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1) TENS
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "3 in 1 TENS UNIT" (K251187) does not contain any information about acceptance criteria or the specifics of a study proving the device meets those criteria, particularly not for an AI/ML medical device.

The document is a standard FDA clearance letter for a Class II medical device (Transcutaneous Electrical Nerve Stimulator For Pain Relief). It primarily covers:

• Device Identification: Trade name, regulation number, product code.
• Regulatory Status: Declaration of substantial equivalence to a predicate device.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
• Additional Controls: Notes potential for special controls for Class II devices and references regulations like the Quality System (QS) regulation.
• Compliance: Reminds the applicant of various other FDA regulations (e.g., UDI Rule, MDR).
• Contact Information: Provides resources for further inquiries.
• Indications for Use: Describes the intended use for TENS (pain relief) and EMS (muscle performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information you're asking for typically comes from the premarket submission itself (which might include detailed validation studies, performance data, and the methodology for establishing acceptance criteria), not from the FDA's clearance letter. This type of detail is particularly crucial for AI/ML-based devices, which this TENS unit is not described as.

If you have a document describing the actual performance study and acceptance criteria for this specific device, please provide it, and I would be happy to help analyze it.

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1) TENS
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided FDA 510(k) Clearance Letter for the "3 in 1 TENS UNIT" (K250759) does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI/algorithm-based medical devices.

This document is a standard FDA clearance letter for a Class II medical device (Powered Muscle Stimulator, TENS/EMS unit). It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations like the Quality System (QS) regulation.

Specifically, the letter does not mention:

• Any AI or algorithmic components of the device.
• Specific performance metrics (e.g., sensitivity, specificity, AUC) that would require a clinical study with acceptance criteria.
• Test sets, training sets, ground truth establishment, expert readers, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based solely on the provided text. The information required for your request (1-9) is typical for AI/ML-based medical devices that require performance validation, which is not described in this standard 510(k) clearance letter for a TENS/EMS unit.

This device, being a "Powered Muscle Stimulator" (TENS/EMS unit), typically undergoes electrical safety, electromagnetic compatibility (EMC), and performance testing related to its electrical output, waveform, and ability to deliver stimulation as intended, rather than AI-driven diagnostic or treatment algorithms.

Ask a specific question about this device