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Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

1. Top layer: Fabric/Foam/ Tan fabric
2. Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
3. Bottom layer: Biocompatible self-adhesive conductive hydrogel
4. Connection: Leadwire/snap button/magnetic button
5. double sides adhesive tape: Which is used for attaching the non-woven fabrics and conducting film
6. Release film: Release film is a protective layer for the hydrogel.
   The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
   For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:

• Leadwire assembly: The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer.
• Snap button/Magnetic button assembly: With 2.5~5mm diameter male socket.

This document is an FDA 510(k) summary for the Shenzhen Roundwhale Technology Co., Ltd. "Self-adhesive Electrode" device. It outlines the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document pertains to a cutaneous electrode, which is a relatively simple medical device. Therefore, the "acceptance criteria" and "study" described are focused on physical and electrical performance and biocompatibility, not on complex diagnostic accuracy metrics like those for AI-powered imaging devices (e.g., sensitivity, specificity, AUC). The request's points regarding MRMC studies, expert concensus for ground truth, and training data are typically applicable to AI/ML device submissions, which are not relevant to this electrode device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established industry standards and comparisons to legally marketed predicate devices. The "reported device performance" demonstrates that the proposed device meets or is comparable to these criteria.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • The document does not specify exact sample sizes (e.g., number of electrodes tested) for each non-clinical test. It generally states that "The submitted sample(s) complied..." However, based on the nature of bench testing for these types of devices, standard engineering practices would involve testing multiple units to demonstrate conformity.
   • Data Provenance: The tests are "Non-Clinical Data" and "Bench Testing," implying in-house lab testing or third-party lab testing. The document does not specify country of origin for the testing itself, but the company is based in Shenzhen, China. The data is retrospective in the sense that it was generated prior to submission.

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

   • This question is not applicable to this type of device submission. For a cutaneous electrode, "ground truth" is established by direct physical, electrical, and chemical measurements against industry standards (e.g., resistance, adhesion force, material composition, cytotoxicity tests). There are no "experts" in the radiological interpretation sense involved in establishing this type of ground truth.

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

   • This question is not applicable. Adjudication methods are relevant for subjective interpretations, particularly in medical imaging or clinical trials where expert consensus resolves disagreements. For bench testing of an electrode, results are objective measurements derived from direct testing.

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:

   • This question is not applicable to this device. MRMC studies are used for AI/ML-enabled diagnostic devices where human readers (e.g., radiologists) interact with an AI system. This submission is for a physical electrode, not a diagnostic AI tool.

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

   • This question is not applicable to this device. "Standalone performance" refers to the performance of an algorithm without human intervention, typically in AI/ML diagnostic tools. This device is not an algorithm.

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

   • The "ground truth" for this device is based on industry standards and objective physical, electrical, and chemical measurements.
     • Physical/Mechanical: E.g., measured peel strength (adhesion) against a specified Newton (N) threshold, measured force to remove wires against a specified pound-force threshold.
     • Electrical: E.g., measured AC impedance against a specified ohm threshold.
     • Biocompatibility: Results of specific ISO 10993 tests (Cytotoxicity, Skin Sensitization, Skin Irritation) which have defined pass/fail criteria based on biological reactions.
     • Safety/EMC: Compliance with well-defined performance requirements in standards like ES60601-1 and IEC 60601-2-2.

7. The sample size for the training set:

   • This question is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

   • This question is not applicable for the same reason as above; there is no training set.

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Self-Adhesive Electrode is intended for as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

Self-Adhesive Electrodes are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Comytens are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

1. Top layer: Fabric/Foam/ Tan fabric
2. Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
3. Bottom layer: Biocompatible self-adhesive conductive hydrogel
4. Connection: Leadwire/snap button/magnetic button
5. double sides adhesive tape: which is used for attaching the non-woven fabrics and conducting film
6. Release liner: plastic film is a protective layer for the hydrogel.
   The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
   For the electrical connection, Comytens provides lead wire type and snap button/Magnetic button type.

The medical device in question is a Self-Adhesive Electrode manufactured by Guangdong Comytens Medical Technology Co.,Ltd. This device is intended for use as a reusable, conductive interface between the patient's skin and marketed electrical stimulators (e.g., TENS, EMS, IF/IFC, PGF) for transmitting electrical current, for both OTC and Prescription use.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document provides a comparison table between the subject device (Self-Adhesive Electrode) and a predicate device (ZMI Self-adhesive electrodes, K180865). This table implicitly defines the acceptance criteria by stating that the subject device's performance is "Same" or "similar" to the predicate, and explicitly lists some technical specifications.

