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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:

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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.

Ask a specific question about this device

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.

• Polyurethane (PU) electrically conductive carbon cloth
• Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426) | Similar |
  | Electrode Pad Size | Within ranges comparable to predicate | Round Min.Ø20mm; Max.Ø85mm
  Rectangle Min.26×26mm; Max.190×110mm
  Elliptical Min.85×45mm;
  Calabash Min.90×47mm; Max.200×88mm
  Butterfly Min.73×53mm; Max.195×95mm
  Palm shape 74×47mm | Similar |
  | Performance Characteristics | | | |
  | Electrode Impedance of Electrode Pad | Within ranges comparable to predicate | Round: 302577Ω
  Rectangle: 303646Ω
  Elliptical: 407676Ω
  Calabash: 401602Ω
  Butterfly: 402626Ω
  Palm shape: 402638Ω | Similar |
  | Patient contact area of electrode | Within ranges comparable to predicate | Round Min.3.14cm²; Max.56.716cm²
  Rectangle Min.6.76cm²; Max.209cm²
  Elliptical Min.38.25cm²; Max.240cm²
  Calabash Min.42.3cm²; Max.176cm²
  Butterfly Min.38.69cm²; Max.185.25cm²
  Palm shape 34.78cm² | Similar |
  | Max. current Density (IRMS=10mA calculation) | Within ranges comparable to predicate | Round: 3.18mA/cm²
  Rectangle: 1.48mA/cm²
  Elliptical: 0.52mA/cm²
  Calabash: 0.24mA/cm²
  Butterfly: 0.52mA/cm²
  Palm shape: 0.29mA/cm² | Similar |
  | Hydrogel thickness | 35mils ± 5mils (0.89mm ± 0.13mm) | 35mils ± 5mils (0.89mm ± 0.13mm) | Same |
  | Hydrogel pH | 4.2 ± 1.0 | 4.2 ± 1.0 | Same |
  | Hydrogel volume resistivity | 1500 ohm-cm max | 1500 ohm-cm max | Same |
  | Compliance/Safety Standards | | | |
  | Standards meet | Compliance with AAMI/ANSI ES 60601-1, ANSI AAMI IEC 60601-2-2, FDA's Impedance Test, ASTM F1980, and manufacturer's requirements (peeling force, simulation use) | • Lead wires test per 8.5.2.3 of AAMI/ANSI ES 60601-1;
  • Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6 and 201.15.101.7 of ANSI AAMI IEC 60601-2-2 Edition 6.0 2017-03;
  • Impedance Test (Dispersion Test) according to FDA's requirement;
  • Peeling force test and Simulation use test according to manufacturer's requirement;
  • Shelf life test per ASTM F1980:2016 | Similar |
  | Biocompatibility | ISO10993-5; ISO10993-10 | ISO10993-5; ISO10993-10 | Same |
  | Sterility Status | Non-sterile (as per predicate) | Non-sterile | Same |
  | Electrical safety | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Same |
  | Other Performance | Good electrical conductivity, good adhesive property (as per predicate) | Good electrical conductivity, good adhesive property | Same |

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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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 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. There are nine shapes of round, rectangle, elliptical, calabash, butterfly, saddle shape, rhombus, meniscus shape and palm shape. For the electrical connection, Jiajian provides lead wire type and snap button type: Lead wire assembly - at least 40mm long wire with 2mm/2.5mm diameter female socket. Snap button assembly - with 2.5~5mm diameter male socket. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/AAMI ES60601-1, subclause 8.5.2.3.

The provided document is a 510(k) summary for the Jiajian Self-Adhesive Electrode, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through clinical studies in the same way a PMA (Premarket Approval) would require.

Therefore, many of the requested points, particularly those related to clinical studies, MRMC studies, training set details, or complex ground truth establishment, are not applicable to this type of regulatory submission (a 510(k)). The manufacturer's conclusion explicitly states: "Clinical data was not including in this submission."

