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The Sofacia System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older.

The Sofacia System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The Sofacia System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console.

Here's an analysis of the acceptance criteria and study details for the Sofacia System, based on the provided text:

Acceptance Criteria and Device Performance (Sofacia System)

Please note: The document doesn't explicitly state "acceptance criteria" in a tabulated format. Instead, it details the primary effectiveness endpoint and observations from a clinical study. I have structured the table to reflect what appears to be the implicit criteria for demonstrating effectiveness based on the study's primary endpoint and patient feedback.

Study Details:

1. Sample Size used for the test set and data provenance:

   • Sample Size: 60 subjects were enrolled, and 59 subjects were treated. (Treated zones: 295, with each subject treated on 5 facial zones).
   • Data Provenance: The study was conducted at 2 investigational sites in the United States. The study is prospective, as indicated by its design to evaluate the safety and effectiveness of the device (enrollment, treatment, and follow-up).

2. Number of experts used to establish the ground truth for the test set and qualifications:

   • Number of Experts: Two blinded investigators (reviewers).
   • Qualifications: The document does not specify the qualifications of these "blinded investigators" (e.g., radiologist, dermatologist, years of experience). It only refers to them as "blinded investigators."

3. Adjudication method for the test set:

   • The "primary effectiveness endpoint" relied on the "agreement of two blinded reviewers." This suggests a two-reviewer agreement method (e.g., 2/2 agreement required for a positive outcome), but the specific adjudication if there was disagreement is not detailed (e.g., if a third reviewer or consensus discussion was used).

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. The clinical study evaluated the device's standalone performance in improving facial lines and wrinkles.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the clinical study described is a standalone performance study of the Sofacia System device as a treatment, without an AI component or a human-in-the-loop performance evaluation in the context typically discussed for AI-powered devices. The device itself is a treatment modality, not an diagnostic or assistive AI tool.

6. The type of ground truth used:

   • The primary ground truth for effectiveness was expert consensus / assessment by "blinded investigators" comparing pre- and post-treatment photographs and using the Fitzpatrick Wrinkle and Elastosis Scale scoring. Patient satisfaction questionnaires provided additional subjective outcome data.

7. The sample size for the training set:

   • The document does not specify a training set sample size. The described clinical study is a performance study for the device itself, not for an AI algorithm that would typically require a separate training set.

8. How the ground truth for the training set was established:

   • This information is not applicable/provided as the study described is a clinical performance study of a therapeutic device, not an AI algorithm requiring a training set with established ground truth.

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