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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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Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual.

Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).

Here's a breakdown of the acceptance criteria and study information for the Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), based on the provided FDA 510(k) summary:

This device is an electrode probe and does not generate energy itself, but rather interfaces with an external electrical stimulator device. Therefore, the acceptance criteria and testing focus on the safety, material compatibility, and physical performance of the probe itself, and its equivalence to predicate devices that have established a safe and effective profile. The "device performance" in this context refers to its ability to meet these safety and functional specifications, rather than a diagnostic or therapeutic accuracy metric typical of AI-powered devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical bench testing rather than human clinical studies with a "test set" in the traditional sense of AI data.

• Test Set Sample Size: Not applicable in the context of clinical data for algorithmic performance. The "samples" refer to units of the manufactured device used for physical and material testing. The exact number of units tested for each benchmark is not specified but is implicitly sufficient to meet the requirements of the cited standards.
• Data Provenance: Not applicable as this is bench testing of physical device components, not retrospective or prospective clinical data from human subjects. The testing was conducted by or on behalf of the manufacturer, Well-Life Healthcare Ltd., based in Taiwan.

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

Not applicable. The ground truth for this type of device (a probe electrode) is established by adherence to recognized national and international standards (e.g., ISO, ASTM, AAMI, IEC) for material safety, electrical performance, and mechanical integrity. There are no "experts" establishing a "ground truth" for diagnostic or clinical accuracy as this is a passive medical device component. The "experts" involved would be the engineers and technicians performing the tests and comparing the results to the predetermined pass/fail criteria of the standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical outcomes that would require an adjudication method like 2+1 or 3+1. Testing involves objective measurements against predefined engineering and biocompatibility 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 a passive probe electrode for stimulation and EMG, not an AI-powered diagnostic or therapeutic tool that would involve "human readers" or AI assistance.

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

Not applicable. There is no algorithm or AI component in this device. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and performance is based on:

• Established engineering standards: e.g., electrical safety parameters, mechanical strength thresholds.
• Biocompatibility standards: ensuring materials are non-toxic, non-irritating, and non-sensitizing.
• Predicate device characteristics: demonstrated safe and effective use of similar devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no AI or machine learning component, therefore no training set.

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

Not applicable. As there is no training set.

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Intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) provides a transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work-related activities. The output port transmits the output signal to the electrode, which is attached to the user's skin; with the combination of the Stimulator 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, arthritis as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) is design changed from OTC MINI PATCH K121353 (Model WL-2301A/WL-2301B).

The main differences between the two are disposable battery change to reusable battery, aside from battery changes, the appearance of the devices is also differnt. Also, minor changes include PCBA component placement changes, frame size changes, and new accessories to improve convenience.

The definition of model name: WL is abbreviation of Well-Life Healthcare Limited. 23 is symbol of device series which are wireless, no monitor and operated by buttoning only. XX is the symbol for different program and output electrical signal in this device. The last English alphabet is the symbol of the appearance of this device, For C, it is oval shape and for E, it is round shape. The model of Stimulator device are WL-2301C, WL-2301E, WL-2306C and WL-2306E, which include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The Stimulator device offers several different preset programs, and will switch automatically, with 21 minutes per session and will turn off automatically after each session. The Stimulator device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity.

The accessories of Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) are electrode which can be patch or garment. 3 models of patches and 5 models of garments are recommended. There are CM7257, CM169100, CM13070 for electrode patch and Well-Life Garment Electrode -Arm (GM-AM-O-X00), Well-Life Garment Electrode -Elbow (GM-EB-O-X00). Well-Life Garment Electrode -Back Strech Belt (EW-BK-00IE), Well-Life Garment Electrode - Wrist (EW-WR-00IE) and Well-Life Garment-Knee (EW-KN-002E).

The electrode Pad composed of non-woven fabric, conductive layer and conductive gel, it is connected to the stimulator through buttons or wires, and is in contact with the skin through conductive gel to transmit electrical signal to the skin to achieve therapeutic effects.

