(70 days)
The Mantra Electrode is intended to be used with Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units.
The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.
The provided document is a 510(k) summary for the Mantra Electrode, which is a cutaneous electrode. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, expert involvement, or MRMC studies.
Therefore, most of the requested information cannot be extracted from this document based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "The device meets the mandatory performance standards" but does not define what those standards are or present any specific performance data from a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No study or test set details are mentioned in the document.
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)
- Cannot be provided. No ground truth establishment or expert involvement for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is mentioned.
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
- Cannot be provided. This document describes a simple medical device (an electrode), not an AI or imaging diagnostic device. Therefore, an MRMC study and AI assistance are not applicable and are not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. As above, this is not an AI or algorithm-driven device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth is mentioned. The substantial equivalence is based on "indications for use," "technological characteristics," and "biocompatibility."
8. The sample size for the training set
- Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth for it is mentioned.
Summary of available information:
The document focuses on demonstrating substantial equivalence to a predicate device (Uni-Patch Electrode Model Re-Ply®, K983097) rather than providing detailed performance study data against specific acceptance criteria. This is common for 510(k) submissions of certain classes of devices.
The basis for substantial equivalence is listed as:
- Same indications for use.
- Equivalent technological characteristics and instructions for use.
- Meets mandatory performance standards (though these are not detailed).
- Biocompatibility established (details not provided).
§ 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).