(133 days)
The MAGNETOLITH Muscle Stimulator is indicated for:
-Relaxation of muscle spasms,
-Prevention or retardation of disuse atrophy,
-Increase local blood circulation.
-Muscle re-education,
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
-Maintaining or increasing range of motion.
The MAGNETOLITH delivers electromagnetic pulses to stimulate muscle tissues by applying the Magnetic Induction Field Principle (high-energy magnetic pulses) directly over (but not in direct contact with) the patient in order to achieve the same powered muscle stimulation without having to place adhesive electrode pads directly onto the patient's body. Key components of the device are the Control Unit, Handpiece Applicator, Applicator holder, a Mains cable, and a Trolley. These device components are provided non-sterile and are intended to be reusable.
The principle of operation of the MAGNETOLITHis by the application of a treatment coil to generate electromagnetic induction. i.e., the production of voltage across an electrical conductor in a changing magnetic field. The duration of the individual pulses is short and therefore the system does not increase temperature within the tissues. In addition, the MAGNETOLITH Applicator is cooled by circulating water.
It seems there are no specific acceptance criteria or details of a study proving the device meets those criteria provided in the document. The document is a 510(k) summary for the Storz Medical MAGNETOLITH Muscle Stimulator, demonstrating substantial equivalence to predicate devices, rather than a report on specific performance acceptance criteria.
The "PERFORMANCE TESTING" section (Page 4-5) states that: "Verification and validation testing was performed and demonstrated that the MAGNETOLITH meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed." However, it does not explicitly list the acceptance criteria or refer to a specific clinical study with patient data and ground truth establishment.
Instead, the performance testing focuses on:
- Software Validation: The MAGNETOLITH software was validated and demonstrated to be of a moderate level of concern.
- Risk Management: Hazard analysis/risk management was performed, and all risks were mitigated to an acceptable level.
- Biocompatibility: Not performed as there are no body-contacting components.
- Conformity to Standards: The device was tested and demonstrated to conform to general safety requirements of IEC 60601-1:2012, IEC 60601-6:2013, electromagnetic compatibility requirements of IEC 60601-1-2:2014, ISO 14971:2000/A1:2007, IEC 62304:2015, and ISO 13485:2016.
The document then provides a comparison table of the MAGNETOLITH with its predicate devices (HPM-6000 and Bemer Classic & Pro) to establish substantial equivalence based on technological characteristics and safety standards. This comparison is not a study proving specific performance criteria with clinical outcomes.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria based on the provided text. The document focuses on demonstrating substantial equivalence through technical comparisons and adherence to regulatory standards, not on a clinical performance study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
§ 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).