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510(k) Data Aggregation
(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 (< 5 %). These findings support the conclusion that the SONIK MONARK 100 device accurately and reliably produces vibration frequencies as intended. This outcome confirms the device's precision achieves its target performance specifications." |
| Force Application (implicitly comparable to predicate) | Although the maximal force threshold for SONIK MONARK 100 (17 N) is different from the KKT-M2 (5 lbs ≈ 22.2 N), the submission states, "Since the force applied during treatment is slightly lower than the maximal force threshold of the KKT-M2 device, this will not impact the respective safety or efficacy of the SONIK MONARK 100 in comparison to the KKT-M2 device." This implies the force is within a safe and effective range relative to the predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes engineering tests, not a clinical study on a patient sample.
- Sample Size: Not applicable in the sense of a patient cohort. The "vibration frequency verification" test would likely involve multiple measurements on the device itself.
- Data Provenance: The tests were conducted by "accredited testing laboratories" (Page 8), implying controlled laboratory environments. Country of origin for data is not specified beyond the manufacturer being in Canada. These are retrospective analyses of device performance.
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)
Not applicable. This device is a physical therapy type device (manipulator device) and not one that produces diagnostic images requiring expert interpretation for ground truth. The ground truth for its performance is engineering specifications (e.g., target frequencies, force outputs).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human adjudication of clinical data.
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 not an AI-assisted diagnostic tool. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. Its "standalone performance" refers to its ability to meet engineering specifications (e.g., produce desired frequencies and forces) independently. The "Vibration Frequency Verification" is an example of such a standalone engineering performance test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating the device's performance is based on engineering specifications and established safety/EMC standards.
- For electrical safety and EMC, the ground truth is compliance with IEC 60601-1 and IEC 60601-1-2 standards.
- For software, the ground truth is compliance with FDA's "General Principles of Software Validation" guidance.
- For vibration frequency, the ground truth is the "target frequency" with an "acceptable margin of error (< 5 %)."
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that requires training data in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
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