(103 days)
For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction
The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.
Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/algorithm-based device. Therefore, many of the requested points, especially those related to AI system validation (e.g., sample size for test datasets, expert ground truth, MRMC studies), are not applicable to this type of submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for an electrotherapy system, mainly through bench testing and technical comparisons, rather than clinical performance studies against a "ground truth" derived from expert consensus or pathology, as would be common for AI-driven diagnostic tools.
Acceptance Criteria and Device Performance (for an Electrotherapy System)
Since this is an electrotherapy system and not an AI/algorithm, the "acceptance criteria" are related to safety, electrical performance, and electromagnetic compatibility. The "reported device performance" demonstrates compliance with these standards.
Table of Acceptance Criteria and Reported Device Performance
| Category / Characteristic | Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 for basic safety and essential performance | Complied. The device was tested and found to comply with IEC 60601-1. |
| EM Compatibility | IEC 60601-1-2 for electromagnetic compatibility | Complied. The device was tested and found to comply with IEC 60601-1-2. |
| Usability | IEC 60601-1-6 for usability | Complied. The device was tested and found to comply with IEC 60601-1-6. |
| Home Healthcare | IEC 60601-1-11 for home healthcare | Complied. The device was tested and found to comply with IEC 60601-1-11. |
| Nerve/Muscle Stim. | IEC 60601-2-10 for performance of nerve and muscle stimulators | Complied. The device was tested and found to comply with IEC 60601-2-10. |
| FCC Requirements | FCC Part 15 Subpart B:2008 Class B | Complied. The device was tested to FCC requirements and found to comply with FCC Part 15 Subpart B:2008 Class B. |
| FCC CFR Title 47 Part 15 Subpart C | Complied. The device was tested to FCC requirements and found to comply with FCC CFR Title 47 Part 15 Subpart C. | |
| Software Validation | FDA's guidance document: General Principles of Software Validation, Jan 2002 | Verified. The device's software was verified in accordance with the requirements, and "software testing demonstrated that the software meets its design requirements." |
| Wireless Coexistence | Performance in environment with other 2.4 GHz wireless devices (Bluetooth, Wi-Fi) | Met all specified requirements. "The performance of VitalStim® Plus Electrotherapy System was evaluated in an environment with other VitalStim device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements." |
| Patient Leakage Current |
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).