring Lite is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision, for the following conditions:

• Chronic edema
• Lymphedema
• Venous insufficiency
• Wound healing
  Dayspring Lite is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

Dayspring Lite consists of two main components: a controller and garment. The garment is powered by an active smart compression technology that is instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Tì) shape-memory alloy that is activated by the controller. A liner is worn as an accessory under the device to prevent direct patient contact with the garment is wrapped around the patient's affected area so that the device fits snugly. The device has up to 14 independently controlled sections in each limb. The controller is pre-programmed to provide sequential compression therapy to the affected area. The device is powered by a rechargeable Lithium-ion battery pack. The device was developed to provide patients with untethered access and a functional range of motion and mobility.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA regarding the Koya Medical, Inc. Dayspring Lite device. This document primarily details the regulatory review process, device description, comparison to predicate devices, and various performance testing conducted to ensure substantial equivalence for a medical device. It does not describe a study involving an AI algorithm or its performance parameters in a diagnostic or clinical decision support context.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving an AI device meets those criteria, as the provided text pertains to a compression system and does not mention any AI components or performance studies typical of AI/ML-enabled medical devices.

The sections you've asked for (such as ground truth, expert consensus, MRMC studies, effect size of AI assistance, standalone algorithm performance, training set details) are characteristic of studies conducted for AI/ML medical devices, which are not present in this document.

In summary, the provided document does not contain the information required to answer your prompt because it is not about an AI-powered device or a study involving AI performance.

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