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.

Device Description

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.

AI/ML Overview

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.	< 5 ms for all three force settings.

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.

Summary

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JAN 1 3 2003

510(k) Summary Impulse " Adjusting Instrument; also known as (aka) Neuromechanical Adjusting Instrument"; aka CBP® Adjusting Instrument Neuromechanical Innovations, LLC Manufacturer: 11011 S. 48th St., Suite 205 Phoenix, AZ 85044

Christopher J. Colloca, D.C. Contact: Phone: 480-785-8442 Fax: 480-893-2412 Email: cicolloca(@neuromechanical.com
Jeff Green

Contract Manufacturer: FA Green 9742 352nd Ave., S.E. Snoqualmie, WA 98065

Contract Manufacturer Contact:

Trade Name(s):

Impulse™ Adjusting Instrument aka (also known as) Neuromechanical Adjusting Instrument™ aka (also known as) CBP® Adjusting Instrument

Manipulator, Plunger-like Joint

K003185 - Full Spectrum Activator III

K973506 ~ Activator II Adjusting Instrument

K930431 - Arthrostim

K010851 - Harrison Hand Held Adjusting Instrument

K001476 - Torque Specific Cervical Adjusting Instrument

Telephone: (425) 888-0007

Facsimile: (425) 888-0675 Email: sensors@centurytel.net

Chiropractic Adjusting Instrument Common or Usual Name:

Classification Name:

Predicate Devices for Substantial Equivalence:

Applied for herein. Establishment Registration #:

Classification: Unclassified Physical Medicine Panel:

R. A. Fisher, Natural Selection and Variation

Performance Standards: None known established

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Device Description & Specifications:

(aka Neuromechanical™, aka CBP®) Adjusting Instrument is a hand-held Impulse "" 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 Both external and internal views of the device are shown in Figure 1. Stylus spring. 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.

Substantial Equivalence Comparison:

Impulse™ (aka Neuromechanical™, aka CBP®) Adjusting Instrument is substantially equivalent to other FDA registered predicate hand-held chiropractic adjusting instruments. Specifically, Impulse™ (aka Neuromechanical™, aka CBP®) Adjusting Instrument has the same intended use, similar technological characteristics, and similar force-time profiles as predicate devices. The current device, perhaps, is most similar in structure and function to the Harrison Hand Held Adjusting Instrument (K010851). Both hand-held adjusting instruments generate the force to protrude the stylus a controlled distance by means of electrical power that transiently charges a solenoid. The current device, however, has several noteworthy technological characteristics that are similar to predicate devices. Therefore, Table 1 has been prepared to provide a comparison of technological characteristics of the the current device and predicate devices.

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Feature	Impulse*	Harrison	Arthrostim	ActivatorII	ActivatorIII
Intended use is chiropracticadjustment of the spine?	Yes	Yes	Yes	Yes	Yes
Hand-held adjusting device?	Yes	Yes	Yes	Yes	Yes
Manually activated thrust?	Yes	Yes	Yes	Yes	Yes
Single thrust per activation?	Yes	Yes	No	Yes	Yes
Thrust force delivered fromspring energy?	No	No	No	Yes	Yes
Thrust force delivered frompowered solenoid activation?	Yes	Yes	Yes	No	No
Adjustable force transmission	Yes	Yes	Yes	Yes	Yes
Preload control spring	Yes	No	No	No	Yes
Rubber contact end on stylus	Yes	Yes	Yes	Yes	Yes

Table 1. Substantial equivalence comparison for the current device (*), the Harrison Hand Held Device (K010851), Arthrostim (K930431), Activator II (K973506), and Activator III (K003185).

Force Transmission Comparison Among Chiropractic Adjusting Devices

The force of the current device (Impulse" Adjusting Instrument) was compared to the Harrison Hand Held Adjusting Instrument (K010851), and the Activator® II Adjusting Instrument (K973506) in a laboratory setting. Ten thrusts were delivered into a load cell (2200 N quartz force ring, PCB model 201A03, PCB Piezotronics, Buffalo, NY') mounted to a table top for each of three force settings for each of the three devices. Collectively, ninety trials were performed, thirty trials with each device consisting of ten trials at each of the three force settings.

Figure 3 provides a comparison of force transmission among the three devices for each of the three force settings. The Impulse "device was found to produce an average peak force of 55.8 N, 150.5 N, and 254.4 N respectively (pulse duration < 5 ms) for each of the three force settings that the device allows. As noted in Figure 3, these forces are very similar to the Activator® II, and the Harrison Hand-Held Adjusting Instrument. The results of this experiment clearly demonstrate that the peak forces transmitted with the current device are of similar magnitude (or lower) to predicate devices and therefore does not raise any new safety or efficacy issues.

Figure 1. External view (left) and internal view (right) of the Impulse™ (aka Neuromechanical" aka CBP®) Adjusting Instrument.

Image /page/2/Figure/8 description: The image shows two diagrams of an adjusting instrument, one displaying the external view and the other displaying the internal view. The external view diagram labels the handle, power cord, trigger, preload control nose, stylus, shaft, impulse, and switch. The internal view diagram labels the thrust element, solenoid, internal spring, preload control nose, trigger, circuit board, power cord lock, and opposite shell casing.

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Image /page/3/Figure/1 description: The image shows a chiropractic adjustment tool with different stylus attachments. The tool itself is labeled with a length of 15 cm and a height of 10 cm. The stylus attachments include a single stylus, a lumbar dual stylus, and a cervical dual stylus, each with labeled dimensions in millimeters.

Figure 2. Measurements of the adjusting instrument (left) and stylus attachments (right).

The current device, Impulse" (aka Neuromechanical™ aka CBP®) Adjusting Figure 3. Instrument was compared to two other FDA registered hand-held chiropractic adjusting devices, the Harrison Hand-Held Adjusting Instrument and the Activator II Adjusting Instrument. Ten trials were performed at each of three force settings. Error bars represent the standard deviations.

Image /page/3/Figure/4 description: This bar graph compares the force in Newtons of three different devices: Activator II, Harrison, and Impulse. The x-axis shows the setting, which ranges from 1 to 3. The y-axis shows the force in Newtons, which ranges from 0 to 350. At setting 3, the Activator II has a force of approximately 200 Newtons, Harrison has a force of approximately 300 Newtons, and Impulse has a force of approximately 250 Newtons.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2003

Christopher J. Colloca, D.C. President Neuromechanical Innovations, LLC 11011 S 48th Street, Suite 205 Phoenix, Arizona 85044

Re: K023462

Trade Name: Impulse – Adjusting Instrument, aka (also known as) CBP Adjusting Instrument, and aka Neuromechanical Adjusting Instrument Regulatory Class: Unclassified Product Code: LXM Dated: June 3, 2002 Received: October 15, 2002

Dear Dr. Colloca:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (R.MA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Christopher J. Colloca, D.C.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Mark A. Millherson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:	K023462
Applicant:	Neuromechanical Innovations, LLC11011 S. 48th St., Suite 205Phoenix, AZ 85044
Contact:	Christopher J. Colloca, D.C.Telephone: 480-893-2400Facsimile: 480-893-2412
Device Name(s):	Impulse™ Adjusting InstrumentNeuromechancial™ Adjusting InstrumentCBP® Adjusting Instrument

Indications For Use:

(aka Neuromechanical™, aka CBP®) Adjusting Instrument is for adjustment, Impulse™ 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR (Per 21 CFR 801.109)

Over-the-Counter-Use

Division Sign-Off Division of General. Restorative and Neurological Devices

510(k) Number K023462

Regulation Number and Section

N/A