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

The document primarily describes bench testing and biocompatibility testing.

• Sample Size for Bench Testing: Not explicitly stated. The document mentions "The Self-Adhesive Electrode was tested..." in several instances (e.g., for electrical & impedance, adhesion, connector & mechanical, packaging, accelerated aging), implying a sample of the manufactured device.
• Sample Size for Biocompatibility Testing: Not explicitly stated. Biocompatibility tests usually involve a defined number of samples for each test (e.g., in vitro cytotoxicity, irritation, sensitization).
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Guangdong Comytens Medical Technology Co., Ltd. from China. The testing itself is described as "Non-Clinical Data" indicating it was conducted in a controlled environment (labs) rather than on human subjects. This is prospective testing, as it's performed specifically to demonstrate compliance for regulatory submission.

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)

This information is not applicable as the device is a cutaneous electrode and the acceptance criteria are based on physical, electrical, and biological performance characteristics measured through bench testing and biocompatibility testing, not on human-interpreted data that requires expert ground truth establishment.

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

This information is not applicable for the reasons stated above (bench and biocompatibility testing). Adjudication methods are typically used for clinical studies involving interpretation of medical images or outcomes where expert consensus is needed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The Self-Adhesive Electrode is a physical medical device, not an AI diagnostic tool.

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

No, a standalone (algorithm only) performance study was not done. The device is not an algorithm or AI.

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

The "ground truth" for this device's performance is established by objective measurements against recognized international and national standards.

• Bench Testing: The "ground truth" for electrical, mechanical, and adhesive properties is derived from the specifications outlined in standards (e.g., IEC60601-1, ASTM F1980) and the predicate device's established performance. The device must meet or exceed these values.
• Biocompatibility Testing: The "ground truth" for biocompatibility is whether the device material elicits a harmful biological response, as assessed by the criteria defined in ISO 10993-1 and subsequent specific tests (Cytotoxicity, Skin Sensitization, Skin Irritation). Failure to pass these tests would indicate a deviation from acceptable biological safety.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set.

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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The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application:
First layer: Non-woven fabric tape
Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd)
Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.
The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Self-adhesive Electrode" (K213879), structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" for each parameter in the way a formal study report might. Instead, it demonstrates substantial equivalence to a predicate device (K090198) by comparing various characteristics and reporting that the new device met specific test standards or manufacturer requirements.

The table below presents the comparative data and implies the "acceptance criteria" are generally that the new device's performance is similar to or meets the standards met by the predicate device, or adheres to established industry standards for such devices.

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

The document does not specify a separate "test set" in terms of patient data. The evaluation relies on non-clinical bench tests performed on the "Self-adhesive Electrode" device itself.

• Sample Size: The document does not explicitly state the number of electrodes tested for each bench test. For example, it lists "Impedance test," "Conformability test," "Fluid tolerance test," "Peeling force test," and "Simulation use test" but doesn't provide the quantity of devices subjected to these tests.
• Data Provenance: The tests were "Bench tests" conducted on the proposed device. The country of origin for the device manufacturer is China (Bozhou Rongjian Medical Appliance Co.,Ltd., Anhui, China). The data is retrospective in the sense that these tests were completed before the 510(k) submission.

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

This information is not applicable as the study did not involve human interpretation or a "ground truth" derived from expert consensus on clinical data. The tests performed were objective bench tests against established standards and comparative measurements.

4. Adjudication Method for the Test Set

This is not applicable as there was no test set involving subjective human assessment or consensus building. The assessments were based on direct measurements and compliance with technical standards.

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

No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not including in this submission."

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

This is not applicable. The device is a self-adhesive electrode, a physical medical device, not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant. The compliance for the device involves physical and electrical characteristics.

7. The Type of Ground Truth Used

For this device, the "ground truth" or reference for performance and safety is established by:

• Established industry standards: Such as ISO 10993 series for biocompatibility, AAMI/ANSI ES 60601-1, and IEC 60601-2-2 for electrical safety and performance.
• Manufacturer's internal requirements: For tests like peeling force and simulation use.
• Predicate device characteristics: Demonstrating that the new device's properties (materials, dimensions, electrical impedance ranges) are similar to those of a legally marketed predicate device (K090198).

