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• The model WL-2402, WL-2403 TENS are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
• The model WL-2401 TENS is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

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This document is a 510(k) clearance letter from the FDA for Transcutaneous Electrical Nerve Stimulators (TENS) and does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. It primarily discusses the regulatory classification and marketing authorization for the devices based on substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, study details, and ground truth from the provided text.

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Indications For Use (Available for WL-2202A, WL-2203A & 'TENS function' of WL-2205A):

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for WL-2204A, WL-2204A-P1, WL-2204A-P2 & 'EMS function' of WL-2205A):

• · Relaxation of muscle spasms.
• · Prevention or retardation of disuse atrophy.
• Increasing local blood circulation.
• Muscle re-education.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• Maintaining or increasing range of motion.

The T-tech Digital TENS series, including WL-2202A. WL-2204A. WL-2204A. WL-2204A-P1. WL-2204A-P2, and WL-2205A are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

T-tech Digital TENS series, models WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for T-tech Digital TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulation (TENS) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific, quantitative acceptance criteria through a standalone clinical study.

Therefore, many of the requested elements for an acceptance criteria study, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this 510(k) submission. Instead, the study demonstrating the device meets the "acceptance criteria" here refers to the testing performed to show equivalence to the predicate device and compliance with relevant standards.

Here's the breakdown of the information that can be extracted and a clear indication of what is not present:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • N/A. This submission is for a TENS device and relies on engineering and performance testing to demonstrate substantial equivalence to a predicate device, not a test set based on patient data in the way an AI/CADe device would. The testing would involve specific units of the device.
   • Data Provenance: The document does not specify the origin of any test data beyond the general submission from Well-Life Healthcare Inc. in Taipei, Taiwan. The studies cited are non-clinical (compliance to standards, software verification).

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

   • N/A. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for this type of device submission. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with engineering standards.

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

   • N/A. Adjudication methods are typically associated with expert review of data/images in clinical studies, which is not described here.

4. 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:

   • No. An MRMC study is not mentioned. This device is a direct patient-use electrical stimulator, not an AI/CADe device designed to assist human readers.

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

   • N/A. This device is hardware with embedded software for control, not a standalone AI algorithm. Its performance is inherent to the device's function.

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

   • The "ground truth" for this 510(k) submission is established by:
     • Predicate Device Performance: The known performance, safety, and effectiveness of the previously cleared predicate device (K030537: WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B).
     • Voluntary Standards: Established engineering and safety standards (ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, EN 60601-1-2).
     • FDA Software Guidance: Best practices for software verification.

7. The sample size for the training set:

   • N/A. There is no mention of a "training set" in the context of machine learning or AI models. This device does not use an AI learning algorithm that requires a training set.

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

   • N/A. As no training set is mentioned, this question is not applicable.

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Indications For Use (Available for WL-2203B & 'TENS function' of WL-2205B): This device is a prescription device and only for symptomatic relief of chronic intractable pain. Indications For Use (Available for WL-2204B, 2204B-P1, 2204B-P2 & 'EMS function' of WL-2205B): - Relaxation of muscle spasms. - Prevention or retardation of disuse atrophy. - Increasing local blood circulation. - Muscle re-education. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Maintaining or increasing range of motion.

The Digi-Pro TENS series, including WL-2203B, WL-2204B-P1, WL-2204B-P1, WL-2204B-P2, and WL-2205B are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. Digi-Pro TENS series, models WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B, consist mainly of two parts: the stimulus generator, electrode. The stimulus qenerator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief. The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

The provided text describes a 510(k) summary for the Well-Life TENS device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo effectiveness study with specific acceptance criteria and performance metrics against a ground truth.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as there wasn't an independent effectiveness study performed in the way an AI/ML device would typically undergo.

Here's why the requested information isn't present:

1. Acceptance Criteria and Reported Device Performance: This device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). Its clearance is based on substantial equivalence to existing TENS/PMS devices (K021359 & K020314, SD603/Model III, SD-605/program and Q-MS). The "acceptance criteria" here are that the new device's technical specifications and safety features are comparable to the predicate devices and meet relevant electrical safety standards (e.g., ANSI/AAMI, EN 60601 series). There are no specific quantitative "performance" metrics (like accuracy, sensitivity, or specificity common in AI/ML studies) reported in this summary.

2. Sample Size and Data Provenance for Test Set: Not applicable. There was no clinical "test set" in the context of an effectiveness study for this 510(k). The evaluation focused on engineering performance and substantial equivalence to predicates.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the sense of expert consensus on diagnostic or efficacy outcomes, was not established for a clinical effectiveness study.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device, so no such study was performed or is relevant.

