(101 days)
The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.
The proposed device is a modification to the Brainsway Deep TMS System that was cleared under DEN170078. Brainsway has implemented minor changes to the helmet configuration, improved the user interface, modified the measurement method, and made other minor component changes. None of these changes alter the technical specifications for the device, which maintains the same voltage and current, same frequencies, and same electrical mains compatibility. The same technological features have previously been cleared by FDA for use in major depressive disorder in K173540.
Consistent with the predicate and reference device, the proposed Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (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 tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
The provided text describes modifications to the Brainsway Deep TMS System and asserts its substantial equivalence to a previously cleared predicate device. It does not provide detailed acceptance criteria or results of a clinical study to prove the device meets specific performance criteria. Instead, it focuses on demonstrating that the modifications do not introduce new questions of safety or effectiveness compared to the predicate device.
Therefore, many of the requested details about acceptance criteria, clinical study methodology, and ground truth establishment cannot be found in the provided document. The document primarily confirms that the modified device functions as intended and meets the same acceptance criteria as the predicate and reference devices, based on software verification, electrical safety, EMC, and bench performance testing.
Here's an analysis based on the provided text, highlighting what is available and what is not:
Acceptance Criteria and Device Performance
The document does not provide a specific table of acceptance criteria with numerical targets and corresponding reported device performance for a clinical study proving efficacy or diagnostic accuracy. Instead, it states:
"In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device."
This implies that the acceptance criteria are generally related to the proper functioning of the device, electrical safety, electromagnetic compatibility, and bench performance, rather than clinical efficacy metrics. For an efficacy study demonstrating treatment outcomes for OCD, such details would typically be found in a separate clinical study report.
The "Indications for Use" section states: "The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder." This is the clinical claim, but the document doesn't present a study proving the device meets this claim with performance metrics. It relies on the substantial equivalence to the predicate device, which presumably had clinical data supporting its efficacy for this indication.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Software Verification & Validation | "the subject device functions as intended" |
| Electrical Safety (IEC 60601-1) | "meets all the same acceptance criteria as the predicate and reference device" |
| EMC (IEC 60601-1-2) | "meets all the same acceptance criteria as the predicate and reference device" |
| Bench Performance Testing | "the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device" |
| Clinical Efficacy for OCD Treatment (Implied from Indications for Use) | The document does not present a new clinical study to establish this for the modified device, but rather relies on substantial equivalence to the predicate, which previously established this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. The document describes "software verification and validation," "electrical safety," "EMC," and "bench performance testing." These are engineering and performance validation tests, not typically clinical studies with "test sets" of patient data in the sense of a machine learning model.
- If a prior clinical study for the predicate device existed for OCD treatment, that information is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. Since this document describes engineering and bench testing, rather than a clinical trial or an AI/diagnostic device study requiring expert ground truth establishment for a patient dataset, this information is not relevant to the described testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. See explanation for #3.
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
- No. This document describes a medical device (Transcranial Magnetic Stimulation System) for treatment, not an AI-assisted diagnostic or imaging device used by "human readers." Therefore, an MRMC study is not relevant to the described device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Stand-alone performance was indirectly evaluated through bench testing and compliance. The device itself is a "human-in-the-loop" device as it delivers treatment under medical supervision. The "standalone" performance here refers to the device's technical specifications and electrical/mechanical performance, which was assessed through the described tests (software, electrical safety, EMC, bench performance). The document states: "In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device." This implies standalone technical performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the technical and safety testing described (software, electrical safety, EMC, bench performance):
- Ground Truth: Engineering specifications, regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2), and comparison to the performance of the predicate and reference devices. The "ground truth" is that the device should operate within specified technical parameters and safety limits.
- For the clinical efficacy of the device for OCD treatment (which is its intended use):
- The document implies that the predicate device (DEN170078) already established clinical efficacy for OCD. This specific document for K183303 relies on "substantial equivalence" and does not describe a new clinical trial for efficacy. If such a trial existed for the predicate, the ground truth would likely have been clinical outcome measures for OCD (e.g., Yale-Brown Obsessive Compulsive Scale (YBOCS) scores or similar psychiatric outcome scales).
8. The sample size for the training set
- Not applicable / Not provided. The Brainsway Deep TMS System is a Transcranial Magnetic Stimulation device, not an AI/machine learning algorithm that requires a "training set" of data in the common sense. Its "training" is its engineering design and manufacturing.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As explained in #8, there is no "training set" in the context of an AI model for this device.
§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.