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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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Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.

The Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1 (herein collectively referred to as "Rapid2 Magnetic Stimulators") are computerized, electromechanical medical devices that provide brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. The subject device is intended to be used in hospitals and clinics such as pain management clinics.

Rapid2 Magnetic Stimulators are integrated systems consisting of a combination of hardware, software, and accessories. Rapid2 Magnetic Stimulators are offered in multiple configurations:

• Rapid2
• Super Rapid2
• Super Rapid2 Plus1

All three configurations have identical intended use/indications for use, common specifications, equivalent performance characteristics and equivalent composition to each other. Specifically, Rapid2 and Super Rapid2 have received prior clearance under K051864 for Peripheral Nerve Stimulation (Product Code: GWF, Regulation 21 CFR 882.1870). All Rapid2 Magnetic Stimulators are made up of components that have received prior clearance under K051864 (e.g., the 3190-00, 3192-00 and 3193-00 coils) and components which have received prior clearance under K051864 but have received modifications due to aspects like obsolescence (Mainframe, Power Supply etc.).

All Rapid2 Magnetic Stimulators are composed from the following main components:

• Stimulating Unit & Power Supply
• User Interface
• Stimulating Coil
• System and Stimulating Coil Cart and Holding Arm

Rapid2 Magnetic Stimulators include temperature monitoring via two independent temperature sensors to ensure surfaces of the coils do not reach unacceptable levels. The cut-off is set to act at 40°C at which point the system will automatically be disabled. Over-temperature conditions are also communicated on the User Interface (UI) via a temperature gauge and alarm system. Rapid2 Magnetic Stimulators also includes the 3910-00 air-cooled coil to further mitigate any temperature conditions. The 3910-00 air-cooled coil comes with all 3 configurations (Rapid2, Super Rapid2 and Super Rapid2 Plus1) as standard.

The provided document is an FDA 510(k) Clearance Letter for the Rapid2 Magnetic Stimulators. It does NOT contain information about a study proving the device meets acceptance criteria related to its performance in pain relief. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of technical characteristics, safety standards compliance, and physical properties.

The document does not describe an AI/ML-driven device, nor does it present results from a clinical study with patients or human readers using AI. The acceptance criteria and performance metrics described are related to physical and electrical characteristics of the magnetic stimulator, not diagnostic accuracy or clinical effectiveness in a traditional sense of "performance" as one might expect for an AI diagnostic device.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type) cannot be answered based on the provided text, as they pertain to clinical or AI/ML performance evaluation, which is not the subject of this 510(k) summary.

However, I can extract information related to the technical acceptance criteria and how they align with the device's measured performance as described in the summary:

Acceptance Criteria and Device Performance (Based on Technical and Safety Equivalence)

The acceptance criteria for the Rapid2 Magnetic Stimulators are primarily based on demonstrating substantial equivalence to the predicate device (MagVenture Pain Therapy) in terms of technical characteristics, safety, and effectiveness for the stated indications for use. The "performance" reported is adherence to these characteristics and safety standards.

Regarding the specific questions that cannot be answered from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable or provided. The "test set" here refers to non-clinical testing of device characteristics, not a clinical study on patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would implicitly be engineering specifications, laboratory measurements, and standard compliance testing, not expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. No adjudication process detailed for establishing technical specifications.
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 is not an AI/ML device, nor is it a diagnostic device being evaluated for reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance evaluation is based on engineering specifications, direct physical measurements (e.g., of magnetic fields, temperatures, electrical properties), and compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993).
8. The sample size for the training set: Not applicable or provided. This device does not use a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable or provided.

In summary, the provided document details the 510(k) clearance process for a non-AI/ML magnetic stimulator for pain relief. The "acceptance criteria" and "performance" are framed around demonstrating substantial technical and safety equivalence to a legally marketed predicate device, rather than clinical efficacy data from patient studies or AI algorithm performance metrics.

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With handheld applicators:

PMS mode:

Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance.

Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation.

TENS mode:

Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.

Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

With Chair Back applicator:

TENS mode:

Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply, handheld applicators and a chair.

The provided document is a 510(k) summary for the Fotona StarFormer (M008-3T) device, a transcutaneous electrical nerve stimulator. However, it does not contain the specific details about acceptance criteria or a comparative effectiveness study that demonstrates how the device meets acceptance criteria.

