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The Ultimate rTMS 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 Ultimate rTMS is composed of stimulation generator and stimulation coil. The stimulation generator contains a high voltage energy storage capacitor charging and discharging system, an auxiliary power supply, a microcomputer control system, and a cooling system. The stimulation coil is composed of a stimulation coil, a cooling system, a data collection system, and a communication system.

• Magnetic Stimulator
• Cooling unit
• Coils
  • Coil Figure-of-eight coil (BF90A)
  • Coil Figure-of-eight coil (BY90A)
  • Coil Figure-of-eight coil-With angle 120°(BY90B)
• Trolley (optional)
• Coil holder (optional)
• PC (optional)
• PC keyboard (optional)

The provided text describes a 510(k) premarket notification for the Brain Ultimate, Inc. Ultimate rTMS device. The main purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a full clinical study with acceptance criteria.

Therefore, the document does not contain an acceptance criteria table from a clinical trial, nor does it describe a study specifically designed to prove device performance against such criteria. Instead, it focuses on non-clinical performance data and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the requested information based on the provided text:

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

This information is not provided in the document as it is a 510(k) submission primarily focused on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific set of clinical acceptance criteria for a new clinical indication. The document presents a side-by-side comparison of the Ultimate rTMS with predicate devices, outlining technical specifications and treatment parameters, not clinical acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/provided as the submission states: "CLINICAL PERFORMANCE DATA: Not applicable. Clinical performance data was not relied upon to demonstrate substantial equivalence." The testing described is non-clinical performance data related to electrical safety, electromagnetic compatibility, biocompatibility, software verification/validation, risk management, and magnetic field characteristics. These tests do not involve human subjects or clinical data sets in the traditional sense of a "test set" for performance evaluation.

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)

This information is not applicable/provided. Since no clinical performance data was relied upon and no "test set" with ground truth established by experts is mentioned, this information is not relevant to this 510(k) submission.

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

This information is not applicable/provided. No clinical test set requiring adjudication is described.

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

This information is not applicable/provided. The device is an rTMS system for Major Depressive Disorder treatment, not an AI-assisted diagnostic or interpretative device that would typically involve human readers or MRMC studies.

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

This information is not applicable/provided. The Ultimate rTMS is a physical medical device (repetitive transcranial magnetic stimulation system), not a standalone algorithm. Its software is mentioned as undergoing verification and validation, but this refers to the software controlling the device, not a standalone performance evaluation.

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

This information is not applicable/provided. As stated, "Clinical performance data was not relied upon to demonstrate substantial equivalence." Non-clinical tests were performed against established standards (e.g., IEC 60601-1, ISO 10993-1, ISO 14971) and against the characteristics of predicate devices. "Ground truth" in the context of clinical performance is not discussed.

8. The sample size for the training set

This information is not applicable/provided. No machine learning or AI algorithm requiring a training set is described for performance evaluation in the supplied text.

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

This information is not applicable/provided. As no training set is described, the method for establishing its ground truth is also not applicable.

Summary of the Study and Device Proof of Meeting Criteria (based on provided text):

The document describes a 510(k) premarket notification for the Ultimate rTMS device. The "study" referenced is a combination of non-clinical performance testing and a comparison to legally marketed predicate devices to demonstrate substantial equivalence, not to prove the device meets specific clinical acceptance criteria in a de novo clinical trial.

The non-clinical performance data included:

• Electrical safety and electromagnetic compatibility testing: Compliance with IEC 60601-1:2012 and IEC 60601-1-2: 2014.
• Biocompatibility evaluation: The positioning cap meets ISO 10993-1:2018 standards.
• Software verification and validation testing: Demonstrated that the software performs as intended and in accordance with specifications, following FDA software guidelines.
• Risk management: Identified and evaluated potential risks in compliance with ISO14971:2019, with risks determined acceptable or addressed.
• Magnetic field characteristics testing: Conducted in accordance with FDA's "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems." This included testing linearity of output levels, magnetic field strength gradients, output waveform, and magnetic field spatial distribution for the Ultimate rTMS coils against a predicate device.

The demonstration of meeting "acceptance criteria" is primarily centered on showing that the Ultimate rTMS is substantially equivalent to predicate devices (MagVita TMS Therapy System, K171481, and Rapid² Therapy System, K143531). This equivalence is based on:

• Identical intended use/indication for use: Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
• Identical treatment parameters: Recommended standard treatment (Magnetic Field Intensity, Frequency, Train duration, Inter-train interval, Number of trains, Magnetic Pulses per Session, Sessions/week, Treatment Schedule, Area of brain to be stimulated).
• Similar technological characteristics: Both use the same mechanism of action (electromechanical instrument producing pulsed magnetic fields to induce electrical currents in the prefrontal cortex).
• Comparison of coils: All coils share the same figure-of-eight transducer design and air core material. Differences in coil dimensions, windings, and cooling mechanisms were analyzed and deemed not to impact safety or effectiveness.
• Comparison of machine output parameters: Amplitude, waveform (biphasic sinusoid for all), active pulse width, pulse amplitude, max magnetic field strength, and max initial dB/dt were compared and deemed substantially equivalent, with minor differences not impacting safety or effectiveness. For instance, the Ultimate rTMS has a slightly lower intensity setting to achieve the same induced current as the predicate device, which is compensated for by adjusting intensity settings for 120% MT treatment. Coil temperature safety shut-off (40°C for Ultimate rTMS vs 41°C for predicate) was considered a slightly enhanced safety feature.
• Compliance with relevant standards: ISO 13485, ISO 10993-1, ISO 14971, IEC 60601-1, and IEC 60601-1-2.

The conclusion is that based on the non-clinical testing and side-by-side comparison, the Ultimate rTMS is substantially equivalent and does not introduce new safety concerns compared to the predicate devices.

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