(29 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 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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Compliant with ISO 10993-1, ISO 10993-5, and ISO 10993-10 |
| Sterilization & Shelf-life | Non-sterile. Accelerated 1-year shelf-life met. |
| Electrical Safety | Compliant with IEC 60601-1:2012 |
| EMC | Compliant with IEC 60601-1-2:2014 |
| Software Verification/Validation | Compliant with IEC 62304:2015 and FDA Guidance Documents |
| Transportation Simulation | ASTM D4169 - Completed / Pass |
| Pressure Verification | Capable of delivering 0-100 mmHg compression pressures - Completed / Pass |
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.
§ 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).