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The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

The BTL-9000 consists of a control unit, connection lead to a BTL-9000 Laser Applicator and other accessories. (A full list of system contents is included in the operator's manual). The Laser Applicator is containing four cold red (660 nm) laser-emitting diodes and is designed to be placed on the skin. The output of the diode (four per applicator) is limited to 50mW ± 15% by a power limiting PCB from the central processing unit. The system can operate using 1 applicator that is connected to the control unit. The control unit is an electrically powered unit (100-240V, 50-60Hz auto-ranging). Once enabled it is controlled using a touchscreen interface. When the Laser Applicator is placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells and therefore reduced in size. The BTL-9000 is a stand-alone device which can be used together with other modalities which are not part of this submission.

Here's an analysis of the provided text regarding the BTL-9000 device, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

The core acceptance criterion for the BTL-9000 device is the temporary reduction of waist circumference by a minimum of 3 cm at a 30-day follow-up as compared to the baseline evaluation.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: 30 subjects (15 in the BTL-9000 LLLT treatment group and 15 in the placebo group).
   • Data Provenance: The document does not specify the country of origin. It indicates it was a prospective, double-blind clinical study.

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

   • The study focuses on objective measurements of waist circumference and patient-reported adverse events. There is no mention of experts being used to establish a subjective "ground truth" for the test set; the ground truth is derived from direct anthropometric measurements.

3. Adjudication method for the test set:

   • Not applicable as the ground truth is based on objective measurements (waist circumference) and adverse event reporting, not on expert interpretation requiring adjudication.

4. 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, this was not an MRMC comparative effectiveness study and does not involve AI or human readers for diagnostic interpretation. It's a clinical trial comparing a medical device to a placebo for a therapeutic outcome.

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

   • Not applicable. This is a medical device (low-level laser system) used for treatment, not an algorithm, and its performance is assessed directly on human subjects.

6. The type of ground truth used:

   • The ground truth was based on objective anthropometric measurements of waist circumference (in centimeters) and observation of adverse events.

7. The sample size for the training set:

   • Not applicable. This device is a hardware-based low-level laser system, not an AI or machine learning algorithm that requires a "training set" of data.

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

   • Not applicable, as there is no training set for this type of device.

Summary of the Study:

The study was a double-blind clinical trial designed to assess the effectiveness and safety of the BTL-9000 device for temporary waist circumference reduction. It involved 30 subjects randomly assigned to either a treatment group (receiving BTL-9000 LLLT) or a placebo group. Both groups received 8 twice-a-week treatments. Waist circumference and weight were measured at baseline, after the 8th treatment, and at a 30-day follow-up. The primary endpoint measured was the change in waist circumference. The results demonstrated a statistically significant reduction in waist circumference in the treatment group compared to the placebo group, meeting the internal acceptance criterion of a minimum 3 cm reduction at 30-day follow-up. No adverse events were reported.

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The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids.

The XP200 system is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field. The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the onscreen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the set power, and other necessary data. The XP200 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, applicator with color screen and control buttons.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

The provided document describes both non-clinical (engineering/performance) testing and a clinical study.

Non-Clinical Testing:

• 1. Sample sized used for the test set and the data provenance: Not explicitly stated for each specific test, but the tests involved the XP200 device and its predicate devices (EXILIS and Pellevé GlideSafeTM Non-Ablative Wrinkle Treatment System) under experimental conditions. The data provenance is implied to be from laboratory testing.
• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for non-clinical, objective performance tests. The ground truth would be based on established engineering principles and measurement standards.
• 3. Adjudication method for the test set: Not applicable for non-clinical objective performance tests.
• 4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was not an MRMC study. These were objective performance tests comparing the device's technical specifications to a set of criteria and predicate devices.
• 5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the non-clinical tests assess the device's standalone performance in terms of frequency, power, wave form, tissue heating, and safety shut-off mechanisms.
• 6. The type of ground truth used: Objective measurements and engineering standards (e.g., standard sinusoid form, specified power levels, documented safe temperature thresholds, established resistance levels for safety shut-off).
• 7. The sample size for the training set: Not applicable. These are hardware/electrical performance tests.
• 8. How the ground truth for the training set was established: Not applicable.

Clinical Testing:

• 1. Sample sized used for the test set and the data provenance:
  • Sample Size: Not explicitly stated, but patients were involved. The document states "the subject going through treatment." While not a specific number, it indicates human participants.
  • Data Provenance: Prospective, as it involved patients undergoing treatment and subsequent follow-up ("pre- and 90-days post treatment"). The country of origin is not specified but is implied to be within the scope of the FDA submission.
• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • Number of Experts: Three (3) principal investigators.
  • Qualifications: "principal investigators" are generally qualified medical professionals (e.g., dermatologists or plastic surgeons) experienced in clinical studies and evaluating dermatologic conditions. Specific experience levels are not detailed.
• 3. Adjudication method for the test set: Not explicitly stated. However, "grading pre- and 90-days post treatment" by principal investigators suggests a subjective assessment by these experts. It doesn't specify if their gradings were pooled, averaged, or adjudicated in cases of disagreement.
• 4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not explicitly an MRMC study. It involved multiple investigators, but the focus was on the performance of the single device (XP200) and its effect, not a comparison of human readers with and without AI assistance.
• 5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this was a clinical study involving human patients and human operators (principal investigators) using the device.
• 6. The type of ground truth used: Clinical outcome data, specifically "wrinkle-reducing effects" graded by clinical investigators, and the absence of adverse events. The "statistically significant reduction in periorbital wrinkles" indicates a quantifiable outcome derived from these clinical assessments.
• 7. The sample size for the training set: Not applicable, as this is a clinical trial, not an AI model training process.
• 8. How the ground truth for the training set was established: Not applicable.

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The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.

The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.

The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device is equipped with a stylus (touch pen) for comfortable control of the touch screen. The vertically oriented design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the surgery. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters.

Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data.

The EXILIS device enables to insert the patient's name and additional corresponding information in its internal memory and link these data with the pre-defined or customer protocols. At the patient's next visit simply call his/her name on the device and apply the preset therapy. The EXILIS device is placed in a specially designed cart, the shape of which provides the maximum comfort of the handling and use of the device. Four stable castors ensure easy moving of the device in the office or surgery.

The acceptance criteria and study information for the EXILIS device (K092191) are detailed below based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices." (Section 10, Clinical Testing). Therefore, there is no separately identified "test set" in the context of clinical data. The performance evaluation was based on non-clinical testing, verification, and validation of the device's hardware and software.

• Sample Size: Not applicable in the context of a clinical test set. The validation was against software design specifications and applicable voluntary standards.
• Data Provenance: The data provenance is internal, based on the manufacturer's (BTL Industries, Inc.) hardware and software development, verification, and validation processes, as well as third-party testing for safety and EMC standards. There is no mention of country of origin for a clinical dataset, nor whether it was retrospective or prospective, as no clinical study was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical testing was performed, there was no clinical "test set" requiring expert consensus for ground truth establishment. The ground truth for the non-clinical testing was based on engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used. The performance was assessed against engineering specifications and regulatory standards.

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

Not applicable. No MRMC study was conducted. The EXILIS device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The EXILIS is a medical device for dermatologic and general surgical procedures, not an algorithm. Its performance is inherent in its operation by a human user.

7. The Type of Ground Truth Used

For the non-clinical testing:

• Hardware and Software Performance: The ground truth was established by the Software Design Specifications and other internal engineering specifications.
• Safety and EMC: The ground truth was established by national and international safety and electromagnetic compatibility (EMC) standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development involves traditional engineering design and testing, not machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

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