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TENS:

1. It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work activities.
2. It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis.
   EMS:
3. To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the intended areas on the body.
4. To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

RelieforMe TENS/EMS Device model UPK-GE01 is designed to focus on pain relief, muscle strengthening and recovery features with TENS/EMS treatment techniques driven and controlled by intelligent programs/software.
RelieforMe TENS/EMS Device, a TENS/EMS combination device, is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (leg), upper extremities (arm) due to strain from exercise or normal household and work activities. The device is for 18 and older.
The device provides pain relief based on the intelligent use of the key pain-killer mechanisms of TENS (Transcutaneous Electrical Nerve Stimulation).

The provided document is a 510(k) Premarket Notification for the "RelieforMe TENS/EMS Device Model UPK-GE01". It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not an AI/ML device. Therefore, the information requested about acceptance criteria, study details, expert consensus, ground truth, and training sets for an AI/ML device is not applicable or present in this document.

The document focuses on comparing the subject device's features (such as power sources, output voltage/current, frequency, pulse width, biocompatibility, electrical safety, and EMC) to those of predicate TENS/EMS devices to show that it is "as safe and effective as the predicate device" and does "not raise new questions of safety and effectiveness."

Specifically, the document states:

• Non-Clinical Performance Data: "To demonstrate safety and effectiveness of RelieforMe TENS/EMS Device model UPK-GE01 and to show substantial equivalence to the predicate device, UMHEAL completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The UPK-GE01 passed the testing in accordance with international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:"
  • Electrical safety testing per IEC 60601-1 – Passed
  • Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 – Passed
  • Software verification and validation per FDA Guidance – results /conclusion
  • Treatment Programs Performance Verification Testing
  • Stability Verification Testing
  • HFE Validation Testing
  • FCC Testing
  • Transportation Testing per ASTM D4169 – Demonstrates package integrity maintained
• Clinical Performance Data: "Not applicable."

Therefore, I cannot provide the requested information regarding AI/ML specific criteria from this document.

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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).

To temporarily increase local blood circulation in healthy muscles (Choose Mode A).

Pain Therapy Device is a household multifunctional device, it can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Pain Therapy Device has three operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin.

The electronic stimulatory main units have the operating elements of ON/OFF knob, Mode Selection key and Time Selection key which can be user-friendly controlled.

The device is equipped with accessories of electrode pads and an electrode wire. The electrode wire is used to connect the pads to the main unit. All the accessories can only be changed by local distributor. "Large Patch Electrode" and "Small Patch Electrode" are cleared in K090198.

"Insole Electrode", "Sole Plant Electrode A" and "Sole Plant Electrode B" are cleared in K151693.

The provided document is a 510(k) Summary for a Pain Therapy Device (K163611). It primarily focuses on demonstrating substantial equivalence to predicate devices based on safety and performance through bench testing and comparison of technical specifications.

Therefore, it does not describe acceptance criteria for a study demonstrating device performance against specific targets, nor does it detail a clinical study with human subjects, ground truth establishment, or multi-reader multi-case analyses.

The document outlines the following information relevant to the device's validation:

1. A table of acceptance criteria and the reported device performance:

The document does not present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) and the device's reported performance against those. Instead, it demonstrates compliance with recognized standards and substantial equivalence to predicate devices through technical specifications.

The "Test Summary" section (page 4) lists the following tests and their compliance:

The "Comparison to predicate device and conclusion" tables (pages 5-12) provide a detailed comparison of the subject device's technical specifications and intended uses against three predicate devices. The "Remark" column consistently states "SE" (Substantially Equivalent), indicating that the subject device's performance characteristics are considered equivalent to those of the legally marketed predicate devices, and that differences do not raise new issues of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. The provided document does not describe a clinical study involving a test set, human subjects, or data provenance in the context of device performance. The testing was primarily bench testing to ensure compliance with standards and equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. As no clinical study or test involving human subjects with a "ground truth" was described, this information is not present. The "ground truth" for the technical comparisons is rooted in the specifications and regulatory clearances of the predicate devices and the relevant international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No clinical test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is a Pain Therapy Device (Transcutaneous Electrical Nerve Stimulator, TENS/EMS). It is not an AI-powered diagnostic imaging device or similar system where "human readers" or "AI assistance" would apply. Therefore, no MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a hardware medical device; the concept of "standalone algorithm performance" is not relevant in the context of this 510(k) submission. The "software verification and validation test" mentioned (page 4) refers to the embedded software within the device and its compliance with FDA guidance, not a standalone algorithm for diagnostic or interpretative purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. For a device of this type, demonstrating "substantial equivalence" relies on technical specifications, safety testing (electrical, EMC, biocompatibility, usability), and comparison of intended use to legally marketed predicate devices. The "ground truth" for this regulatory submission is compliance with established standards and the characteristics of the predicate devices. There is no mention of clinical outcomes data in the sense of a dedicated clinical trial to establish efficacy against a "ground truth" condition.

8. The sample size for the training set:

Not Applicable. The document does not describe the development or training of an AI algorithm, therefore, no training set or its sample size is mentioned.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI algorithm, this information is not provided.

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The Electronic Pulse Stimulator MDTS100 is 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 and work activities.

The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles. The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic. The MDTS100 is adopted the method that inputting the specific low frequency pulse current into the human body through the human skin to treat the pain. The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The MDTS100 comes with 2 independent output channels by pressing the CHA button. Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over the counter use. The device does not contain drug or biological products. The device is software-driven and software validation is provided in software.

