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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 to increase lymphatic flow in the treatment of many conditions such as:

• · Lymphedema
• · Primary lymphedema
• Post mastectomy edema
• · Edema following trauma and sports injuries
• · Post immobilization edema
• · Venous insufficiency
• · Reducing wound healing time
• · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
• · Lipedema
• Phlebolymphedema

The Dayspring system consists of two main components: a controller and garment is powered by an active smart compression technology that is calibrated, instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Tì) shape-memory alloy the controller. A liner or lite weight clothing is worn under the garment 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 independently controlled sections in each limb. The controller can be programmed to provide graduated 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.

The Koya Medical Dayspring system is a prescription-only wearable compression system. The provided text describes the regulatory filing and testing performed for this device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided input:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance related to its therapeutic indications (e.g., specific reductions in lymphedema volume). Instead, the performance evaluations focus on safety, functionality, and manufacturing quality. The reported performance confirms compliance with established standards and successful benchtop testing.

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

The document mentions benchtop performance tests, which typically do not involve human subjects as a "test set" in the clinical sense. Instead, the "samples" are the device units or components themselves. No specific sample sizes for these benchtop tests are provided in the summary.

• Provenance: This is not applicable in the context of benchtop testing as described.

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

This information is not provided as the testing described is primarily technical and regulatory compliance-focused, rather than involving expert assessment of diagnostic accuracy or treatment efficacy against a "ground truth" derived from expert consensus.

4. Adjudication method for the test set:

This is not applicable as the described testing does not involve subjective human interpretation or a need for adjudication methods like 2+1 or 3+1. The tests are objective measurements against defined standards.

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:

This is not applicable. The device (Dayspring) is a compression system for various lymphedema-related conditions, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this device description.

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

This is not applicable. The Dayspring device is a physical medical device (a compressible limb sleeve with a controller), not an algorithm or AI system for standalone performance evaluation in the described context.

7. The type of ground truth used:

For the performance data provided:

• Benchtop Tests (Biocompatibility, Shelf-life, Electrical Safety, EMC, Packaging, Pressure Verification): The "ground truth" is defined by international and national standards (e.g., ISO 10993 series, IEC 60601 series, ASTM D4169) and the device's own design specifications (e.g., delivering 0-100 mmHg pressure). These are objective, measurable criteria.
• Software Verification and Validation: The "ground truth" is established by software design specifications, requirements, and compliance with standards such as IEC 62304:2015 and relevant FDA guidance documents for software in medical devices.

8. The sample size for the training set:

This is not applicable. The description focuses on regulatory submission and direct performance testing of a physical device. There is no mention of a "training set" in the context of machine learning or AI.

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

This is not applicable for the same reasons as #8.

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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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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 to increase lymphatic flow in the treatment of many conditions such as:

• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports injuries
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
• Lipedema
• Phlebolymphedema

The Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

The Dayspring system consists of two main components: a controller and garment. The garment is powered by an active smart compression technology that is calibrated, instantacting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by the controller. A liner is worn as an accessory under the device to prevent direct patient contact with the garment. 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 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.

The Koya Dayspring is a wearable compression system intended for use in clinic or home settings by medical professionals and patients under medical supervision to increase lymphatic flow in the treatment of various conditions.

Here's an overview of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The provided document does not indicate the use of a "test set" in the context of a clinical study with patients or data. The performance evaluations were primarily based on benchtop testing and assessments of compliance with recognized standards. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) for patient data is not applicable here.

3. Number of Experts and Qualifications for Ground Truth

No experts were explicitly mentioned for establishing ground truth in a clinical or patient data context, as the evaluation was based on benchtop performance testing and compliance with technical standards.

4. Adjudication Method

As there was no clinical study employing human readers or interpretation of medical images/data, an adjudication method (such as 2+1, 3+1) is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported. The submission focuses on device performance through benchtop testing and regulatory compliance, not comparative effectiveness with or without AI assistance for human readers.

6. Standalone (Algorithm Only) Performance

The device is a physical wearable compression system, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The system includes embedded firmware with the ability to connect to a mobile application, but its performance evaluation is centered on the physical device's functions and safety, not an AI algorithm's standalone diagnostic or interpretive capabilities.

7. Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

• Compliance with recognized industry standards: e.g., ISO, IEC, ASTM standards for biocompatibility, electrical safety, EMC, software, and mechanical testing.
• Benchtop performance measurements: such as pressure verification, demonstrating the device's ability to deliver specified compression ranges.

8. Sample Size for Training Set

The document does not describe a "training set" in the context of machine learning or AI development, as the device is a physical medical device. Software verification and validation were performed, but details of datasets used for training (if any, related to specific software functionalities) are not provided.

9. How Ground Truth for Training Set was Established

Given that the document does not discuss a "training set" for an AI or machine learning model, information on how its ground truth was established is not applicable.

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