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The BTL-199 is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-traumatic pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The BTL-199 is for use on patients 18 and older.

The BTL-199 is an electromagnetic stimulator that delivers brief, focused electromagnetic pulses to non-invasively stimulate peripheral nerves, providing pain relief.

The device consists of a main unit and specialized applicators, designed to deliver precise and effective therapy. The main unit is equipped with an intuitive color touch screen that provides step-by-step guidance for the operator throughout the therapy process. The device features a preset treatment protocol for ease of use, while also allowing operators to customize parameters to meet specific therapeutic needs. Adjustable parameters include frequency (up to 150 Hz), therapy time (up to 30 minutes), and intensity (0-100%). The interface displays detailed information about the therapy settings and session progress (i.e., treatment duration). The device uses a temperature sensor to monitor the temperature of the coil to ensure that the maximum permissible temperature of the applicator's contact areas (i.e., 43°C) are not exceeded. It also has an intensity predictor function that limits the maximum adjustable intensity of the device based on the therapy parameters set, so as not to overheat and damage the device.

The device is equipped with three sets of applicators: AP-C-1, AP-C-2, and AP-C-4/5. Each applicator is intended for a different body area depending on the size and shape of the treated body part.

• Applicator AP-C-1 is intended for treatment of larger body areas, such as back, waist, thighs, etc.
• Applicator AP-C-2 is intended for treatment of smaller body areas, such as hands, arms, legs, etc.
• Applicators AP-C-4/5 (AP-C-4 and AP-C-5 - for each side of the body respectively) is primarily intended for treatment of waist and lower back.

The provided FDA 510(k) clearance letter and summary for the BTL-199 device does not include any clinical study data or describe acceptance criteria related to device performance in a clinical setting.

The submission is based on the device being "substantially equivalent" to predicate devices, which generally means that it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. For devices like the BTL-199, classified as Class II, substantial equivalence can often be demonstrated through non-clinical testing (bench testing, electrical safety, biocompatibility, etc.) and a comparison of technological characteristics with predicate devices that have already been cleared.

The "Clinical Testing" section explicitly states "Not applicable," which confirms that a clinical study proving device performance against specific acceptance criteria (like accuracy, sensitivity, or improvement in patient outcomes) was not required or submitted for this 510(k) clearance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text, as such information is not present. The document focuses on demonstrating substantial equivalence for regulatory clearance, not on presenting performance data from a clinical trial.

If this were a device requiring clinical performance data (e.g., an AI-powered diagnostic device), the 510(k) summary would typically include a section detailing the clinical study, its methodology, and the results compared against pre-defined acceptance criteria. This is not the case for the BTL-199.

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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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The device is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

The BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only. The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments. The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.

The provided text is a 510(k) Premarket Notification from the FDA for a device called "BTL-398". This document primarily focuses on demonstrating substantial equivalence to a predicate device (HPM-6000UF) for regulatory clearance. It does not include information about clinical studies with human participants, AI components, or detailed performance data against acceptance criteria for such clinical or AI-specific assessments.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment, particularly concerning AI or human-in-the-loop performance, cannot be extracted from this document. The document explicitly mentions "non-clinical testing" and "performance bench data," suggesting that equivalence was primarily established through engineering and electromagnetic performance tests, not clinical efficacy trials for the UI treatment itself.

However, I can extract information related to what was used for acceptance and testing:

Acceptance Criteria and Device Performance (Based on "Non-clinical Testing")

Study Details (as per available information):

1. A table of acceptance criteria and the reported device performance:
   (See table above) The document states, "All pre-determined acceptance criteria were met." However, it does not provide specific numerical targets or results for the bench performance tests (e.g., exact magnetic field strength measured vs. target range). It only confirms compliance with standards and successful completion of tests.

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

   • Test Set Sample Size: Not applicable in the context of human subjects or AI test sets. The testing described is non-clinical bench testing of the device's electrical, mechanical, thermal, electromagnetic, and software functions.
   • Data Provenance: N/A for clinical data. The data is from internal bench testing (performance bench data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. Ground truth for clinical outcomes or diagnoses is not mentioned as this was primarily non-clinical testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. No human reader or expert adjudication process for clinical data or AI output is described.