This document is a 510(k) Premarket Notification for the Electronic Pulse Stimulator Model MDTS100, which is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device (Prospera OTC TENSE Electronic Pulse Massager, Model PL029, K122744).

The document details the device's indications for use, its technical characteristics compared to the predicate, and functional and safety testing performed.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical effectiveness. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, which inherently means meeting safety and performance characteristics similar to a device already deemed safe and effective by the FDA. The comparison tables (Table 3-1 and Table 3-2) illustrate the technical characteristics of the proposed device against the predicate.

While no quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device, a table comparing key technical parameters and their reported values for both the proposed and predicate device is provided.

Table: Comparison of Technical Characteristics and Performance

The document concludes that the differences in output parameters (voltage, current, pulse duration, charge) between the proposed device and the predicate device "do not raise any new questions of safety or effectiveness." This statement effectively serves as the "acceptance criteria" for these differing parameters – that they fall within a range considered safe and effective for TENS devices when evaluated against recognized safety standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document focuses on non-clinical (bench) testing for substantial equivalence, not clinical studies involving human subjects with a "test set" in the context of clinical performance. Therefore, there is no mention of a human "test set" sample size or data provenance in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical submission. Ground truth, in a clinical context, is not established for this type of submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an Electronic Pulse Stimulator (TENS), not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. While the device is "software-driven," the performance evaluation is not an "algorithm-only" standalone test in the context of AI or diagnostic algorithms. The device's performance is tested as a complete system (hardware and software) through bench testing against electrical safety and EMC standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing:

• Electrical Safety & EMC: The "ground truth" is defined by the voluntary standards cited: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2010, and IEC 60601-2-10:2012. These standards specify thresholds and testing methodologies for electrical characteristics, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators.
• Biocompatibility: The "ground truth" for the electrode pads is established by their prior FDA clearance (K090198) and compliance with ISO 10993 standards, which cover biological evaluation of medical devices.
• Software Validation: The "ground truth" for software functionality is established against the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
• Cleaning: The "ground truth" is simply that the cleaning instructions were tested and found sufficient, as presented in the system test report.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

The provided text is a 510(k) summary for the Mailuokang Self-adhesive Electrode. It describes the device, its intended use, and compares it to a predicate device (THERATRODE, K112312) to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for impedance test: 12 electrode pairs.
• Data Provenance: The document does not explicitly state the country of origin for the impedance and adhesion self-evaluation tests. It refers to "self-evaluation tests," which implies these were conducted by the manufacturer. The biocompatibility tests are also stated as "Mailuokang's hydrogel has passed three biocompatibility tests," suggesting these were likely conducted by or for the manufacturer. The study is prospective in the sense that these tests were conducted to demonstrate equivalence for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts or ground truth established by experts for the test set. The performance tests (impedance, adhesion, biocompatibility) are objective measurements based on established standards or internal evaluations, not expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The performance tests are objective measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a study involving human readers or AI assistance. It's a medical device submission for an electrical stimulation electrode.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device. The device itself is a physical electrode.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

• Objective Measurements: Impedance values, adhesion force, and observation of biological response in biocompatibility tests.
• Compliance with Standards: Adherence to established industry standards like ANSI/AAMI EC 12:2000/(R)2005.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training" set in the context of machine learning or algorithms. Its performance is based on material properties and design, validated through direct testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set involved. The performance (ground truth) is established through physical and electrical testing of the electrodes.

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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.

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. The double-channel subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The electrode pad used consists of gel, carbon film, cloth backing, and electrode connector, which is 510(k)-cleared and biocompatible. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.

Here's a breakdown of the acceptance criteria and the study information based on the provided document. It's important to note that this document is a 510(k) summary for a medical device and not a clinical study report for an AI device. Therefore, many of the requested fields related to AI, human readers, and ground truth establishment from a clinical perspective will indicate "Not Applicable" or "Not Provided," as they are not relevant to this type of submission.

Device Name: IQ Technologies (Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS))
510(k) Number: K131290

1. Table of Acceptance Criteria and the Reported Device Performance

This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting distinct "acceptance criteria" with specific performance metrics in the way one might for an AI diagnostic algorithm. The acceptance is based on meeting the same safety and effectiveness standards, functional characteristics, and intended use as the predicates, verified through non-clinical testing and comparison of specifications.

Study Information:

This document is a 510(k) Premarket Notification based on non-clinical testing for substantial equivalence to legally marketed predicate devices. It does not describe a clinical study in the traditional sense of evaluating device effectiveness on patients or evaluating an AI algorithm's performance.

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. The "test set" here refers to the actual subject device undergoing engineering and electrical testing, not a dataset of patient cases.
   • Data Provenance: Not applicable. The data comes from direct measurements and engineering tests of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth, in the context of an AI device often referring to clinical diagnosis, is not established for this type of non-clinical engineering and electrical performance testing. Compliance with standards and comparison to predicate device specifications are the "ground truth."

4. Adjudication method for the test set:

   • Not applicable. Electrical and mechanical specifications are objectively measured and compared, not subject to expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), not an AI-powered diagnostic tool. No human reader involvement in performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Partially applicable, but in a different context. The device's electrical and mechanical performance was evaluated in isolation (standalone) during non-clinical testing. It's a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Ground Truth: Compliance with established industry electrical and safety standards (IEC 60601 series) and direct comparison to the physical and functional specifications of legally marketed predicate devices.

8. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. This device is not an AI algorithm that requires a training set.

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