Search Results

TENS function of the device is indicated for the following use: Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain NMES function of the device is indicated for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

Device Description

The OGYILI TENS/NMES Stimulator E01 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The OGYILI TENS/NMES Stimulator is a programmable device that come equipped with 14 preset programs along with 14 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The OGYILI TENS/NMES Stimulator is programmed to default to program P- 14 which contains the most common setting. The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs. The OGYILI TENS/NMES Stimulator has the following specifications: There is pulse mode with a bi-phase rectangular pulse frequency is 2Hz to 150Hz, the pulse width is 100-200 us. The power supply is DC 3.7-volt lithium battery. OGYILI TENS/NMES Stimulator package is comprised of the following items: - One TENS/NMES unit powered by DC 3.7-volt lithium battery ● - Two UL industry standard wires for electrodes conforming to FDA standards, ● - Four standard commercially available round 100 (mm) self adhesive electrodes. - One UL 110 battery rechargeable unit - Instruction manual. ● - Quick start instruction manual. ● - . Full package carrying case. The device has physical dimensions of 92 x 60 x 18 mm, and weighs 90 grams with battery.

AI/ML Overview

The provided document describes the OGYILI TENS/NMES Stimulator and its substantial equivalence to predicate devices, rather than an acceptance criteria study for a novel device. Therefore, the information requested regarding a new device's acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set, and ground truth establishment is not present in this document.

However, I can extract the performance standards and compliance for the OGYILI TENS/NMES Stimulator, which serve as evidence that the device meets certain technical acceptance criteria. These are derived from comparisons to legally marketed predicate devices.

Here's the relevant information based on the provided text, structured to best fit your request:

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

For the OGYILI TENS/NMES Stimulator, the "acceptance criteria" appear to be compliance with relevant IEC and ISO standards and having performance characteristics that are "similar" or "within the range covered by the predicate device." The reported device performance is its demonstrated compliance with these standards and its measured output parameters.

Acceptance Criteria (Standard Compliance & Performance Similarity to Predicate)	Reported Device Performance (OGYILI TENS/NMES Stimulator)	Remarks (Comparison to Predicate)
Biocompatibility: Complies with ISO 10993-1	Biocompatible per ISO 10993-1	Substantially Equivalent (SE)
Electrical Safety: Complies with IEC 60601-1	Tested to demonstrate compliance with IEC 60601-1	SE
Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2	Tested to demonstrate compliance with IEC 60601-1-2	SE
Performance Standards (Nerve and Muscle Stimulators): Complies with IEC 60601-2-10	Tested to demonstrate compliance with IEC 60601-2-10	SE
Usability Standards: Complies with IEC 60601-1-6	(Mentioned as a standard conformed to, but no specific test results on usability presented)	Not explicitly compared in Table 5.4, but listed as conformed to.
Biological Evaluation: Complies with ISO 10993-1	(Mentioned as a standard conformed to, and in Table 5.4)	SE
Output Pulse Shape: Rectangular, similar to predicate devices	Rectangular	SE
Maximum Output Voltage: Within range of predicate devices	17-20v +/-20%@ 500kΩ
48-60v +/-20%@ 2KΩ
95-125v +/-20%@ 10KΩ	SE (output parameters are either within range or in close proximity to predicate devices)
Maximum Output Current: Within range of predicate devices	36-40mA +/-20%@ 500Ω
24-30mA +/-20%@ 2KΩ
9-12.5mA +/-20%@ 10KΩ	SE (output parameters are either within range or in close proximity to predicate devices)
Pulse Duration: Within range of predicate devices	100-200 μS @ 500Ω	SE (within range or in close proximity to predicate devices)
Frequency: Within range of predicate devices	2-150 Hz	SE (within range or in close proximity to predicate devices)
Net Charge per Pulse: Within range of predicate devices	12-21 [μC] @ 500Ω	SE (within range or in close proximity to predicate devices)
Maximum Phase Charge: Within range of predicate devices	12-21 [μC] @ 500Ω	SE (within range or in close proximity to predicate devices)
Maximum Current Density: Within range of predicate devices	0.16-0.54mA/cm2@500Ω	SE (within range or in close proximity to predicate devices)
Maximum Average Power Density: Within range of predicate devices	0.0002-0.0026mA/cm2@500Ω	SE (within range or in close proximity to predicate devices)
Burst Mode: Functional parameters within range of predicate devices	Pulses per Burst: 9
Bursts per Second: 2
Burst duration: 175 μs – 5s
ON Time: 5-8 seconds
OFF time: 5-12 seconds	SE (functional parameters within range or in close proximity to predicate devices)
Average DC current through electrodes (device on, no pulses): User pure AC, no DC current used	User pure AC, No DC current used	SE
Method of current isolation: Individually isolated circuits, and transistors	Individually isolated circuits, and transistors	SE
Regulated Output: Regulated Voltage (similar to one predicate)	Regulated Voltage	SE

2. Sample size used for the test set and the data provenance
The document does not detail a "test set" in the context of human data or AI evaluation. The study described is a device comparison and performance testing against standards. The performance testing involves bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is not an AI/clinical performance study requiring expert ground truth for interpretation.

4. Adjudication method for the test set
Not applicable. The study is not an AI/clinical performance study 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 is not an AI-assisted diagnostic device; it is a TENS/NMES stimulator.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm for diagnostic or assistive performance in the way described. The "performance testing" referenced is for the device's electrical and mechanical output according to industry standards.

7. The type of ground truth used
The "ground truth" for this device's performance is established by compliance with recognized international standards (IEC, ISO) and the measured physical and electrical output characteristics which are then compared to legally marketed predicate devices.

8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

9. How the ground truth for the training set was established
Not applicable. No training set is involved.

Ask a Question

Ask a specific question about this device

Page 1 of 1