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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, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS(Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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TENS:
The device is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities.

EMS:
The device is used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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N/A

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The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

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The provided text is an FDA clearance letter for a medical device: "TENS and EMS Unit." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

The letter is a regulatory document stating market clearance and does not detail the technical performance or supporting studies for the device. Instead, it refers to the device's "Indications for Use" and mentions regulatory compliance.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the 510(k) summary or the full 510(k) submission for K251706, which would typically contain the performance data and details of any studies conducted.

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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, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

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

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the "TENS AND EMS (TENS and Muscle Stimulator)" device (K243856) does not contain the detailed information necessary to answer your request regarding acceptance criteria and performance study data.

This 510(k) letter is a legal document from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It primarily covers administrative details such as:

• The device name and models
• The applicant's information
• Regulation numbers and product codes
• Regulatory classification (Class II)
• The date of clearance
• General controls provisions (registration, listing, GMP, labeling)
• Information about when new 510(k) submissions might be needed for device changes
• Requirements for Quality System (QS) regulation, UDI rule, and adverse event reporting
• Contact information for the FDA

Crucially, it does not include any technical details about the device's performance, clinical study results, acceptance criteria, or the methodology of studies (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, or standalone performance). This information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this FDA clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions you've asked based on the provided text.

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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, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

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

Not Found

I am sorry, but the provided FDA 510(k) clearance letter for the TENS AND EMS (TENS and Muscle Stimulator) devices (K250360) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter confirming the substantial equivalence of the device to a legally marketed predicate device. It outlines regulatory information, such as:

• Device name and product codes
• Regulation numbers and regulatory class
• Indications for Use
• Requirements for manufacturing and post-market surveillance (e.g., Quality System regulation, MDR, UDI rule)

It does not include:

• Details on performance studies.
• Specific acceptance criteria used for performance verification.
• Information on study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

To provide the information you've requested, one would typically need access to the summary of safety and effectiveness data (SSED) or the full 510(k) submission, which are often much more detailed than the public clearance letter.

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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, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS (Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

The provided text is a 510(k) clearance letter from the FDA for a TENS and EMS device (TENS and Muscle Stimulator). This type of letter does not contain the detailed information about the acceptance criteria and study data that would be submitted as part of the 510(k) premarket notification.

A 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate device. While this process involves demonstrating safety and effectiveness, the FDA approval letter itself does not typically include the specific performance metrics, study designs, sample sizes, or ground truth methodologies that an AI/ML device submission would detail. Those technical details are part of the original submission package, not the clearance letter.

Therefore,Based on the provided FDA 510(k) Clearance Letter for the TENS AND EMS (TENS and Muscle Stimulator) device (K250053), there is no information available regarding the acceptance criteria or the specific study details that would prove the device meets these criteria. The letter is an official notification of clearance, stating that the device is substantially equivalent to a predicate device, and does not contain the detailed technical data typically found in a product's technical file or a clinical study report.

The following information cannot be extracted from the provided document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present.
3. Number of experts used to establish ground truth and qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical device, not an AI/ML algorithm.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable (not an AI/ML device, so no training set in the typical sense).
9. How ground truth for the training set was established: Not applicable.

The letter focuses on regulatory compliance, outlining the device's classification, applicable regulations (e.g., Quality System regulation, UDI Rule), and general controls. It refers to the device as a "TENS and Muscle Stimulator," which is a traditional physical medical device, not an AI/ML software device. Therefore, the questions related to AI/ML specific studies (like MRMC, training sets, ground truth establishment methods for algorithms) are not relevant to this type of device and would not be found in its 510(k) clearance.

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

Not Found

This document is a 510(k) clearance letter from the FDA for a Tens & Ems Device (TU1080). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The letter only confirms FDA clearance based on substantial equivalence, which is a regulatory pathway, not a performance study report.

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Transcutaneous Electrical Nerve Stimulation (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Electrical Muscle Stimulation (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS & EMS Stimulator(Model:MHD-1083) is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulation (EMS) qualities in one device.
TENS & EMS Stimulator has 36 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. And the TENS (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36) to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Electrical Muscle Stimulation (EMS) (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35) to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
The electronic stimulatory module has the operating elements of Switch, LCD Display screen, Screen lock key, Intensity Modification keys, Timing key, Output sockets, and USB port for battery charging.
The LCD screen can display treatment remaining time, battery power, selected program, output port, current intensity, selected intensity and lock state.
The device is equipped with accessories of electrode pads, electrode cables, a battery charger and a USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the AC charger and the built-in lithium battery. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the specialized person. Please ask the retailer to replace it.
The electrodes are interchangeable. The application area of electrode pads must be larger than 10cm². The electrode pads are provided by Dong Guan Ou Kang Electronics CO., LTD. with 510(k) cleared Number K181234.

