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Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include elbow, knee or back band.

Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

The provided FDA 510(k) clearance letter and Indications for Use statement for the "Garment Electrodes" (K222863) do not contain information typically found in a study demonstrating device performance against specific acceptance criteria. This document is a regulatory clearance, not a technical report detailing performance testing.

Therefore, I cannot provide the requested information that would usually be found in a performance study, such as:

• A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria (e.g., impedance, current distribution, adhesion) or report performance metrics against them.
• Sample size and data provenance for the test set: Not available.
• Number of experts and their qualifications: Not applicable, as this is not a study requiring expert interpretation of results.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone performance: Not detailed.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable (this is an electrode, not an AI/ML device).
• How ground truth for the training set was established: Not applicable.

What the document does tell us:

The document indicates that the Garment Electrodes are cutaneous electrodes for use with legally marketed TENS or NMES devices. They are described as non-sterile reusable OTC conductive garments intended to deliver stimulation signals.

The FDA's review determined that the device is substantially equivalent to legally marketed predicate devices. This implies that testing was done to ensure the Garment Electrodes meet the same safety and effectiveness standards as previously cleared devices of similar type, but the specific details of that testing are not disclosed in this public clearance letter. Such testing might typically involve electrical performance (e.g., impedance, current density), biocompatibility, durability, and safety aspects relevant to a cutaneous electrode.

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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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The Cutaneous Electrodes including Garment electrodes, which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

Not Found

This is a 510(k) premarket notification for "Cutaneous Electrodes." This document does not describe a study that uses AI or machine learning models. Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device.

The document discusses the regulatory approval for medical electrodes and their intended use, but it does not involve any performance evaluation of an intelligent algorithm.

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Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.

The EMSI Garment Electrodes are a cloth type device weft knitted of a continuous fiber made up of 77% Nylon and 23% Silver. Each device is flexible, and is available in a range of sizes to ensure good patient contact. A male snap connector is placed within the fabric weave and is connected via the female snap connector to a short lead wire, The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The entire fabric is made up of conductive material to provide uniform current distribution when connected to a stimulator.

The provided text describes the 510(k) summary for the "EMSI Garment Electrodes." This device is a Class II medical device, product code GXY (Cutaneous Electrodes), intended for use as reusable cutaneous, flexible, conductive garment/fabric electrodes for electrical stimulation.

Based on the provided information, the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove novel performance against specific acceptance criteria. Therefore, most of the requested fields related to a performance study will not be applicable or cannot be extracted from this document, as a typical clinical performance study with AI algorithms is not described.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that are typically associated with AI-based diagnostic or prognostic devices. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence through specific tests.

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

Not applicable. The document describes bench testing and biocompatibility testing, not a clinical study on a patient test set using an AI algorithm.

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

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not applicable. This device is an electrode garment, not an AI algorithm. Its performance is related to its physical and electrical properties, not an algorithmic output.

7. Type of Ground Truth Used

For the bench tests and substantial equivalence claims, the "ground truth" (or reference standard) would implicitly be:

• Biocompatibility: Adherence to established biocompatibility testing standards (e.g., ISO 10993).
• Impedance/Resistance: Measurements against electrical engineering principles and comparison to the predicate device's measured values.
• Durability: Functional testing after wash cycles, likely comparing pre-wash and post-wash electrical characteristics and structural integrity to predefined specifications or those of the predicate.

8. Sample Size for the Training Set

Not applicable. This is not an AI device with a training set.

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

Not applicable. This is not an AI device with a training set.

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