The Activator V is a hand-held electromechanical chiropractic adjusting instrument with a plunger-like mechanism that is intended to be used for chiropractic adjustment of the spine and extremities. The device is only intended to be used by a health care professional licensed by the state in which he or she practices. The thrust is provided by battery power rather than manual force. This makes it easier and less tiring for the chiropractor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Activator V, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Thrust Delivery)	Reported Device Performance (N)
To deliver approximately 75 N	75 N
To deliver approximately 125 N	125 N
To deliver approximately 175 N	175 N
To deliver approximately 250 N	250 N
Rechargeable battery safety and performance	Tested for safety and performance by the battery manufacturer.

The document indicates that the device's performance aligns with the stated acceptance criteria: "The Activator V has been mechanically tested and shown to deliver approximately 75, 125, 175 or 250 N, depending on the selected thrust setting." The rechargeable battery's safety and performance were also confirmed through manufacturer testing.

Study Information

Sample size used for the test set and the data provenance: The document does not specify a separate "test set" in the context of clinical data for performance evaluation in humans. The performance data provided is related to mechanical testing of the device itself, not patient outcomes. Therefore, sample size and data provenance for a human test set are not applicable or provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the physical output of the device (thrust force), established through mechanical testing, not by expert consensus on clinical data.
Adjudication method for the test set: Not applicable. As the performance relates to mechanical testing of force output, an adjudication method for a clinical test set is not relevant.
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: Not applicable. This device is a chiropractic adjusting instrument; it is not an AI-powered diagnostic or interpretive tool that would involve human "readers" or an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself performs a standalone function (delivering thrust). The "performance data" provided refers to the mechanical output of the device without human intervention beyond selecting the thrust setting.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance claims (thrust delivery) is based on mechanical measurements of force output.
The sample size for the training set: Not applicable. The Activator V is a mechanical device, not an AI or algorithmic system that requires a "training set."
How the ground truth for the training set was established: Not applicable, as no training set is relevant for this device.

Summary

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OCT 2 % 2007 510(k) Summary of Safety and Effectiveness 6.

This 510(k) Summary of Safety and Effectiveness for the Activator V is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.

Applicant:	Activator Methods International Ltd.
Address:	2950 N. Seventh Street, Suite 200
	Phoenix, AZ 85014 USA
Contact Person:	Arlan W. Fuhr, D.C.
Telephone:	602-224-0220
Fax:	602-224-0230
Preparation Date:	September 4, 2007
Device Trade Name:	Activator V
Common Name:	Chiropractic adjusting instrument
Classification Name:	Plunger-like joint manipulator
Product Code:	LXM
Legally Marketed	K003185, Full Spectrum Activator III
Predicates:	K010851, Harrison Hand Held Adjusting Instrument
	K023462, Impulse Adjusting Instrument
Device Description:	The Activator V is a hand-held electromechanical
	chiropractic adjusting instrument with a plunger-like
	mechanism that is intended to be used for chiropractic
	adjustment of the spine and extremities. The device is
	only intended to be used by a health care professional
	licensed by the state in which he or she practices. The
	thrust is provided by battery power rather than manual
	force. This makes it easier and less tiring for the
	chiropractor.
Intended Use:	The Activator V is indicated for chiropractic adjustmentof the spine and extremities. It is intended for externaluse only
Performance Data:	The Activator V has been mechanically tested and shownto deliver approximately 75,125, 175 or 250 N,depending on the selected thrust setting. Therechargeable battery has been tested for safety andperformance by the battery manufacturer.
Conclusion:	The Activator V is substantially equivalent to thepredicate plunger-like chiropractic adjustment deviceswith respect to intended use, performance, andtechnological characteristics.

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510(k) Summary of Safety and Effectiveness for the Activator V, continued:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, clutching a staff with two snakes wrapped around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.

OCT 2 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Activator Methods International, Ltd. % Arlan W.Fuhr, D.C. President 2950 North 7th Street, Suite 200 Phoenix, Arizona 85014

Re: K072519

Trade/Device Name: Activator V Spinal Adjusting Instrument Regulatory Class: Unclassified Product Code: LXM Dated: September 4, 2007 Received: September 7, 2007

Dear Dr. Fuhr:

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 (PMA), 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 - Arlan W.Fuhr, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark A. Milhusan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5. Indications for Use Statement

Activator V Spinal Adjusting Instrument Intended Use:

The Activator V is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K07

Regulation Number and Section

N/A