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 MRMC study was mentioned. The device is a non-invasive electromagnetic stimulator, not an imaging or diagnostic AI device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable for an AI algorithm. The device, the BTL-398, is a physical medical device. Its software functions were verified and validated, but this does not imply an AI component in the typical sense of diagnostic or image analysis AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests, the "ground truth" was established based on engineering specifications and compliance with recognized standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for software verification and validation. For magnetic field strength, coil surface temperature, and PWT features, the ground truth would be the expected performance range derived from design specifications.

8. The sample size for the training set:
   Not applicable. No machine learning training set is mentioned.

9. How the ground truth for the training set was established:
   Not applicable. No machine learning training set is mentioned.

Summary of what the document focuses on:

The entire document pertains to establishing substantial equivalence of the BTL-398 to a predicate device (HPM-6000UF) through non-clinical testing. The key differences noted between the subject device (BTL-398) and the predicate are the inclusion of a "PWT feature" (Pressure Wave Technology for patient positioning) and a "DHT Feature" (Dynamic HFEM Technology for coil adjustment). The non-clinical tests were conducted to ensure these new features and the overall device design do not raise new questions of safety or effectiveness.

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The BTL-754 device with BTL-754-4 handpiece has the following indications for use:

The 2940nm Fractional handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The 1540nm Fractional handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The combined 1540mm and 2940mm Fractional handpiece is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The BTL-754 is a medical device containing two laser wavelengths. A laser is a device that can generate light in the visible or invisible part of the electromagnetic spectrum. The generation of radiation occurs by means of so-called stimulated emission, thanks to which its beam has specific properties - the laser beam is well directed and can propagate over long distances without much divergence. It can also be focused into a very small spot where a very high intensity is achieved.

The BTL-754 consists of a main unit, articulated mirror arm and applicator. The main unit is equipped with a color touch screen with a wide that makes the device easy to use. The onscreen information informs the operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about therapy parameters. The device is equipped with the Emergency laser stop button for immediate termination of the laser emission.

The provided FDA 510(k) summary for the BTL-754 device does not describe a study involving an AI/Machine Learning component, nor does it specify acceptance criteria for such a system.

Instead, the document details a medical device (a laser surgical instrument) and its substantial equivalence to a predicate device. The "Non-clinical Testing" section refers to compliance with applicable medical device safety standards and basic device performance verification, typical for hardware medical devices, not AI/ML performance. The "Clinical Testing" section explicitly states "Not applicable to this submission".

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them, as the provided text does not contain any reference to AI/ML device performance or associated studies.

The information provided is geared towards demonstrating the BTL-754 is substantially equivalent to a legally marketed predicate device (Palomar Icon Aesthetic System, K142376) based on intended use, technological characteristics, and safety standards for laser surgical instruments.

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The device is indicated for aesthetic use including facial and neck or body skin stimulation.

The BTL-785BNF-E is a state-of-the-art electrostimulation device that enables the application of therapy by electrical stimulation to patient's skin for aesthetic use. The main control unit 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, the remaining therapy time and the main therapy parameters on the screen. The generated electrical stimulation is intenact with the tissues of the human body in order to achieve skin stimulation in the face. The device consists of the following main components: BTL-785 main unit, BTL-785-7 Handpiece, Single-use application electrodes, Holding arm, Connection cables, Therapy discomfort button.

The provided document is a 510(k) summary for the BTL-785BNF-E device. It describes the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed.

Crucially, the document explicitly states under the "Clinical performance data" section: "A clinical study was not conducted."

This means that the information typically required to answer your questions regarding acceptance criteria and performance studies (such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not available within this document because no clinical study was performed.

The substantial equivalence determination for this device is based on its similarity to a legally marketed predicate device (BTL-785BNF Handpiece, K233604) and non-clinical testing (electrical safety, EMC, usability, risk management, and biocompatibility standards compliance), not on a new clinical performance study. The key difference in the subject device is the introduction of a new disposable applicator (BTL-785-7-11), which the manufacturer asserts does not significantly influence safety or effectiveness given its similar materials, manufacturing, and technology.

