(66 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
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 text describes a 510(k) premarket notification for the Ulthera System (UC-1 Control Unit PRIME). The submission aims to demonstrate substantial equivalence to a predicate device (Ulthera System, K180623), primarily focusing on modifications to the console.
Based on the provided text, the device is an aesthetic device (Focused Ultrasound Stimulator System for Aesthetic Use) and NOT a diagnostic device or an AI/ML-driven device that involves human readers or complex image interpretation.
Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not applicable or not detailed in this submission.
The "study" described is a series of non-clinical performance tests validating the modified console's functionality and safety, rather than a clinical study evaluating diagnostic accuracy or reader improvement.
Here's an attempt to address the points based on the available information, noting where information is not present due to the nature of the device and submission:
Acceptance Criteria and Device Performance for Ulthera System (UC-1 Control Unit PRIME)
The 510(k) submission primarily focuses on demonstrating that modifications to the Ulthera System's console do not significantly affect its clinical functionality or performance compared to the predicate device. The acceptance criteria are essentially that the modified device functions "as intended" and remains "as safe and effective" as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not a diagnostic device with specific performance metrics like sensitivity/specificity, the "acceptance criteria" relate to engineering, software, and physical performance.
| Acceptance Criteria Category | Reported Device Performance/Verification |
|---|---|
| Biocompatibility | User-contacting components verified in accordance with ISO 10993-1. (Performance: Verified) |
| Electrical Safety and EMC | Verified in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, and IEC 60601-2-62. (Performance: Compliant) |
| Software Verification & Validation | Conducted as recommended by FDA Guidance, "Content of Premarket Submissions Device Software Functions." A basic documentation level was used as a failure would not present a hazardous situation with a probable risk of death or serious injury. (Performance: Conducted, Passed; Functions as intended.) |
| Usability | Conducted in accordance with IEC 62366-1 and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Specific checks included console's portability, GUI visibility and layout, and display responsiveness. (Performance: Clinicians able to use device in representative environment; no new risks identified.) |
| Mechanical Testing | Display hinge of the console verified via mechanical cyclic testing. (Performance: Verified) |
| Packaging, Transit, & Environmental | Packaging and transit testing per ASTM D4169 and ASTM D4332. Environmental conditioning testing conducted to verify device functionality at defined operating and storage conditions. (Performance: Verified) |
| Ultrasound Output Testing | Acoustic reliability verified using simulated treatment over the device's service life. Power output and imaging were verified to be within specification. (Performance: Within specification, operates as intended) |
| Overall Comparison (Subject vs. Predicate) | The submission states: "These non-clinical performance tests of the Ulthera System demonstrated the modified console continues to operate as intended and that it is as safe and effective as its predicate for the proposed indications for use." (Performance: Demonstrates substantial equivalence, safety, and effectiveness compared to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
This is not a clinical study involving a "test set" of patient data in the typical sense for AI/ML. The "testing" involves engineering and software validation on the device itself. Therefore, concepts like "sample size" for patient data and "data provenance" (country, retrospective/prospective) are not applicable here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for this device's performance is established by engineering specifications, regulatory standards compliance, and direct verification of the device's physical and software functions. There are no "experts" establishing ground truth in the context of interpreting medical images or clinical outcomes for a test set.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" of cases requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human reader performance (with or without AI assistance) is being evaluated relative to a reference standard. This device is an aesthetic treatment system, and the submission is for console modifications, not a new diagnostic algorithm.
6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an AI/ML diagnostic algorithm. The device has an "imaging mode" for visualization and user guidance (proper coupling, depth avoidance) but is fundamentally an energy delivery system for aesthetic treatment. Its performance is tied to its physical and software functions (power output, imaging capabilities, safety features), which were tested directly.
7. The Type of Ground Truth Used
The "ground truth" for the various tests were:
- Engineering specifications and design requirements: For mechanical, electrical, and acoustic performance.
- International standards (ISO, IEC, ASTM): For biocompatibility, electrical safety, EMC, usability, packaging, and transit.
- FDA Guidance: For software verification and validation, and usability/human factors.
- Predicate device's established safety and effectiveness: The ultimate "ground truth" for substantial equivalence is demonstrating that the modified device performs comparably to the legally marketed predicate.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for machine learning.
§ 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.