The document indicates that:

• Nonclinical testing was performed, including electrical safety, mechanical strength, thermal safety, electromagnetic compatibility, software verification and validation, and cybersecurity testing. It explicitly states, "All pre-determined acceptance criteria were met" for these tests.
• No premarket clinical investigations were conducted. The rationale provided is that "performance of StarFormer is based on the well-established magnetic stimulation technology and does not carry significant residual risk for patients."

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (since these are not specified beyond a general statement of compliance).
2. Sample size used for a test set or data provenance (as no clinical test set is described).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size on human readers.
6. Stand-alone performance (algorithm only) as this is a device and not an AI algorithm being evaluated in a clinical "standalone" sense.
7. Type of ground truth used (as no clinical study is detailed).
8. Sample size for the training set (as no AI/ML model training is described in the context of clinical performance evaluation).
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices primarily through comparison of technological characteristics and compliance with nonclinical performance standards, rather than clinical efficacy studies with specific acceptance criteria that might be seen for novel AI/ML devices.

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

The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.

The provided document is a 510(k) summary for the Axon Therapy device, which is a magnetic stimulator system intended for pain relief. The submission seeks to establish substantial equivalence to a previously cleared device (K210021, also Axon Therapy by NeuraLace). This document does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of an AI/ML medical device submission.

Instead, it focuses on demonstrating substantial equivalence by highlighting that the subject device has identical design, dimensions, materials, intended use, and technological characteristics to the predicate device. The primary change is an expansion of the Indications for Use to include "chronic painful diabetic peripheral neuropathy in the lower extremities."

Therefore, the information regarding acceptance criteria, test set details, expert ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document. The document describes a clinical study done to support the expanded indication, which is different from a performance study for an AI/ML algorithm.

Here's a breakdown of what can be extracted and what is missing/not applicable based on the provided text, assuming the request is looking for AI/ML device study details:

Information Present or Inferable:

• 1. A table of acceptance criteria and the reported device performance:
  • Acceptance Criteria (Inferable for Clinical Study): The primary efficacy objective for the clinical study was to compare the proportion of "responders" (>=50% reduction from baseline in neuropathic pain intensity as measured by an in-clinic visual analog score (VAS) for the primary area of pain at Day 30, with no increase over baseline pain medications within four weeks of the Day 30 visit) between the Axon Therapy plus CMM group and the Sham plus CMM group. While not a formal "acceptance criteria" table for AI/ML, this is the clinical endpoint criteria.
  • Reported Device Performance:
    • Axon Therapy group: -57.6% reduction in VAS pain scores.
    • Sham group: -12.5% reduction in VAS pain scores.
    • p-value:

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To stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older

The MagVenture Pain Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic and post-surgical pain. The subject device is intended to be used in hospitals and clinics such as pain management clinics. The device consists of Magnetic Stimulator, Stimulation Coils, Liquid Cool Unit (optional), and a Trolley. All coils of the MagVenture Pain Therapy have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the skin of the patient or operator. The temperature allowed by the system is maximum 43°C or between 44°C for less than 10 minutes. The system will automatically disable if this maximum temperature is reached.

The provided document is a 510(k) Premarket Notification for the MagVenture Pain Therapy device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness. Therefore, the information regarding specific acceptance criteria and a study proving those criteria are not directly presented in the format requested for a device with novel claims.

However, based on the document, we can infer acceptance criteria from the comparison to the predicate device and the discussion of technological characteristics. The study proving the device meets these inferred criteria is essentially a comparison study against the predicate device and an assessment of why any differences do not raise new questions of safety or effectiveness.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations of a 510(k) submission:

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

The "acceptance criteria" for a 510(k) are typically that the new device is "substantially equivalent" to a predicate device, meaning it has the same intended use and either has the same technological characteristics or, if it has different technological characteristics, those do not raise different questions of safety and effectiveness. The performance is reported by comparing it to the predicate.

The "study" demonstrating these criteria are met is the comparison presented in the 510(k) submission, specifically the "Comparison of Technological Characteristics" table and the "Substantial Equivalence Notes" which explain why differences do not raise new safety or effectiveness questions.

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

The document does not describe a clinical "test set" in the traditional sense of a clinical trial. Instead, the "testing" references non-clinical testing performed on the predicate device (K094019) and the argument that the current device is "identical in all features (e.g., design, dimensions, materials, biocompatibility), except for the indications for use." Therefore, "no new bench testing is needed."

This implies that the "data provenance" for the foundational performance characteristics comes from the testing previously conducted for the predicate devices (MagPro Family device K094019 and Axon Therapy K210021), not a new test set for this submission.

