(90 days)
Impulse™ (aka Neuromechanical™, aka CBP®) Adjusting Instrument is for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities by a licensed health care professional. The device is for external use only.
Impulse "" (aka Neuromechanical™, aka CBP®) Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument intended to be used for chiropractic adjustment or manipulation/mobilization of the joints of the spine and extremities. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices. The instrument's shaft measures approximately 15 cm in length and 3.5 cm in width. The instrument's handle is rigidly attached to the shaft and measures approximately 10 cm in length. The external housing of the device consists of high impact plastic that surrounds its main internal components. The major external components of the device consist of the instrument's shaft, handle, force adjustment switch, trigger, preload control nose, stylus and power cord. Three types of interchangeable stainless steel stylus' attach to the preload control nose which make contact with the patient by means of a neoprene rubber end. The major internal components of the device consist of a circuit board, power supply, internal thrust element, solenoid, internal spring. Both external and internal views of the device are shown in Figure 1. Stylus specifications are shown in Figure 2, illustrating the three kinds of stylus', a single stylus, and two double contact stylus' that allows for dual contact to each side of the spine simultaneously. These styluses have been designed for appropriate anatomical contact with the spine. The instrument is manually triggered by the operator and contains a safety mechanism consisting of a triggering mechanism that does not allow for activation of the device unless the preload control spring is maximally compressed. In this manner, the clinician (operator) is able to test the patient's tolerance to contact prior to the instrument being able to be activated. The device is equipped with a force adjustment switch which allows for control of force produced by the instrument, high, medium, and low, representing transmitted peak forces of 265 N, 150 N, and 50 N respectively. Peak forces for all three settings are delivered in less than 5 ms. The device is operated in the following manner. After locating the target area to be treated the rubber end of the stylus makes contact with the treatment location. An approximate 15 N of preload force compresses the spring allowing for activation of the instrument's trieger mechanism. The operator is then able to manually trigger the device to deliver a single thrust ranging from 50 - 265 N depending on the force setting used.
The provided text describes a 510(k) premarket notification for the Impulse™ Adjusting Instrument and a study comparing its force transmission to predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense for the Impulse™ Adjusting Instrument's performance, but rather aims to demonstrate substantial equivalence to predicate devices, particularly regarding force transmission. The implicit acceptance criterion is that the new device's force output should be similar to or lower than that of predicate devices, thereby not raising new safety or efficacy concerns.
| Feature/Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Impulse™ Adjusting Instrument) |
|---|---|---|
| Peak Force - Low Setting | Similar to or lower than predicate devices (e.g., Activator® II and Harrison Hand-Held) | 55.8 N (Figure 3 indicates this is comparable to Activator II and Harrison at comparable settings) |
| Peak Force - Medium Setting | Similar to or lower than predicate devices (e.g., Activator® II and Harrison Hand-Held) | 150.5 N (Figure 3 indicates this is comparable to Activator II and Harrison at comparable settings) |
| Peak Force - High Setting | Similar to or lower than predicate devices (e.g., Activator® II and Harrison Hand-Held) | 254.4 N (Figure 3 indicates this is comparable to Activator II and Harrison at comparable settings; Harrison shows higher force at 300N) |
| Pulse Duration | Not explicitly stated as acceptance criteria, but reported for the device and predicate devices. |
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