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

Adhesive Electrodes are composed of non-woven fabric, carbon film coated with silver and conductive hydrogel; It is identical in technological characteristics compared to the predicate device, Adhesive Electrodes, OACWN serial cleared in K160138 and the subject devices are also to be sold for over-the-counter (OTC) use and prescription use, which is the same as the predicate device.

Adhesive Electrodes manufactured by Voncare Medical Device Co., Ltd are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.

First layer: Insulating backing material-nonwoven coated with 30-50um bio-compatible medical adhesive tape
Second layer: Conductive film
Third layer: Bio-compatible self-adhesive conductive hydrogel, thickness 1.0+/-0.2mm
Protective silicon liner: PET

The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.

The provided text describes the regulatory clearance (K212191) for "Adhesive Electrodes" manufactured by Voncare Medical Device Co., Ltd. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the study details are primarily related to non-clinical performance and safety testing.

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

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

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

• Sample Size for Test Set: The document does not specify the sample size for individual tests. It states that "Non-clinical tests were conducted."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given that the manufacturer is based in China, it's highly probable the testing was conducted there or overseen by the manufacturer.

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 and not provided in the document. The tests performed are non-clinical (e.g., electrical impedance, mechanical strength, biocompatibility), which rely on standardized measurement methods rather than expert interpretation of a "ground truth" in the clinical sense.

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

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or challenging endpoints.

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 MRMC study was conducted. The device is an adhesive electrode, a passive component, not an AI-powered diagnostic or assistive tool for human readers. The document explicitly states: "No clinical study is included in this submission."

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

Not applicable. The device is an adhesive electrode, not an algorithm, and does not involve AI or standalone performance in the context of diagnostic or interpretive tasks.

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

For the non-clinical tests, the "ground truth" is defined by the applicable standards requirements (e.g., ANSI/AAMI ES60601-1 for safety/performance, ISO10993 for biocompatibility) and the predicate device's performance characteristics. The tests verify that the subject device meets these established performance and safety benchmarks.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm and therefore does not have a training set.

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

Not applicable. This device is not an AI algorithm and therefore does not have a training set.

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The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.

The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin. Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application: EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET. The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).

The provided text describes ShenZhen Quality Medical Technology Co.,Ltd's "Adhesive Electrodes" (K171381) and indicates its substantial equivalence to predicate devices, rather than outlining a detailed study proving the device meets specific acceptance criteria in the manner requested. The document is a 510(k) summary for a medical device focusing on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

Here's what can be extracted and inferred based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

According to the document, the acceptance criteria are largely based on equivalence to predicate devices and adherence to relevant ISO standards.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing" and "non-clinical tests" which typically involve a number of units for various evaluations (e.g., electrical, mechanical, biocompatibility). However, the specific number of units tested for each criterion is not provided.
• Data Provenance: The testing was conducted by or on behalf of ShenZhen Quality Medical Technology Co.,Ltd, which is based in Shenzhen, Guangdong, China. This indicates the testing was likely performed in China. The data is retrospective in the sense that it supports a regulatory submission for a device designed and tested prior to the submission date.

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

• Not Applicable. This device is an adhesive electrode, and the testing described is primarily physical, electrical, and biocompatibility testing. It does not involve interpretation of medical images or data by human experts for establishing ground truth as would be relevant for diagnostic AI/CAD devices. The "ground truth" here is the objective measurement against established standards or predicate device performance.

4. Adjudication method for the test set

• Not Applicable. As per point 3, there's no "ground truth" established by human interpretation that would require an adjudication method.

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 not an AI/CAD/diagnostic device. No MRMC study was conducted or is relevant for this type of medical device (adhesive electrodes).

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

• Not Applicable. This is a hardware medical device (adhesive electrodes). There is no algorithm in the traditional sense that would have a "standalone" performance. The performance is purely that of the physical device.

7. The type of ground truth used

• The "ground truth" for the device's performance is established by objective measurements against recognized industry standards (e.g., ISO, ASTM) and comparison to the performance characteristics of legally marketed predicate devices. For example, "A.C. Impedance <300 ohms" is a measurable standard. Biocompatibility is assessed against ISO 10993.

8. The sample size for the training set

• Not Applicable. This device is not an AI/machine learning device; hence, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

The proposed device, Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator, i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.

The intended environment for the proposed device includes home use and hospital use. The intended population for the proposed device includes children and adults.

The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.

The provided text is a 510(k) summary for Reno Medical Ltd.'s Adhesive Electrodes, and it specifically states: "No clinical study is included in this submission."

Therefore, a detailed description of acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment related to a clinical study cannot be provided from this document. The submission relies entirely on non-clinical testing to demonstrate substantial equivalence to a predicate device.

However, based on the non-clinical tests mentioned, we can infer the reported approach to meeting performance criteria.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide a specific table of acceptance criteria with reported performance metrics for the proposed device in a clinical context. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

The comparison table (Table 1) shows that the proposed device is considered "Identical" to the predicate device (K132588) across various characteristics, including:

• Product Code: GXY
• Regulation Number: 21 CFR 880.1320
• Class: II
• Intended Use: Adhesive electrodes for use as disposable, conductive interface between patient's skin and Electrical Stimulators (TENS/EMS) for OTC use.
• Design Feature: Substrate / Wire / Hydro-Gel Scrim / Conductive Fiber Carbon Conductive Film / Liner
• OTC or Prescription: For OTC use
• Biocompatibility: Conforms to ISO 10993 series standards
• Label/Labeling: Complied with 21 CFR part 801

The acceptance criteria for these aspects are implicitly that the proposed device's characteristics match those of the predicate device and comply with relevant standards and regulations.

