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For WL-2315C(M) and WL-2315E(M) models:

The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication.

For WL-2405H(M) model:

The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).

The Well-Life Pain relief (Menstrual Plus) Electrical Stimulator is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis This stimulator should be applied to the normal, healthy, dry, and clean skin of adult patients with the aim of stimulating healthy muscles and enhancing muscle performance.

There are three available models: WL-2405H(M), WL-2315E(M), and WL-2315C(M). WL-2405H(M) is derived from the WL-2405H (FDA 510K no. K172809) with modifications. It includes the original TENS modes P1-P8 and EMS modes P1-P6, along with two additional TENS modes (P9, P10). TENS P9 is used for Pain Relief/Menstrual pain relief, while TENS P10 is suitable for Pain Relief. The WL-2405H(M) model offers 16 preset modes, with 10 modes for TENS (Transcutaneous Electrical Nerve Stimulation) and 6 modes for EMS (Electrical Muscle Stimulation). It features an LCD/LED display and a user-friendly interface that allows for adjustments to preset modes, output signal intensity, and treatment duration. It also includes two output channels.

The WL-2315E(M)/WL-2315C(M) model is a distinct version that exclusively focuses on the TENS P9 mode for dysmenorrhea pain relief, derived from the WL-2405H(M) model. This series of products is an adaptation of the mini-TENS stimulator.

The provided document is a 510(k) premarket notification from Well-Life Healthcare Limited to the FDA for their "Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator." This document asserts substantial equivalence to predicate devices and describes non-clinical testing performed. It explicitly states that no clinical performance testing was conducted or necessary for this device and indications for use. Therefore, no study proving the device meets acceptance criteria through clinical data is available in this document. The acceptance criteria for this device seem to be based solely on non-clinical performance (electrical safety, EMC, software validation) and comparisons to predicate devices for substantial equivalence.

Here's the information about the acceptance criteria and the provided device performance, based on the non-clinical testing and comparison to predicate devices, as no clinical study information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily established against benchmark engineering standards and comparison with predicate devices to demonstrate substantial equivalence, rather than specific performance metrics from a clinical study for a novel device. The document focuses on demonstrating that the subject device's technical specifications and safety profile are comparable to or within acceptable limits of the predicate devices and relevant electrical 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)

• Test Set Sample Size: Not applicable. The document explicitly states: "No clinical performance testing was conducted or necessary for this device and indications for use." The testing described is non-clinical bench testing.
• Data Provenance: The bench testing likely occurred at the manufacturer's facilities or a certified testing lab. The country of origin of the device manufacturer is Taiwan (Well-Life Healthcare Ltd., New Taipei City, Taiwan). The nature of this testing (electrical, EMC, software validation) means it's not "data provenance" in the clinical sense.

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 performance testing was conducted, there were no "experts" establishing ground truth in a diagnostic or clinical efficacy sense. Ground truth, in the context of electrical safety and performance, is established by adherence to recognized international standards (e.g., IEC 60601 series, AAMI NS4) and internal design specifications.

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

• Not applicable, as no clinical performance testing involving human adjudication was conducted. Assessment for non-clinical testing is typically pass/fail against predefined acceptance criteria for each test according to the relevant standards.

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 electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). No MRMC study was conducted.

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

• Not applicable. This device is an electrical stimulator and does not involve an AI algorithm with standalone performance characteristics. Its function is to deliver electrical impulses.

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

• For the non-clinical testing, the "ground truth" is defined by:
  • International standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, AAMI NS4.
  • Manufacturer's design specifications: Bench testing verified output parameter specifications against these.
  • FDA guidance documents: For software validation ("General Principles of Software Validation: Final Guidance for Industry and FDA Staff") and shelf life ("Shelf Life of Medical Devices").
  • Predicate devices' established performance and safety profiles: For demonstrating substantial equivalence.

8. The sample size for the training set

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

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

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

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The Everyway EV-820 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Everyway EV-820 OTC Pain Relief TENS is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.