The Well-Life Garment Electrode series are blending by Non-conductive textile and conductive textile, from the name of the conductive garment the user can identify the applicable body part, and the textile technology is adjusted to make the product fit on the skin. It is connected to the stimulator through buttons or wires, and is in contact with the skin through conductive textile to transmit electrical signal to the skin to achieve therapeutic effects.

The Stimulator device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium-ion battery. The accessories must comply with AAMI/ ANSI/ES60601- 1, IEC 60601-1-2 and IEC 60601-2-10. The accessories include: An external power adaptor, an electrode cord I cable attached to electrodes pads and battery.

This document is a 510(k) summary for the Well-Life Mini TENS Stimulator, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The purpose of this summary is to demonstrate substantial equivalence to a legally marketed predicate device, not to present a de novo clinical study with specific acceptance criteria in the typical sense for an AI/ML device.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, or AUC) is not applicable to this submission. This 510(k) summary is for a medical device that relies on established TENS technology and demonstrates substantial equivalence through non-clinical bench testing, biocompatibility testing, and comparisons to predicate devices based on technical specifications and safety standards.

The document explicitly states: "No clinical testing was conducted for this device." This means there was no study performed to measure the device's performance against clinical endpoints or to assess how it might improve human reader performance with AI assistance. As such, there are no acceptance criteria, sample sizes, expert ground truth establishment, or adjudication methods as would be found in a study for an AI/ML algorithm requiring such validation.

Instead, the "acceptance criteria" for this device's clearance were its adherence to relevant electrical safety, biocompatibility, and performance standards for TENS devices, and its demonstrated substantial equivalence (based on design, intended use, energy type, etc.) to already cleared predicate devices.

Here's a breakdown of the information that is available in the document, framed against your request, highlighting why some points are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a TENS device relying on substantial equivalence to predicates, the "acceptance criteria" are compliance with relevant safety and performance standards for TENS devices and demonstrating that its specifications are similar to or justify differences from the predicate. The "reported device performance" are the results of non-clinical bench testing and adherence to these standards.

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The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following:

TENS can be used for the following applications:

• 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.

EMS can be used for the following applications:

• For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Heat Mode:

• Heat can be used for temporary relief of minor aches and pains.

Well-Life OTC TENS/EMS/Heating Stimulator Device, Model no. WL-2405K* provides a combination of transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work related activities, Electrical Muscle Stimulator (EMS) can be used to stimulate healthy muscles in order to facilitate muscle performance, relax muscle spasms, prevent or retard disuse atrophy, reeducate muscles and to maintain or increase the range of motion, Heat can be used in warming the muscle for soothing comfort.

The stimulator generates the output current specified as the input of controller. The output port transmits the output current & heat to the electrode, which is attached to the user's skin ; ; 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, upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities, and to be used to stimulate healthy muscle in order to improve and facilitate muscle performance.

The device includes several operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS/EMS and heat. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43°C.

For the heating cycle, the temperature will get to 43 degree Celsius in 130 seconds after turning on the heating mode, and when it reaches 43 degree Celsius then it will cool down to body temperature for 20 seconds, then back to 43 degree Celsius for 20 seconds , the cycle will continue for 15 minutes.

The device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature. Channel 1 can provide electrical stimulation signal, such as TENS/EMS, and it can only be performed by connecting an electrode and wire dedicated to electrical stimulation. Channel 2 can provide heat treatment, and it can only be carried out by connecting heat-exclusive electrode and wires. The exclusive accessories used for electrical stimulation or thermotherapy are marked by color to prevent misuse by the user. If you accidentally use it incorrectly, there will be a protective mechanism in the device to prevent it from operating and causing harm.

Based on the provided text, the device in question is the "Well-Life TENS/EMS/Heating Stimulator (Model: WL-2405K+)". This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the information typically requested for demonstrating device performance against acceptance criteria in a clinical study (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not provided in this type of submission. This summary primarily relies on non-clinical testing (bench testing, usability, biocompatibility, electrical safety, shelf life, software validation) and direct comparison to predicate devices, asserting equivalence in safety and effectiveness.

Here's a breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards the device claims to meet and the performance benchmarks of the predicate devices. However, explicit numerical acceptance criteria and direct performance results are primarily presented for non-clinical tests rather than clinical outcomes.

