(56 days)
The SONIK MONARK 100 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the device to deliver precise impulses at a required vector configuration.
The SONIK MONARK 100 (SM-100) device is used for the management of chronic pain due to noncongenital defects. It operates through the delivery of low-frequency impulses onto intact skin. The device converts electrical energy into mechanical energy, which is then transmitted to the patient's tissues through the stylus tip. It employs a mode of action that involves the application of controlled and repeatable low-intensity mechanical impulses to the treatment site. The device can be used in a handheld manner or mounted to a movable arm on a cart.
The FDA 510(k) summary for the SONIK MONARK 100 device does not contain a typical "acceptance criteria and reported device performance" table as one might find for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (KKT-M2) by comparing technological characteristics and verifying specific engineering performance aspects.
The "study that proves the device meets the acceptance criteria" is primarily an engineering performance verification rather than a clinical trial with patient outcomes. The acceptance criteria are implicit in the comparison to the predicate device and the successful completion of specific technical tests.
Here's an analysis based on the provided text, addressing your points where information is available:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct table of acceptance criteria vs. performance results in the classical sense of diagnostic accuracy. Instead, the acceptance criteria are largely met by demonstrating substantial equivalence to the predicate and by verifying specific operational parameters.
Implicit Acceptance Criteria and Reported Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to KKT-M2 Predicate | "The SONIK MONARK 100 is substantially equivalent to the predicate KKT-M2 device in terms of its intended use, indications of use, operating principles, technological characteristics, and risk profile." |
| Electrical Safety (IEC 60601-1) | "The device has been successfully tested to... IEC 60601-1 Medical Electrical Equipment - Part 1" |
| Electromagnetic Compatibility (IEC 60601-1-2) | "The device has been successfully tested to... IEC 60601-1-2 Medical Electrical Equipment - Part 1-2" |
| Software Verification & Validation (FDA Guidance "General Principles of Software Validation") | "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'General Principles of Software Validation.'" (Assessed as "Moderate" level of concern) |
| Accurate and Reliable Vibration Frequency Production | "The frequencies produced by the device did not deviate from the target frequency by more than the acceptable margin of error ( |
N/A