(287 days)
The Magstim® Double 70mm Air Film™ Coil is a stimulating coil solely intended for use with the Magstim® Rapid2 Stimulating Unit for the purposes of peripheral nerve stimulation. The coil is an accessory of the Magstim® Rapid2 Unit.
The Magstim Double 70mm Air Film Coil is an air-cooled coil intended for peripheral stimulation of the nerves. This coil enables deep, and otherwise inaccessible, nerves to be stimulated easily and relatively painlessly. Additionally, no skin preparation is required and stimulation can be achieved through clothing. The Magstim Double 70mm Air Film Coil is for use by, or under the supervision of, a medical practitioner only.
The provided text is a 510(k) submission for the Magstim® Double 70mm Air Film™ Coil. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested items (e.g., acceptance criteria for reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) because the submission's purpose is not to evaluate the diagnostic or treatment effectiveness of an AI/ML model.
This submission is for a physical medical device (a stimulating coil) that is an accessory to another device. Its clearance is based on demonstrating that it is as safe and effective as existing legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from 510(k) comparison) | Reported Device Performance (Magstim® Double 70mm Air Film™ Coil) |
|---|---|
| Average Inductance (Comparable to predicates) | 12 µH (Predicate 1: 16.35 µH, Predicate 2: 15.50 µH) - Note: Lower value, considered acceptable if overall safety/effectiveness is maintained. |
| Manner of Stimulation (Peripheral) | Peripheral |
| Cooling (Feature comparison) | Yes (Predicates: No) - Note: This is a distinguishing feature, not an acceptance criterion in the traditional sense, but part of the comparison. |
| Multiple Use (Yes) | Yes |
| Sterile (No) | No |
| Weight (Comparable to predicates) | 3kg (Predicate 1: 1.6kg, Predicate 2: 1.8kg) - Note: Higher value, considered acceptable if overall safety/effectiveness is maintained. |
| Integral Adapter (Feature comparison) | Yes (Predicates: No) - Note: Distinguishing feature, not an acceptance criterion. |
| Safety and Effectiveness (Demonstrated as similar to predicates) | "The Magstim Double 70mm Air Film Coil is both safe and effective and is similar in its risks and benefits, as well as its manner of performance, to the predicate devices listed above." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission does not involve a "test set" in the context of evaluating an AI/ML model's performance on clinical data. The comparison is based on device specifications and intended use.
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)
- N/A. No ground truth established by experts for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable, as there is no test set for clinical performance evaluation.
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
- N/A. No MRMC study was conducted. This is a physical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Not applicable, as there is no ground truth generation in the context of clinical performance evaluation for this device. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- N/A. Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- N/A. Not applicable.
§ 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).