(302 days)
The XP1100 RF is indicated for temporary reduction in circumference of the abdomen and thighs.
The XP1100 RF system is designed for temporary reduction in circumference of the abdomen and thighs by means of high-frequency electromagnetic field. The multi-jointed arm firmly supports the applicator during treatment. Large knobs lock and unlock the ioints to make positioning the applicators to the patient quick, easy and secure.
The control unit consists of the control system and the electronic system. The control system contains the main microcomputer and software for control of the entire equipment; the electronic system contains the complete electromagnetic field generation. Easy-to-use color touch screen allows for maximum operator comfort. A large control knob is provided to increase and decrease output power.
The XP1100 RF system is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office.
The XP1100 RF consists of the following main components:
- . microprocessor-driven control unit
- . high-frequency electromagnetic energy generator
- user interface with 8.4" color touch screen .
- . applicator on a multi-jointed arm
This document describes the XP1100 RF device, which is indicated for temporary reduction in circumference of the abdomen and thighs. The acceptance criteria and the study that proves the device meets them are outlined below:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria | Reported Device Performance |
---|---|
Primary Efficacy Outcome: ≥1 cm thighs circumferential reduction in > 80% of subjects. | Achieved. More than 80% of subjects had ≥1 cm thighs circumferential reduction. Thighs circumference change (Baseline vs. 30-day and 90-day Follow Up) was statistically highly significant. |
Secondary Objective: Absence of adverse events. | Achieved. No adverse events were recorded. |
Secondary Objective: > 80% subjects satisfaction with therapy at 30-day and 90-day Follow Up. | Met. More than 80% of treated subjects reported satisfaction with the therapy at 30-day and 90-day Follow Up. |
Aesthetic appearance improvement at 30-day Follow Up. | More than 80% of treated subjects reported aesthetic appearance improvement at 30-day Follow Up. |
Aesthetic appearance improvement at 90-day Follow Up. | More than 76% of treated subjects reported aesthetic appearance improvement at 90-day Follow Up. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 40 subjects (28 women, 12 men).
- Data Provenance: The document does not explicitly state the country of origin, but the submission is to the U.S. FDA, suggesting the study likely took place in the U.S. or followed U.S. regulatory standards. The study was prospective as it involved active treatment and follow-up.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly mention the use of experts to establish a "ground truth" in the traditional sense (e.g., for diagnostic accuracy). The primary and secondary outcomes were based on direct measurements (circumference reduction) and patient self-reported satisfaction/aesthetic improvement.
4. Adjudication Method for the Test Set
Not applicable. The outcomes measured (circumference reduction, adverse events, patient satisfaction) do not require an adjudication method by experts in the way image interpretation or diagnostic studies would.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. This was a clinical study evaluating the effectiveness of a medical device (XP1100 RF) for circumference reduction, not a diagnostic imaging study involving human readers and AI assistance. Therefore, an MRMC study and effects of AI assistance on human readers are not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a medical device that requires human operation (applying the device, monitoring treatment, etc.). The study evaluated the device's performance in a clinical setting with human involvement, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for the study's primary efficacy outcome was based on direct physical measurements of thighs circumference reduction. The secondary outcomes were based on reported absence of adverse events and patient self-reported satisfaction and aesthetic appearance improvement.
8. Sample Size for the Training Set
The document does not mention a "training set" as this is a clinical efficacy study for a medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI model is described.
§ 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.