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

This information is not provided because no clinical study was conducted. The "test set" in this context refers to the non-clinical tests' samples. The document does not specify the sample sizes or data provenance for these non-clinical tests.

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 study with human subject data requiring expert ground truth was performed.

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

Not applicable, as no clinical study with human subject data requiring adjudication was performed.

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

Not applicable. The device is an adhesive electrode, not an AI-powered diagnostic tool, and no MRMC study was conducted.

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

This is not an AI algorithm. The device performance was assessed via non-clinical tests, not an algorithm's standalone performance.

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

Not applicable, as no clinical study with human subject data requiring ground truth was performed. For the non-clinical tests, the "ground truth" would be established by validated test methods and reference standards for material properties, electrical performance, biocompatibility, etc.

8. The sample size for the training set

Not applicable, as this is not an AI-powered device and no training set was used.

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

Not applicable, as this is not an AI-powered device and no training set was used.

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The Adhesive Electrodes are 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 (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.

Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

First layer: Insulating backing material: Fabric/foam/tan fabric
Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film
Third layer: Biocompatible self-adhesive conductive hydrogel
Protective liner: PET

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 electrode is connected to the electrical stimulator by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.

This document is a 510(k) premarket notification for "Adhesive Electrodes" manufactured by GMDASZ Manufacturing Co., Ltd. The submission seeks to expand the sales of their existing electrodes (previously cleared under K092546) to include Over-The-Counter (OTC) use, and also introduces new electrodes with an Aluminum foil film conductive layer, comparing them to the predicate device K132998 (Wandy self-adhesive electrodes).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria." Instead, it compares the subject device's performance against two predicate devices (K092546 and K132998) across various technical specifications, which implicitly serve as acceptance criteria. The key performance metrics and their comparison are:

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 does not specify the sample size for any conducted tests.
The data provenance is from GMDASZ Manufacturing Co., Ltd., which is based in Guangdong Province, P.R. China. The studies appear to be prospective testing conducted by the manufacturer to demonstrate substantial equivalence.

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/not provided. The device is an adhesive electrode, and the evaluation relies on technical and performance testing against established standards and predicate devices, not on expert interpretation of medical images or conditions where "ground truth" is typically established by medical professionals.

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

This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image interpretation studies where multiple readers assess cases and discrepancies are resolved. The studies described here are laboratory/performance 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

This information is not applicable/not provided. An MRMC study is for evaluating diagnostic performance, often with AI. The device is a medical accessory (adhesive electrode) and is not an AI diagnostic tool.

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

This information is not applicable/not provided. This device is an electrode, not an algorithm. Therefore, "standalone" algorithm performance is not relevant. The device's performance is inherently tied to its physical and electrical properties.

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

The "ground truth" for the performance tests appears to be established industry standards (e.g., EC12/EC53, ISO10993) and the documented performance characteristics of legally marketed predicate devices. The tests conducted (safety, adhesion, current dispersion, reusability, stability) evaluate whether the device meets these pre-defined technical specifications.

8. The sample size for the training set

This information is not applicable/not provided. This medical device is a physical product (electrode) and does not involve machine learning or AI models that require a "training set."

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

This information is not applicable/not provided, as there is no training set for this type of device.

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Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

The proposed device. Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator. i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.

The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.

The provided text describes a 510(k) premarket notification for "Adhesive Electrodes". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness for a new medical device. Therefore, the information typically found in a clinical study for a new device (like specific performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, or detailed ground truth establishment) is not present in this document.

The "study" that proves the device meets acceptance criteria, in this context, is a non-clinical test that demonstrates compliance with relevant standards and substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an adhesive electrode, the acceptance criteria are generally compliance with recognized standards and demonstration of substantial equivalence to a predicate device. Specific numerical performance metrics against acceptance criteria are not detailed in this summary for the product itself beyond standard compliance.

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

• Sample Size for Test Set: Not specified. The document only mentions "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These would likely involve testing of manufactured units, but the number of units is not provided.
• Data Provenance: The tests are "Non clinical tests", implying laboratory testing of the device itself rather than data from human subjects. The manufacturing company, Top-Rank Health Care Co., Ltd, is located in China.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI-driven devices. For an adhesive electrode, the "ground truth" is established by adherence to recognized performance standards (like ANSI/AAMI HF18:2001) and material biocompatibility standards (ISO 10993). No human experts are described as establishing "ground truth" for the performance of the adhesive electrode itself.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in diagnostic studies. This is not a diagnostic device and the referenced "Non clinical tests" are likely laboratory-based.

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 not a diagnostic device, and there is no mention or implication of AI or human readers being involved in its evaluation.

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

No. This is not an algorithm-based device.

7. The Type of Ground Truth Used

For this device, the "ground truth" for proving it meets acceptance criteria is primarily:

• Compliance with established industry performance standards (ANSI/AAMI HF18:2001 for electrosurgical devices).
• Compliance with biocompatibility standards (ISO 10993).
• Demonstration of functional and material correspondence to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. See point 8.

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Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with U.S. legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Adhesive Electrodes

This document is a 510(k) premarket notification letter from the FDA regarding "Reno Medical Adhesive Electrodes". It focuses on the regulatory approval of the device based on substantial equivalence to existing predicate devices.

Based on the provided text, there is no information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed study parameters you've requested.

The letter explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the approval is based on a comparison to existing devices, not a new study demonstrating performance against specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria or details about a study to prove device performance because this information is not present in the provided FDA letter.

The document is a regulatory approval letter, not a scientific study report.

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