(88 days)
The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The Apollo TMS Therapy System is comprised of four principal components: User Interface, Main Unit, Stimulation Coil, and Coil Positioning System. The operator controls the system via the User Interface. The Treatment and Data Management Software administrates the treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. The stimulation is applied via the Stimulation Coil which is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system.
The provided text is a 510(k) summary for the Apollo TMS Therapy System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a clinical study with detailed performance metrics.
Therefore, the document does not contain acceptance criteria and a study proving the device meets those criteria in the way one might expect for a new diagnostic or AI-driven interpretative device. Instead, it focuses on demonstrating substantial equivalence to existing, approved devices.
Here's an analysis based on your request, identifying what information is available and what is not:
1. Table of acceptance criteria and reported device performance:
The document doesn't explicitly define "acceptance criteria" for performance in the typical sense of a new clinical trial. Instead, it demonstrates how the Apollo TMS Therapy System is substantially equivalent to predicate devices. The "performance" here is related to mirroring the characteristics and functionality of those predicates.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Apollo TMS Therapy System) |
|---|---|
| Indications for Use: | |
| - Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | - Met: Identical to predicate devices. |
| Treatment Stimulation Parameters: | |
| - Area of brain to be stimulated: Left DLPFC | - Met: Left DLPFC |
| - Stimulation intensity: 120% of MT | - Met: 120% of MT |
| - Stimulation frequency: 10 Hz | - Met: 10 Hz |
| - Pulse train duration: 4 sec | - Met: 4 sec |
| - Inter-train interval: Similar to predicate | - Met: 11 – 26 sec |
| - Trains per session: 75 | - Met: 75 |
| - Max No. of Pulses: 3,000 | - Met: 3,000 |
| Output Stimulation Parameters: | |
| - Amplitude in SMT units: Similar range to predicate | - Met: 0 – 2.0 SMT |
| - Pulse width (± accuracy): Similar to predicate | - Met: 167 μs (± 10%) |
| - Frequency (± accuracy): Similar to predicate | - Met: 0-100 Hz (± 2%) |
| Stimulation Coil Parameters: | |
| - Configuration: Figure 8 Coil | - Met: Figure 8 Coil |
| - Core material: Similar to predicate | - Different but deemed equivalent: Air (Predicate: Iron Core or Air) |
| Coil Positioning System: | |
| - Similar functionality to predicate devices | - Met: Integrated into Head-and-Neck-Support System, Landmark-Aided Coil Placement |
| Safety and EMC: | |
| - Compliance with IEC 60601-1:2005 MOD | - Met: Complies with IEC 60601-1:2005 MOD |
| - Compliance with IEC 60601-1-2:2007 | - Met: Complies with IEC 60601-1-2:2007 |
| Software Verification & Validation: | |
| - Per FDA guidance for "moderate level of concern" | - Met: Conducted with documentation provided |
| Risk Management: | |
| - Compliance with ISO 14971:2007 | - Met: Identified and evaluated risks per ISO 14971:2007 |
2. Sample size used for the test set and the data provenance:
This document describes non-clinical testing for substantial equivalence, not a clinical study on patient outcomes with a "test set" in the context of, for example, diagnostic accuracy. Therefore, this information is not applicable and not provided. The "testing" primarily involved engineering and safety assessments (electromagnetic field characteristics, electrical safety, EMC, software, risk management).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As no clinical test set for diagnostic or interpretative performance is described, this information is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set requiring expert adjudication is described, this information is not applicable and not provided.
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 device is a therapeutic system (Repetitive Transcranial Magnetic Stimulation) for Major Depressive Disorder, not an AI-assisted diagnostic or interpretive tool that would involve human readers. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a therapeutic system, not an algorithm. Performance evaluation focuses on its physical and functional characteristics, and its equivalence to predicate devices, not on a standalone algorithm's performance. Therefore, this concept is not applicable.
7. The type of ground truth used:
For the non-clinical testing performed, the "ground truth" would be established by:
- Engineering standards and specifications: For electromagnetic field characteristics, pulse width, frequency accuracy, amplitude, etc.
- International safety standards: Such as IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC.
- FDA guidance documents: For software verification and validation, and special controls for rTMS systems.
- Risk management standards: ISO 14971.
8. The sample size for the training set:
As this is a 510(k) submission for a physical medical device, not a machine learning model, the concept of a "training set" is not applicable and not provided.
9. How the ground truth for the training set was established:
As the concept of a training set is not applicable, this information is not provided.
§ 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.