(409 days)
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.
| Parameter | Acceptance Criteria (based on predicate INTERX5000) | Reported Device Performance (SCENAR Cutaneous Electrode Family) |
|---|---|---|
| Type of electrodes | classic – coaxial bipolar | |
| comb – multipoint bipolar | ||
| small circular – coaxial bipolar | small – coaxial bipolar | |
| comb – multipoint bipolar | ||
| point – coaxial bipolar | ||
| Dimensions (without cable) | classic – ~ 80x40x20 mm | |
| comb – ~ 80x40x20 mm | ||
| small circular – ~ Ø16x130 mm | small – 45x37x22 mm | |
| comb – 55x37x22 mm | ||
| point – Ø11x117 mm | ||
| Weight (whole electrode) | data not available | small – 0.028 kg |
| comb – 0.040 kg | ||
| point – 0.022 kg | ||
| Cable length | data not available | small – 910 mm |
| comb – 905 mm | ||
| point – 907 mm | ||
| Compliance with Standards | Not explicitly stated as "acceptance criteria," but implicit for a predicate. | Complies with 21 CFR 898.12 (patient lead wires and electrodes), IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 (safety and EMC). |
| Intended Use | Relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain. | Relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain. |
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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).