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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS and Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.
TENS and Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. AS8012 has 20 operation programs and AS8015 has 24 operation programs.
The electronic stimulatory module has the operating elements of an On/Off Switch, LCD display screen, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging,etc.
The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity,etc.
The device is equipped with accessories of electrode pads, electrode cables a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charge and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.

The provided text is a 510(k) summary for a TENS and Muscle Stimulator device. It details the device's technical specifications and compares them to two predicate devices to demonstrate substantial equivalence, rather than providing a study proving a device meets specific acceptance criteria.

As such, the document does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the way typically required for AI/ML-based medical devices or diagnostic devices that require performance evaluation against clinical ground truth.

The provided text focuses on electrical safety and performance standards for a TENS and Muscle Stimulator, which are typically assessed through bench testing, not clinical studies with "acceptance criteria" related to diagnostic accuracy, sensitivity, specificity, etc., or human reader improvement with AI assistance.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This document lists technical specifications and compliance with electrical safety standards, not diagnostic performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable here, as it's not a performance study on a test set of patient data.
3. Number of experts used to establish the ground truth and qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study or effect size: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (not an AI/ML device in the context of this document).
9. How the ground truth for the training set was established: Not applicable.

What the document does provide in terms of "acceptance":

The document demonstrates that the new device meets electrical safety and performance standards the FDA considers essential for this type of device to be "substantially equivalent" to legally marketed predicate devices. The "acceptance criteria" in this context are primarily the successful completion of tests according to the following voluntary standards:

• ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD): General safety requirements.
• IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators: Specific safety and performance requirements for nerve and muscle stimulators.
• ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests: Requirements for electromagnetic compatibility.
• IEC 62133-2 Edition1.0 2017-02 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems: Battery safety.
• IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment: Requirements for home healthcare use.

The statement "The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform its intended tasks as well as the legally marketed predicate devices." serves as the proof of compliance with these "acceptance criteria" (i.e., meeting the requirements of the cited standards).

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Transcutaneous Electrical Nerve Stimulation (TENS): To be used 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. Powered Muscle Stimulation (PMS): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

This is a K143268 510(k) premarket notification for a TENS and Powered Muscle Stimulator device. It is a clearance letter from the FDA, not a study report. Therefore, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

• Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means it has similar therapeutic effects and is as safe and effective as other legally marketed devices.
• Regulatory Classification: The device is classified as Class II, under regulation 21 CFR 890.5850 for Powered Muscle Stimulator, with product codes NGX and NUH.
• General Controls: The letter advises the manufacturer to comply with general controls provisions of the Act, including registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use: It specifies the intended uses for the TENS function (temporary relief of pain in various body parts due to strain) and the Powered Muscle Stimulation function (to stimulate healthy muscles to improve and facilitate muscle performance).
• Type of Use: It is intended for Over-The-Counter Use.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text. The FDA clearance letter confirms regulatory approval based on demonstrating substantial equivalence to existing devices, rather than presenting a detailed performance study with acceptance criteria.

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