(111 days)
The Neurological Theray Devices - Accessories including Garment electrodes which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.
The Neurological Therapy Devices - Accessories -Conductive fiber(Model:Electrotherapy device Electrode for Knee, Electrotherapy device Electrode for Elbow, Electrotherapy device Electrotherapy device Electrode socks.Neurological physiotherapy devices-accessories), are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into Neurological Therapy Devices - Accessories garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves.
The Neurological Therapy Devices - Accessories-conductive silicone rubber(Model:Electrotherapy device Electrode belt for back of body, Electrotherapy device Electrode belt for Abdominal Muscle TrainerToning, Electrotherapy device Electrode belt for Body joints,Electrotherapy device Electrode belt for arm of body,Electrotherapy device Electrode belt for back of body,Electrotherapy device Electrode belt for shoulder of body,Neurological physiotherapy devices-accessories), is made of conductive silicone rubber coated in conductive garments material, has excellent conductive performance and good flexibility and plasticity, can adapt to the needs of different shapes and sizes of electrodes.
The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin.
The Neurological Therapy Devices - Accessories utilize conductive silicone rubber as a conduit for current transmission. When current passes through the garment electrodes, the conductive silicone rubber transmit the current to the surface of the body, thus enabling the transmission of current. The entire surface of the Neurological Therapy Devices - Accessories is very conductive having a resistance of less than 7 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these Neurological Therapy Devices - Accessories for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices).
The Neurological Therapy Devices - Accessories are non- sterile external devices which are designed for single patient, for multiple uses and are intended for Prescription Use and/or OTC use with FDA Cleared TENS and NMES class II devices.
The provided FDA 510(k) summary (K232995) describes the acceptance criteria and the study conducted to demonstrate that the Neurological Therapy Devices - Accessories meet these criteria.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material (Biocompatibility) | Compliant with ISO 10993-5:2009 (Cytotoxicity) | Compliant |
| Compliant with ISO 10993-23:2021 (Skin Sensitization) | Compliant | |
| Compliant with ISO 10993-10:2021 (Skin Irritation) | Compliant | |
| Electrical Performance | Resistivity less than 7 ohms per inch | Less than 7 ohms per inch (through multiple washings) |
| Uniform delivery of low doses of current to the skin | Achieved during bench testing | |
| Durability/Reusable | Maintain inherent conductivity with multiple washings | Bench testing confirmed no significant adverse effect on conductivity after multiple washings |
| Intended Use | To be used with legally marketed electrical stimulating devices (TENS/NMES) to deliver stimulation signals | The device is designed and demonstrated to work with such devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document explicitly states "No clinical testing was performed" (Section 8). Therefore, there isn't a "test set" in the context of human subjects or clinical data. The performance was evaluated through non-clinical bench testing. The sample sizes for the materials tested in biocompatibility and electrical performance bench tests are not specified in this summary.
- Data Provenance: The company is Shenzhen Roundwhale Technology Co., Ltd. in China. The testing would presumably have been conducted in China or by laboratories contracted by the company, adhering to international standards. The data is non-clinical (bench testing).
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)
Not applicable. As no clinical testing was performed, there was no "test set" requiring expert ground truth establishment in a clinical context. The performance was assessed against technical specifications and international standards in a laboratory setting.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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
Not applicable. This device is an accessory (an electrode) for electrotherapy devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. It is a physical accessory (electrode). The "standalone" performance refers to the device's electrical conductivity and biocompatibility, which were assessed via bench testing as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- International Standards: Specifically, ISO 10993 series for biocompatibility testing (ISO 10993-5, ISO 10993-10, ISO 10993-23).
- Technical Specifications: Defined electrical performance criteria (e.g., resistivity less than 7 ohms per inch).
- Comparison to Predicate Devices: Demonstrating similarity in design, materials, function, and performance to legally marketed devices.
8. The sample size for the training set
Not applicable. As this device is a physical cutaneous electrode and not an AI/machine learning model, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).