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The SCENAR Cutaneous Electrode Family with SCENAR TENS devices is indicated for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.

The SCENAR Cutaneous Electrode Family is intended to be used with electrostimulation devices produced by RITM OKB ZAO as external add-on electrode accessories. The SCENAR Cutaneous Electrode Family does not contain any electrical components. Electrodes are made of stainless steel, brass with silver plated, ABS plastic and fluoroplastic placed in ABS plastic case. The electrodes are connected to electrostimulator by wiring through a connector cable.

Here's the breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) submission for a medical device accessory and the "study" described is a substantial equivalence comparison rather than a clinical trial in the traditional sense.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a predicate device. This means the new device (SCENAR Cutaneous Electrode Family) should have similar technological characteristics and indications for use, and perform at least as safely and effectively as the predicate. The performance evaluation focuses on direct comparison of physical and technical specifications rather than clinical outcomes.

Key Finding: The report asserts that differences in dimensions are "minor" and do not affect the Indications for Use or Fundamental scientific technology. The devices meet relevant electrical safety and EMC standards.

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

• Sample Size: The document does not describe a clinical "test set" with human subjects or a specified number of devices tested for performance comparison. Instead, the comparison is based on the published specifications of an existing predicate device (InterX5000 optional external electrode accessories) and the specifications of the new SCENAR Cutaneous Electrode Family.
• Data Provenance: This is not a study involving patient data. The data provenance is from the manufacturer's internal specifications and publicly available information (published data) for the predicate device. The information originates from Russia (RITM OKB ZAO) for the new device.

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

Not applicable. This is not a study that establishes ground truth through expert consensus on clinical cases. The "ground truth" for this submission are the technical specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is a technical comparison, not a clinical study involving case assessment.

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 transcutaneous electrical nerve stimulator electrode family, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant to this submission.

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

Not applicable. This device is a passive accessory (an electrode) and does not involve an algorithm or standalone performance in the sense of AI or automated diagnostic systems. The electrodes have no power or software on their own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the technical specifications and safety standards for transcutaneous electrical nerve stimulator electrodes. The comparison is made against the established characteristics of the legally marketed predicate device (InterX5000 optional external electrode accessories) and relevant international safety and EMC standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and FDA regulations (21 CFR 898.12).

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, no training set is relevant.

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

Not applicable. As there is no training set for an AI model, no ground truth needed to be established for one.

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For relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.

SCENAR transcutaneous electrostimulators are designed for delivering general noninvasive treatment via human skin areas for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain. SCENAR devices generate low and medium frequency bipolar electric pulses. The shape of the pulses dynamically varies with changing electrophysiological characteristics of the skin. The device has an upper cover, case with a built-in electrode and a battery cover. All components except for the batteries are located on the printed circuit board inside the device's case. The device's controls and visual indicators are located on the upper side of its case.

The provided document is a 510(k) Summary for the SCENAR transcutaneous electrostimulators, seeking substantial equivalence to a predicate device (InterX5000). The focus of this submission is on demonstrating the equivalence of technological characteristics and performance, not on clinical performance against specific acceptance criteria. Therefore, most of the requested information regarding clinical studies, ground truth, expert involvement, and sample sizes is not explicitly available or applicable in the provided text.

Specifically, this document describes a device for pain relief, which typically does not involve an "algorithm" in the sense of AI/image processing algorithms that would have specific performance metrics like sensitivity, specificity, or reader improvement studies. The "performance" described here refers to technical specifications and compliance with safety standards rather than clinical efficacy metrics.

Here's a breakdown of the information that can be extracted and a clear statement of what is not present:

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

The document does not define specific "acceptance criteria" for clinical performance. Instead, it compares the technical specifications of the SCENAR devices to the predicate device, InterX5000, and states that evaluation tests demonstrate substantial equivalence.

Note: The "Acceptance Criteria" column is inferred from the document's goal of demonstrating substantial equivalence to the predicate device and compliance with regulatory standards.

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 in the document. The submission references "evaluation tests" and "test reports" but does not detail sample sizes, types of data (e.g., patient data), or data provenance. This is typical for submissions focused on technical equivalence rather than clinical performance.

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. The device is an electrostimulator for pain relief, not an diagnostic imaging or AI device that would require expert consensus for ground truth on a test set. The "tests" mentioned are likely technical and electrical performance tests conducted by engineers or testing labs.

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

This information is not applicable and not provided for the same reasons as #3.

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 and not provided. The SCENAR is a standalone electrostimulation device, not an AI-assisted diagnostic tool.

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

This is implicitly asserted through the demonstration of substantial equivalence in technical specifications and compliance with safety standards. The device is a "standalone" electrostimulator. There isn't an "algorithm" in the AI sense, but its fundamental operation is described as generating specific electrical pulses. The document states that the "technological characteristics and performance of SCENAR devices are substantially equivalent to those of InterX5000," which serves as the "standalone" performance assessment for regulatory purposes.

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

For the technical performance aspects, the "ground truth" would be established by validated measurement methods and engineering standards (e.g., power meters, oscilloscopes, electrical load simulators) to verify parameters like voltage, current, and frequency against the design specifications and relevant international standards (IEC 60601 series). For the pain relief indication, the document does not present clinical study data for efficacy, rather it relies on the predicate's established efficacy.

8. The sample size for the training set

This information is not applicable and not provided. The device is not based on machine learning or AI that would require a "training set."

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

This information is not applicable and not provided for the same reason as #8.

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