(56 days)
The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. The electrode is for single patient use only.
Ambu Neuroline Ground electrode should only be used by or on the order of a physician.
Ambu Neuroline Ground electrode is used to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination.
Ambu Neuroline Ground electrode is provided non-sterile. Ambu Neuroline Ground electrode is a single patient use disposable device.
Ambu Neuroline Ground electrode is a multi-layer construction containing a hydrogel, a conductive film and a lead wire.
The provided text describes a 510(k) summary for the Ambu Neuroline Ground electrode. It is a submission for a medical device seeking clearance based on substantial equivalence to existing legally marketed predicate devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not in the context of clinical performance metrics like sensitivity or specificity. Instead, they refer to the demonstration of substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Electrical Functionality: Equivalent electrical characteristics to predicate devices. | Laboratory tests performed to ensure electrical functionality. |
| Mechanical Functionality: Equivalent mechanical characteristics to predicate devices. | Laboratory tests performed to ensure mechanical functionality. |
| Biocompatibility: Device is biocompatible. | Biocompatibility of the electrode has been established. |
| Safety and Effectiveness: As safe and effective as predicate devices. | Concluded that the device has equivalent electrical and mechanical functionality, meets mandatory performance standards, and is as safe and effective as the predicate devices. |
| Aging Test Performance: Maintained performance over time. | Aging tests were performed. |
2. Sample Size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "laboratory tests" and "aging test" but does not quantify the number of electrodes or test cycles used.
- Data Provenance: Not explicitly stated, but the tests are described as "laboratory tests" implying they were conducted in a controlled environment by the manufacturer (Ambu A/S). There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For this type of device and 510(k) submission, "ground truth" is not established by clinical experts in the way it would be for diagnostic algorithms. The ground truth here is derived from the established performance and safety profiles of the predicate devices, against which the new device's engineering and material properties are compared.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There was no clinical study involving human interpretation or adjudication. The non-clinical tests likely involved objective measurements and comparisons to pre-defined engineering specifications or performance metrics of the predicate devices.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This is an electrode device, not an AI or imaging diagnostic tool.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (an electrode), not an algorithm or software. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this submission is the established performance and safety characteristics of the legally marketed predicate devices. The new device aims to demonstrate substantial equivalence to these existing devices through comparison of technological characteristics and non-clinical test results. In essence, the predicate devices are the "ground truth" for what is considered safe and effective for this product type.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
§ 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).