(171 days)
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:
- lift the eyebrow
- lift lax submental (beneath the chin) and neck tissue
- improve lines and wrinkles of the décolleté
The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal layers of tissue to:
- ensure proper coupling of the transducer to the skin
- confirm appropriate depth of treatment such as to avoid bone
The Ulthera® System consists of the following components:
• Ulthera® Control Unit
• Handpiece
• Transducers
The Ulthera® System, which uses focused ultrasound for aesthetic treatment, was evaluated for an expanded indication to improve lines and wrinkles of the décolleté.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Improvement in lines and wrinkles of the décolleté as evaluated by a masked assessment of pre and post-treatment photographs. (Note: No pre-specified success criteria were established for this primary endpoint at the beginning of the trial due to issues with the initial Fabi-Bolton Scale validation). | 36 out of 54 evaluable subjects (~67%) showed improvement by masked assessment of pre- and post-treatment photographs at 180 days post-treatment. |
| Safety: No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to the treatment. | No SAEs or UADEs related to treatment were reported. All adverse events were mild, with the exception of two moderate events (one of which was not device-related), and all resolved. |
| Treatment Efficacy at Specific Energy Levels: Efficacy achieved at Level 4 for 7-3.0 and 4-4.5 transducers, and Level 3 for 10-1.5 transducer. | Treatment efficacy was achieved at the pre-set energy levels: Level 4 for the 7-3.0 and 4-4.5 transducers, and Level 3 for the 10-1.5 transducer. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set:
- Initial Enrollment: Up to 130 female subjects.
- Subjects Completing Protocol: 108 subjects.
- Evaluated Photo Sets (Test Set): 54 subjects. This subset was chosen as their day 180 photos were identified as "most consistent in photo quality" after excluding 54 photos with inconsistencies.
- Data Provenance: The study was a prospective safety and efficacy study. The document does not specify the country of origin of the data, but the submission is to the US FDA, implying it was conducted to meet US regulatory requirements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document mentions "masked assessment of pre and post treatment photographs" but does not specify the number or qualifications of the experts who performed this masked assessment. It also states that the initial Fabi-Bolton Scale, a published validated scale, could not be successfully validated during the clinical trial due to low kappa scores for both intra-rater and inter-rater reproducibility, leading to the change in primary endpoint to a post-hoc masked assessment.
4. Adjudication Method for the Test Set:
The document mentions "masked assessment," which implies multiple raters, but it does not explicitly state the adjudication method used to arrive at the final assessment (e.g., 2+1, 3+1, majority vote, etc.). The mention of inter-rater reproducibility issues with the Fabi-Bolton scale suggests that inter-rater agreement was a consideration, but the method for resolving discrepancies in the masked assessment is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported. This study evaluates the device's direct clinical effect on patients, not the performance of an AI algorithm assisting human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The Ulthera® System is a medical device for treatment, not an AI algorithm for diagnostic interpretation in a standalone context. The "performance data" refers to the clinical outcomes of patients treated with the device.
7. The Type of Ground Truth Used:
The ground truth for the expanded indication of improving lines and wrinkles on the décolleté was established through:
- Expert Consensus (implied): "Masked assessment of pre and post treatment photographs." While not explicitly stated as "consensus," this type of assessment by presumably trained evaluators serves as the "ground truth" for visual improvement.
- Clinician Global Aesthetic Improvement Scores (CGAIS): An unmasked assessment performed by clinicians.
- Patient Satisfaction Questionnaires: Patient-reported improvement.
The primary endpoint shifted to the masked assessment due to issues with the initial validated scale.
8. The Sample Size for the Training Set:
This information is not provided in the document. The study described is a clinical trial to evaluate the device's effectiveness, not an AI model's development. Therefore, there isn't a "training set" in the context of machine learning. The "training" for this device would refer to the development and engineering process, which is not detailed in terms of data sets.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a "training set" for an AI algorithm in this context. The study focuses on evaluating the clinical performance of the Ulthera® System treatment itself.
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.