(113 days)
The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.
Indications for Use:
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain
As a pulsed mode device, indications are for the following conditions:
- Relaxation of muscle spasm
- Increasing local blood circulation
- Retardation or prevention of disuse atrophy
- Maintenance or increase of range of motion
The Chattanooga Revolution Wireless is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Chattanooga "Revolution Wireless stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles.
The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
The Chattanooga® Revolution Wireless stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450 [mAh] battery.
The docking station is the part on which all the other components (modules, remote and accessories) are stored when the Chattanooga Revolution Wireless system is not in use. The docking is continuously connected to an AC wall socket and it allows charging simultaneously the 4 stimulation modules and the remote control. The docking main part is intended to be fixed and not for transportation purposes, but the tablet may be removed and used as a portable charging station for the remote and modules. The docking station includes a removable tray where the user can store electrodes, quick start guide, the remote and modules for transportation.
The wireless protocol of the Chattanooga® Revolution Wireless Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to
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Send particular information from remote control to stimulation modules (stimulation settings)
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Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status,
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Transfer binary data to stimulation modules, and
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Allow synchronization from stimulation modules to remote control clocks.
The provided documentation describes the Chattanooga Revolution Wireless, a powered muscle stimulator and transcutaneous electrical nerve stimulator (TENS) device. The information details the device's characteristics, indications for use, comparison to a predicate device (Vectra Neo), and performance testing conducted for its 510(k) premarket notification.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative table format with pass/fail values. Instead, the document discusses compliance with recognized standards and successful completion of various tests. The reported device performance is presented as a confirmation of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | The device was tested and found to comply with AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012, a recognized standard for medical electrical equipment. |
| Electromagnetic Compatibility (EMC) | The device was tested and found to comply with IEC 60601-1-2 Edition 3:2007-03, a recognized standard for electromagnetic compatibility in medical electrical equipment. |
| Nerve and Muscle Stimulator Specific Safety | The device was tested and found to comply with IEC 60601-2-10 Edition 2.0 2012-06, a recognized standard for the basic safety and essential performance of nerve and muscle stimulators. |
| FCC Radio Frequency Compliance | The device was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.249. |
| Software Verification | The device's software was verified in accordance with FDA's guidance document: General Principles of Software Validation, January 11, 2002. The testing demonstrated that the software meets its design requirements. Also complies with IEC 62304 First Edition 2006-05 (Medical Device Software - Software Life Cycle Processes). |
| Usability/Human Factors | Usability/Human Factors testing was performed, demonstrating that established requirements for usability were met, and the design is appropriate for intended users and use environment. The study "substantiates the acceptability of the use-related risks." Complies with IEC 60601-1-6 Edition 3.0 2010-01 (Usability) and IEC 62366:2007, Ed. 1 (Application of Usability Engineering). |
| Wireless Coexistence | The performance was evaluated in an environment with other Chattanooga Revolution Wireless devices and other 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements. |
| Risk Management | Complies with ISO 14971:2007 (Medical Devices - Application of Risk Management). |
| Electrode Lead Wires & Patient Cables | Complies with 21 CFR 898 (Performance standard for electrode lead wires and patient cables). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance tests (e.g., electrical safety, software verification, usability). There is also no mention of data provenance (e.g., country of origin, retrospective/prospective). The tests described are primarily engineering verification and validation studies rather than clinical trials with human participant data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the performance testing primarily involves engineering compliance with standards and functional verification, the concept of "ground truth" established by experts in the clinical sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for these tests would be the specifications outlined in the recognized standards themselves, and the expertise would lie with the engineers and testers performing the measurements and assessments against those standards. No specific number or qualifications of such experts are provided beyond implied expertise in regulatory and engineering compliance.
4. Adjudication Method for the Test Set
As the studies described are compliance-based engineering tests and not clinical studies requiring expert consensus on complex outcomes, an explicit adjudication method like "2+1" or "3+1" is not mentioned or relevant. Compliance is typically determined by whether the device's performance meets the defined parameters of the relevant standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The device is a physical therapy device (stimulator), and the evaluation focuses on its safety and performance against established standards and a predicate device, not on assessing the improvement of human readers (e.g., doctors interpreting scans) with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The device itself is a physical medical device, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance studies are for the integrated device system.
7. Type of Ground Truth Used
The "ground truth" for the performance testing is implicitly defined by:
- Recognized Standards: Such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 14971.
- Design Requirements: For the software verification and usability testing, the device's own design requirements serve as the ground truth against which performance is measured.
- FCC Regulations: For radio frequency compliance.
There is no mention of pathology, clinical outcomes data, or expert consensus (in a diagnostic context) as ground truth.
8. Sample Size for the Training Set
This information is not provided. The document describes premarket notification for a physical medical device, not an AI/ML product that typically involves a "training set." The software verification mentioned refers to traditional software engineering verification, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The ground truth for the device's design and functionality is established through engineering specifications, regulatory standards, and intended use definitions.
§ 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).