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The BTL-785MJ device with the controller and single-use applicators has the following indications for use:

1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
2. Muscle re-education
3. Increasing blood flow
4. Maintain or increase mandibular range of motion

The BTL-785MJ is a state-of-the-art electrostimulation and radiofrequency platform with accessories that enables the application of therapy by electrical stimulation.
The control unit of the system is equipped with a large color touch screen that 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 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.
The generated electromagnetic field is intended to interact with the tissues of the human body in order to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, muscle re-education, increase blood flow and maintain or increase mandibular range of motion.
The BTL-785MJ device consists of the following main components:

• Main unit
• Handpiece
• Holding arm
• Connection cables
• Single-use applicators
• Therapy discomfort button

The provided FDA clearance letter (K243290) for the BTL-785MJ device does not contain explicit acceptance criteria or a detailed clinical study demonstrating the device meets such criteria. Instead, it relies on substantial equivalence to a predicate device.

Here's an analysis of the information available and what is missing relative to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds for the BTL-785MJ device's effectiveness in treating the listed indications. The "device performance" reported is primarily compliance with various electrical safety, EMC, usability, software, risk management, and biological evaluation standards.

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

• Sample size: Not applicable. The document explicitly states: "A clinical study was not conducted." Therefore, there is no test set of patients for clinical efficacy.
• Data provenance: Not applicable.

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

Not applicable, as no clinical study was conducted.

4. Adjudication method for the test set

Not applicable, as no clinical study was conducted.

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

The device is a physical muscle stimulator, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or AI assistance in that context. Therefore, an MRMC comparative effectiveness study is not relevant to this device, and none was performed.

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

Not applicable. This is a physical electrostimulation device, not an algorithm.

7. The type of ground truth used

Not applicable for clinical efficacy. The substantial equivalence relies on comparing the BTL-785MJ's technical characteristics and indications for use to a legally marketed predicate device (D function, K203525) that presumably established its effectiveness. The ground truth for safety and performance is based on compliance with international standards (IEC, ISO) through non-clinical testing.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary of Device Acceptance and Study:

The BTL-785MJ device received FDA clearance (K243290) based on substantial equivalence to an existing predicate device, the "D function" (K203525). This means its safety and effectiveness were demonstrated by showing that it has similar technological characteristics and the same intended use as the predicate device.

Specifically, the "study" demonstrating this involves:

• Non-clinical testing: Compliance with various electrical safety, electromagnetic compatibility (EMC), usability, software lifecycle processes, risk management, and biological evaluation standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 62304, ISO 14971, ISO 10993 series). These tests verify the physical and operational safety of the device.
• Comparison to a predicate device: A detailed table in the 510(k) summary (page 8-10) outlines the similarities in indications for use, principle of action, clinical use, energy source, electrical safety, energy type, accessory attachment, therapy time, pulse width, output frequency, output current, max output voltage, max current density, pulse shape, channel numbers, electrical safety class, features (timer, buzzer, display), and electrode properties. The applicant argues that "Any differences between the predicate device and BTL-785MJ device have no significant influence on safety or effectiveness of the BTL-785MJ device."

Crucially, no clinical study was conducted to directly prove the clinical efficacy of the BTL-785MJ device itself. Its acceptance is predicated on its similarity to a device that was previously cleared and is presumed safe and effective for its stated indications.

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