(150 days)
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.
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, which can also affect the appearance of lax tissue in the submental and neck regions
- Improve lines and wrinkles of the décolleté
- Improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms
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 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.
The provided document is a 510(k) summary for the Ulthera System, seeking clearance for expanded indications for aesthetic use on the abdomen, anterior arms, and posterior arms.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative acceptance criteria in a typical "numeric threshold" format. Instead, the acceptance is based on demonstrating "clinically significant skin improvement" and an acceptable safety profile, comparable to the predicate device. The performance is reported qualitatively based on the outcomes of the reviewed clinical studies.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Document) |
|---|---|
| Safety | "From a safety perspective, there were no unexpected or severe adverse events (AEs), and all observed AEs resolved without long-term sequalae." |
| Effectiveness (Abdomen) | Three clinical studies (n=54 subjects) demonstrated "clinically significant skin improvement up to 180 days post-treatment via a variety of endpoints, including blinded clinician photographic assessment, physician and subject Global Aesthetic Improvement Scores (GAIS), patient satisfaction surveys, and other validated clinical endpoints." |
| Effectiveness (Arms) | Five clinical studies (n=113 subjects) demonstrated "clinically significant skin improvement up to 180 days post-treatment via a variety of endpoints, including blinded clinician photographic assessment, physician and subject Global Aesthetic Improvement Scores (GAIS), patient satisfaction surveys, and other validated clinical endpoints." |
| Functionality (Non-clinical) | "In all instances, the subject device functioned as intended." (Biocompatibility, Electrical Safety, Software V&V) |
| Substantial Equivalence | The device has the "same general intended use and principle of operation as the predicate device. The minor changes in device hardware and software do not raise different questions of safety or effectiveness and do not affect clinical functionality or performance specifications." |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: The document does not describe a traditional "test set" in the context of an AI/algorithm performance study. Instead, it references a literature search of existing clinical studies supporting the expanded indications.
- Abdomen: 54 subjects across 3 unique clinical studies.
- Arms (anterior and posterior): 113 subjects across 5 unique clinical studies.
- Total: 167 subjects across 7 unique clinical studies (some studies likely included both abdomen and arms, though this is not explicitly broken down for unique subjects per region).
- Data Provenance: The document states "a comprehensive literature search was performed." This implies the data were
- Retrospective: The studies were already completed and published, not prospectively designed for this 510(k) submission.
- Country of Origin: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The concept of "experts establishing ground truth" as typically seen in AI performance studies (e.g., radiologists annotating images) is not directly applicable here. The "ground truth" for the effectiveness of the Ulthera system is based on:
- Blinded clinician photographic assessment: This indicates that medical professionals (clinicians) evaluated photographic evidence, likely pre- and post-treatment, without knowing which was which. The number and qualifications of these clinicians are not specified.
- Physician Global Aesthetic Improvement Scores (GAIS): Physicians assessed improvements. The number and qualifications of these physicians are not specified.
- Subject Global Aesthetic Improvement Scores (GAIS): Patients themselves provided self-assessments.
4. Adjudication method for the test set
The document does not detail an adjudication method for the clinical outcomes. While "blinded clinician photographic assessment" and "physician GAIS" suggest clinical evaluation, there's no mention of how discrepancies between multiple assessors were resolved (e.g., 2+1, 3+1). If multiple clinicians assessed the same case, their consensus or a defined adjudication process is not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not conducted. This submission is for a device that delivers energy for aesthetic treatment, not an AI diagnostic algorithm that assists human readers in reading cases. The clinical data reported focuses on the device's direct effect on patients, not on how an AI component improves human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Ulthera System is a therapeutic device with an imaging component. It is not an AI algorithm, and therefore, a standalone performance study in the context of an AI system would not apply. The device's imaging function allows visualization for proper coupling and depth confirmation, but it's not a diagnostic AI system with an "algorithm only" performance metric. The "software verification and validation testing" mentioned is for the device's operational software, not an AI diagnostic algorithm.
7. The type of ground truth used
The ground truth for effectiveness was primarily clinical and subjective-to-observer:
- Blinded clinician photographic assessment: Implies visual expert assessment.
- Physician Global Aesthetic Improvement Scores (GAIS): Expert (physician) subjective assessment.
- Subject Global Aesthetic Improvement Scores (GAIS): Patient subjective assessment.
- Patient satisfaction surveys: Patient subjective assessment.
- Other validated clinical endpoints: While vaguely described, this suggests other established clinical metrics were used.
No mention of pathology (biopsy) or long-term outcomes data beyond 180 days is provided as primary ground truth.
8. The sample size for the training set
The concept of a "training set" is not applicable here as the submission is for a medical device (focused ultrasound system) with new anatomical indications, not a machine learning model developed with a training set. The existing clinical studies were used as evidence to support the expanded indications, analogous to a validation set rather than a training set for an AI/ML model.
9. How the ground truth for the training set was established
As there is no "training set" for an AI/ML model in this submission, this question is not applicable.
§ 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.