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Quantum Mitohormesis Medical Device is intended for:

• Stimulating healthy limb muscles to improve and facilitate muscle performance.
• Preventing or retardation of disuse atrophy of muscles.

Quantum Mitohormesis (QMT) is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. Users (adults ≥ 22 years old) place one group of muscles in the lower limbs into the field applicator of QMT device, which for a defined duration generates specific electromagnetic fields that stimulates healthy muscles to improve and facilitate muscle performance, and prevents and retards muscle disuse atrophy.

QMT is applied directly to muscles (without direct contact) to stimulate muscle activity. In order to achieve optimized treatment outcome, QMT is applied to muscles on a weekly basis, once or twice a week, with each treatment application lasting a brief 10-minutes.

The device consists of the following high-level components:

• Base unit, which includes signal generator, power amplifier, and micro-controller unit.
• Field applicator, which includes electro-magnetic coils generating specific magnetic pulses.
• User Interface Panel, which allows users to operate the device and display necessary device information.
• Signal cord.
• Height and tilt adjustment knobs, which allow users to adjust the height and tilt of field applicator; and

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to QuantumTX Pte. Ltd. regarding their Quantum Mitohormesis (QMT) device. It confirms the device's substantial equivalence to legally marketed predicate devices, allowing its marketing.

The document discusses:

• Regulatory information: Device classification, regulation numbers, and general controls.
• Device description: How the QMT device works (pulsed electromagnetic fields for muscle therapy) and its components.
• Intended Use/Indications for Use: Stimulating healthy limb muscles to improve and facilitate muscle performance, and preventing or retarding disuse atrophy of muscles.
• Comparison to Predicate Devices: A detailed table comparing the QMT device with two predicate devices (Storz Medical MAGNETOLITH Muscle Stimulator and Bemer Classic & Pro) across various parameters (device name, manufacturer, intended use, principle of action, technical specifications, etc.). This comparison aims to demonstrate substantial equivalence, not to prove performance against specific acceptance criteria.
• Summary of Non-Clinical Testing: States that the QMT device passed various non-clinical performance tests (biocompatibility, electrical safety, electromagnetic disturbance/immunity, and software verification/validation) in accordance with relevant ISO and IEC standards. These are safety and engineering compliance tests, not performance studies against specific clinical acceptance criteria for the intended use.
• Summary of Clinical Testing: Explicitly states, "There is no clinical data submitted with this submission."

Therefore, I cannot provide the requested information, particularly the table of acceptance criteria and reported device performance, the sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text. The submission relies solely on non-clinical testing and substantial equivalence to predicate devices, not on a clinical performance study.

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