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The Koya Dayspring system 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:

• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports injuries
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
  The Koya Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

The Koya Dayspring™ system is powered by an active smart compression technology that is calibrated, instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by a controller system. A disposable stockinette is worn as an accessory under the device to prevent direct patient contact with the device is wrapped around the patient's arm so that the device fits snugly. The device has up to 16 independently controlled sections in each arm. The controller can be programmed to provide sequential compression therapy to the affected area over a range of 0-100 mmHg. 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 while treating chronic lymphedema.

The Koya Dayspring is a wearable compression system intended for lymphedema and related conditions. The FDA determined it to be substantially equivalent to the Flexitouch Plus System.

No specific acceptance criteria related to a study of device performance for diagnostic use (like sensitivity, specificity, accuracy) are mentioned in this document. The provided information focuses on engineering and regulatory testing to ensure device safety and functional equivalence to a predicate device, rather than a clinical performance study with defined acceptance criteria for diagnostic efficacy.

Here's a breakdown of the studies conducted, as per the provided text, and how they contribute to demonstrating the device's acceptability:

1. A table of acceptance criteria and the reported device performance

As stated above, this document does not present clinical performance data against acceptance criteria for diagnostic outputs. Instead, it describes engineering and safety testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document primarily describes benchtop engineering and safety tests, not clinical studies involving patient data.
• For biocompatibility, electrical safety, software V&V, and mechanical testing, the "sample size" would refer to the number of devices or components tested. This specific number is not provided in the summary.
• Data provenance is not specified, but these are typically prospective engineering tests conducted in a lab setting rather than clinical data from a specific country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable as no "ground truth" for diagnostic purposes or clinical interpretation by experts was established in the context of this submission. The tests performed are objective engineering measures (e.g., pressure output, electrical safety, material biocompatibility).

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

• This is not applicable as there was no expert review or adjudication of a test set for diagnostic performance.

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

• A MRMC comparative effectiveness study was not done. This device is a therapeutic compression system, not an AI-assisted diagnostic tool for human readers.

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

• This is not applicable as the Koya Dayspring is a physical medical device delivering compression therapy, not an algorithm, and its performance is assessed directly through its physical output and safety features.

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

• For the engineering and safety tests, the "ground truth" is defined by established engineering standards, biocompatibility requirements, and direct physical measurements (e.g., actual pressure output compared to expected output, current leakage within limits, material cytotoxicity results). There is no "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense for these types of tests.

8. The sample size for the training set

• This is not applicable. The Koya Dayspring is not an AI/ML device that requires a training set of data for an algorithm.

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

• This is not applicable as there is no training set for this device.

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