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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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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

This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.

Upon reviewing the provided document, it appears to be an FDA 510(k) clearance letter for a medical device called "D function," a powered muscle stimulator. The document primarily focuses on demonstrating the substantial equivalence of the "D function" to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for diagnostic accuracy or clinical effectiveness in the way one might expect for an AI/ML-based diagnostic device.

The document does not contain the following information typically found in a study proving a device meets acceptance criteria:

• A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy.
• Sample sizes used for test sets or data provenance for such studies.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods for test sets.
• MRMC comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for and ground truth establishment for training sets (this device is a stimulator, not an AI/ML diagnostic).

Instead, the document focuses on:

• Regulatory information: Device classification, product codes, predicate devices.
• Device description: How the device works (current stimulation).
• Indications for Use: What the device is intended to treat (muscle spasm, TMJ dysfunction, muscle re-education, blood flow, range of motion).
• Comparison of technological characteristics: Comparing pulse width, output frequency, and output current with predicate and reference devices, highlighting differences and justifying how these differences are supported by existing devices.
• Performance Data (Non-clinical Testing): This section refers to compliance with standards (e.g., electrical safety, EMC, software life cycle processes), and verification/validation that the device meets design/software requirements. It states that "The verification results demonstrate that the proposed device complies with the standard, IEC62304:2006/ Amd.1: 2015 Medical device software - Software life cycle processes. Additionally, the proposed device meets its design requirements in accordance with the requirements of FDA's guidance for the Content of Premarket Submissions for Software." It also states "The validation results demonstrate that the software specifications conform to user needs and that the particular requiremented through the proposed device can be consistently fulfilled."

Given the nature of this document (510(k) for a powered muscle stimulator), the "acceptance criteria" and "study" are primarily focused on non-clinical performance (electrical safety, electromagnetic compatibility, software validation, and physical/electrical specifications) to ensure the new device is as safe and effective as existing legally marketed predicate devices, despite some technological differences. It is not an AI/ML device, so typical AI/ML performance metrics (accuracy, sensitivity, specificity, AUC) are not applicable or presented.

Therefore, I cannot extract the information requested in the prompt as it pertains to AI/ML diagnostic device regulatory submissions, because this document describes a traditional medical device (a stimulator).

If you can provide a document related to an AI/ML medical device, I would be happy to attempt to extract that information.

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As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.

A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.

The provided text describes the Myo-trode SG disposable electrodes and its FDA 510(k) submission. It includes information about safety and effectiveness, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The document primarily focuses on establishing substantial equivalence to predicate devices and addressing potential hazards like skin irritation.

However, I can extract the information that is present and indicate where requested information is not available in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). The document mentions "an independent testing laboratory" for biocompatibility testing, but no further details.

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

• Not applicable/Not specified. The assessment primarily relied on laboratory testing (biocompatibility, impedance) rather than expert-established ground truth for a test set in the traditional sense of clinical or diagnostic studies.

4. Adjudication Method for the Test Set

• Not applicable/Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This type of study (MRMC) is generally relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Myo-trode SG is a disposable electrode for muscle stimulation, not a diagnostic device.

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

• Not applicable. This device is a physical electrode, not software or an algorithm with standalone performance.

7. The Type of Ground Truth Used

• Laboratory test results: Biocompatibility testing (irritation, cytotoxicity, allergic potential) was performed against established standards (ISO 10993).
• Impedance testing: Used to demonstrate effectiveness as a conductive interface.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.

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

• Not applicable. (See point 8)

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Used to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, to relax muscles and establish a physiologic occlusion, to take occlusal registrations, to take denture impressions, to increase local blood circulation and to increase or maintain mandibular range of motion.

The device is an ultra-low frequency, battery operated muscle stimulator used to relax the muscles of the head and neck. It is capable of stimulating either two or four muscle groups at once.

This document is a 510(k) premarket notification for the Model J-5 Myo-monitor and does not contain the information required to answer the questions about acceptance criteria and a study proving device performance. The letter states that the device is substantially equivalent to a legally marketed predicate device (Model J-4 Myo-monitor) based on its intended uses and fundamental technology. The substantial equivalence is determined without requiring clinical studies or data that would typically include acceptance criteria or detailed study results.

Therefore, I cannot provide the requested information from the provided text.

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