(104 days)
MagPro R20 is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
MagPro R20 is a Magnetic stimulator used for Magnetic stimulation. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The MagPro R20 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The MagPro R20 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R20 is controlled via a user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R20 has a built-in computer and 2 small displays. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 20 pulses per second (pps).
The provided text is a 510(k) summary for the MagPro R20 device, comparing it to a predicate device, the MagPro R30. The document focuses on demonstrating substantial equivalence for a medical device rather than proving performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.
Therefore, the requested information about acceptance criteria, study design for AI/algorithm performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for AI devices is NOT available in this document.
The document states:
- The intended use of the MagPro R20 is "stimulation of peripheral nerves for diagnostic purposes".
- The conclusion is that "The MagPro R20 has the same intended use as the predicate device and the same technological features. The MagPro R20 does not raise new issues of safety and effectiveness and is substantially equivalent to the predicate device."
The "Testing" section refers to electrical safety and electromagnetic compatibility (EMC) testing, which are standard regulatory requirements for medical devices to ensure they are safe for use and do not interfere with other equipment. These are not performance studies for a diagnostic algorithm.
Here's a breakdown of why the requested information cannot be provided from the given text:
- A table of acceptance criteria and the reported device performance: Not applicable. The device is a stimulator, not a diagnostic algorithm with performance metrics like sensitivity/specificity. The document lists physical and functional characteristics for comparison to a predicate, not performance against diagnostic accuracy targets.
- Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm's diagnostic performance study. The testing mentioned is for electrical safety and EMC.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for diagnostic accuracy is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for diagnostic accuracy.
- 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 is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for diagnostic accuracy.
- The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
This document describes a device approval process based on demonstrating substantial equivalence to a legally marketed predicate device, focusing on similar intended use and technological characteristics, and compliance with safety and EMC standards. It does not involve the type of performance evaluation typically associated with AI/ML diagnostic devices.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).