The Everyway EV-820 OTC Pain Relief TENS consists 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 user's skin so as to transmit this stimulus current for pain relief.

The stimulation modes for Everyway EV-820 OTC Pain Relief TENS is pre-program modes with fixed pulse width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simple design change from the pre-program modes of comparison clear model, existing 510(k) cleared devices, Low Back Pain Relief System/ Model EV-820(K110716). Every operation mode of Everyway EV-820 OTC Pain Relief TENS Syste has its individual stimulation operation cycle.

I am unable to provide a description of acceptance criteria and a study that proves the device meets the acceptance criteria from the provided document. The document is a 510(k) premarket notification letter from the FDA to Everyway Medical Instruments Co., Ltd. regarding their Everyway EV-820 OTC Pain Relief TENS device.

Here's why I cannot fulfill your request based on the provided text:

• No specific acceptance criteria are stated: The document primarily focuses on establishing substantial equivalence to predicate devices based on regulatory classification, intended use, and technological characteristics. It does not define specific performance metrics or acceptance criteria for the device itself (e.g., pain reduction percentage, battery life benchmarks).
• No detailed study is presented to prove acceptance criteria: The document explicitly states: "No particular Clinical Test was conducted for Everyway EV-820 OTC Pain Relief TENS." It mentions compliance with voluntary standards (IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2) and software verification, which are non-clinical tests for safety and performance, but these are not presented as studies designed to prove specific acceptance criteria for the device's therapeutic effectiveness. The comparison tables provided highlight characteristics, not performance against acceptance criteria.
• The document is a regulatory submission, not a research paper: A 510(k) summary aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a detailed clinical study proving device effectiveness against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document.

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The EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles.

The proposed device, EM25 - glute toning device is a self-adhesive EMS device for muscle training. The device can be applied with accuracy thanks to the use of EMS technology. Made from medical-quality silicone rubber, the elegantly designed EMS pad is extremely slim and flexible and adapts perfectly to the area to be treated. The high-tech circuit provides energy-efficient treatments of 20 minutes each.

Electrical muscle stimulation (EMS) is a widespread and generally recognized method and has been used in sports medicine and rehabilitation for years. In sports and fitness, EMS is used to complement conventional muscle training, to increase the performance of muscle groups and to adjust physical proportions to achieve the desired aesthetic results.

EMS devices work by passing electrical currents over the skin. The gel pad is used as a transfer medium and is subject to natural wear and tear. The gel pad must be replaced if it stops providing sufficient contact, as this will prevent the EMS pad from sticking to the skin. If it is not replaced, the partially increased current density could irritate the skin.

The proposed device, EM25 - glute toning device is assembled with the PCBA and electrode, and the LR03 (AAA) battery supplies the safe low-frequency current. The electrode stuck on the human skin purposes to train the deep muscle. There are 0-15 intensity levels for EM25 - glute toning device. The maximum voltage is divided by 15 (levels) and accumulated for each voltage. But the each increased amperage cannot be over 2%. The intensity level will be minimum when turning on. The user can adjust it from 0 to 15 and gradually increase the intensity level. The whole treatment time is 20 minutes, and then the device switches off automatically.

The EM25 - glute toning device is a powered muscle stimulator intended to improve muscle tone of the buttocks muscles in healthy persons through transcutaneous electrical muscle stimulation (EMS).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., a specific percentage improvement in muscle tone measured by a defined metric). Instead, the acceptance criteria are implicitly defined by compliance with a series of recognized safety and performance standards. The "reported device performance" is essentially that the device met these standards, and is deemed substantially equivalent to a predicate device.

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

No test set related to clinical performance or human efficacy is mentioned. The primary "test set" for this submission refers to the physical device itself and its components undergoing engineering and biocompatibility testing. The data provenance for these tests is implicitly from the manufacturer's testing (Hivox Biotek, Inc., Taiwan). The document confirms that no clinical test data was used to support the decision of safety and effectiveness (Section 5.9).

