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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 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.

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.

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