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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.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 10 thrusts for each of three force settings for each of the three devices. This means 30 trials per device, and a total of 90 trials (3 devices * 3 settings * 10 thrusts).
• Data Provenance: The study was conducted in a laboratory setting at an unspecified location. The data is prospective in the sense that the measurements were specifically performed for this comparison. No country of origin for the data collection is specified, but the manufacturer is based in Phoenix, AZ, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This study is a physical performance test measuring force output using a load cell, not an expert-based evaluation. Therefore, there are no "experts" establishing ground truth in the context of clinical or diagnostic assessment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was a physical performance test using a load cell, not requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study focused on the physical force output of the device itself, not on its clinical effectiveness or reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device itself is a "standalone" mechanical instrument, the study conducted was a standalone performance test of the physical forces it generates. It did not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for the force transmission comparison was objectively measured physical force (Newtons) detected by a calibrated load cell (2200 N quartz force ring, PCB model 201A03, PCB Piezotronics, Buffalo, NY).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical adjusting instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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