The provided text is a 510(k) Premarket Notification from the FDA for a TENS & EMS Stimulator (MHD-1083). This document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing specific acceptance criteria for a novel AI/ML-driven medical device and then proving it meets those criteria through a dedicated performance study.

Therefore, the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "ground truth establishment" cannot be found within this document.

This document details the following:

• Acceptance Criteria & Device Performance: The document does not describe acceptance criteria in the typical sense for a new AI/ML algorithm's performance. Instead, it compares the new device's specifications to those of its predicate devices to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it falls within similar ranges or uses similar technology to cleared predicates.

  • Table of Acceptance Criteria and Reported Device Performance: Not applicable in the context of an AI/ML algorithm's performance study. The table provided (on pages 6-7) is a comparison of the new device's technical specifications against two predicate devices (K190115 and K133929). It highlights similarities and differences in parameters like power source, output modes, channels, waveform, maximum output voltage/current, pulse width, frequency, and safety compliance. For example:
    • Parameter: Indications for Use
      • New Device: TENS for temporary pain relief; EMS to stimulate healthy muscles for performance.
      • Predicate K190115: TENS for temporary pain relief; PMS (Powered Muscle Stimulation) to stimulate healthy muscles for performance.
      • Predicate K133929: TENS for temporary pain relief; PMS to stimulate healthy muscles for performance.
      • Comparison: Same (in terms of general use).
    • Parameter: Number of Output Modes
      • New Device: 36
      • Predicate K190115: 12
      • Predicate K133929: 25
      • Comparison: Similar (Note 2 states this difference doesn't impact safety/effectiveness).
    • Parameter: Maximum Output Voltage
      • New Device: 82V±20% @ 500Ω; 158V±20% @ 2kΩ; 168V±20% @ 10kΩ
      • Predicate K190115: 78V±15% @ 500Ω; 153V±15% @ 2kΩ; 161V±15% @ 10kΩ
      • Predicate K133929: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ
      • Comparison: Similar (Note 3 states differences don't exceed safety limits and meet IEC 60601-2-10 requirements).

• Sample sizes for test and training sets: Not applicable. This submission relies on technical specifications and adherence to recognized safety standards rather than a clinical performance study with test/training datasets for an AI algorithm.

• Data provenance: Not applicable. No clinical data or images are involved for AI training/testing.

• Number of experts and qualifications: Not applicable. Ground truth for an AI algorithm is not established here. The comparison is against established predicate device specifications and recognized safety standards.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device that involves human readers.

• Standalone performance: Not applicable. The device's operation is purely electrical stimulation, not an AI algorithm.

• Type of ground truth: Not applicable. The "ground truth" here is compliance with electrical safety standards (e.g., IEC 60601 series) and demonstrating that the device's functional parameters are within ranges considered safe and effective, similar to already-cleared devices.

• How ground truth for training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for an electrical stimulator, not an AI/ML-driven device. Therefore, the specific criteria and study details relevant to AI/ML device acceptance (as outlined in your prompt) are not present. The "proof" of the device meeting "acceptance criteria" here is its demonstrated adherence to relevant electrical safety standards and substantial equivalence to predicate devices, focusing on hardware and electrical characteristics.

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The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

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This document is a 510(k) clearance letter from the FDA for a device called "TENSWave," which is a Transcutaneous Electrical Nerve Stimulator for pain relief.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to predicate devices, its regulatory classification, and applicable general controls and regulations.

Therefore, an answer to the request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be generated from the given text.

The provided information only states:

• Trade/Device Name: TENSWave
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
• Regulatory Class: Class II
• Product Code: GZJ
• Indications for Use: The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

To answer the user's request, information regarding performance testing, clinical study results, and defined acceptance criteria would be necessary, which is absent in this FDA clearance letter.

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TENS (mode 1-3)

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.

EMS (mode 4-6)

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

Not Found

The provided document is a 510(k) clearance letter from the FDA for TENS and EMS units (SM9109A, SM9109B). This type of document does not typically contain acceptance criteria or detailed study results for the device's performance.

510(k) clearances are primarily based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness from scratch. The letter confirms that the device is substantially equivalent for the stated indications for use, meaning its performance is considered comparable to existing devices on the market.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. This information would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated test reports and clinical data summaries provided by the manufacturer to the FDA.

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