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The BTL-785X device has the following indications for use:

The BTL-785X with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785X with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785X with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785-4 with BTL-785-4 applicator used with tips BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785X device used with tips BTL-785-4-4, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

The BTL-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 singleuse electrodes is intended to provide:

• heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

• non-invasive temporary reduction of facial wrinkles

The BTL-785X is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.

The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785X device comes with five different types of applicators.

The BTL-785X device consists of the following main components:

• microprocessor-driven control unit
• radiofrequency generator
• user interface with 15.6" color touch screen
• applicators for an application of radiofrequency
• exchangeable applicator tips

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:

Acceptance Criteria and Device Performance

The core acceptance criterion for the new indication (non-invasive temporary reduction of facial wrinkles) of the BTL-785X with the BTL-785-7 hands-free applicator was based on a statistically significant reduction in wrinkle severity.

Secondary Acceptance Criteria and Device Performance:

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size: N = 42 subjects completed all study treatments and follow-up visits.
• Data Provenance: The study was conducted at a "single site." The document does not specify the country of origin, but given the applicant and sponsor are based in Marlborough, Massachusetts, USA, it is likely a US-based study. The study design is classified as "interventional," indicating prospective data collection.

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

• Number of Experts: 3 blinded dermatologists.
• Qualifications: The document identifies them as "blinded dermatologists." Specific years of experience or other additional qualifications are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• The primary efficacy outcome measure required at least 2 out of 3 blinded dermatologists to agree on a statistically significant reduction of at least 1.0 score in the FWES scale. This indicates an adjudication method, where a simple majority (2 out of 3) determined the positive outcome.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted. This study focused on the standalone performance of the device in reducing wrinkles, with dermatologists assessing the outcome.

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

• This question is not applicable in the context of the provided document. The device is a radiofrequency system with applicators for therapeutic use, not an AI-driven algorithm for image analysis or diagnosis. The performance related to "non-invasive temporary reduction of facial wrinkles" was evaluated in human subjects.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Expert Consensus: The primary ground truth for wrinkle reduction was established by expert consensus, specifically the assessment of 3 blinded dermatologists using the Fitzpatrick Wrinkle and Elastosis Scale (FWES).
• Outcomes Data: Patient satisfaction and adverse events were also collected as outcomes data.

8. The sample size for the training set:

• The document describes a clinical study to demonstrate the performance, efficacy, and safety of the device for a new indication. This is a validation study (test set), not a training set for an algorithm. Therefore, there is no information about a separate training set.

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

• As mentioned above, there is no description of a training set for an algorithm in this document, so this question is not applicable.

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