(56 days)
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:
· lift the eyebrow
• Ift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions
· 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 inaging is to visualize the dermal and subdermal 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 Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
Here's an analysis of the acceptance criteria and study information for the Ulthera System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint for "lifting lax submental (beneath the chin) and neck tissue": Improvement in lift, though specific quantitative metric for "improvement" is not defined, only that it refers to a lift of ≥20 mm². | - Quantitative Assessment: 51 out of 70 patients (72.9%) had an improvement of ≥20 mm² in lift. |
| Qualitative Assessment from Masked Evaluators: Improvement identified qualitatively. | - Qualitative Assessment: Of the 51 patients with ≥20 mm² lift, 84.3% were identified as showing improvement by masked evaluators. |
| Adverse Events: Mild, short-lived, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs). | - Adverse Events: Adverse events were mild, short-lived in duration, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 70 patients.
- Data Provenance: The document does not explicitly state the country of origin. It describes an "open-label clinical trial," which implies prospective data collection.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: The document mentions "masked evaluators" but does not specify the number of individuals.
- Qualifications of Experts: Not provided. The term "masked evaluators" suggests they were independent of the treatment process.
4. Adjudication Method
- The document mentions "masked evaluators" identifying improvement. It doesn't detail a specific adjudication method like 2+1 or 3+1 for resolving discrepancies, implying a single assessment per evaluator or a simple consensus if multiple evaluators were involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study described for human readers with and without AI assistance. This study focuses on the device's direct clinical effect on patients. The device itself uses imaging as an aid for the operator, but the clinical trial evaluates the treatment outcome, not the efficacy of the AI component in guiding human readers.
6. Standalone (Algorithm Only) Performance Study
- Not applicable/Not done. The Ulthera System is a therapeutic device that involves human operation. The performance assessed here is the clinical outcome of the treatment when performed by an operator, not a standalone algorithmic output. The "imaging" component is a visualization aid for the operator, not a diagnostic algorithm with standalone performance metrics.
7. Type of Ground Truth Used
- Clinical Outcomes/Quantitative Measurement: The primary ground truth for the effectiveness of "lifting lax submental and neck tissue" was a quantitative assessment of lift (≥20 mm² improvement) and qualitative assessment by masked evaluators. Adverse events were also monitored as part of the safety profile.
8. Sample Size for the Training Set
- Not applicable/Not provided. This document describes a clinical trial for an aesthetic treatment device. The "Ulthera System" itself is a device that generates focused ultrasound; it's not explicitly described as having an AI component that is "trained" in the typical machine learning sense to perform a task. If the "system software" (Version 1700) has an AI component that processes data and learns, the training set size is not disclosed in this document. The clinical study detailed is a validation study for the device's clinical efficacy for a new indication, not an AI model training or validation set.
9. How Ground Truth for Training Set Was Established
- Not applicable/Not provided. As stated above, the document does not discuss the training of an AI model.
§ 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.