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510(k) Data Aggregation
(70 days)
NEUROMECHANICAL INNOVATIONS, LLC
The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.
The Impulse iQ Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument. The device has three force settings (low, medium, high), a preload-control indicator light that turns from red to green upon achieving the proper preload, and an internal accelerometer to provide closed-loop feedback controlling thrust pulse rate. 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 provided text describes a 510(k) summary for the "Impulse iQ Adjusting Instrument" and the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on providing a detailed clinical study demonstrating the device's efficacy against specific acceptance criteria.
Therefore, the information required to populate most of the requested sections (e.g., acceptance criteria, test set details, ground truth, MRMC study, training set) is not present in the provided text.
Here's what can be extracted based on the given document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. | Produces approximately 100 N, 200 N, and 400 N on its low, medium, and high force settings, respectively. |
| Pulse rate varies between 4-12 Hz. |
Note: The document states "Performance Standards: None known established." This indicates that the device was not evaluated against predefined formal performance standards or acceptance criteria. The performance data provided are descriptive measurements of the device's output.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The document describes mechanical testing of the device's force and pulse rate, not a study involving a test set of data (e.g., patient data or images).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Ground truth establishment by experts for a test set is not relevant to the mechanical testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods are not relevant to the mechanical testing described.
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. This device is a chiropractic adjusting instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical chiropractic adjusting instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For the mechanical performance data, the "ground truth" would be the direct measurement of force and pulse rate using calibrated equipment, not expert consensus or clinical outcomes.
8. The sample size for the training set
Not applicable/Not provided. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. This device does not involve machine learning or a training set.
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(90 days)
NEUROMECHANICAL INNOVATIONS, LLC
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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