Therefore, I cannot provide a table of acceptance criteria and proven performance based on a clinical study for this device, nor can I answer the specific questions about clinical study design parameters.

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BTL-899MS is indicated to be used for:

· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

• · Strenathening, toning and firming of buttocks, thighs and calves.
• · Improvement of muscle tone and firmness, for strengthening muscles in arms.

The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The BTL-899MS device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

• · Relaxation of muscle spasms
• · Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• · Muscle re-education
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• · Maintaining or increasing range of motion

The BTL-899MS is a non-invasive therapeutic device. The device is comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.

The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying tissue accompanied by a pleasant feeling of warming in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.

The BTL-899MS 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.

Based on the provided FDA 510(k) summary for the BTL-899MS device (K240234), here is an analysis of its acceptance criteria and the study proving it meets them:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed clinical study results for a novel device. Therefore, the information regarding acceptance criteria, specific performance metrics, and detailed study methodologies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for novel AI/software devices) is limited or absent. This document primarily outlines compliance with safety and performance standards relevant to a medical device's physical and electrical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are primarily related to meeting established electrical safety, electromagnetic compatibility, usability, risk management, and biocompatibility standards, and demonstrating substantial equivalence to predicate devices in terms of technological characteristics and intended use. There isn't a table of quantitative performance metrics for disease detection or diagnostic accuracy in this submission because it's a physical therapy device, not an AI diagnostic tool.

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

The document explicitly states "Clinical Testing: Not applicable" on page 6. This indicates that a clinical study with real patient data (test set) for performance evaluation, as would be expected for an AI/software device, was not conducted or deemed necessary for this 510(k) submission. The evaluation was based on non-clinical testing (bench testing) and comparison to predicate devices, focusing on the device's physical and electrical characteristics and mechanism of action.

Therefore, questions regarding sample size, data provenance (country, retrospective/prospective), experts, and adjudication methods for a test set are not applicable in this context.

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

Not applicable, as no clinical test set for performance evaluation was conducted.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no clinical test set for performance evaluation was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a powered muscle stimulator, not an AI diagnostic device intended to assist human readers (e.g., radiologists interpreting images).

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

Not applicable. This is a physical device, not an algorithm, and its functionality is not standalone in the sense of an AI model's performance.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's acceptance is based on:

• Compliance with established international and national technical standards (e.g., IEC 60601-1, ISO 14971) for safety, EMC, usability, and biocompatibility.
• Demonstrated substantial equivalence to previously cleared predicate devices, meaning its intended use and technological characteristics are similar enough that it does not raise new questions of safety or effectiveness. The "ground truth" for this equivalence often relies on the established safety and efficacy of the predicate devices themselves, backed by their own clearances or long-standing market presence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a training set of data.

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

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

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BTL-499 is indicated to be used for:
Non-invasive lipolysis (breakdown of fat) of the abdomen.
Reduction in circumference of the abdomen.
Non-invasive lipolysis (breakdown of fat) of the thighs.
Reduction in circumference of the thighs.
BTL-499 is intended for use with skin types I - VI.
Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV.
Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.
The BTL-499 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-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-499 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators. The BTL-499 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. The system console consists of the RF, HV and massage generators, computer, and a touch-screen control panel. The system combines bipolar radiofrequency with electromagnetic stimulation and mechanical massage. The device is accompanied by the following applicators: 499-AP-MRA-1, 499-AP-MR-2, 499-AP-MRA-4 & 499-AP-MRA-5

Given the provided document, the device in question is the BTL-499, an electrosurgical device. The document states "Clinical Testing: Not applicable to this submission" on page 5. This explicitly indicates that no clinical studies were performed for this submission, and therefore, no data exists to answer questions regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for clinical performance.

