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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 Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Mag Vita TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The MagVita TMS Therapy System is indicated for Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons. In the MagVita TMS therapy system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC). The MagVita TMS Therapy System consists of the following components: MagPro Stimulator , Trolley and Super Flexible Arm . Coil for MT determination . Marking apparatus for locating treatment area . Coil for Depression Treatment . Isolation Transformer

This document, K171967, is a 510(k) summary for a modification to the MagVita TMS Therapy System, not a study presenting new clinical efficacy data for the device itself.
Therefore, the document does not present acceptance criteria or a study proving the device meets those criteria in the way a clinical trial would for a new device's efficacy.

Instead, this submission is to demonstrate substantial equivalence of a modified device (one without a proprietary treatment chair and head support) to a previously cleared device. The "acceptance criteria" here are essentially the demonstration that the modified device's performance characteristics are largely unchanged and that it adheres to relevant safety standards.

Here's how to interpret the provided information in the context of your request:

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

The document provides a comparison table (pages 5 & 6) between the modified MagVita TMS Therapy System and its predicate device (MagVita TMS Therapy System K150641/171481), as well as other predicate devices regarding the treatment chair. The "acceptance criteria" are implied to be the characteristics of the predicate device, and the "reported device performance" is how the modified device compares.

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

This document does not describe a clinical study with a test set of patient data. It describes a technical and regulatory comparison for a device modification. The "data" here refers to the device's technical specifications and compliance with standards.

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

Not applicable. This is not a study assessing clinical performance based on expert review of medical data. The ground truth for the device's technical specifications and safety compliance is established through engineering design, testing, and adherence to recognized standards.

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

Not applicable, as there is no test set in the sense of patient data requiring 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 Transcranial Magnetic Stimulator (TMS), not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

Not applicable. The MagVita TMS Therapy System is a physical medical device for treatment, not a standalone algorithm.

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

The "ground truth" for this 510(k) submission is the technical specifications, performance characteristics, and safety standards of the predicate device (MagVita TMS Therapy System K150641/171481) and recognized international standards (ISO, IEC). The aim is to demonstrate that the modified device is substantially equivalent to this established ground truth.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning algorithm requiring a training set.

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

Not applicable. There is no training set mentioned in this document.

In summary: The K171967 document is a premarket notification for a modification to an existing device. It demonstrates substantial equivalence by comparing the modified device's technical specifications and adherence to safety standards against its predicate, rather than presenting a clinical study with patient data and performance metrics like sensitivity/specificity.

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The Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to recieve satisfactory improvement from prior antidepressant medication in the current episode

The MagVita TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The Mag Vita TMS Therapy System is indicated for Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons. In the MagVita TMS therapy system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).

The provided document is a 510(k) summary for the MagVita TMS Therapy System (K171481). This document asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study designed for that purpose. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in terms of clinical efficacy against numerical thresholds, is not present in this document.

The document focuses on demonstrating that the modified MagVita TMS Therapy System (K171481) is as safe and effective as previously cleared predicate devices (MagVita TMS Therapy System, K150641, and Neurostar TMS Therapy System, K160703). The primary modification is a reduction in inter-train interval, leading to shorter treatment times.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what is missing:

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

The document does not provide a formal table of explicit acceptance criteria with numerical thresholds for clinical performance (e.g., specific rates of symptom reduction or remission). Instead, it states that the device is "safe and effective," and that "all other identified differences between the three systems are minor and without impact on safety or efficacy."

The table provided in the document compares various technical specifications and operational parameters of the subject device to its predicates. These comparisons serve as the "performance" data to argue for substantial equivalence, rather than direct measurements against pre-defined clinical acceptance criteria.

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

This information is not provided as the submission is a 510(k) for substantial equivalence, not a clinical trial report with a test set of patient data for efficacy evaluation. The "test set" in this context refers to the device's adherence to the technical specifications of its predicates. Non-clinical performance data for components was "tested as required" and cleared in previous 510(k) submissions (K091940 and K150641), but no details on sample sizes or data provenance are given for these tests.

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)

This information is not applicable/not provided. The "ground truth" in this submission relates to the technical specifications and operational parameters, which are established through engineering design, testing, and regulatory standards, not expert clinical consensus on patient data.

