(119 days)
The NQ TMS for MDD 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 NeuroQoreTMS System (NQ TMS for MDD) enables direct non-invasive activation of brain structures. TMS is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
The NeuroQoreTMS System is composed of the following main components:
· TMS Stimulator and Cooling Unit
· Treatment Coil (Applicator) (Figure-of-eight)
· Coil Arm (Applicator Arm)
· Treatment Cap
The provided text is a 510(k) summary for the NQ TMS for MDD (NQv1-MU-01) device, comparing it to a predicate device, the MagVita TMS Therapy System (K171481). The purpose of this summary is to demonstrate substantial equivalence, not to present a study proving the device meets specific clinical acceptance criteria in terms of efficacy on patients.
Therefore, the document does not contain information about:
- Specific clinical acceptance criteria (e.g., a certain percentage improvement in depression scores).
- Any studies on human subjects to prove the device meets such clinical acceptance criteria.
- Sample sizes for test sets where clinical efficacy against a ground truth was evaluated.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods for a test set.
- MRMC comparative effectiveness studies.
- Standalone performance in a clinical context (other than engineering performance).
- Type of ground truth used regarding patient outcomes.
- Sample size for training sets, or how ground truth for a training set was established.
Instead, the document focuses on demonstrating technical and operational equivalence to a previously cleared predicate device. The "acceptance criteria" discussed are primarily engineering and performance specifications to confirm that the subject device operates safely and similarly to the predicate.
Here's the information that can be extracted from the provided text regarding the closest equivalent to "acceptance criteria" and the "study" demonstrating it:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table of technological characteristics between the subject device (NeuroQore rTMS) and the predicate device (MagVita TMS Therapy System). The "acceptance criteria" in this context are the engineering and operational parameters of the predicate device, and the "reported device performance" is how closely the subject device's parameters match or are considered equivalent.
| Criteria | NeuroQore rTMS (Subject Device) Performance | Predicate Device (MagVita TMS Therapy System K171481) Performance | Equivalence Comments |
|---|---|---|---|
| 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 to Subject Device | Identical Indication for Use |
| Recommended Standard Treatment | |||
| Magnetic Field Intensity | 120% of the MT | 120% of the MT | Identical recommended treatment parameters. |
| Frequency | 10 Hz | 10 Hz | The subject and predicate device provide the same treatment option of 18.8-minutes treatment duration, using 11 sec inter-train intervals. |
| Train duration | 4 sec | 4 sec | |
| Inter-train interval | 11 sec | 11-26 sec | The subject device does not provide the legacy 37-minutes treatment using 26 sec inter-train intervals, which has been superseded in the past few years by the 18.8 minutes treatment prevailing in the current clinical practices. Both machines use identical treatment parameters (for the 18.8 min treatment). |
| Number of trains | 75 | 75 | |
| Magnetic Pulses per Session | 3000 | 3000 | |
| Treatment Session Duration | 18.8 min | 18.8-37.0 min | |
| Sessions/week | 5 | 5 | |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | |
| Area of brain to be stimulated | Frontal Cortex | Frontal Cortex | |
| Coils | |||
| Configuration | Figure-of-eight coil | Figure-of-eight coil | Same figure-of-eight configuration in both coils. |
| Core material | Air core | Air core | Same core material design. |
| Cooling | Liquid cooling | Liquid cooling | Same liquid-cooling mechanism in both coils. |
| Coil parameters (Inner/Outer diameter, turns) | Inner D: 25mm, Outer D: 100mm, N: 2 wings x 1 layer x 15 turns | Inner D: 35mm, Outer D: 75mm, N: 2 wings x 2 layers x 5 turns | Equivalent, with no additional concerns for safety and effectiveness. (See Note A for equivalence explanation of coil parameters such as dimensions and windings). |
| Machine Output Parameters | |||
| Amplitude in Standard Motor Threshold (SMT) units | 0% Intensity → 0 SMT, 44.3% Intensity → 1.0 SMT, 100% Intensity → 2.7 SMT | 0% Intensity → 0 SMT, 37.8% Intensity → 1.0 SMT, 100% Intensity → 3.0 SMT | Equivalent, with no additional concerns for safety and effectiveness. (See Note B for equivalence explanation of Intensity/Amplitude). |
| Waveform | Biphasic triangular | Biphasic sinusoid | Equivalent, with no additional concerns for safety and effectiveness. (See Note C for equivalence explanation of Waveform). |
