(200 days)
The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue.
The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.
The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable.
The PLASONIC has two systems (two handpieces) :
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- Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.
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- Ultrasound (SONOPASS Handpiece)
The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being
The provided text describes a 510(k) submission for a medical device called "PLASONIC." It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.
Therefore, I cannot provide the requested table or answer questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the given text.
The text does state the following regarding studies:
- Non-clinical tests:
- Compliance with several IEC and ISO standards for electrical safety, electromagnetic compatibility, usability, software lifecycle processes, and risk management (listed in section 7).
- An ex vivo model study where handpieces were applied to analyze temperature change via thermal imaging, and tissue coagulation length, width, and depth via photography and histological evaluation.
- Clinical tests: "No clinical test was performed."
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.