(451 days)
ALTMS Magnetic Stimulation 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 ALTMS Magnetic Stimulation Therapy System is a computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The ALTMS Magnetic Stimulation Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. It includes a Mobile console which houses the electronic components, provides mechanical support for the ferromagnetic Treatment Coil. The Standing Arm, an accessory device included in the ALTMS provides the coil positioning function.
The provided text is a 510(k) summary for the ALTMS Magnetic Stimulation Therapy System, which is a medical device for the treatment of Major Depressive Disorder. This document primarily focuses on demonstrating substantial equivalence to a predicate device, the Rapid2 Therapy System (K143531), rather than presenting a detailed clinical study with specific acceptance criteria and results for the device's effectiveness in treating MDD.
However, based on the provided text, I can extract information related to the device's safety and performance against established standards, as this forms the basis of its substantial equivalence claim.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of clinical efficacy for Major Depressive Disorder as typically seen in a randomized controlled trial. Instead, it demonstrates compliance with safety and performance standards to establish substantial equivalence.
Here's a table based on the safety and performance data presented:
| Acceptance Criteria (Based on FDA Recognized Standards & Predicate Device Characteristics) | Reported Device Performance (ALTMS Magnetic Stimulation Therapy System) |
|---|---|
| Biocompatibility: Meet ISO 10993-1 requirements for medical devices. Specific tests include: Cytotoxicity, Repeated Patch Dermal Sensitization, Primary Skin Irritation. | Biocompatibility Testing: Completed with favorable results for Cytotoxicity, Repeated Patch Dermal Sensitization Test (GLP - Buehler Method Modified for Medical Devices), and ISO Primary Skin Irritation Test. Biocompatibility risk assessments concluded no additional testing necessary. |
| Design Verification & Validation: Meet predefined safety and performance requirements; effectiveness of risk control measures (per ISO 14971:2012). | Design Verification and Validation (DV&V) Testing: Favorable results demonstrating the device meets predetermined safety and performance requirements and that risk control measures are effective. The design output matches design input and is appropriate for intended use. |
| Electrical Safety & Performance: Compliance with various IEC 60601 series and IEC 61000 series standards. | IEC Electrical Safety and Performance Testing: Comprehensive completion with favorable test results for IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11, and IEC 62366. |
| Software Verification & Validation: Ensure software functions correctly and safely. | Software Verification and Validation Testing: Completed (results implied to be favorable, though not detailed). |
| Shipping Validation: Meet pre-determined requirements for shipping. | Shipping Validation Test: Results demonstrate that the device (equivalent to Talent-Pro Electromagnetic Stimulator in size and weight) met all pre-determined shipping validation test requirements. |
| Technological Characteristics (similar to Predicate Device): Pulse Shape, Pulse Train Duration Range, Inter-train interval range, Pulse Width, Magnetic Field Intensity, Number of trains, Magnetic pulses per session, Treatment session duration, Sessions per week, Area of the brain to be stimulated, Applicator configuration and core material, Coil Parameters, Maximum trains per session, Temperature on Surface at Maximum Output, Magnetic Field: Peak Magnetic Field Strength at 2cm (in dB/dt), Machine Output Stimulation Parameters. | Technological Characteristics Comparison: The document states that the "critical aspects... are substantially equivalent to the predicate device." While some minor differences exist (e.g., Pulse Train Duration, Inter-train interval range, Pulse Width), these are "not considered to raise different questions of safety and effectiveness." The device’s performance on these parameters is documented in the comparison table on page 8, showing substantial similarity or acceptable variations. For example, Pulse Width is 430 μs for the proposed device vs. 300 μs for the predicate, and Temperature on Surface at Maximum Output is 41°C for both. |
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 describes engineering and performance testing of the device itself and its components, not a clinical trial involving a "test set" of patients. Therefore, concepts like sample size for a clinical test set or data provenance in terms of patient data (e.g., country of origin, retrospective/prospective) are not applicable to the studies presented for this 510(k) submission.
The studies mentioned (biocompatibility, design verification, electrical safety, software, shipping validation) are laboratory-based or bench testing, focusing on the device's physical and functional characteristics.
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 is not applicable as there was no clinical "test set" requiring expert ground truth establishment. The studies are technical and engineering evaluations conducted by qualified personnel in testing facilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3. There was no clinical test set requiring adjudication.
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 MRMC comparative effectiveness study was done. This device is a therapeutic (magnetic stimulation) device, not an AI-assisted diagnostic or interpretive device that would involve "human readers." The 510(k) summary focuses on demonstrating the device's safety and performance equivalence to a predicate device, not its comparative clinical effectiveness in a human trial setting.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device performance standalone, not an algorithm's performance. The entire submission details "standalone" testing of the ALTMS Magnetic Stimulation Therapy System (excluding its clinical use in patients, which is assumed to be similar to the predicate based on equivalence).
The studies described (biocompatibility, design verification, electrical safety, software, shipping validation) are all evaluations of the device in a standalone capacity (i.e., the physical device and its associated software components are tested directly).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the safety and performance studies described:
- Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and the expected biological responses in specific in vitro or in vivo tests.
- Design Verification & Validation: Ground truth is the "predefined safety and performance requirements" and the "design input" as established by the manufacturer, often guided by regulatory standards.
- Electrical Safety & Performance: Ground truth is defined by the specific parameters and limits outlined in the referenced IEC and other recognized consensus standards (e.g., maximum temperature, electrical leakage, electromagnetic compatibility).
- Software Verification & Validation: Ground truth is the software's functional specifications and adherence to design requirements.
- Shipping Validation: Ground truth is the "pre-determined shipping validation test requirements."
8. The sample size for the training set
This is not applicable. The document describes laboratory and bench testing of a physical medical device, not the development or training of an AI algorithm.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 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.