(443 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility of patient-contacting materials | Compliant to ISO 10993-1, ISO 10993-5, and ISO 10993-10. |
| Shelf stability / Non-deterioration of components over time | Accelerated shelf-life testing performed and supports shelf stability. |
| Electrical safety and electromagnetic compatibility (EMC) | Compliant to IEC 60601-1:2012, IEC 60601-1-11:2015, and IEC 60601-1-2:2014. |
| Software quality and safety (for embedded firmware and mobile app) | Software lifecycle planning, documentation, and verification testing performed per IEC 62304:2015 and FDA guidance documents. Moderate level of concern addressed. |
| Robustness of packaging and transportation | ASTM D4169 completed and passed. |
| Pressure delivery capability (0-100 mmHg) | Pressure Verification Testing completed and passed, capable of delivering 0-100 mmHg. |
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.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).