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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 Maior Depressive Disorder.

The Neurosoft TMS principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

The Neurosoft TMS consists of the following main components:

• Main unit of the magnetic stimulator
• Cooling unit
• Extra power supply unit
• Coils
• Cooled figure-of-eight coil FEC-02-100-C
• Cooled figure-of-eight coil AFEC-02-100-C
• Figure-of-eight coil FEC-02-100 (optional)
• Figure-of-eight coil AFEC-02-100 (optional)
• K8 coil holder
• K3 flexible arm for coil positioning
• Trolley with casters

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as well, as this is a 510(k) summary, which often relies on comparison to predicate devices rather than de novo clinical studies for performance.

Important Note: The provided document is a 510(k) premarket notification summary for a medical device (Neurosoft TMS). Such submissions typically demonstrate substantial equivalence to a previously cleared predicate device, rather than proving direct clinical efficacy through new, large-scale clinical trials. Therefore, information regarding clinical effectiveness studies, particularly those involving human readers, ground truth establishment through expert consensus or pathology, and detailed statistical performance metrics like sensitivity/specificity for AI algorithms, are generally not present in these types of documents for TMS devices. The focus here is on non-clinical performance (safety, electrical, mechanical) and a comparison of technical specifications.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for the Neurosoft TMS are primarily based on demonstrating substantial equivalence to its predicate devices, especially its own prior version (Neurosoft TMS K160309) and the MagVita TMS Therapy System (K171481). The key "performance" demonstrated relates to its technical specifications matching or being comparable to these cleared devices, and changes not introducing new safety concerns.

Table of Acceptance Criteria and Reported Device Performance

• Magnetic Field Intensity: 120% of the MT
• Frequency: 10 Hz
• Train duration: 4 sec
• Inter-train interval: 11-26 sec (Modified from fixed 26 sec in K160309, comparable to MagVita)
• Number of trains: 75
• Magnetic Pulses per Session: 3000
• Treatment Session Duration: 18.8 min-37.0 min (Due to variable inter-train interval)
• Sessions/week: 5
• Treatment Schedule: 5 daily sessions for 6 weeks
• Area of brain to be stimulated: Frontal Cortex |
  | Device Components | Comparable components (Main unit, Cooling unit, Power supply, Coils, Coil holders, Flexible arm, Trolley). | Lists identical and optional coils (FEC-02-100-C, AFEC-02-100-C, FEC-02-100, AFEC-02-100). "The Neurosoft TMS and the predicate devices have the same components..." |
  | Coil Specifications | Comparable coil designs (figure-of-eight, air core, cooling methods) and parameters (Inner/Outer diameter, Area, Inductance, Amplitude in SMT units, Waveform, Active pulse width, Max initial dB/dt). | Detailed specifications for all listed coils provided, showing close similarity to K160309 and comparable ranges to MagVita. |
  | Safety Standards | Compliance with relevant electrical safety and quality standards (e.g., IEC 60601-1, ISO 13485, ISO 14971). | "Complies with IEC 60601-1 and IEC 60601-1-2."
  "Company complies with DIN EN ISO 13485: 2012, ISO 10993-1: 2009, ISO 14971: 2007." |
  | Non-clinical Performance | Satisfactory performance in required non-clinical tests as demonstrated for the predicate device (K160309). | "The non-clinical performance testing of Neurosoft TMS has been tested as required, and cleared by the FDA earlier on K160309. These tests demonstrate that the Neurosoft TMS is safe and effective for use in treatment of Major Depressive Disorder." |
  | New Safety Concerns | The modifications (e.g., variable inter-train interval) should not introduce any new safety considerations. | "On the basis of the only modification of the treatment parameter, the Neurosoft TMS does not introduce any new safety considerations in comparison to the predicate device. All other identified differences between the two systems are minor and without any known impact on safety or efficacy." |

Study Information (Based on the Provided Document):

The document primarily refers to non-clinical performance data and relies on the substantial equivalence paradigm rather than a new clinical study for this specific 510(k) submission.

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

   • No specific sample size for a "test set" or clinical trial is provided. The document refers to "non-clinical performance testing."
   • Data Provenance: Not specified in terms of country of origin. The testing is described as having been "tested as required, and cleared by the FDA earlier on K160309," implying the data underpinning the original clearance (and now referenced) would be from the manufacturer's internal testing as part of their regulatory submissions. The nature of these tests (e.g., electrical, mechanical, EMC) would be retrospective from the previous submission perspective.

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

   • Not applicable / Not specified. As this is a 510(k) for a TMS device based on substantial equivalence and non-clinical data, there is no mention of a ground truth established by human experts for performance evaluation in the context of an AI/human reader study. The "ground truth" for a TMS device's safety and effectiveness is typically established through a combination of regulatory standards, engineering principles, and clinical data from predicate devices or general scientific consensus on the treatment.

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

   • Not applicable / None specified. No clinical test set involving human readers or expert adjudication is described in this document.

4. 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 done or reported in this document. This device is a direct treatment device (rTMS system), not an imaging analysis or diagnostic AI tool that would typically involve MRMC studies.

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

   • Not applicable. This device is a hardware system for direct medical treatment; it is not an algorithm for diagnostic interpretation in the way AI/ML software as a medical device (SaMD) might be evaluated for standalone performance. The "algorithm" here refers to the internal programming of the TMS device to deliver stimulation according to parameters.

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

   • For the device's fundamental function (producing magnetic fields of specific parameters), the "ground truth" would be physical measurements and engineering specifications.
   • For the device's clinical indication (treatment of MDD), the "ground truth" used for prior clearances (and thus for this substantial equivalence claim) would be the clinical evidence supporting the predicate devices' efficacy (which may have originally involved clinical trials measuring patient outcomes or expert clinical assessments of depression severity). This document itself does not detail new outcomes data.

7. The sample size for the training set:

   • Not applicable / Not specified. This document does not describe a machine learning model with a "training set."

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

   • Not applicable. As no machine learning training set is described.

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