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

• Test Set Sample Size: Not applicable. No clinical test set data is provided or mentioned as being used for substantial equivalence. The "test sets" mentioned refer to non-clinical bench testing.
• Data Provenance: Not applicable for clinical data. For non-clinical tests, tests were conducted at an "accredited test laboratory" (location not specified beyond Taiwan for the manufacturer).

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

• Not applicable. No external "experts" were used to establish ground truth as no clinical test set requiring human interpretation for ground truth was performed or presented. The "ground truth" for the non-clinical tests is based on the specifications of the standards (e.g., IEC, ISO, ASTM).

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set involved human readers or ground truth requiring adjudication.

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

• No. The document explicitly states: "No clinical test data was used to support substantial equivalence." (Page 10, Section 9.1). Therefore, no MRMC study was performed.

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

• Not applicable. This device is a physical stimulator, not an AI algorithm. Its performance is related to its electrical and heating outputs and physical characteristics.

7. The Type of Ground Truth Used

• For Non-Clinical Tests: The "ground truth" is established by adherence to recognized voluntary consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, ISO 10993 series, ASTM F1980-16, FDA guidances for software and shelf life). These standards define the acceptable range or performance for various parameters.
• For Substantial Equivalence: The primary "ground truth" is the performance and indications of the legally marketed predicate devices. The claim is that the subject device is similar enough in terms of safety and effectiveness.

8. The Sample Size for the Training Set

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

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

• Not applicable. As above, no training set for an algorithm.

Summary of the Study:

The "study" that proves the device meets the acceptance criteria is primarily a non-clinical evaluation documented in the "Non-Clinical Testing Summary" (Section 9) and a comparison to predicate devices for substantial equivalence (Section 10). The manufacturer performed:

• Usability Testing: To meet IEC/EN 60601-1-6 and IEC/EN 62366 standards.
• Biocompatibility Testing: Covering cytotoxicity, sensitization, and irritation, in compliance with ISO 10993 standards. It leverages the fact that the electrode is identical to one cleared in a predicate device.
• Electromagnetic Compatibility and Electrical Safety Testing: To meet IEC 60601-1, IEC 60601-1-11, and ANSI/AAMI ES 60601-1 standards, and Li-ion battery safety.
• Performance Testing: To meet the IEC 60601-2-10 standard for nerve and muscle stimulators.
• Shelf Life Testing: Following FDA guidance and ASTM F1980-16.
• Software Validation: Following FDA guidance on software for medical devices.

The entire submission is geared towards demonstrating substantial equivalence to existing predicate devices (HIVOX OTC Electrical Stimulator K203574 and Otc combo tens/ems system K172809) based on these non-clinical tests and a detailed comparison of technical specifications, rather than new clinical trials with patient outcomes. The premise of a 510(k) is that if a new device is as safe and effective as a legally marketed predicate device, it does not require a new PMA (Premarket Approval) process which typically involves extensive clinical data.

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The Well Life Garment Electrodes (GM Series) are intended to be used with legally marketed TENS devices.

The Well-Life Garment Electrodes (GM Series) will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

They can be used on body parts such as arm and elbow.

Well-Life Garment Electrodes (GM, Series), Models AM and EB, are intended to be used with legally Marketed Transcutaneous Electrical Nerve Stimulation (TENS) devices which could be used in place of traditional cutaneous electrode patches. The Well-Life Garment Electrodes (GM Series) are blended with Nonconductive textiles (polyurethane, nylon and polyester) and conductive textiles (Silver Fabric). Non-conductive area is used to fix and support Well-Life Garment Electrodes (GM Series) on the body. Two types of Garment Electrodes are designed.

The different series of model means different placement of the garment electrode. For "AM" it is to be place around the arm with conductive areas are on the upper arm and lower arm and there are two sets of snap facing outward, finally for "EB" it is to be place around the elbow with conductive area surrounds the elbow and there are one sets of snap facing outward. There are three sizes for each series of model (S/M/L). The conductive area between different sizes is fixed. There is four conductive area divided into upper arm area and lower arm area on model "AM", the areas is a pair of 39 cm² and a pair of 39 cm². There is only two conductive area on model "EB", the areas is a pair of 25.5 cm2.