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

Not applicable. No clinical test set with human data and expert ground truth was established for this submission. The "ground truth" for the non-clinical tests was adherence to the specified international standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication method was used, as no clinical studies were performed.

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 muscle stimulator, not an AI-assisted diagnostic or imaging device, and does not involve "human readers" or AI assistance in that context.

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

Not applicable. See point 5. This device is a physical therapeutic device, not an algorithm, and does not have a "standalone" algorithmic performance in the typical sense of AI/software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on adherence to recognized international technical standards for safety, biocompatibility, software lifecycle, and electrical safety (e.g., ISO 10993 series, IEC 62304, IEC 60601 series, ISO 14971). The claim of "effectiveness" is supported by substantial equivalence to an existing predicate device, rather than direct clinical evidence for efficacy.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm was used, as this is not an AI/software device that requires machine learning.

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

Not applicable. See point 8.

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The OTC Patch, Model WL-2406, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The OTC Patch, model WL-2406 is a single channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The outbut and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit. The OTC Patch, model WL-2406, 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 user's skin so as to transmit this stimulus current for pain relief. The stimulation modes for OTC Patch is pre-program modes with fixed pulse rate, frequency, and fixed timer, only amplitude is adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model WL-2406(K052785). Every operation mode of OTC Patch, model WL-2406 has its individual stimulation operation cycle. For the device included in this submission, we use the following of our 510(K) legally marketed predicate electrodes: K082065, "Well-Life Self Adhesive Electrode", CM Series/ model no. CM-130x70, size 130x70mm, snap type. With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, the OTC Patch, Model WL-2406. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving independent efficacy through new clinical studies measuring clinical outcomes against acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for an AI/CADe device. Instead, the "study" described is a non-clinical comparison to predicate devices.

However, I can interpret the request in the context of the provided document by extracting the comparison data that serves as the basis for the "substantial equivalence" claim.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of a 510(k) for a TENS device, "acceptance criteria" are typically met by demonstrating that the new device shares the same intended use, fundamental technological characteristics, and similar performance specifications as legally marketed predicate devices, or that any differences do not raise new questions of safety or effectiveness. The reported device performance is presented as a comparison to these predicates.

Study Proving Device Meets Acceptance Criteria:

The study described is a non-clinical bench testing and comparison study to demonstrate substantial equivalence to previously cleared predicate devices.

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

• Sample Size: Not applicable in the traditional sense of a clinical trial with patient data. The "test set" here refers to the device parameters and performance characteristics which are compared against those of the predicate devices. This involves analyzing the technical specifications and output characteristics of the new device.
• Data Provenance: The data comes from the technical specifications, design documents, and bench testing of the new device (OTC Patch, Model WL-2406) and the predicate devices (WL-2406 K052785, WL-2407 K091757). The document implies the origin is Well Life Healthcare Limited in Taiwan, ROC, the submitter. The data is retrospective in the sense that it relies on existing specifications of cleared devices and new device test results.

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 this context, refers to the established specifications and performance of the predicate devices, as recognized by their previous 510(k) clearances. The evaluation is a comparative engineering assessment, not an expert review of clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable. The "adjudication" is essentially a comparison of the technical specifications and performance data of the new device against the established parameters of the predicate devices, as reviewed by the FDA.

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:

• No. This is a TENS device, not an AI/CADe medical imaging device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this submission.

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

• No. This is a physical device submission; there is no "algorithm only" performance concept here beyond the device's electrical characteristics. The device operates standalone in the sense that it delivers electrical stimulation as programmed without continuous human intervention during therapy, but it is not an AI diagnostic standalone system.