Instead, the submission relies on bench testing and a comparison to an existing predicate device to demonstrate substantial equivalence, focusing on technical specifications, materials, and non-clinical performance.

Here's an analysis based on the available information:

1. Acceptance Criteria and Reported Device Performance (as demonstrated by testing and comparison):

The document doesn't present a formal table of "acceptance criteria" paired with "reported performance" in the way one might expect from a clinical study. Instead, it outlines the tests performed to show the device's adherence to relevant standards and its substantial equivalence to a predicate device. The implicit acceptance criterion is that the device performs as well as or similarly to the predicate device across key parameters and meets relevant safety standards.

Here's a table summarizing the relevant data points and how they compare to the predicate, as presented in the "Substantially Equivalent Comparison Conclusion" table:

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

• Test Set Sample Size: For the bench tests (e.g., impedance, conformability, fluid tolerance, peel strength, shelf life, reuse), the document states: "All test samples were drawn from batches, with 3 samples for each specification."
• Data Provenance: The tests were conducted internally by Wuxi Jiajian Medical Instrument Co., Ltd. in China, as indicated by the submitter/manufacturer address. The data is retrospective, as it's part of a premarket submission.

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

• This is Not Applicable (N/A). For a 510(k) submission based on bench testing and substantial equivalence, "ground truth" established by human experts (like radiologists for image analysis) is not relevant. Performance is measured against engineering specifications and industry standards.

4. Adjudication method for the test set:

• N/A. As there are no human experts establishing a "ground truth" for a medical imaging/AI dataset, no adjudication method is performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• N/A. The document states "Clinical data was not including in this submission." MRMC studies apply to performance of diagnostic devices often involving human interpretation of results, which is not the case for this external electrode.

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

• N/A. This device is a passive electrode, not an algorithm or AI. Standalone performance refers to the accuracy of an AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" or reference was based on engineering specifications, established industry standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-2-2), and the performance characteristics of the legally marketed predicate device (K090198). Essentially, the device's performance was compared against these defined benchmarks.

8. The sample size for the training set:

• N/A. This is not an AI/ML device requiring a training set.

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

• N/A. This is not an AI/ML device requiring a training set or its associated ground truth establishment.

Ask a specific question about this device

DL Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

DL Adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.

DL Adhesive Electrode is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate) or LDPE(Low Density Polyethylene).

DL Adhesive Electrode is non-sterile and intended for single adult patient multiple application use. The Adhesive Electrode has various shapes and sizes.

To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner.

The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.

The provided document is a 510(k) Pre-market Notification for the DL Self-adhesive Electrode (K182111). The document describes the device, its intended use, and importantly, presents non-clinical testing to demonstrate substantial equivalence to predicate devices, thereby ensuring its safety and effectiveness.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DL Adhesive Electrode are primarily based on comparisons with two predicate devices:

• Primary Predicate: K152648 - Ennova Self-adhesive Electrode
• Reference Predicate: K100418 - Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (specifically for the conductive hydrogel)

The equivalence is demonstrated through various non-clinical (bench) tests and a direct comparison of technological characteristics.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The document explicitly states: "Clinical data was not including in this submission."
Therefore, the device's substantial equivalence is demonstrated solely through non-clinical (bench) testing and comparison of technical characteristics to legally marketed predicate devices.

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

   • Sample Size: Not explicitly stated in terms of number of devices tested for each standard. The document only lists the standards applied and that "Bench tests were conducted on DL Adhesive Electrode to verify that the proposed device met all design specifications."
   • Data Provenance: The tests were performed internally or by accredited labs on samples of the DL Adhesive Electrode. The data origin is thus the manufacturer's testing or contract testing facilities, likely within China (where the manufacturer is located). The provenance is prospective with respect to the regulatory submission, as these tests were conducted specifically to support this 510(k). No patient data is involved.