| Active pulse width (µs) | 300 | 290 | Equivalent, with no additional concerns for safety and effectiveness. (See Note D for equivalence explanation of Pulse Width and Amplitude). |
| Pulse amplitude (V) | 38.56 | 39.12 | Equivalent, with no additional concerns for safety and effectiveness. (See Note D for equivalence explanation of Pulse Width and Amplitude). |
| Max magnetic field strength 2 cm from coil (T) | At 30%: 0.088, At 50%: 0.229, At 70%: 0.332, At 100%: 0.490 | At 30%: 0.126, At 50%: 0.246, At 70%: 0.326, At 100%: 0.510 | Equivalent, with no additional concerns for safety and effectiveness. (See Note E for equivalence explanation of Max magnetic field strength). |
| Max initial dB/dt (kT/s) (coil surface z=0) | 15.28 | 15.51 | Equivalent, with no additional concerns for safety and effectiveness. (See Note F for equivalence explanation of dB/dt). |
| Max initial dB/dt (kT/s) (2cm from coil z=2) | 5.30 | 5.59 | |
| Coil Temperature at Max Intensity (shutdown) | 41 °C (106 °F) | 41 °C (106 °F) | Regardless of the intensity setting, both devices have a coil temperature safety feature that shuts down the system when the threshold temperature is reached. |
| Frequency range (Hz) | 0.1 to 20 | 0.1 to 30 or 0.1 to 100 (depending on model) | The differences in these parameters are simply the differences in the overall capabilities of these machines. These capabilities encompass the recommended treatment parameters for MDD listed above. Both machines use identical treatment parameters for MDD. |
| Pulse train duration range (s) | 1 to 4 | Rep Rate: 0.1-100Hz, Pulses in Train: 1-1000, Train duration = P/RR | |
| Inter-train interval range (s) | 1 to 11 | 1 to 120 | |
| Maximum trains per session | 75 | 500 | |
| Maximum number of pulses per session | 3000 | 500,000 | |
| Standards | |||
| Electrical safety | Complies with IEC 60601-1, IEC 60601-1-2 | Complies with IEC 60601-1, IEC 60601-1-1 and IEC 60601-1-2 | N/A (Both comply with relevant standards for safety) |
| ISO Standards met | ISO 13485:2016, ISO14971 | ISO 13485:2012 | N/A (Both comply with relevant quality management system standards) |
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 provided in the document. The testing described is primarily non-clinical, focusing on device performance characteristics rather than clinical outcomes in human subjects.
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 provided. Ground truth in this context refers to the established technical specifications of the predicate device and relevant international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. This concept is not applicable to the non-clinical testing performed.
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 type of study is not discussed as the device is a therapeutic rTMS system, not an AI-assisted diagnostic tool or reader support system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The "studies" conducted are standalone engineering and performance tests of the device's electrical, magnetic, mechanical, thermal, and software functionalities. These tests confirm the device's intrinsic operating characteristics meet specifications and are comparable to the predicate. The document states:
- "The following performance tests specified in this guidance document were performed and the results were compared for a determination of substantial equivalence between the subject device (NQ TMS System) and the predicate device (MagVita TMS System): Electric Field, Magnetic Field, Electrical/Mechanical/Thermal Safety (IEC 60601-1), Electromagnetic Compatibility (IEC 60601-1-2), Biocompatibility (ISO 10993-1), Software Validation (FDA Guidance)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on:
- Established engineering principles and measurements: For electric field, magnetic field, pulse characteristics, temperatures, etc.
- International standards: Such as IEC 60601-1 series for electrical safety and electromagnetic compatibility, ISO 10993-1 for biocompatibility, and ISO 13485/14971 for quality management and risk management.
- The performance specifications of the legally marketed predicate device: Which the subject device aims to be substantially equivalent to.
8. The sample size for the training set
This information is not provided. The device is an rTMS system, and the document focuses on its engineering specifications relative to a predicate, not on a machine learning algorithm that would typically require training data.
9. How the ground truth for the training set was established
This information is not provided for the same reasons as #8.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.