By adjusting the area of the non-conductive area, the customer's body curve can be fitted. Conductive area is used as a transmission interface which enabling electrical stimulation devices to transmit signals to the skin. The devices must be used wet when in contact with the skin. When using Well-Life Garment Electrodes (GM Series), buckle the one port of lead wire or any connection terminal from legally marketed stimulator to the set of closest snap buttons on Garment Electrodes. Make sure electrical signals could reach the path from electrical stimulation to the Garment Electrodes.

For Garment Electrodes with multiple sets of buttons, only one set of buttons can be used at a time. The surface of conductive area has a resistance of less than 14 ohms per inch. The signal is generated by an electrical stimulator, and is transmitted evenly through the wire to the conductive area of the Garment Electrodes, and transmitted to the skin.

Here's a breakdown of the acceptance criteria and study information for the Well-Life Garment Electrodes (GM Series) based on the provided FDA 510(k) summary:

This device is an electrode, specifically a cutaneous electrode, and not an AI/ML powered device. Therefore, a significant portion of the requested information (such as AI-specific components like training/test sets, ground truth methodology involving experts, MRMC studies, or standalone algorithm performance) is not applicable to this submission. The "study" here refers to non-clinical testing to demonstrate performance and safety, primarily through bench testing and biocompatibility assessments, rather than clinical trials with human readers or AI performance metrics.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established standards for medical devices, particularly those related to biocompatibility and electrical safety/performance of electrodes. The reported performance demonstrates compliance with these standards.

Specific Information Requested (and applicability to this device):

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

   • Sample Size: Not explicitly stated as individual "test sets" in the context of clinical data. For bench testing of physical characteristics, samples of the device (GM Series electrodes) were tested in a laboratory setting. For biocompatibility, samples of the patient-contacting materials were tested.
   • Data Provenance: All data appears to be prospective laboratory and bench testing conducted specifically for this 510(k) submission, following recognized standards. The country of origin for the testing is not specified but the submitter is Well-Life Healthcare Ltd. in New Taipei City, Taiwan.

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

   • Not Applicable. This is a hardware medical device (cutaneous electrode) and not an AI/ML powered device requiring interpretation of medical images or other data by experts to establish ground truth for a test set. Ground truth here is defined by physical and electrical properties measured objectively in a lab.

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

   • Not Applicable. This is not a clinical study involving subjective interpretation or diagnostic accuracy where adjudication among experts would be needed. Bench testing and biocompatibility follow objective, standardized protocols.

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:

   • Not Applicable. This is not an AI-powered diagnostic device, so MRMC studies, human reader improvement with AI assistance, and effect sizes are irrelevant to this submission.

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

   • Not Applicable. This device contains no "algorithm" to be tested in a standalone fashion. It is a passive conductive garment electrode.

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

   • The "ground truth" for this device's performance and safety is established through:
     • Objective measurements and physical properties: e.g., impedance readings, current density, power density, material composition.
     • Standardized test methods: defined by ISO, IEC, and ASTM, which specify how to measure parameters and what constitutes acceptable performance/safety.
     • Biocompatibility test results: conforming to ISO 10993 series.

7. The sample size for the training set:

   • Not Applicable. This device does not use an AI/ML algorithm that requires a "training set."

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

   • Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of the Study:

The "study" for the Well-Life Garment Electrodes (GM Series) consisted of a series of non-clinical tests to demonstrate that the device meets established safety and performance standards for cutaneous electrodes. These tests include:

• Biocompatibility testing: Performed according to ISO 10993 series, confirming that the materials in contact with the patient's skin are safe (no cytotoxicity, sensitization, or irritation).
• Electrical performance and safety testing: Including compliance with IEC 60601-2-10 for nerve and muscle stimulators, impedance distribution uniformity testing to prevent "hot spots," and measurements of maximum average current density and maximum peak power density.
• Shelf life testing: Conducted via accelerated aging (ASTM F1980) to determine the product's stability over time.
• Reusability testing: To ensure the device maintains its performance after multiple uses and washes for a single patient, per in-house specifications.

