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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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The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation). The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.

GMDASZ TENS electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application (Refer to attached BOM): First layer—insulating backing material: Fabric, foam or tan fabric Second layer—Conductive plastic film Third Layer – Biocompatible self-adhesive conductive hydro gel Protective liner-PET. The electrodes are designed for single-patient/ multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the stimulating device 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 as required in IEC60601-1 Subclause 56 3(c). Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.

The provided text describes a 510(k) summary for GMDASZ TENS Electrodes, which is a regulatory submission to the FDA. It does not contain a study that establishes performance criteria or tests the device against those criteria. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided document is a regulatory submission for a simple medical device (TENS electrodes), and such submissions typically rely on established standards and substantial equivalence to already cleared devices, rather than comprehensive clinical performance studies involving AI or complex outcome measures.

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The Pepin Manufacturing, Inc. cutaneous electrotherapy and recording electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals.

Example electrical stimulation current applications of these electrodes are:

a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief.
b) Electrical muscle stimulation (EMS); Powered Muscle Stimulators.
c) Functional electrical stimulation (FES).
d) Galvanic stimulation.
e) Microcurrent electrical nerve stimulation (MENS).
f) Interferential stimulation.
g) Neuromuscular electrical stimulation (NMES).

Pepin Manufacturing Incorporated (PMI) has a 510(k) clearance for TENS Electrodes, reference 510(k) K932849. This 510(k) submission addresses two modifications to these electrodes:

1. Sterile TENS electrodes variation will be commercially available.
2. Use of these TENS electrodes as cutaneous electrotherapy electrodes consistent with the cutaneous electrode classification, 21 CFR 882.1320: "A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation."

The electrodes described by this 510(k) submission remain single patient use devices. The electrodes provide the patient contact device when connected to commercially available electrotherapy (electrical stimulation) and recording devices.

The cutaneous electrotherapy and recording electrodes do not contain active electronics, software or firmware. The cutaneous electrotherapy electrodes connect to the user's electronic device. The electrode construction is equivalent to the predicate devices.

This document is a 510(k) summary for a cutaneous electrotherapy and recording electrode, a device that does not perform diagnostic tasks or provide "performance" in the sense of AI/ML algorithms. Therefore, the questions related to acceptance criteria, study design, ground truth, and expert evaluation are not applicable.

The submission is for a medical device that physically contacts the patient's skin to apply electrical stimulation or record physiological signals, such as an EEG. The purpose of this 510(k) is to demonstrate substantial equivalence to existing predicate devices, rather than showcasing specific performance metrics of a novel algorithm.

Here's an breakdown of why many of the requested points are not applicable:

• 1. A table of acceptance criteria and the reported device performance: This device is compared for functional equivalence to predicate devices. There are no performance metrics like sensitivity, specificity, or AUC that would be typically found in an AI/ML or diagnostic device submission. The "performance" is its ability to conduct electricity and adhere to the skin, which is assumed to be equivalent to the predicate devices.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or data of this nature is described, as it's not a data-driven device.
• 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): Ground truth as it pertains to diagnostic accuracy is not relevant here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. There is no training set for an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of the K070807 510(k) Submission:

This 510(k) submission (K070807) from Pepin Manufacturing, Inc. is for "Cutaneous Electrotherapy and Recording Electrodes." The purpose of the submission is to obtain clearance for two modifications to their previously cleared TENS electrodes (K932849):

1. Commercial availability of sterile TENS electrodes.
2. Expanded indications to include use as general cutaneous electrotherapy electrodes, consistent with the classification 21 CFR 882.1320, for both applying electrical stimulation and recording physiological signals.

Technological Characteristics & Conclusion:

The device is a passive component; it "do[es] not contain active electronics, software or firmware." Its construction is stated to be "equivalent to the predicate devices."

The regulatory review concluded that the device is substantially equivalent to the predicate devices (K932849, K010431, K983097, K023347). The basis for this equivalence is that the modifications do not raise "new questions of safety or effectiveness."

Predicate Devices:

The submission lists four predicate devices:

• K932849: Pepin Manufacturing Incorporated, PMI TENS Electrodes (This is the company's own prior device that is being modified)
• K010431: Lead-Lok, Lead-Lok Reusable TENS/NMES Electrodes
• K983097: Uni-Patch, Inc., TENS/FES/FMES Electrodes
• K023347: Chattanooga Group, Vital Stim Electrodes

These predicates serve as the benchmark for "acceptance criteria" not in terms of performance metrics, but in terms of safety, fundamental design, and intended use as a cutaneous electrode. The study that "proves" the device meets acceptance criteria is primarily an engineering and materials comparison, alongside a demonstration that the sterility modification and expanded indications do not alter the fundamental safety or effectiveness established by the predicate devices.

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TENS Electrodes are to be used for nerve stimulation.

TENS Electrodes

The provided text describes a 510(k) premarket notification for MSB Tens Electrodes and the FDA's determination of substantial equivalence. However, it does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The document is a regulatory letter from the FDA to MSB Limited, confirming that their Tens Electrodes are substantially equivalent to devices marketed prior to May 28, 1976. This letter signifies a regulatory clearance to market the device, but it does not detail the testing or studies that led to this determination. Such studies would typically be part of the 510(k) submission, but their results are not included in this particular document.

Therefore, I cannot provide the requested information based on the given text.

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