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The CloudTMS Edge for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The CloudTMS Edge for OCD 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 Obsessive-Compulsive Disorder (OCD).
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.General functionalities provided by the system are: - Single pulse stimulation (motor threshold detecting)

• Repetitive stimulation (therapy)
• Patient's data entering
• Stimulation algorithm editing
• Review of stimulation history
• Treatment report generation and printing
• Operation with list of treatment (selection for review, removal, etc.).
  The CloudTMS Edge for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coll; 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.

This document describes K233742, CloudTMS Edge for OCD, a transcranial magnetic stimulation (rTMS) system intended as an adjunct treatment for adult patients with Obsessive-Compulsive Disorder (OCD).

Based on the provided text, there is no clinical study that explicitly defines acceptance criteria and then presents device performance against those criteria in a table. The submission relies heavily on a comparison with a predicate device (CloudTMS for OCD, K221129) and asserts substantial equivalence based on technological and operational similarities, and non-clinical testing.

Here's an attempt to extract and synthesize the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, a formal table of acceptance criteria and device performance from a clinical study is not provided in this document. The document focuses on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

Since no clinical study comparing the device to acceptance criteria is described, there is no information on the sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The document primarily discusses non-clinical testing for safety and electromagnetic compatibility.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as no clinical study with a ground truth established by experts is described for this device in the provided text.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical study requiring an adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or performed according to the provided text. The document focuses on the device itself and its equivalence to a predicate, not on how human readers might improve with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm was not described or performed in the provided text. The device is a physical rTMS system, not an AI algorithm requiring standalone performance evaluation in the usual sense.

7. Type of Ground Truth Used

No ground truth (expert consensus, pathology, outcomes data, etc.) was established or used for the CloudTMS Edge for OCD in the context of a clinical performance study as described in this document. The document relies on predicate device equivalence and non-clinical testing for safety and electrical characteristics.

8. Sample Size for the Training Set

This information is not applicable. The device is an rTMS system that produces magnetic fields, not an AI algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set mentioned for this device.

Summary of Device Evaluation in the Document:

The evaluation of the CloudTMS Edge for OCD, as presented in this 510(k) summary, is based on demonstrating substantial equivalence to its predicate device, CloudTMS for OCD (K221129). The key points of the evaluation are:

• Identical Indications for Use: The subject device has the exact same indications for use as the predicate.
• Technological Comparison: The design, operational characteristics, and technological characteristics are nearly identical, with minor modifications.
  • Both systems are rTMS systems, produce non-invasive, repetitive pulsed magnetic fields to induce neural action potentials in the prefrontal cortex for OCD treatment.
  • Both use the same mechanism of action, coil (DCC-03-125-C), and software.
  • Operational procedures, including system setups, motor threshold determination, coil positioning, and treatment stimulation parameters, are identical.
  • Minor modifications in the subject device: automatic voltage detection (110V/220V), upgraded power supply for faster charging, obsolescence replacement for cooled coil connections, and improved graphical user interface. These modifications are asserted to have no known impact on safety or efficacy.
• Non-Clinical Performance Characteristics:
  • Electrical/mechanical/thermal safety and electromagnetic compatibility were verified through testing against IEC 60601-1:2005/(R)2012 and IEC 60601-1-2:2014. (These standards implicitly define some acceptance criteria for these aspects).
  • Biocompatibility characteristics are identical to the predicate because the same patient caps are used.
  • Characteristics of electric and magnetic fields are identical to the predicate (due to the same double cone coil and treatment parameters), including linearity of output, biphasic sinusoidal waveform, pulse width and intensity, magnetic field spatial distribution, and magnetic field strength gradient.
• Conclusion: The device "does not introduce any new safety or effectiveness considerations" compared to the predicate, and all modifications are minor and have no known impact on safety or efficacy.

In essence, the "study" proving the device meets acceptance criteria is a comparison to a legally marketed predicate device, supplemented by non-clinical testing to recognized safety and performance standards for medical devices (IEC 60601 series). No new clinical performance data for efficacy was presented, as the submission relies on the established efficacy of the predicate device.

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