(267 days)
Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.
Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery. When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2. The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket. The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state. The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked. The modification key "3A" and "3B" are for intensity level adjustment during stimulation. The outlet socket is used to connect skin electrodes by lead wires. The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11).
The provided document is a 510(k) summary for the Jiajian® TENS device and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.
However, based on the information provided, here's what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., pain reduction scores, patient satisfaction). Instead, it focuses on demonstrating technical equivalence and compliance with safety standards as a basis for being "substantially equivalent" to a predicate device.
The table below summarizes the comparison of technical specifications between the new device and the predicate device. While not acceptance criteria in the sense of clinical study endpoints, these indicate the technical specifications that the new device meets and how they compare to the predicate.
| Parameter | Acceptance Criteria (from predicate) | Reported Device Performance (Jiajian® TENS) |
|---|---|---|
| Functional/Safety Characteristics | ||
| Intended Use | For symptomatic relief and management of chronic intractable pain, adjunctive treatment in the management of post surgical and post traumatic pain | For symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain. |
| Power Source | 9V Battery type 6F22 | 9V Battery type 6F22 |
| Average DC current through electrodes (no pulses) |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).