Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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).

Ask a specific question about this device