There is no clinical ground truth (e.g., pathology, outcomes data) as no clinical study was performed.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.

Self-adhesive electrode is available in Lead wire type and snap type. Both types are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel and plastic film. The construction difference is the lead wire or snap. It functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin.

The provided document is a 510(k) summary for a "Self-adhesive Electrode" device. It outlines the device's technical characteristics and compares them to a predicate device to establish substantial equivalence. However, it does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically expected for a diagnostic or AI-driven medical device.

This document focuses on establishing substantial equivalence for a Class II medical device, which generally means demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves performance testing against recognized standards rather than extensive clinical studies with acceptance criteria based on diagnostic accuracy.

Given the nature of this submission (a 510(k) for a cutaneous electrode), the "acceptance criteria" are primarily based on meeting established electrical, physical, and biocompatibility standards relevant to such devices, rather than clinical performance metrics like sensitivity or specificity for a diagnostic claim.

Here's a breakdown of the requested information based on the provided text, with acknowledgments of what is not present because it's largely irrelevant for this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify sample sizes for non-clinical performance tests (electrical impedance, current uniformity, adhesion). These are typically bench tests, and exact sample numbers are not detailed in this summary.
• Biocompatibility tests (cytotoxicity, skin irritation, sensitization) are conducted on samples of the device materials, but specific sample numbers (e.g., number of animals or cell cultures) are not provided in this summary.
• Shelf life verification involves testing samples over time, but the specific sample size is not mentioned.
• Data provenance is not explicitly stated in terms of country of origin for the test data, nor is it classified as retrospective or prospective for these non-clinical tests. These are internal engineering and lab tests.

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

• This question is not applicable in the context of this device and submission. The "ground truth" for non-clinical performance tests (like electrical impedance or adhesion) is determined by the measurement standard itself (e.g., a multimeter reading, adherence force). For biocompatibility, the "ground truth" is adherence to established biological response criteria laid out in the ISO standards, evaluated by qualified lab personnel, but not "experts" establishing a diagnostic ground truth in the sense of clinical decision-making.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes, typically for diagnostic devices where there might be inter-reader variability. For the performance and biocompatibility tests described here, the results are objectively measured against defined criteria within recognized 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, to assess the impact of AI assistance on human performance. The "Self-adhesive Electrode" is a passive component for electrical stimulation and does not involve AI or human interpretation in its intended use.

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

• No, a standalone performance evaluation of an algorithm was not done. As stated, this device is a passive electrode and does not contain any algorithms or AI components.

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

• For the performance tests: The "ground truth" is defined by the measurement standards and specifications (e.g., impedance values in ohms, percentage of current deviation, adhesion time, physical dimensions).
• For biocompatibility tests: The "ground truth" is defined by the assessment criteria within the ISO 10993 series standards (e.g., lack of cytotoxicity, skin irritation, or sensitization exceeding defined thresholds).
• There is no clinical "ground truth" (like pathology or outcomes data) established for this device, as it's not a diagnostic device.

8. The sample size for the training set

• This question is not applicable. The device is an electrode, not an AI model or a device requiring a "training set" in the machine learning sense. The manufacturer doesn't mention any AI components in the device description or testing.

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

• This question is not applicable, as there is no training set for an AI model.

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The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals

This type of electrode features a high density carbon mesh that evenly distributes current throughout the electrode surface. It connects to a TENS device through single or twin lead wire. Various standard sizes can be chosen. Any custom design can also be manufactured.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for "Self-Adhesive Electrodes" and primarily focuses on establishing substantial equivalence to predicate devices, regulatory information, and intended use.

The text explicitly states that no clinical investigation was performed: "Therefore, we need not perform clinical investigation. And, the safety and performance of Adhesive Electrodes is verified." This means there would be no study to describe in the context of device performance against specific acceptance criteria.

The document refers to "Testing reports, analysis" and "Performance Characteristics (If/when applicable) — 1. See the Exhibits." However, the actual content of these reports or exhibits, which would contain detailed performance data and acceptance criteria, is not included in the provided text.

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

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Ask a specific question about this device