(141 days)
The device is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
MagPro R30 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 R30 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-125 and MC-B70 in K926516 can be used with the MagPro R30 as well as the coils C-100, C-B60 and MMC-140-II. The MagPro R30 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R30 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R30 has a built-in computer and a 8.4" display. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 30 pulses per second (pps).
The provided text is a 510(k) summary for the MagPro R30 Magnetic Stimulator. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving clinical performance against specific acceptance criteria through a study as would typically be done for a novel AI/software medical device.
Therefore, many of the requested elements for a study proving device meets acceptance criteria are not applicable to this submission, as it's not a performance study in the context of AI or diagnostic accuracy. Instead, the submission relies on demonstrating that the new device has the same intended use and similar technological features to legally marketed predicate devices, and therefore does not raise new issues of safety and effectiveness.
Here's how to address your request based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence claim for a magnetic stimulator, the "acceptance criteria" are intrinsically tied to demonstrating that the new device (MagPro R30) performs comparably to the predicate devices and meets established safety standards. There are no specific quantitative "acceptance criteria" and "reported device performance" metrics in the sense of diagnostic accuracy (e.g., sensitivity, specificity) for a study of this nature. Instead, the performance is evaluated against the predicate's known functionality and safety.
| Acceptance Criteria (Implied from Substantial Equivalence Claim) | Reported Device Performance (from K061645) |
|---|---|
| Intended Use Equivalence: Same intended use as predicate devices. | "The MagPro R30 is intended to be used for stimulation of peripheral nerves for diagnostic purposes." (Matches predicate's use) |
| Technological Feature Equivalence: Similar technological features (e.g., power electronics, user interface, magnetic coils, waveform, frequency). | "MagPro R30 has the same characteristics as the predicate devices... All include a user interface... The waveforms for the MagPro R30 and the Magstim Super Rapid² are biphasic, for the MagPro the waveforms are biphasic and monophasic. The Max. stim. frequency is 30 pulses per second for MagPro R30 and Magpro..." |
| Coil Compatibility/Equivalence: New coils can be used; new coils are comparable to predicate coils in mechanical, electrical, and magnetic parameters. | "The original coils MC-125 and MC-B70 in K926516 can be used with the MagPro R30 as well as the coils C-100, C-B60 and MMC-140-II." "The mechanical, electrical and magnetic parameters of the coils in this submission are very near to the parameters of the predicate coils." |
| Safety and Effectiveness: Does not raise new issues of safety and effectiveness. | "The MagPro R30 and coils do not raise new issues of safety and effectiveness and is substantially equivalent to the predicate devices." (Supported by compliance with standards) |
| Compliance with Standards: Adherence to relevant medical device and electrical safety standards. | "The MagPro R30 is CE-marked and complies with the Medical Device Directive 93/42/EEC... developed and manufactured according to EN13485... complies with the standard for electrical safety standard, IEC 60601-1, and has been tested at a certified test center, UL Demko. EMC testing has been performed for compliance with the EMC standard, IEC 60601-1-2." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance study with a "test set" in the context of diagnostic data. The evaluation is based on comparing the device's technical specifications and intended use to predicate devices and adherence to recognized standards.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No clinical data or patient data is discussed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This document does not detail a study involving expert consensus for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not applicable.
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. This is not an AI/software medical device requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an AI/software medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of a diagnostic performance study. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices and the adherence of the new device to recognized performance and safety standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: 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).