The document primarily focuses on non-clinical testing for electrical safety and compliance with medical device standards, and a comparison to predicate devices to demonstrate substantial equivalence based on technological characteristics and intended use, rather than direct comparative clinical performance.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance evaluation, which was explicitly stated as "Not applicable to this submission."

Here's a breakdown of what can be determined from the document:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Non-Clinical/Safety Standards): The document lists several IEC and ISO standards that the BTL-499 device was found to comply with. These standards implicitly serve as the acceptance criteria for the non-clinical performance (safety, EMC, software lifecycle, risk management, biocompatibility).
  • IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
  • IEC 62304: Medical device software - Software life cycle processes
  • ISO 14971: Medical devices – Application of risk management to medical devices
  • ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
  • ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
• Reported Device Performance (against standards): The document states: "The BTL-499 device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards." This is the reported performance – that it complies with the listed standards. No specific quantitative performance metrics beyond compliance are provided in this summary.

The following information is NOT available in the provided text because clinical testing was not applicable to this submission:

• 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established from experts for this submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. The device is not described as an AI-assisted device in this context, and no clinical comparative effectiveness study against human readers was performed.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an energy delivery system, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth data was used for this submission.
• 8. The sample size for the training set: Not applicable. No training set for clinical performance was used.
• 9. How the ground truth for the training set was established: Not applicable.

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

The BTL-785S 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-785S 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-785S 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 applicator used with tips BTL-785-4-1, 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-785S device used with tips BTL-785-4-3, 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-785S with BTL-785-7 Handpiece used with hands-free applicators:

BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide:

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

BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide:

• Non-invasive temporary reduction of facial wrinkles.

BTL-785-7-9 single-use applicator is intended to:

• Affect the appearance of lax tissue in the submental area.

The BTL-785S 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-785S device comes with five different types of applicators.

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

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

The BTL-785S device, specifically with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator, was studied to support a new indication for use: "Affect the appearance of lax tissue in the submental area."

Here's an analysis of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: N=56 subjects.
• Data Provenance: The study was a "single-center single-arm, open-label, interventional design" clinical investigation. The document does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data relevant for the U.S. market. It is a prospective clinical study.

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

• Number of Experts: Three independent reviewers were used for the GAIS (Global Aesthetic Improvement Scale) evaluation.
• Qualifications of Experts: The document does not specify the qualifications of these experts (e.g., radiologist with 10 years of experience). It only states they were "independent reviewers."

4. Adjudication Method for the Test Set:

• The document states "GAIS evaluation by three independent reviewers." This implies a form of consensus or independent grading by multiple experts, but the specific adjudication method (e.g., arithmetic mean, majority vote, or whether disagreements were arbitrated) is not explicitly detailed. It does not mention "2+1" or "3+1" specifically.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study focuses on the standalone performance of the device and its effect on patients. The device is a radiofrequency device, not an AI diagnostic tool for human readers.

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

• Yes, a standalone clinical performance study was done for the device when used with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator. The study assessed the device's direct effect on patient outcomes (appearance of lax tissue, satisfaction, comfort, and safety) without human interpretation of device output in a diagnostic sense.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• The ground truth was established through a combination of:
  • Expert Consensus: General Aesthetic Improvement Scale (GAIS) evaluation by three independent reviewers.
  • Objective Measurement/Outcomes Data: Measurable reduction in the submental area (≥ 20 mm²).
  • Patient-Reported Outcomes/Feedback: Subject satisfaction with therapy outcomes and comfort levels.

8. The Sample Size for the Training Set:

• The document does not provide information on a "training set" as it pertains to an AI/algorithm development. This was a clinical study designed to demonstrate the safety and efficacy of the physical device for a specific indication, not to train an AI model.

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

• As mentioned in point 8, there is no information about a training set or how ground truth for a training set was established, as this was not an AI/algorithm development study.

