(88 days)
ZapStim Controller Application is intended for use with the Neurosoft TMS system and is indicated for use in delivering the FDA cleared treatment protocol for treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode.
ZapStim Controller Application is a software application that is indicated to be used by clinicians for the treatment of Major Depressive Disorder. The software resides on a computer system and functions by controlling a third party TMS system (Neurosoft Cloud TMS system, K173441). ZapStim Controller Application software is to be used in place of the Neurosoft TMS User interface for setting certain aspects of the treatment administered by the TMS system. The third party TMS system will physically deliver the therapy to the patient. The ZapStim Controller Application is compatible with the Neurosoft TMS System, K173441, and it is intended to be used in tandem with the Neurosoft TMS System to provide treatment.
The software includes a user interface that allows the user to control limited aspects of the treatment administered by the TMS system. The system is currently intended to deliver the FDA cleared treatment protocol for MDD as stated in the indications for use.
The ZapStim software is compatible and is to be used in tandem with the specific Neurosoft TMS System components listed below:
- Main unit of the magnetic stimulator .
- Cooling unit
- Extra power supply unit ●
- Cooled figure-of-eight coil AFEC-02-100-C ●
- USB A to B cable .
The ZapStim Controller Application consists of the following main components:
- . ZapStim Application (ZapStim.exe)
- . Simulator Driver (stimneurosoft.exe)
Both components are utilized when using the device.
The ZapStim Controller Application is to be distributed predownloaded onto a commercial off the shelf PC.
The ZapStim Controller Application is to be accessed on the PC is to be connected via USB to the Neurosoft TMS System. The ZapStim Controller Application can be used to select the treatment protocol to be administered, which at this time will only be the FDA cleared treatment protocol for MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode. The user cannot edit the treatment protocol using the ZapStim Controller Application. The user can also start, pause, and end the administration of treatment using the ZapStim Controller Application.
The ZapStim Controller Application relays the treatment protocol information to the Neurosoft TMS System, which then administers the magnetic stimulation.
The document outlines the 510(k) summary for the ZapStim Controller Application (Z1023), a software application intended for use with the Neurosoft TMS system for treating Major Depressive Disorder (MDD). The key focus of the submission is to demonstrate substantial equivalence to the predicate device, Neurosoft TMS (K173441).
Here's an analysis of the provided information regarding acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison of the ZapStim Controller Application's functionalities and output parameters with those of the predicate Neurosoft TMS system. The study aims to demonstrate that the ZapStim software, when controlling the Neurosoft TMS hardware, performs equivalently to the predicate device's own control interface.
| Acceptance Criteria Category | Specific Criteria (Implicitly from Predicate Comparison) | Reported Device Performance (ZapStim Controller Application) |
|---|---|---|
| Functional Equivalence | - Ability to start, stop, and pause a train sequence on the Neurosoft CloudTMS (predicate device). |
- Ability to determine the train sequence.
- Ability to determine the train length.
- Ability to determine the inter-train length.
- Control stimulation frequency.
- Control pulse train duration.
- Control inter-train interval.
- Control trains per session. | - "The verification results (RP-5021-1.0.7746) demonstrate that the ZapStim software interface functions with the Neurosoft Cloud TMS hardware as intended and as required."
- "The tests run during verification show that ZapStim Software can perform the functions of starting, stopping, and pausing a train sequence on the Neurosoft CloudTMS (predicate device) as well as determining the train sequency, train length, and intertrain length; these are all functions that the predicate device is also capable of performing."
- "The verification results show that the ZapStim software can control stimulation frequency, pulse train duration, inter-train interval, and trains per session of the CloudTMS system." |
| Accuracy of Delivered Treatment Parameters| - No statistically significant difference between the frequency set by the ZapStim Software and the frequency delivered by the CloudTMS machine at all tested frequencies. - No change in the waveform shape of the stimulation pulse delivered by the CloudTMS system when using the ZapStim Software (biphasic nature maintained). | - "The validation results (RP-5022-1.0.7746) demonstrate ZapStim software's ability to control the functions listed above of the r TMS Stimulator system does not negatively alter the accuracy set for treatment. At all frequencies tested, there was no statistically significant difference between the frequency set by the ZapStim Software and the frequency delivered by the CloudTMS machine."
- "Waveforms showing the biphasic nature of the stimulation pulse delivered were also included in the validation tests to demonstrate that using the ZapStim Software does not change the waveform shape of the pulse delivered by the CloudTMS system." |
| Safety and Effectiveness (Non-inferiority)| - The technological differences between ZapStim Controller Application and the predicate device should not raise new issues regarding effectiveness or safety. (This is an overarching goal of the comparison and testing.) | - "These technological differences between the ZapStim Controller Application and the predicate do not raise any new issues on effectiveness or safety." (This is a statement from the submitter, supported by the verification and validation testing.) - "Comparison of the intended use, indications for use, technological characteristics, and performance testing demonstrate the substantial equivalence of the subject device ZapStim SW to the legally marketed predicate device, Neurosoft (K173441)." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The study described appears to be a non-clinical performance evaluation (bench testing), focusing on the functional and accuracy aspects of the software controlling the hardware. Such studies typically involve testing across the operational range of parameters rather than patient-specific data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The ground truth in this context is the expected functional output and accuracy of the TMS system when controlled by the software, as measured by instruments during testing. It does not involve expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set
This is not applicable as the study is a non-clinical performance evaluation focused on objective measurements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. The ZapStim Controller Application is software that controls an existing FDA-cleared TMS hardware system. The study focuses on the functional equivalence and accuracy of this control software, not on human reader performance or diagnostic accuracy. Therefore, there is no effect size related to human reader improvement with AI assistance.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-loop Performance) Was Done
Yes, the described study is essentially a standalone performance evaluation of the software's control capabilities. The "device" in this context is the software (ZapStim Controller Application) interacting with and controlling the existing Neurosoft TMS hardware. The tests verify that the software correctly sends commands and that the hardware executes them accurately, without direct human intervention in the loop during the performance measurement phase, beyond initiating the tests.
7. The Type of Ground Truth Used
The ground truth used in this non-clinical study is based on objective measurements and engineering specifications of the TMS system's output. For example:
- The functional ground truth is whether the software successfully initiates, pauses, and stops treatment sequences, and correctly communicates parameter settings (frequency, train duration, inter-train interval, trains per session) to the hardware.
- The accuracy ground truth for frequency delivery is the precisely measured output frequency of the TMS machine using calibrated instruments.
- The waveform ground truth is the expected biphasic shape of the stimulation pulse, measured by appropriate equipment.
8. The Sample Size for the Training Set
The document does not provide information on a training set sample size. The ZapStim Controller Application isn't described as a machine learning (ML) or artificial intelligence (AI) device that requires training data in the conventional sense. It's control software with predefined logic to interact with hardware.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit mention of a "training set" for an ML/AI algorithm, this information is not provided and likely not applicable in the context of this device's regulatory 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.