Search Results

TENS: 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. EMS: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a TENS and EMS Stimulation device, confirming its substantial equivalence to predicate devices and outlining regulatory requirements. It does not contain details about specific performance studies, sample sizes, ground truth establishment, or expert reviews.

Ask a specific question about this device

TENS: 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. EMS: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a TENS and EMS Stimulation device, detailing its regulatory classification and indications for use. It does not include specifics on performance metrics, study design, or data analysis as requested in your prompt.

Ask a specific question about this device

TENS: 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. EMS: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a TENS and EMS Stimulation (OTC) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document only provides the following:

• Device Name: TENS and EMS Stimulation (OTC)
• 510(k) Number: K230174
• Indications for Use:
  • TENS: 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.
  • EMS: Stimulation of healthy muscles in order to improve or facilitate muscle performance.
• Type of Use: Over-The-Counter Use

Therefore, I cannot provide the requested table and details about the study because the necessary information is not present in the given FDA 510(k) clearance letter. This type of letter confirms regulatory clearance but typically does not include the detailed performance study results that were submitted to the FDA as part of the overall submission.

Ask a specific question about this device

TENS mode: It is used for temporary relief of pain associated with sore and aching muscles in the neck, joint, hip, hand, abdomen, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS mode: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided text is an FDA 510(k) clearance letter for a TENS and EMS Stimulation device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document DOES NOT contain information about specific acceptance criteria and a study that proves the device meets those criteria, especially not in the context of an AI/ML medical device.

The document is a regulatory clearance for a physical device (TENS and EMS stimulator) and contains:

• The FDA's determination of substantial equivalence.
• Regulatory information and requirements for the manufacturer.
• The indications for use for the TENS and EMS modes.

Therefore, I cannot extract the requested information (table of acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details) from this document. This information would typically be found in a separate clinical study report or a more detailed submission document (which is not included in the provided text).

Ask a specific question about this device