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The DEKA PHYSIQ 360 is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs, in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The PHYSIQ 360 is a diode laser device. The device is provided with:

• Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
• An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
• One wavelength, 1060 ±20 nm (infrared)
  The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)

This document is a 510(k) summary for the DEKA PHYSIQ 360 device, a diode laser intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to a predicate device (Sculpsure K171992) rather than presenting a study proving that the device meets specific acceptance criteria related to a diagnostic or AI-driven performance.

Therefore, the requested information, such as acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device), clinical study data to demonstrate that the device meets these criteria, sample sizes for test sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

This document primarily relies on the comparison to a predicate device and non-clinical performance data (electrical safety, EMC, software validation) to demonstrate substantial equivalence, rather than new clinical efficacy or performance studies with specific acceptance criteria that would typically be associated with AI/diagnostic devices.

Here's why the requested information isn't present in this specific type of document:

• Device Type: The DEKA PHYSIQ 360 is a laser for aesthetic use (non-invasive lipolysis). Its clearance is based on demonstrating that it is substantially equivalent to an existing legally marketed predicate device, not on demonstrating a specific diagnostic performance or AI-driven capabilities.
• 510(k) Pathway: The 510(k) premarket notification pathway often relies on comparison to a predicate device and non-clinical testing rather than extensive new clinical studies, especially if the new device has the same technological characteristics and similar indications for use as a cleared predicate.
• "Clinical Performance Data: None": As explicitly stated in the document, no clinical performance data was submitted. This confirms that a study of the type you're asking about (with performance metrics against acceptance criteria) was not part of this submission.
• Focus on Substantial Equivalence: The primary objective of this 510(k) summary is to argue that the DEKA PHYSIQ 360 is "as safe, as effective, and performs as well as the legally marketed predicate device." This is achieved by showing identical or substantially similar technological characteristics and indications for use, and by providing non-clinical safety testing.

In summary, based on the provided document, I cannot fulfill your request for acceptance criteria and a study proving the device meets them, because this type of information is not included in this 510(k) summary for the DEKA PHYSIQ 360.

The document details:

• Non-Clinical Performance Data:
  • Electrical safety and electromagnetic compatibility (EMC) testing based on ANSI AAMI ES60601-1 and IEC 60601-1-2.
  • Software Validation and Verification Testing as per FDA guidance.
  • Additional non-clinical testing per IEC 60601-2-22 and IEC 60825-1.

These non-clinical tests ensure device safety and functionality but are not "performance data" in the sense of diagnostic accuracy or clinical efficacy against specific statistical acceptance criteria for a human performance or AI-driven system.

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