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

Not applicable. This is a 510(k) submission based on substantial equivalence, not a de novo clinical study with a new "test set" requiring expert ground truth establishment. The ground truth for safety and effectiveness is established by the prior clearance of the predicate device.

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

Not applicable. As above, there is no new clinical "test set" with adjudication.

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 Transcutaneous Electrical Nerve Stimulator for Pain Relief, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

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

Not applicable. This is a physical medical device (magnetic stimulator), not an algorithm or AI system. Its performance is intrinsic to the device's physical operation, not an algorithm's output.

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

The ground truth for the safety and effectiveness of the device's underlying technology and performance characteristics is established through:

• Prior FDA clearances: The substantial equivalence relies on the fact that the predicate devices (MagPro Family and Axon Therapy) were previously cleared by the FDA based on their demonstrated safety and effectiveness.
• Compliance with recognized standards: The document explicitly states compliance with standards like IEC60601-1 v3.1 (electrical, mechanical, chemical, thermal safety) and ISO 10993 (biocompatibility). These standards represent established "ground truths" for various aspects of device safety.
• Physiological understanding: The justification for wider pulse frequencies and repetition rates refers to the "range of physiological action potentials (from 0.05 to 500 Hz) of the human nervous system," indicating an appeal to established physiological knowledge as a "ground truth" for safety.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable.

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The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and postsurgical pain for patients 18 and older.

The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.

The provided text describes the 510(k) premarket notification for Axon Therapy by NeuraLace Medical, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel acceptance criteria in the traditional sense of a clinical trial for a new drug or high-risk device. Therefore, the "acceptance criteria" here largely refer to meeting the requirements for substantial equivalence to a legally marketed predicate device, primarily through non-clinical and clinical testing designed to show that the new device is as safe and effective as the predicate.

Given this context, I will interpret "acceptance criteria" as the performance and safety benchmarks established by the predicate device and the relevant FDA standards, which the Axon Therapy must meet or surpass. The "study that proves the device meets the acceptance criteria" refers to the set of tests and clinical data provided to demonstrate this substantial equivalence.

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

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implicitly defined by the characteristics of the predicate device (Shenzhen Roundwhale Technology Co., Ltd. R-C1 TENS and EMS Stimulator; K181688) and other reference devices, along with relevant industry standards (IEC, etc.). The reported device performance demonstrates how the Axon Therapy aligns with or improves upon these.

Table of (Implicit) Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • Clinical Studies:
     • Total subjects: n=105.
     • Subgroup 1: 25 subjects.
     • Subgroup 2: 80 subjects (105 - 25).
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It states "NeuraLace conducted multiple clinical studies," implying prospective studies conducted by the company.

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

   • This information is not explicitly provided. For a pain relief device, "ground truth" is typically subjective patient-reported pain scores (NRS/MVAS) rather than readings established by experts.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned, as the primary outcome (pain scores) is patient-reported.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. The clinical studies focused on the effectiveness and safety of the device itself (with or without a human in the loop, but the device is user-applied in a clinical setting). It was not a comparative study of human readers assisted by AI vs. unassisted human readers.

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

   • This question is generally relevant for AI/software-based diagnostic devices. For a physical medical device like Axon Therapy, a "standalone algorithm" is not applicable in the same way. The device functions to stimulate nerves, and its performance is measured by its physical output (magnetic pulses) and clinical outcomes (pain relief), not by an algorithm making a diagnosis or interpretation. The software validation mentioned (IEC 62304) ensures the software controlling the device operates correctly, which is part of the integrated device performance.

6. The Type of Ground Truth Used:

   • Clinical Efficacy: Patient-reported outcome measures (PROMs) using the Numeric Rating Scale (NRS) or Mechanical Visual Analog Scale (MVAS) for pain. This is a subjective patient outcome as ground truth for pain relief.
   • Safety: Occurrence of adverse events, evaluated by clinicians and reported.
   • Technical Performance: Quantitative measurements from performance testing (e.g., magnetic field characteristics, stimulation protocol accuracy, temperature). Compliance with electrical safety, EMC, and usability standards are also part of the "ground truth" for device safety and functionality.

7. The Sample Size for the Training Set:

   • This document describes a premarket notification for a physical medical device, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The term "training set" is not applicable here. The clinical studies described (n=105 total subjects) are the testing/validation set for the device's clinical performance and safety.

8. How the Ground Truth for the Training Set was Established:

   • See point 7; "training set" in the AI/ML sense is not relevant. The device's "training" refers to its design, engineering, and manufacturing process, optimized through non-clinical and preclinical testing to ensure it meets its intended function prior to clinical evaluation.

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