6. Standalone Performance: Not applicable as there is no "algorithm" in the modern AI sense. The device's "standalone" performance is its electrical output and safety characteristics, which were assessed against standards and predicate device specifications.

7. Type of Ground Truth: Not applicable. The ground truth for this type of device regulatory submission is compliance with established electrical safety and performance standards for therapeutic devices, and demonstration that its technical characteristics are consistent with predicate devices that have prior clearance for their intended uses.

8. Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no training set in that context.

9. How Ground Truth for Training Set was Established: Not applicable.

What the document does describe in terms of performance and testing:

• Non-Clinical Tests: Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2.
• Software Verification: Carried out according to FDA software guidance.
• Conclusion: Verification and validation tests demonstrate that differences in the submitted models maintain the same safety and effectiveness as the cleared predicate devices, and do not affect the intended use or alter the fundamental scientific technology.

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The Mini-TENS including a series of TENS models (WL-2401, WL-2402, WL-2403, and WL-2302) is intended for symptomatic relief of chronic intractable pain.

The Mini-TENS series, including WL-2401, WL-2402, WL-2403, and WL-2302 are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

Mini-TENS series, models WL-2401, WL-2402, WL-2403, and WL-2302, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for Mini-TENS is burst mode with fixed pulse rate, frequency, and fixed timer. Only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2102A. Every model of Mini-TENS has its individual stimulation operation cycle.

The Mini-TENS series (WL-2401, WL-2402, WL-2403, and WL-2302) are almost identical in function outlook and specification.

This document describes the 510(k) summary for the Well-Life Mini-TENS series (models WL-2401, WL-2402, WL-2403, and WL-2302), which are transcutaneous electrical nerve stimulators (TENS devices). The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (Well-TENS, model WL-2102A).

This submission does not contain information related to the performance of an AI/ML device in the context of acceptance criteria from a study. It focuses on the comparison of specifications and intended use of new TENS device models against a predicate TENS device for 510(k) clearance. Therefore, a table of acceptance criteria and reported device performance isn't applicable in the context of an "AI/ML device" and a study proving it meets acceptance criteria.

However, I can extract the comparative information presented in the document, which serves as the basis for determining substantial equivalence for these medical devices.

Summary of Device Comparison and Non-Clinical Tests (as presented in the 510(k) submission):

The document presents a comparison of the new Mini-TENS series with the predicate device (WL-2102A) to demonstrate substantial equivalence. The "acceptance criteria" here implicitly refer to the notion that the new devices should not raise new questions of safety or effectiveness, and their characteristics should be comparable to or within acceptable limits relative to the predicate device and relevant standards.

Table of Performance Comparisons for Substantial Equivalence (derived from the document):

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Indications For Use (Available for WL-2203 & 'TENS function' of WL-2205): This device is a prescription device and only for symptomatic relief of chronic intractable pain. Indications For Use (Available for WL-2204 & 'EMS function' of WL-2205): - Relaxation of muscle spasms. - Prevention or retardation of disuse atrophy. - Increasing local blood circulation. - Muscle re-education. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Maintaining or increasing range of motion.

The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief. The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

The provided text describes a 510(k) summary for a Transcutaneous Electrical Nerve Stimulation Device (TENS) called Digi-Pro TENS, but does not contain any information about acceptance criteria or a study proving its performance against acceptance criteria.

The document primarily focuses on:

• Submitter's Identification: Well-Life Healthcare Inc.
• Device Name: Well-Life TENS (Digi-Pro TENS series, including WL-2203, WL-2204, WL-2205).
• Information of the 510(k) Cleared Device (Predicate Device): Refers to Part 6, which is not provided.
• Device Description: Explains the basic function of the TENS device (stimulus generator, electrode, adjustable output/waveform, different operation modes via microprocessor control).
• Intended Use: Mentions that intended uses and contraindications are defined in the instruction manual and also provides a standard format for indications for use for different models (WL-2203 and the "TENS function" of WL-2205 for chronic intractable pain relief; WL-2204 and the "EMS function" of WL-2205 for muscle spasms, disuse atrophy, blood circulation, muscle re-education, post-surgical calf stimulation, and range of motion).
• FDA Communication (K020314): A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, classifying the device as Class II (Powered muscle simulator), and outlining general controls and regulatory requirements.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them based on the text provided. The document is a 510(k) summary for regulatory clearance, not a clinical or performance study report.

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This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.

The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous r he Dig TTO reason of sed for pain relief and/or powered muscle stimulator by applying an electrical norrent to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: Digit to TENO benerator, electrode. The stimulus generator generates the output current specified the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulation (TENS) device. It describes the device, its intended use, and provides some regulatory information, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a submission for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish strict performance against predefined acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) submission might.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study from the provided text. The document focuses on device description, intended use, and regulatory classification.

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