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

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies when establishing ground truth from multiple expert interpretations of medical data. This document focuses on technical equivalence.

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

This information is not applicable/not provided. An MRMC study is relevant for diagnostic devices often involving human interpretation of images or other data with and without AI assistance. This device is a therapeutic system (rTMS) for Major Depressive Disorder, not a diagnostic imaging device. It does not involve "human readers" in the sense of interpreting outputs that an AI could also interpret.

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

This information is not applicable/not provided. This device is a physical therapeutic system and does not function as an "algorithm only" device without human involvement. It requires a trained clinician for setup, motor threshold determination, coil positioning, and ongoing patient monitoring.

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

The "ground truth" in this context is based on:

• Compliance with established medical device standards (e.g., ISO 13485:2012, IEC60601-1, IEC60601-1-1, IEC60601-1-2).
• Demonstration of technical and operational equivalence to predicate devices cleared by the FDA, which were previously determined to be safe and effective based on their own clinical evidence (or substantial equivalence to even earlier devices).
• The premise that minor modifications (like adjusted inter-train interval for shorter treatment time) do not introduce new safety concerns or alter efficacy, meaning the "ground truth" of safety and efficacy established for the predicates applies.

8. The sample size for the training set

This information is not applicable/not provided. No "training set" of patient data is mentioned or implied, as this is a traditional medical device submission for a physical therapy system, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable/not provided for the same reasons as point 8.

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The MEP Monitor is an accessory for the MagPro stimulators (MagPro R30, MagPro R30 including MagOption, MagPro X100, and MagPro X100 including MagOption) and is intended to monitor evoked potentials.

The MEP Monitor is a small accessory device which is connected to the rear side of a MagPro magnetic stimulator. The MagPro magnetic stimulators are FDA cleared in K061645 and K091940. The device in this submission is not used alone but is connected to the MagPro stimulators on the rear side of either of the 4 cleared stimulators. The setup of the MEP Monitor is done in the MEP menu on the stimulator. The display on the stimulator shows a curve with the MEP response. The Motor Evoked Potential (MEP) Monitor is an optional component which allows the user to capture EMG signals and display them on the MagPro UI. Device with 1 channel input. Isolated input DIN-connector (Body Floating). Directly connected to the rear panel of the magnetic stimulator device. The MEP Monitor is designed to be used with surface electrodes only. Supports connections of standard electrode cables and surface electrodes.

The provided text is a 510(k) summary for the MEP Monitor, a medical device accessory. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria through clinical or algorithmic testing.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in an AI/algorithm context, a specific study proving it meets those criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth for training was established.

This is a regulatory submission based on substantial equivalence, which means the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, rather than providing novel performance data against predefined acceptance criteria from a new study. The "Testing" section primarily refers to compliance with electrical safety and EMC standards, not clinical performance metrics for an AI/algorithm.

In summary, none of the requested information about acceptance criteria, study details, sample sizes, expert involvement, or AI-specific performance metrics is present in the provided text.

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The STM9000 is intended for stimulation of peripheral nerves for diagnostic purposes.

The STM 9000 are magnetic stimulators used for magnetic stimulation. Magnetic stimulation is a noninvasive technique for stimulating neural and cortical tissue. Application areas of magnetic stimulation are a subset of the application areas for current stimulation. The STM 9000 is connected to a magnetic coil which transfers the magnetic stimulation to the tissue. The STM 9000 consists of power electronics to generate the magnetic field in the magnetic coil. The STM 9000 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is capable of biphasic and monophasic waveforms and the stimulate with a frequency up to 100 pulses per second (pps).

This document is a 510(k) Premarket Notification for the STM9000 device, which is an evoked response electrical stimulator. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies heavily on showing that the new device has similar technological characteristics and performance to existing devices, rather than comprehensive clinical trial data for novel claims.

Therefore, the structure of the provided text does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/Machine Learning (ML) enabled medical device. The STM9000 is a magnetic stimulator, and the performance data presented is focused on demonstrating its safety and basic functionality in comparison to a predicate device, as required for a traditional 510(k).

