(136 days)
The Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.
Disposable Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. There are two types of electrodes, one with fixed lead wire and the other without lead wire, tab electrodes. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations. Tab electrode can be connected, using a lead wire with alligator clip, to the gel free contact strip at the electrode end.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria with numerical targets or performance metrics for the device. Instead, it focuses on the device's adherence to intended use and its substantial equivalence to predicate devices, supported by bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-invasive use with recording and monitoring equipment | Intended for non-invasive use with recording and monitoring equipment |
| Suitable for stimulating/monitoring/recording EEG, sEMG, and EP | Used for stimulating, monitoring, and recording EEG, surface EMG, and EP |
| Designed for single-patient/multiple application use | Designed for single-patient/multiple application use |
| Requires no securing material for fixation | Because of adhesive gel, no securing material required |
| Performance characteristics confirmed through bench testing | Bench testing conducted to confirm performance characteristics |
| Substantially equivalent to predicate devices for safety/effectiveness | Comparison to predicate devices demonstrates substantial equivalence for safety and effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "bench testing" was performed, but no details on the number of samples or specific test cases are provided.
- Data Provenance: The testing was conducted by Technomed Europe, which is based in The Netherlands. It is implied to be internal (bench) testing, not necessarily human subject data. The study is retrospective in the sense that it's a summary of testing already performed, rather than a prospective trial design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish a ground truth for any test set. The evaluation focuses on the physical and functional characteristics of the electrodes through bench testing and comparison to predicate devices, not on diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication is mentioned or implied, as the study relies on bench testing and comparison to predicate devices for electrode performance, not subjective interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- No MRMC study was done. This device (Cutaneous Electrodes) is a hardware component used in medical procedures, not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, there's no mention of AI assistance or human reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done
- Not applicable. This is a hardware device (electrodes), not an algorithm or software. Its performance is assessed through physical and functional bench testing, not as an "algorithm only" study.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily engineering and manufacturing specifications, along with performance characteristics defined by relevant standards and the performance of the predicate devices. For example, the adhesive qualities, conductivity, material safety, and signal acquisition capabilities would be objectively measured without requiring a clinical "ground truth" like pathology or expert consensus.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, there's no ground truth established for one.
§ 882.1320 Cutaneous electrode.
(a)
Identification. 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.(b)
Classification. Class II (performance standards).