7. The Type of Ground Truth Used:

• The "ground truth" for comparison is the technical specifications, output characteristics, safety standards compliance (e.g., IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2), and intended use of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. (See #8)

Summary of the "Study" (Non-Clinical Comparison):

The "study" conducted for K133723 is a comprehensive non-clinical comparison study that evaluates the new device against two predicate TENS devices (K052785 and K091757). The core of this study involves:

• Comparison of Intended Use: The new device combines and expands the indications of the two predicate devices, stating temporary relief of pain in "low back as well as upper and lower extremities (arm and/or leg)." This is considered substantively equivalent or a logical extension based on the predicate devices.
• Comparison of Technological Characteristics: Detailed comparison tables (Sections 7, 8, and 9) provide side-by-side analysis of:
  • Operational modes and pre-programmed parameters (fixed pulse rate, frequency, timer).
  • Output characteristics (waveform, shape, max voltage, max current, pulse duration, frequency).
  • Safety features (patient leakage current, isolation, automatic shut-off).
  • Physical characteristics (power source, dimensions, materials).
  • Electrode type and size.
• Compliance with Voluntary Standards: The device demonstrates compliance with applicable voluntary standards, including IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2, as well as FDA software guidance. This demonstrates that the device meets recognized safety and performance benchmarks.
• Detailed Calculation Comparison: "Through the detailed calculation comparison of stimulation output energy for each operation model in particular the output current density and power density), we found the output level in each operation mode for our OTC Patch, model WL-2406 and predicate device are very close and within the acceptable range as specified in FDA guidance." This explicitly addresses that despite slight differences in "detailed output parameters (mainly in the pulse duration and electrode sizes)," the overall output energy, current density, and power density are comparable and safe.
• Conclusion of Substantial Equivalence: The study concludes that the new device has "the same intended use and the similar technological characteristics as the cleared devices" and that the "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." Meaning that the engineering differences do not affect intended use or alter the fundamental scientific technology.

This approach is standard for 510(k) submissions where a new device is substantially equivalent to a predicate device, and new large-scale clinical trials are not typically required unless there are significant changes in technology, indications, or safety profiles.

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The LONG LIFE PAD™ is intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. These pads should be used only with the Omron Electrotherapy Pain Relief Unit, (PM3030) and applied on normal, healthy, dry, clean skin of adults.

The LONG LIFE PAD™ is intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. These pads should be used only with the Omron Electrotherapy Pain Relief Unit, (PM3030) and applied on normal, healthy, dry, clean skin of adults.

The LONG LIFE PADs™ are non-sterile, disposable, laminated, flexible structures composed of the following three main construction layers from bottom to top:
. Polyester protective film,
. gel,
. carbon layer,
. non-skin contact polyethylene lamination layer
. snap connection

The electrodes are designed for single-patient/multiple application use. Because of the Adhesive's nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin.

The pad patient contacting surface is a biocompatible hydrogel. The electrode has one connection point that is used to connect the stimulation device to the electrodes. This connection point is compatible only with the Omron PM3030.

The information provided is about a 510(k) premarket notification for a medical device called "LONG LIFE PAD™," which is a cutaneous electrode. This document details the device's comparison to a predicate device and bench testing performed to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary states that the Long Life Pads met all requirements, specifications, and the "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode." While specific numerical acceptance criteria are not explicitly detailed in the provided text, the document indicates compliance with the following types of tests:

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

The document mentions "bench tests" but does not specify the sample sizes (number of pads tested) or the provenance (country of origin, retrospective/prospective) of the data for these tests. It only states that the tests were performed.

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

This information is not applicable to the provided document. The performance evaluation presented is based on bench testing of the device's physical and electrical properties, not on clinical assessment or interpretation by human experts.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically associated with clinical studies involving human interpretation or outcomes, not bench testing of device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission is for a cutaneous electrode and relies on bench testing to demonstrate substantial equivalence to a predicate device, not a comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not applicable to the device described. The "LONG LIFE PAD™" is a physical medical device (cutaneous electrode), not an algorithm or AI system. Its performance is inherent to its physical properties and design, not an "algorithm only" performance.

7. The Type of Ground Truth Used:

For the bench tests, the "ground truth" would be the established scientific and engineering standards and specifications (e.g., electrical resistance limits, adhesion strength targets, material biocompatibility standards as per ISO 10993-1) against which the device's performance was measured. It is not an expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.

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

This information is not applicable as there is no training set for this device.

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