Search Results

BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The BTL-99-OC 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-99-OC 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 quides the Operator through the entire therapy procedure. The therapeutic parameters are set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device functions with: M1 figure-of-8 coil applicator. The therapy is provided with the applicator attached to the applicator arm. The BTL-99-OC composed of stimulation generator and stimulation coil. The stimulation generator is driven by software, which the operator controls through the GUI and contains a high voltage energy storage capacitor charging and discharging system, a power supply and a microcomputer control system. The software capabilities for administering treatment in the subject device are the comparable to these in the predicate devices. The stimulation coil is composed of a stimulation coil, an air forced cooling system and an applicator holder. The main unit BTL-99-OC with the M1 coil is intended to be used for both - MT threshold estimation and subsequent application of OCD therapy.

The provided text is a 510(k) summary for the BTL-99-OC device, which is a transcranial magnetic stimulation (TMS) system intended as an adjunct treatment for Obsessive-Compulsive Disorder (OCD). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MagVenture TMS Therapy system - K193006) and a reference device (BTL-995-rTMS - K212723), rather than presenting a performance study with specific acceptance criteria and detailed findings from a clinical trial.

Therefore, the document does NOT contain the information needed to fill out a table of acceptance criteria and reported device performance based on clinical study outcomes, nor does it detail a study structure that includes sample sizes for test sets, data provenance, expert consultation for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text mostly describes:

• The device's intended use and technical characteristics.
• Comparisons of the BTL-99-OC with its predicate and reference devices, primarily focusing on physical and electrical parameters (e.g., magnetic field intensity, coil parameters, electrical safety compliance) to establish technical substantial equivalence.
• Compliance with electrical safety, software lifecycle, and risk management standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971).
• Bench testing results comparing induced fields in a phantom head, showing values are substantially equivalent within a certain range.

In summary, there is no information in the provided document about a clinical study that proves the device meets specific acceptance criteria related to its clinical efficacy or performance in diagnosing/treating OCD. The substantial equivalence is argued based on technological similarities and adherence to safety standards.

Therefore, I cannot populate the requested table or describe the study details as they are not present in this 510(k) summary.

Ask a specific question about this device