(318 days)
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.
| Parameter | Predicate Device (InterX5000) Performance | SCENAR Device Reported Performance | Acceptance Criteria (Not explicitly stated as such, but implied by comparison) |
|---|---|---|---|
| Supply Voltage | 9 V | CHANS-01-SCENAR, CHANS-01-SCENAR-M: 9 V; SCENAR-1-NT (version 02): 4.0 to 6.4 V | Comparable to predicate device. |
| Maximum Supply Current | Data not available | CHANS-01-SCENAR, CHANS-01-SCENAR-M: not more than 85 mA; SCENAR-1-NT (version 02): not more than 650 mA | Within acceptable limits for safety and function. |
| Amplitude of the stimulating pulse at a standard load | not more than 450 V (measuring conditions not available) | not more than 150 V | Within an acceptable range relative to the predicate device for pain relief. |
| Pulse Frequency | 15 to 350 Hz | CHANS-01-SCENAR, CHANS-01-SCENAR-M: 14, 60, 90, 340 Hz; SCENAR-1-NT (version 02): 15 to 350 Hz | Comparable to predicate device. |
| Weight | not more than 0.3 kg | CHANS-01-SCENAR, CHANS-01-SCENAR-M: not more than 0.2 kg; SCENAR-1-NT (version 02): not more than 0.4 kg | Comparable to predicate device. |
| Dimensions | 220x60x45 mm | CHANS-01-SCENAR, CHANS-01-SCENAR-M: not more than 140x55x35 mm; SCENAR-1-NT (version 02): not more than 190x70x40 mm | Comparable to predicate device. |
| Safety and EMC Standards Compliance | (Implied by existing clearance of predicate) | IEC 60601-2-10:2001 + A1:2001, IEC 60601-1:1988 + A1:1991 + A2:1995, EMC: IEC 60601-1-2:2001 (ed. 2) | Full compliance with relevant international safety standards. |
| Software Verification | (Implied by existing clearance of predicate) | Conducted according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff- May 11, 2005" | Full compliance with FDA software guidance. |
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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