The results of these tests were used to demonstrate substantial equivalence to legally marketed predicate devices, particularly in areas of intended use, principle of operation, and overall safety and performance profiles. The differences noted (e.g., specific impedance values, exact design/size) were evaluated and determined not to raise new questions of safety or effectiveness.

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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. (Choose TENS Modes P1 through P7)

For temporary relief of pain associated with sore and aching muscles in the upper extremities ( arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)

For symptomatic relief and management of chromic, intractable pain associated with arthritis. (Choose TENS Mode P8)

For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

Not Found

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a TENS/EMS device. It primarily discusses the device's regulatory classification, its substantial equivalence to predicate devices, and its indications for use.

Crucially, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. These details would typically be found in the accompanying 510(k) submission summary or clinical study reports, which are not provided in this document.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input.

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Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A):
· For symptomatic relief of chronic intractable pain

Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A):

• · Relax muscle spasms
• Prevent or retard disuse atrophy
• Increase local blood circulation
• · Re-educate muscles
• · Maintain or increase the range of motion

Not Found

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the WELL LIFE Rx Wireless TENS/EMS Stimulator. This document indicates that the device has been deemed 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 specific acceptance criteria in the manner you've outlined for diagnostic or AI-driven medical devices.

Instead, the 510(k) process focuses on demonstrating equivalence to another legally marketed device, often through a comparison of technological characteristics, safety, and performance. While performance data may be submitted, it's typically to show that the new device performs as intended and is as safe and effective as the predicate, rather than meeting predefined numerical acceptance criteria against a clinical ground truth as would be seen in studies for novel diagnostic algorithms.

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text. The requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in detailed clinical validation reports that are not part of this summary FDA clearance letter.

Here's what I can and cannot infer from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states the device is "substantially equivalent" to predicate devices. This implies it meets the performance and safety standards of those predicates, but it doesn't provide specific numerical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for a new device's performance against a gold standard.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The 510(k) process primarily reviews comparisons to predicate devices and engineering/bench testing, not necessarily large-scale clinical trials with defined test sets.

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

• Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.

4. Adjudication method for the test set:

• Not applicable. The document does not describe a study with a test set 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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS), not an AI-driven diagnostic tool that would typically involve an MRMC study.

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

• Not applicable. This device is a stimulator, not an algorithm. Its performance is inherent in its electrical output and design.

7. The type of ground truth used:

• Not applicable. No "ground truth" (in the context of a diagnostic or AI study) is mentioned. Compliance with safety and performance standards for TENS/EMS devices would be verified through engineering tests and comparison to predicates.

8. The sample size for the training set:

• Not applicable. No "training set" is relevant for this type of device and submission.

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

• Not applicable.

In summary: The provided document is an FDA clearance letter for a medical device (TENS/EMS stimulator) based on substantial equivalence. It does not contain the detailed methodology and results of a clinical study designed to establish acceptance criteria or evaluate performance against a ground truth, as would be expected for a diagnostic or AI-enabled device.

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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. (Choose TENS Modes P1 through P7)

For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7)

For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Modes P8)

For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

Not Found

This document is an FDA 510(k) clearance letter for a medical device, specifically a "Well Life Wireless TENS/EMS Stimulator." It is not a study report and therefore does not contain the detailed information required to answer the prompt regarding acceptance criteria and a study proving device performance.

The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the applicant in their 510(k) submission, which typically includes performance data to demonstrate equivalence, but the details of that data and the acceptance criteria are not present in this regulatory letter itself.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not a detailed description of performance studies and acceptance criteria.

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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. (Choose TENS Modes P1 through P7)

For temporary relief of pain associated with sore and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7)

For symptomatic relief and management of chronic, intractable pain associated with arthritis. ( Choose TENS Modes P8)

For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6)

Not Found

I am sorry, but the provided text from the FDA 510(k) K141299 letter for the "OTC Combo TENS/EMS System, model WL-2405" does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a letter from the FDA determining substantial equivalence for the device. It focuses on regulatory classifications, general controls, and the indications for use. It does not detail performance specifications, clinical study results, or the methodological specifics of any studies conducted by the manufacturer to demonstrate safety and effectiveness.

Therefore, I cannot provide the requested table and points, as the information is not present in the document.

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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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