(147 days)
- Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
- Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.
The Ultimate Contour is a medical device that combines the technologies of radio-frequency energy and ultrasound in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece of the appropriate energy intensity based on the settings selected.
Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
Delivered ultrasound is accomplished with a piezo transducer located in the ultrasound handpiece that is bonded to the handpiece contact surface. The handpiece is applied directly to the patient skin at the abdominal area and the emitted ultrasound energy focuses within the subdermal fatty tissue, causing reduction in waist circumference.
The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.
The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device compliance, as requested:
Device: Ultimate Contour, Ultimate Contour Mini
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance in a tabular format. However, it implicitly defines the effectiveness acceptance criterion through the primary effectiveness endpoint of the clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Achieve a waist circumference reduction of at least 1 inch for non-invasive reduction in abdominal circumference on adults with a BMI of 25 or greater. | Achieved an average circumference reduction of 2.0 inches, which was statistically significant compared to the 1.0-inch threshold (p=0.05). |
| Safety Endpoint: Acceptable safety profile with no serious or significant adverse events. | Most adverse events (skin rash, changes in bowel movement, urine consistency) resolved within 1-2 days or with over-the-counter products. 7 subjects reported ringing/buzzing, 2 discontinued, but follow-up audiology showed no worsening. No serious adverse events mentioned. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 42 subjects completed the treatment regimen.
- Data Provenance: The study was a "single-site single-arm study." The country of origin or specific demographic details beyond "majority of study subjects were Caucasian females" are not explicitly stated. It was a prospective study as it involved treating subjects and then evaluating outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish a ground truth for the test set. For the primary effectiveness endpoint (waist circumference reduction), measurements were conducted by clinicians, but their specific qualifications or the number involved are not provided. The information only states: "Clinicians were blinded relative to measuring pre-treatment and post-treatment."
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states that "Clinicians were blinded relative to measuring pre-treatment and post-treatment," implying that a single clinician or a group of clinicians performed measurements, but there's no mention of a consensus or adjudication process if discrepancies arose.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported in this document. The device is a direct treatment device (radiofrequency and ultrasound for aesthetic/therapeutic purposes), not an AI diagnostic or assistive tool for clinicians interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The "Ultimate Contour" is a physical medical device that applies energy (RF and ultrasound) directly to the patient, not an algorithm that functions standalone or with human-in-the-loop. Its performance is measured by its direct effect on the patient (e.g., waist circumference reduction).
7. The Type of Ground Truth Used
The ground truth for the effectiveness endpoint was established by clinically meaningful waist circumference reduction measurements. This was defined as "a value of at least 1 inch of waist circumference reduction of the treatment regimen," and this clinically meaningful value was "identified based on published studies utilizing other devices for the same purpose."
For safety, the ground truth was observed adverse events and serious adverse events reported by subjects and assessed by the study team.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of device performance or clinical evaluation. The device is not an AI/ML product that typically requires a training set. The clinical study described involved direct treatment of subjects.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned as being applicable to this device or its evaluation, this question is not applicable.
§ 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.