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BTL-995-rTMS is indicated to be used for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The BTL-995-rTMS is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex. BTL-995-rTMS consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device functions with two applicator types: figure-of-8 coil applicator and circular coil applicator. The therapy is provided with the applicator attached to the applicator arm.

The provided document is a 510(k) Summary for the BTL-995-rTMS device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results and acceptance criteria for algorithmic performance.

Based on the document, here's an analysis of the requested information:

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

The document does not explicitly state acceptance criteria for device performance in the form of metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with an AI/machine learning device. This is because the device is a therapeutic medical device (rTMS system), not a diagnostic or AI-powered analytical tool. The "performance" discussed primarily relates to electrical safety and electromagnetic compatibility.

• Acceptance Criteria (Implicit from Non-Clinical Testing): Compliance with specific international standards for medical electrical equipment.
• Reported Device Performance:
  • Electrical Safety: Complies with IEC 60601-1
  • Electromagnetic Disturbances: Complies with IEC 60601-1-2
  • Usability: Complies with IEC 60601-1-6
  • Software Life Cycle Processes: Complies with IEC 62304
  • Risk Management: Complies with ISO 14971
  • Biological Evaluation (Cytotoxicity): Complies with ISO 10993-5
  • Biological Evaluation (Irritation & Skin Sensitization): Complies with ISO 10993-10

For the therapeutic parameters, the device reports the following parameters, which are comparable to the predicate device, implying that the device "performs" by delivering these specified outputs:

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 explicitly states: "No clinical testing was performed for this device." Therefore, there is no test set, sample size, or data provenance to report in the context of clinical or AI performance. The evaluation was based on non-clinical (bench) testing and comparison to a predicate device.

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. As no clinical testing or AI algorithm performance evaluation was conducted, there was no ground truth to establish by experts for a test set.

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

Not applicable. No clinical testing or AI algorithm performance evaluation, so no adjudication method was used for a test set.

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. The BTL-995-rTMS is a therapeutic device, not a diagnostic imaging or AI assistance tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a Repetitive Transcranial Magnetic Stimulation (rTMS) system, a physical medical device, not an AI algorithm. Its function is to deliver magnetic pulses for therapeutic purposes, not to provide an independent diagnosis or analysis.

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

Not applicable in the context of AI/diagnostic evaluation. The "ground truth" for this device's performance is its compliance with safety and performance standards (bench testing) and its ability to deliver the specified therapeutic parameters as designed.

8. The sample size for the training set

Not applicable. The device is not an AI/machine learning system that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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