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

   • Not Applicable. As no clinical data was used, there was no "ground truth" derived from expert consensus on patient cases. The "ground truth" for the non-clinical tests are the specified performance limits within the referenced national and international standards (e.g., AAMI, ISO, ASTM) and the technical specifications of the predicate devices. These standards are developed by expert committees, but individual experts were not involved in establishing ground truth for a test set in the context of this submission.

3. Adjudication method for the test set:

   • Not Applicable. Since there was no clinical study involving human readers or subjective interpretations of data, an adjudication method for a test set is not relevant. The assessment relies on objective measurements against pre-defined engineering and performance criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC study was not done. This device is a passive accessory (an electrode); it does not involve AI, human-in-the-loop performance, or image interpretation.

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

   • No. This device is an electrode, not an algorithm or AI system.

6. The type of ground truth used:

   • Technical Specifications and Regulatory Standards. The ground truth for this submission is established by adherence to recognized national and international consensus standards (ASTM, ISO, AAMI/ANSI IEC) for medical electrical equipment, biocompatibility, and shelf-life, as well as direct comparison to the established performance characteristics of the legally marketed predicate devices. Key safety criteria, such as maximum power density, also refer to FDA guidance.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

   • Not Applicable. No training set was used.

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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.

Ask a specific question about this device

ZMI Self-adhesive electrodes are intended for use 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 (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

ZMI Self-adhesive electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, reusable, flexible structures composed of laminated materials commonly used in the application:

Top laver: Insulation material: Fabric/foam/tan fabric
Middle layer: Conductive film (Silver coated Carbon film/Aluminum foil film)
Bottom layer: Biocompatible self-adhesive conductive hydrogel
Connection: Leadwire/snap button/magnetic button

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.

The provided document, a 510(k) Premarket Notification for ZMI Self-Adhesive Electrodes (K180865), is a regulatory submission to the FDA. It does not describe studies proving a device meets acceptance criteria for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices for a physical medical electrode.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) as it is not present in the document. The document focuses on material composition, intended use, and physical/electrical performance tests relevant to an electrode, not on studies involving AI/ML algorithms, image analysis, or human reader performance.

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This product is an adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

The Reusable and Self-Adhesive Electrodes are made of conductive hydrogel, fabric cloth and carbon film. They work when sticking to human skin and connecting with electrical stimulators by lead wires. During the treatment, electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.

The provided document is a 510(k) premarket notification for a medical device: "Reusable and Self-Adhesive Electrodes." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present a comprehensive study proving novel acceptance criteria for a new type of device or algorithm.

Therefore, many of the requested categories for AI/algorithm-based studies (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable to this type of regulatory submission. This document details the non-clinical testing performed to show equivalence in basic device performance and biocompatibility.

Here's an analysis based on the information available:

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

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

• Sample Size: Not specified in the document. For non-clinical tests like material strength, impedance, and biocompatibility, sample sizes are typically determined by relevant ISO standards or internal quality procedures.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by the manufacturer (Shaoxing DongZhi Electrical Technology Co., Ltd. in China) or a certified testing laboratory. The standard for biocompatibility is ISO 10993-1:2009. These are prospective tests conducted on manufactured device samples.

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

• Not applicable. These are non-clinical device performance and material safety tests, not diagnostic or interpretive tasks requiring expert consensus. The "ground truth" is established by direct measurement and adherence to defined physical and biological standards.

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

• Not applicable. Adjudication is for human interpretation and consensus. These tests involve objective measurement against predetermined criteria.

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 is a medical device for electrical stimulation, not an AI diagnostic or interpretive tool.

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

• Not applicable. This is not an algorithm-based device.

