(322 days)
The Neurosoft TMS 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 Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.
This document describes a 510(k) premarket notification for the Neurosoft TMS device. The core of this submission is to demonstrate substantial equivalence to predicate devices, namely the Tonica Electronik A/S MagVita TMS Therapy System and the Magstim Company Limited Rapid2 Therapy System. The document does not describe an acceptance criteria study with direct device performance measurement against these criteria, but instead relies on showing feature-by-feature similarity to already-approved predicate devices.
Therefore, the requested information elements cannot be fully populated as they would typically apply to a clinical trial or performance study against predefined metrics. However, an interpretation of "acceptance criteria" and "reported device performance" in this context would be the comparative features and specifications between the Neurosoft TMS and its predicate devices, as presented in Table 5-1.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:
1. A table of acceptance criteria and the reported device performance
In the context of a 510(k) submission showing substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is the Neurosoft TMS's specifications, which are presented as being equivalent, or not raising new safety/efficacy concerns, compared to the predicates.
| Criteria (Implied "Acceptance Criteria" from Predicate Devices) | Neurosoft TMS Reported Performance (Substantial Equivalence Claim) |
|---|---|
| Intended Use (Treatment of MDD in adult patients who failed prior antidepressant medication) | Identical |
| Magnetic Field Intensity (120% of MT) | 120% of MT |
| Frequency (10 Hz) | 10 Hz |
| Train duration (4 sec) | 4 sec |
| Inter-train interval (26 sec) | 26 sec |
| Number of trains (75) | 75 |
| Magnetic Pulses per Session (3000) | 3000 |
| Treatment Session Duration (~37.0 - 37.5 min) | ~37.0 min |
| Sessions/week (5) | 5 |
| Treatment Schedule (5 daily sessions for 6 weeks) | 5 daily sessions for 6 weeks |
| Area of brain to be stimulated (Frontal Cortex) | Frontal Cortex |
| Coil Configuration (Figure-of-eight coil) | Figure-of-eight coil |
| Coil Core material (Air core) | Air core |
| Waveform (Biphasic sinusoid) | Biphasic sinusoid |
| Active pulse width (μs) (~290-300 µs) | 280 µs (claimed to be substantially equivalent) |
| Max initial dB/dt (kT/s) near the coil surface (Various, e.g., 35-36 kT/s for predicates) | FEC-02-100-C 25, AFEC-02-100-C 38, FEC-02-100 25, AFEC-02-100 32 (claimed to be substantially equivalent) |
| Coil temperature auto-disable (40-41 °C) | 41 °C (106 °F) |
| Electrical safety standards compliance (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2) | AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2 |
| ISO Standards met (ISO 13485, ISO 10993-1, ISO 14971) | DIN EN ISO 13485: 2012, ISO 10993-1: 2009, ISO 14971: 2007 |
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 primarily describes non-clinical performance data for the Neurosoft TMS focusing on electrical safety, EMC, biocompatibility, software verification/validation, risk analysis, and magnetic field characteristics. There is no mention of a "test set" in the context of a clinical study, as the submission relies on substantial equivalence to predicate devices, which are already approved for clinical use.
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)
Not applicable. This document does not describe a clinical study where ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical test set is described, no adjudication method would be required.
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 Repetitive Transcranial Magnetic Stimulation (rTMS) system, a treatment device, not an image analysis or diagnostic aid involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes non-clinical performance data for the Neurosoft TMS:
- Electrical safety and electromagnetic compatibility testing (compliant with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2: 2007).
- Biocompatibility evaluation of coils (meet ISO 10993-1 (2009)).
- Software verification and validation testing (performs as intended and in accordance with specifications, described in section 16, not provided here).
- Risk analysis (compliance with ISO14971).
- Magnetic field characteristics (plots and acoustic output measurements conducted as per FDA guidance).
These are performed on the device itself and its components, representing "standalone" performance in terms of its technical and safety specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests:
- Electrical safety/EMC: Ground truth is defined by the requirements of the cited standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2).
- Biocompatibility: Ground truth is defined by the requirements of ISO 10993-1 (2009).
- Software verification/validation: Ground truth is the defined software specifications and requirements.
- Magnetic field characteristics: Ground truth is derived from physical measurements and comparison to established parameters of predicate devices and FDA guidance.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based diagnostic device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.