(126 days)
Resurgeonz pHantom Trilogy(TM) is indicated for use as a non-surgical, non-invasive aesthetic treatment for the temporary reduction of the circumference of waist, hips, thighs through the process of disrupting adipocyte cells, within the fat layer, for the release of fat and lipids from the targeted cells.
The Resurgeonz pHantom Trilogy™ is a non-surgical, non-invasive, fat reducing low level laser system using a combination of Red and Infrared light spectrums to propagate laser frequencies of 660nm, 808nm and 980nm into a patient's dermal and adipose tissues for the reduction of the measured circumference of the patients waist, hips, and thighs. The device features an LCD touchscreen. Mode of operation is continuous. Allows individual patient session controls of: treatment time, energy, pulse and delay. Emergency safety cut off switch. Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12. Paddles include built in air fan cooling. Combination of Coherent Frequencies of red and infrared: 26 diodes per big paddle, (13 red diodes at 660nm) and thirteen (13 infrared diodes) of the 13 infrared diodes, (6 diodes) are 808nm and (7 diodes) are 980nm. Two smaller paddles are available to swap out in place of two big paddles. The two smaller paddles only have 2 diodes each of red diodes at 660nm and are used for smaller hard to reach body areas. Power output or each diode is variable up to 72mW to per diode for all red and infrared diodes. The device does not have wireless and/or external wired communication. The device is powered by 120V, 60Hz. There is a side holder for paddles when not in use.
The provided document is a 510(k) summary for the Resurgeonz PHantom Trilogy™ low-level laser system. It details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or specific study data proving the device meets acceptance criteria in the way requested for an AI/ML medical device.
The questions provided in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are typically relevant for the regulatory review of Diagnostic AI/ML-enabled devices, particularly those that involve image analysis, disease detection, or treatment recommendations based on complex algorithms.
The PHantom Trilogy™ is described as a "low-level laser system for aesthetic use" for temporary reduction of circumference, operating via physical principles (laser light disrupting adipocyte cells). Its regulatory clearance is based on substantial equivalence to existing predicate devices, meaning it has similar technological characteristics and performs similarly in its intended use. This type of device's "performance data" typically refers to non-clinical (bench) tests to demonstrate its physical and electrical characteristics meet safety and performance standards, and potentially limited clinical data demonstrating the stated aesthetic effect, rather than the complex statistical validation required for AI/ML diagnostic tools.
Given the nature of this document and the device, I cannot fill in the requested table and answer the detailed questions relevant to an AI/ML device because that information is not present in this 510(k) summary. The document states:
- "Resurgeonz pHantom TrilogyTM overall performance testing passed all specified test requirements of non-clinical (bench) tests conducted for determination of Substantial Equivalence (SE) results, and show of Substantial Equivalence (SE) with the predicate devices." (Page 3-4)
- "The Resurgeonz PHantom Trilogy™ meets the functional claims, and Intended Use as described in the product Labeling." (Page 5)
- "The safety and effectiveness are equivalent to the predicate device K192275 and predicate device K130341." (Page 5)
These statements indicate that the "study" proving the device meets acceptance criteria was primarily a comparison to predicate devices, supported by bench testing, rather than a clinical trial with the detailed statistical and ground truth methodologies typically found for AI/ML diagnostic tools.
Therefore, the requested information cannot be extracted from this document. If this were a submission for an AI/ML device, the detailed sections on performance, study design, and clinical data would be significantly different and much more extensive.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.