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BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The BTL-99-OC is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex. BTL-99-OC consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information quides the Operator through the entire therapy procedure. The therapeutic parameters are set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device functions with: M1 figure-of-8 coil applicator. The therapy is provided with the applicator attached to the applicator arm. The BTL-99-OC composed of stimulation generator and stimulation coil. The stimulation generator is driven by software, which the operator controls through the GUI and contains a high voltage energy storage capacitor charging and discharging system, a power supply and a microcomputer control system. The software capabilities for administering treatment in the subject device are the comparable to these in the predicate devices. The stimulation coil is composed of a stimulation coil, an air forced cooling system and an applicator holder. The main unit BTL-99-OC with the M1 coil is intended to be used for both - MT threshold estimation and subsequent application of OCD therapy.

The provided text is a 510(k) summary for the BTL-99-OC device, which is a transcranial magnetic stimulation (TMS) system intended as an adjunct treatment for Obsessive-Compulsive Disorder (OCD). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MagVenture TMS Therapy system - K193006) and a reference device (BTL-995-rTMS - K212723), rather than presenting a performance study with specific acceptance criteria and detailed findings from a clinical trial.

Therefore, the document does NOT contain the information needed to fill out a table of acceptance criteria and reported device performance based on clinical study outcomes, nor does it detail a study structure that includes sample sizes for test sets, data provenance, expert consultation for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text mostly describes:

• The device's intended use and technical characteristics.
• Comparisons of the BTL-99-OC with its predicate and reference devices, primarily focusing on physical and electrical parameters (e.g., magnetic field intensity, coil parameters, electrical safety compliance) to establish technical substantial equivalence.
• Compliance with electrical safety, software lifecycle, and risk management standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971).
• Bench testing results comparing induced fields in a phantom head, showing values are substantially equivalent within a certain range.

In summary, there is no information in the provided document about a clinical study that proves the device meets specific acceptance criteria related to its clinical efficacy or performance in diagnosing/treating OCD. The substantial equivalence is argued based on technological similarities and adherence to safety standards.

Therefore, I cannot populate the requested table or describe the study details as they are not present in this 510(k) summary.

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The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The BTL-899M device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

The BTL-899M is a non-invasive therapeutic device. The device is comprised of a main unit and an applicator that deliver electromagnetic energy to the targeted tissue. The device's output enables handsfree treatment.

The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying muscles, joints and connective tissue accompanied by a pleasant feeling of warming sensation in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.

The BTL-899M 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.

This document (K232937) is a 510(k) premarket notification for a medical device called BTL-899M, a Powered Muscle Stimulator. The key takeaway from this document is that the FDA has determined the BTL-899M device is substantially equivalent to a legally marketed predicate device (HPM-6000, K160992).

Therefore, the primary method of proving the device meets acceptance criteria is through demonstrating substantial equivalence to a predicate device by satisfying safety and performance standards for the device type, rather than conducting a separate clinical study with specific acceptance criteria as one might for a novel AI device with new claims.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a traditional medical device (Powered Muscle Stimulator) and not an AI/ML diagnostic tool, the "acceptance criteria" are primarily related to safety, electrical performance, and functional equivalence to the predicate device, demonstrated through non-clinical testing and comparison. There are no specific "performance metrics" in the sense of accuracy, sensitivity, or specificity as there would be for an AI-driven diagnostic.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states "Clinical Testing: Not applicable" (page 7). This means there was no clinical test set or associated data provenance (e.g., country, retrospective/prospective) in the traditional sense for evaluating device performance against a diagnostic or therapeutic outcome. The testing was primarily non-clinical (bench testing) to ensure safety and functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since there was no clinical testing or a "test set" in the context of diagnostic performance, there were no experts used to establish ground truth in this manner. The ground truth, in a regulatory context, for this type of device, is established by its compliance with recognized safety and performance standards and its comparison to an already cleared device.

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

Not applicable, as no clinical test set requiring adjudication was performed.

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. This device is a powered muscle stimulator, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This is not an AI/algorithm-driven device.

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

The "ground truth" for this submission is compliance with recognized standards for electrical safety, software safety, risk management, biocompatibility, and functional equivalence to the legally marketed predicate device. There is no "ground truth" related to disease diagnosis or treatment outcomes in the way one would describe it for an AI/diagnostic device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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