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

• The "ground truth" for the non-clinical tests is established by:
  • Physical measurements: For electrical impedance, adhesive strength, and tensile strength, the ground truth is the direct measurement of these properties using calibrated equipment, compared against numerical specifications derived from relevant performance standards.
  • Biological assays: For biocompatibility (cytotoxicity, irritation, sensitization), the ground truth is determined by standardized laboratory assays where effects on biological systems (e.g., cell cultures, animal models) are observed and evaluated against criteria defined in ISO 10993 series.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

The provided text is a 510(k) summary for the Mailuokang Self-adhesive Electrode. It describes the device, its intended use, and compares it to a predicate device (THERATRODE, K112312) to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for impedance test: 12 electrode pairs.
• Data Provenance: The document does not explicitly state the country of origin for the impedance and adhesion self-evaluation tests. It refers to "self-evaluation tests," which implies these were conducted by the manufacturer. The biocompatibility tests are also stated as "Mailuokang's hydrogel has passed three biocompatibility tests," suggesting these were likely conducted by or for the manufacturer. The study is prospective in the sense that these tests were conducted to demonstrate equivalence for this submission.

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

There is no mention of experts or ground truth established by experts for the test set. The performance tests (impedance, adhesion, biocompatibility) are objective measurements based on established standards or internal evaluations, not expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The performance tests are objective measurements, not subjective evaluations 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 is not a study involving human readers or AI assistance. It's a medical device submission for an electrical stimulation electrode.

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

Not applicable. This is not an algorithm-based device. The device itself is a physical electrode.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

• Objective Measurements: Impedance values, adhesion force, and observation of biological response in biocompatibility tests.
• Compliance with Standards: Adherence to established industry standards like ANSI/AAMI EC 12:2000/(R)2005.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training" set in the context of machine learning or algorithms. Its performance is based on material properties and design, validated through direct testing.

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

Not applicable, as there is no training set involved. The performance (ground truth) is established through physical and electrical testing of the electrodes.

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Ennova Self-adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous 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.

Ennova Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. Ennova Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient(age=18) multiple application use. Ennova Self-adhesive Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.

The provided text describes a 510(k) premarket notification for the Ennova Self-adhesive Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about a study proving device acceptance criteria cannot be extracted from this document, as a clinical study was explicitly not included in this submission.

Here's an analysis based on the information available:

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

The document doesn't define "acceptance criteria" in the traditional sense of a clinical trial's primary or secondary endpoints. Instead, it outlines design specifications and performance standards for the device and compares them to predicate devices to establish substantial equivalence.

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

• Sample Size for Test Set: Not applicable for a clinical study in this submission. The tests performed are bench tests on the physical device components. The document does not specify the number of individual electrodes or batches tested for these non-clinical evaluations.
• Data Provenance: The tests were conducted by Suzhou Ennova Electronics Technology Co., Ltd. in China ("Bench tests were conducted on the proposed Self-adhesive Electrode to verify that the proposed device met all design specifications"). The data is non-clinical, originating from laboratory testing. It is neither retrospective nor prospective in the clinical study sense.

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

• Not applicable. This submission relies on non-clinical bench testing against recognized industry standards (e.g., ASTM, ISO, AAMI/ANSI, IEC) and comparison to legally marketed predicate devices. Ground truth in the context of expert consensus (e.g., for image interpretation) is not relevant here. The "ground truth" for these tests comes from objective measurements and adherence to specified performance metrics in the standards.

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

• Not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. The tests performed here are objective bench tests.

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 self-adhesive electrode, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

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

• Not applicable. This is a hardware component (electrode), not an algorithm.

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

• The "ground truth" for this submission is based on established industry standards (e.g., ISO, ASTM, AAMI/ANSI, IEC) and the performance characteristics of legally marketed predicate devices. For example, biocompatibility is assessed against ISO standards, and electrical performance against AAMI/ANSI and IEC standards. The efficacy is inferred from the substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for their intended use.

8. The sample size for the training set:

• Not applicable. This device's approval is based on substantial equivalence demonstrated through bench testing and comparison to predicates, not through machine learning model training.

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

• Not applicable. See point 8.

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