Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)

• K Number: K242332
• Device Name: Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
• Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.
• Date Cleared: 2024-11-05 ( 90 days)
• Product Code: NUH , NYN
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with osteoarthritis.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for Transcutaneous Electronic Nerve Stimulators. It discusses:

• The FDA's review and determination of substantial equivalence for the listed devices.
• Regulatory aspects such as general controls, special controls, quality system regulations, UDI rules, and adverse event reporting.
• Contact information for FDA resources.
• Crucially, it includes the "Indications for Use" for the devices.

There is no mention of:

• Specific performance metrics or acceptance criteria for the TENS device's functionality (e.g., electrical output, consistency, safety).
• Any studies involving test sets, training sets, ground truth establishment, expert readers, or multi-reader multi-case (MRMC) studies. These types of studies are typically associated with AI/ML-enabled devices, diagnostic imaging devices, or devices requiring clinical performance evaluation beyond basic safety and electrical parameters.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC studies or effect sizes for human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

Regulation Number and Section

§ 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).