The document addresses:

• Biocompatibility Testing: To ensure the device materials are safe for contact with the human body.
• Electrical Safety and Electromagnetic Compatibility (EMC): To ensure the device operates safely in its electromagnetic environment and does not pose electrical hazards.
• Software Verification and Validation Testing: To ensure the software functions correctly and reliably, commensurate with its "Moderate" level of concern.

It does not contain the kind of performance data (e.g., sensitivity, specificity, AUC, accuracy) that would be derived from a study proving an AI/ML diagnostic or prognostic device meets acceptance criteria. There are no mentions of:

• A test set of patient data (e.g., images, physiological signals).
• Ground truth established by experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set details for an ML model.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert involvement, or MRMC studies, as this information is not present in the provided 510(k) document for the STM9000. The performance data provided is about the device's inherent safety and functional compliance, not its diagnostic or prognostic accuracy on a dataset.

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The Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The MagVita TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The Mag Vita TMS Therapy System is indicated for Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons.

In the MagVita TMS therapy system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be as effective as the predicate device in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).

The MagVita TMS Therapy System is an integrated system consisting of the following components:

• MagPro Stimulator and Trolley
• Coil for MT determination
• Marking apparatus for locating treatment area
• Patient head fixation
• Coil for Depression Treatment
• Isolation Transformer

The provided text is a 510(k) summary for the MagVita TMS Therapy System. It states that the device is substantially equivalent to a predicate device (NeuroStar TMS Therapy System) and therefore does not require new acceptance criteria or a new study to prove its efficacy. Instead, it relies on the established safety and effectiveness of the predicate device.

Therefore, the document does not contain the specific information requested about acceptance criteria and a new study proving the device meets those criteria for the MagVita TMS Therapy System itself. It instead focuses on demonstrating substantial equivalence to a previously cleared device.

However, I can extract information related to the comparison of the two devices and their intended use, which might indirectly address some of your points as they relate to the predicate device's established performance.

Here's an analysis based on the provided text, extrapolated to address your request where possible, but with the critical caveat that this document does not present de novo acceptance criteria or a new study for the MagVita TMS Therapy System.

1. Table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, there are no new acceptance criteria defined in this document for the MagVita TMS Therapy System. Instead, the performance is compared to the predicate device, aiming to show similar or equivalent performance parameters.

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

The document states that "The non-clinical performance testing of the components of the MagVita TMS Therapy System has been tested as required, and cleared by the FDA earlier on K061645, K071821 and K091940." It further mentions that "These tests along with the supportive clinical information from the predicate device demonstrate that the MagVita TMS Therapy System is as safe and effective as the predicate device."

This implies that no new clinical study (test set) for the MagVita TMS Therapy System's efficacy in treating Major Depressive Disorder was conducted for this 510(k) submission. The submission relies on the existing clinical data and regulatory clearance of the predicate device (NeuroStar TMS Therapy System) and previous clearances of MagVita TMS Therapy System components. Therefore, information about sample size, country of origin, and retrospective/prospective nature for a new test set for efficacy is not present in this document.

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

Not applicable, as no new clinical efficacy test set was conducted for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable, as no new clinical efficacy test set was conducted for this 510(k) submission.

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 Transcranial Magnetic Stimulator, not an AI-powered diagnostic imaging device that would involve human readers.

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

Not applicable. This device is a therapeutic device, not an algorithm. Its performance is measured directly by its physical output (magnetic fields) and its therapeutic effect, which is established by clinical trials for the predicate device.

7. The type of ground truth used:

For the predicate device, the ground truth for its efficacy would have been established through clinical trials, likely involving patient outcomes data (e.g., reduction in depression symptom scores as measured by standardized clinical scales) and expert consensus from diagnosing clinicians. This document specifically states the indication for the predicate (and thus the new device) is for "treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode," implying that clinical improvement in depressive symptoms is the primary measure of efficacy.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device. The "training set" for a medical device's performance would refer to the data used to validate its design and manufacturing. The document refers to non-clinical performance testing and previous clearances of components (K061645, K071821, K091940), which would have involved their own testing samples.

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

Not applicable for a "training set" in the AI sense. For the non-clinical performance testing mentioned, the "ground truth" would be established by predefined engineering and safety specifications and measurements (e.g., magnetic field strength, pulse width accuracy, frequency control).

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