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The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.

The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.

The Cathay Manufacturing Corp. TENS Electrodes (K160081) were compared against a primary predicate device (K080276) and a reference device (K132588) to establish substantial equivalence. The study involved bench testing (non-clinical) to assess performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Maximum and minimum values within ±10% of average value. | Met: No significant deviation; max/min values within ±10% of average. |
   | Stability and shelf life | 2 year | 2 year (demonstrated to be equivalent) |

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes (number of electrodes) used for each individual performance test (e.g., electrical impedance, tensile strength) on the subject device. It mentions "Largest model: CM100180FC (Rectangle shape: 100 x 180 mm); Smallest model: CM2222FC (square shape: 22 x 22 mm); Irregular representative: CM2542YC(crescent )" were used for testing electrode types, shapes, and sizes. This suggests at least one of each representative size and shape were included.

The data provenance is not specified beyond being "bench testing (non-clinical)." There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the study described is a non-clinical bench testing study of TENS electrodes, not a study involving human-in-the-loop performance or expert interpretation of diagnostic images/data. Therefore, there was no ground truth requiring expert establishment.

4. Adjudication Method:

This section is not applicable for the same reasons as above. There was no expert review or adjudication of results required for this type of non-clinical bench testing.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to TENS electrodes' physical and electrical performance evaluation.

6. Standalone Performance Study:

Yes, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done, but not for an AI algorithm. The "algorithm" in this context refers to the device itself and its intrinsic performance as measured by various physical and electrical tests. The bench testing evaluated the device's performance directly against the defined acceptance criteria without human interaction influencing the measurement results.

7. Type of Ground Truth Used:

The "ground truth" for this study was based on objective, quantitative measurements and established industry standards (e.g., IEC 60601-1, IEC 60601-2-10:2012, AS07-003 / GB/T4852-2002). The results of the tests (e.g., resistance values, weight held, adhesion percentage) served as the direct evidence of performance against these pre-defined benchmarks.

8. Sample Size for the Training Set:

This section is not applicable. The device in question is a physical medical device (TENS electrodes), not an AI algorithm that requires a training set. The "design" and "validation" mentioned relate to engineering and manufacturing processes, not machine learning model training.

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

This section is not applicable for the same reason as above. There was no training set for an AI algorithm.

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This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.

The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided. Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag. The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.

The provided text describes a submission for a Disposable Neutral Electrode (Model: GP202) and its substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria with performance metrics.

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment cannot be extracted from the provided text. This document is a 510(k) summary focused on demonstrating equivalence and compliance with general safety and performance standards.

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

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

• Cannot be provided in the requested format. The document states that "Laboratory testing was conducted to validate and verify that the Disposable Electrosurgical Pencil met all design specifications, including electrical safety, EMC, biocompatibility, specification." (Section 5) and that "Electrical safety test, Mechanical performance test, and Biocompatibility test have been done to demonstrate the safety and performance of subject devices." (Section 7.0). However, it does not list specific numerical acceptance criteria (e.g., maximum impedance, minimum adhesion strength) or the quantitative performance results achieved by the device against those criteria. It only states that the tests demonstrated compliance and did not result in safety hazards.

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

• Cannot be determined from the text. The document does not specify sample sizes for any of the tests (electrical safety, mechanical performance, biocompatibility). It also does not mention data provenance (country of origin, retrospective/prospective). These tests appear to be laboratory-based rather than clinical data 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 / Cannot be determined. This device is a disposable neutral electrode, and the testing described (electrical safety, mechanical, biocompatibility) does not involve human interpretation or "ground truth" established by clinical experts in the way an imaging AI device would. The "ground truth" for these tests would be objective measurements against predefined standards.

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

• Not applicable / Cannot be determined. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement. The laboratory tests for this device would have objective pass/fail criteria based on 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. This is not an AI device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Objective standards and measurements. For the tests mentioned (electrical safety, mechanical performance, biocompatibility, EMC), the "ground truth" would be the established international and national standards (e.g., IEC60601-1, IEC 60601-2-2, ISO 10993-5, ISO 10993-10) and objective measurements verifying compliance with these standards.

8. The sample size for the training set

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

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

• Not applicable. There is no training set.

Summary of what the document DOES provide:

• Device Name: Disposable Neutral Electrode, Model GP202
• Intended Use: For adult patients with conductive adhesive gel, used as a neutral reference during electrosurgical procedures.
• Testing Conducted: Electrical safety test, Mechanical performance test, Biocompatibility test.
• Compliance Standards:
  • "510(k) Guidance Document for General Surgical Electrosurgical Devices"
  • ANSI/AAMI American National Standard for Electrosurgical Devices
  • IEC60601-1 (International Standard for electrical medical device)
  • IEC 60601-2-2 (International Standard for Electrosurgical Devices)
  • ISO 10993-5 and ISO 10993-10 (Biocompatibility)
• Conclusion: The tests demonstrated compliance with requirements and did not reveal any safety hazards, leading to a conclusion of substantial equivalence to predicate devices and that the device is safe and effective.

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