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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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For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic acute pain.

Delta Scanner devices are micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and as adjunctive treatment in the management of post-traumatic and post surgical pain. They are handheld, easy-to-use battery operated portable devices, for use in the home or clinic. The technological characteristics of these devices, including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM

The provided text is a 510(k) summary for the Med-Lectric Corporation's Delta Scanner devices. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting new clinical trials with acceptance criteria and performance metrics described in the way a de novo or PMA submission would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a specific study proving the device meets them, as it relates to performance benchmarks (e.g., sensitivity, specificity, accuracy).

Here's why the information is not present and what the document does state:

• Acceptance Criteria & Reported Device Performance: This information is not explicitly stated in the context of a performance study for the Delta Scanner devices. The submission claims substantial equivalence based on technological characteristics and intended use matching predicate devices. The document implies that the "acceptance criteria" are met if the new device's characteristics are similar enough to existing cleared devices.
• Study That Proves the Device Meets Acceptance Criteria: There is no specific clinical study described that proves the Delta Scanner devices meet quantitative performance acceptance criteria in terms of efficacy or safety beyond demonstrating substantial equivalence to predicate devices. The submission mentions "verification and validation tests" but provides no details on their methodology, results, or how they relate to specific performance metrics.

Breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria (Inferred): Substantial equivalence to predicate devices (InterX5000™, K042912, K053626; Body-Stim™, Biomodulator™, Best-RSI™, Best Pro™, K062641). Specifically, "technological characteristics... including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM." Also, the "intended uses" are the same.
   • Reported Device Performance: Not mentioned in terms of quantitative clinical outcomes or performance metrics (e.g., pain reduction percentage, adverse events rate, etc.) for the Delta Scanner itself, beyond the claim of substantial equivalence to predicate devices which are presumed to be safe and effective.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance is detailed for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is detailed.

4. Adjudication method 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 device is a TENS device, not an AI-based imaging or diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a TENS device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. No training set is detailed.

9. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:

The 510(k) summary for the Delta Scanner devices relies on demonstrating "substantial equivalence" to already cleared devices. The "verification and validation tests" mentioned are general statements regarding software compliance and overall device equivalence, rather than detailed clinical performance studies with specific acceptance criteria and results for the new device itself.

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