(70 days)
The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The Ampa One System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The Ampa One System is an integrated system composed of the following hardware and software components with associated functions to enable its intended use:
- Ampa L and M Coils - MT determination and Depression treatment
- Ampa Pulse Generator - Provide Electrical power to the coils
- Ampa Control Pad - The software interface for operators to control TMS treatment
- Axon Cable - Provides connections between the Ampa Pulse Generator and Ampa Control Pad
- Ampa Magic Arm - Support system to securely hold the coils in place during treatment
- Neuronavigation Cap - Fabric cap worn by patient with integrated markings for determination of cerebral cortex treatment targets
The system comes preloaded with a mobile app on the Ampa Control Pad containing the software interface for operation of the system.
This FDA 510(k) clearance letter pertains to a modification of an existing device, the Ampa One System (AMPA-001), specifically replacing a bridging connector and external pulse generator with an integrated Ampa Pulse Generator. The clearance relies on demonstrating substantial equivalence to the previously cleared Ampa One System (K243319).
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" with specific quantitative thresholds. Instead, it states that the acceptance criteria are based on demonstrating "substantially equivalent magnetic characteristics compared to the predicate devices" and "equivalent in terms of safety and effectiveness." The reported performance is articulated through comparative testing against the predicate device.
| Category | Acceptance Criteria (Inferred from Document) | Reported Device Performance |
|---|---|---|
| Magnetic Characteristics (Effectiveness) | Substantial equivalence in the amplitude of magnetic field strength as a function of power input; substantial equivalence in spatial characteristics of the magnetic field. | Testing demonstrated that the Ampa One System (new configuration) produced substantially equivalent magnetic characteristics compared to the predicate devices (Ampa One System with MagVenture MagPro R30). Specifically, tests confirmed equivalence in: |
- Amplitude of the magnetic field strength as a function of power input.
- Spatial characteristics of the magnetic field.
- Waveforms (210 μs biphasic sinusoid for both L and M coils with the new system vs. 290 μs with predicate, deemed substantially equivalent) |
| Safety | The device is able to function as intended, with risks assessed of TMS therapy mitigated through design. | Safety testing established that the Ampa One System (new configuration) is able to function in its configuration with the Ampa One pulse generator to perform its intended use. Development and testing performed in conformance with FDA Special Controls Guidance on Transcranial Magnetic Stimulator devices and voluntary consensus standards (e.g., IEC 60601-1 and IEC 60601-1-2 for electrical safety). |
| Treatment Protocol Parameters | Identical or substantially equivalent to the predicate device's parameters. | Identical: Repetition rate, pulses per train, number of trains, inter train interval, treatment time, coil configuration, patient contacting materials, coil positioning system.
Substantially Equivalent: L Coil SMT range (0-1.7 SMT vs 0-2.0 SMT for predicate), M Coil SMT range (0-1.4 SMT vs 0-1.7 SMT for predicate). These differences are considered substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Data was not applicable for this submission."
Therefore, there was no clinical test set in the traditional sense, and thus no sample size for clinical efficacy or safety, nor data provenance information for such a test set. The testing conducted was non-clinical (bench testing) to demonstrate substantial equivalence of the modified device's performance to the predicate device.
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)
Since no clinical data or human evaluation of the device's diagnostic or therapeutic outcome was conducted for this 510(k), there were no experts used to establish a "ground truth" in the context of a clinical test set. The validation was based on engineering and performance specifications compared against the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As per point 3, no clinical test set requiring expert adjudication was utilized for this submission.
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
Not applicable. This device is a Repetitive Transcranial Magnetic Stimulation System, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not relevant to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "standalone" performance in this context would refer to the performance of the Ampa One System itself, measured through its magnetic characteristics and functional safety. This type of non-clinical, standalone performance testing was indeed done. The effectiveness testing specifically focused on the magnetic characteristics of the Ampa One System with the new pulse generator, comparing them to the predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this non-clinical submission, the "ground truth" for demonstrating substantial equivalence was effectively the established performance characteristics of the legally marketed predicate device (Ampa One System K243319), as defined by its prior FDA clearance and the relevant FDA Special Controls Guidance. The new device's performance was measured and compared against these established characteristics to prove it met the same reasonable expectation of safety and effectiveness.
8. The sample size for the training set
Not applicable. This 510(k) pertains to a hardware modification of an existing medical device, not a machine learning or AI-driven system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there was no training set for this submission.
§ 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.