(317 days)
The KKT-M2 device is to be used in the aid of management of chronic pain due to noncongenital 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 KKT-M2 device to deliver precise impulses at a required vector configuration.
The KKT device has been developed for the aid in management of chronic pain. More specifically, conditions of chronic pain arising from structural anomalies such as misalianments and muscle imbalances. Conditions of brain stem irritation as a result of musculoskeletal imbalances that may arise from impact. Typical conditions treated include: strains to soft tissue surrounding vertebral column, whiplash injuries to the head and neck, and biomechanical disrelationships of the axial skeleton. This device is not intended to be used in acute situations of pain management. The KKT Device's mode of action consists of low-intensity mechanical impulses applied to the treatment site in a controlled and repeatable manner. The control of the direction (vector), amplitude and duration of the impulses allows for a known, finite, and predetermined amount of force and/or energy to be applied to the treatment site. This control is predetermined and then prescribed by a qualified medical practitioner where the treatment parameters to be correlated with (or derived from) data from X-rays, imaging systems, and physiological length, strength or distance measurements and used for the patient's treatment. The treatment protocol consists of a series of pulses applied to the atlas vertebra. Each pulse consists of a constant 16Hz frequency for approximately 750msec, a frequency sweep of 50 to 80 Hz in steps of 1 Hz for one full cycle each, followed by an extension while a twist is applied through the stepper motor, then a pause for approximately 750msec before the next pulse. The number of pulses can be set by the operator as can the amplitude of the stylus vertical motion and the amount and direction of the rotation. The device consists of a treatment head supported by an electrically actuated stand. Power is supplied through a grounded receptacle to an auto sensing 24VDC power supply. All actuators and controls are powered at 24VDC or lower. The vertical tower is positioned manually by sliding on the base plate and vertical and horizontal adjustment is controlled by redundant momentary switches located on either side of the horizontal arm. The position of the treatment head is set manually using the positioning display on the LCD screen mounted on the horizontal arm. Treatment parameters for duration and intensity are entered using the same screen or automatically through Client Application software. A release mechanism is incorporated into the treatment stylus to prevent excessive pressure being applied to the patient. This mechanism is interlocked through firmware to halt treatment and raise the treatment head when activated.
The provided text does not contain information about specific acceptance criteria for the KKT-M2 device's performance in treating chronic pain, nor does it detail a study that proves the device meets such criteria. Instead, it describes a 510(k) premarket notification for a medical device (KKT-M2) intended to aid in chronic pain management. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (KKT-M1) and adherence to safety and electrical standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from KKT-M2 Description) | Reported Device Performance (from KKT-M2 Description) |
|---|---|---|
| Functional Parameters | ||
| Force | Not more than 5 pounds (suggested force of 10.3 N (2.3 pounds)) | Accurately adjustable and not more than 5 pounds, with suggested force of 10.3 N (2.3 pounds) |
| Stylus Vertical Displacement | Up to 3mm (1/8") during treatment | Up to 3mm (1/8") during treatment |
| Wave Form | Sinusoidal | Sinusoidal |
| Frequency | Accurately adjustable and not more than 110 Hz (suggested treatment: 16Hz + 50-80Hz for disc treatment) | Accurately adjustable and not more than 110 Hz (suggested treatment: 16Hz + 50-80Hz for disc treatment); also stated as 50-80Hz |
| Rotational Angle | +/- 30 deg max. | Same as predicate (+/- 30 deg max.) |
| Rotational Direction | Clockwise, counterclockwise | Same as predicate (Clockwise, counterclockwise) |
| Rotational Repetitions | Once per cycle | Same as predicate (Once per cycle) |
| Safety and Electrical Standards | ||
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2 | Successfully tested to Standard (Cert./Report # 27382 Rev1.4) |
| IEC 60601-1 | Medical electrical equipment - Part 1 | Successfully tested to Standard (CB Certification US/3467/ITS 100290268BOX-001) |
| IEC 62366 | Application of Usability Engineering to Medical Device | Successfully tested to Standard (100290268BOX-002) |
Note for Table: The document primarily compares the KKT-M2 to its predicate KKT-M1, indicating that performance and principles of operation are similar, with improvements in design and manufacturing. No specific performance study (e.g., a clinical trial demonstrating pain reduction efficacy against a baseline or control) is described with explicit acceptance criteria for chronic pain management and corresponding reported performance. The "reported device performance" in the table above refers to the functional specifications and safety compliance as described for the KKT-M2 itself, indicating it meets its own design parameters and applicable safety standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the context of evaluating the device's efficacy in patients. It mentions that the device has been tested for safety and effectiveness and that there have been no adverse outcomes reported in over 10,000 KKT treatments. However, this refers to cumulative clinical experience, not a controlled study with a defined patient test set for performance evaluation against specific criteria. Details on data provenance (country of origin, retrospective/prospective) for these 10,000 treatments are not provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The document does not describe a study that required expert-established 'ground truth' for a test set to prove the device's performance in treating chronic pain. The "diagnostic imaging that qualifies the misalignment between vertebrae" is part of the clinical procedure, not a ground truth establishment for a performance study in this context.
4. Adjudication Method for the Test Set
Not applicable. No clinical study with a test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance
Not applicable. This device is a mechanical manipulator, not an AI-driven diagnostic or treatment assistance tool, and no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical treatment device requiring human operation, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the purpose of performance evaluation (e.g., efficacy in chronic pain management), the document does not specify a "ground truth" used in a formal study. The primary focus of this 510(k) submission is substantial equivalence to a predicate device and compliance with safety standards rather than a de novo clinical efficacy study with defined ground truth. The "studies cited above" that "support the efficacy of the treatment" are not detailed or provided within this document. The 10,000 treatments with no adverse outcomes suggest real-world usage, but not a controlled ground-truth study.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a ground-truthed training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/machine learning device.
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