(8 days)
The Ulthera" System is indicated for use as a non-invasive dermatological aesthetic treatment to: lift the eyebrow.
The Ulthera® System consists of the following components:
● Ulthera® Control Unit
● Handpiece
● Transducers
The Ulthera® System, K122528, is indicated for use as a non-invasive dermatological aesthetic treatment to lift the eyebrow. The submission discusses an accelerated aging study to support the extension of the shelf life for the Ulthera® System Transducers from six months to one year. This study aimed to demonstrate that the transducers would continue to meet performance criteria over the extended shelf life.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain "technological characteristics" over 12 months | Transducers met predetermined acceptance criteria in performance testing after accelerated aging. |
| Maintain "performance criteria" over 12 months | Transducers met predetermined acceptance criteria in performance testing after accelerated aging. |
| No detrimental effect on transducer functionality over 12 months | Twelve-month shelf life study demonstrated no detrimental effect on transducer functionality. |
| No detrimental effect on patient safety over 12 months | Twelve-month shelf life study demonstrated no detrimental effect on patient safety. |
| No detrimental effect on efficacy over 12 months | Twelve-month shelf life study demonstrated no detrimental effect on efficacy. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions an "accelerated aging study (per ASTM Standard F 1980 (2011))" and "performance testing protocol," but does not specify the sample size of transducers tested or the number of units used in the accelerated aging study.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective, beyond being a study conducted to support the shelf life extension.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study described is a technical performance test of the device's shelf life, not a clinical study involving human assessment of ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the relevant study is a technical performance test, not a clinical study requiring human adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The provided document concerns a shelf life study for device transducers, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a shelf life study for a physical device (transducers), not an algorithm.
7. The Type of Ground Truth Used:
For the shelf-life study, the "ground truth" was the predetermined acceptance criteria identified in the performance testing protocol. These criteria would likely be objective measurements related to the transducers' physical and functional characteristics (e.g., ultrasonic output, structural integrity, electrical performance) that are defined in technical specifications rather than based on expert clinical consensus, pathology, or outcomes data, which are typical for diagnostic or therapeutic efficacy studies.
8. The Sample Size for the Training Set:
Not applicable. The provided information relates to a device's shelf life, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this document does not describe a machine learning study.
§ 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.