The Frye Adjusting Instrument is a chiropractic, adjusting instrument for use in spinal manipulative therapy. The Frye Adjusting Instrument is a modification of the Full Spectrum Activator® III Adjusting Instrument developed to offer easier use to those chiropractors that have limited strength or dexterity in their hands. Typically, these are chiropractors that have arthritis, age-related problems, or have a physical disability of their upper extremity. Thus, these chiropractors have difficulties using currently available adjusting instruments. The main differences between currently available adjusting instruments, such as the FS Activator® III, and the Frye adjusting instrument are that the Frye adjusting instrument is activated pneumatically by a simple push-button and it is shaped in a 'gun-like' configuration rather than a 'plunger-like' configuration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Frye Adjusting Instrument. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the manner of AI/software or diagnostic devices.

Therefore, many of the requested categories related to AI/software performance studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" for a novel device is usually tied to specific performance metrics demonstrated through testing against predefined thresholds. In this 510(k), the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, the FS Activator® III. The performance reported is the similarity in function and outcome.

Acceptance Criterion (Implicitly "Substantial Equivalence")	Reported Device Performance (Frye Adjusting Instrument)
Indicated for chiropractic adjustment of the spine?	Yes
Hand held adjusting device?	Yes
Impact force delivered by spring energy?	Yes
Adjustable impact force?	Yes
Silicone rubber body contact member?	Yes
Precision operating force setting?	Yes
Similar peak dynamic loads at minimum, mid, and maximum settings compared to predicate device.	Achieved.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as "sample size" in the context of clinical trials or data sets. The "test set" was the comparison of the Frye Adjusting Instrument against the FS Activator® III. It involved bench testing of the devices themselves.
Data Provenance: Bench data performed by an independent laboratory. No country of origin for the data is specified, but the manufacturer is in the USA. The data would be prospective in that it was generated for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a mechanical device comparison, not a diagnostic or AI performance study requiring expert ground truth for classification. The "ground truth" here is the physical measurement of force.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a mechanical device comparison, not a study requiring adjudication of expert interpretations.

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

Not applicable. This is a mechanical device, not an AI or diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable to a mechanical chiropractic adjusting instrument. The device itself is "standalone" in that it performs its function without an explicit human-in-the-loop analytical component (like an AI system providing a diagnosis that a human then acts upon). However, it is an instrument used by a human practitioner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the physically measured peak dynamic loads produced by the device at various settings. This is an objective measurement of a mechanical property.

8. The sample size for the training set

Not applicable. This is a mechanical device; there is no "training set" in the machine learning sense. The device's design and engineering would be based on mechanical principles and iterative development, not a data-driven training process.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this device.

Summary

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02/1238

OCT 09 2002510(k) SummaryFrye Adjusting Instrument page 1 of 2
Manufacturer:	Frye Health Systems Inc3126 S. Garnett Road, Suite HTulsa, OK 74146
Contact:	Bruce Frye, D.C.918-665-0036
Trade name:	Frye Adjusting Instrument
Common name:	chiropractic adjusting device
Classification name:	Plunger-like joint manipulator
Substantial equivalence:	FS Activator® III, K003185Activator Methods, Phoenix, Arizona

Intended Use:

The Frye Adjusting Instrument is intended for chiropractic adjustment of the spine and extremities.

Device Description:

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K021238

page 2 of 62

Comparison to predicate device:

Like the FS Activator® III, the Frye Adjusting Instrument is a manual hand-held chiropractic adjusting device which provides a repeatable force and displacement to the spine and extremities when activated. Both devices have a precision force setting feature and a silicone rubber body contact member. See Table 1 below for a comparison of the Frye Adjusting Instrument and the FS Activator® III.

	FS Activator® III	Frye AdjustingInstrument
Indicated for chiropractic adjustment of thespine?	Yes	Yes
Hand held adjusting device?	Yes	Yes
Impact force delivered by spring energy?	Yes	Yes
Adjustable impact force?	Yes	Yes
Silicone rubber body contact member?	Yes	Yes
Precision operating force setting?	Yes	Yes
Spring activated directly by chiropractor?	Yes	No, is activatedpneumatically

Table 1. Substantial Equivalence Comparison

Summary of data upon which substantial equivalence was based:

Bench data performed by an independent laboratory compared the Frye Adjusting Instrument to the FS Activator® III. Results indicated that both devices produce similar peak dynamic loads at minimum, mid, and maximum settings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 9 7002

Frye Health Systems c/o Ms. Deborah F. Koeneman Regulatory Consultant 2751 East Hale Street Mesa, Arizona 85213

Re: K021238

Trade/Device Name: Frye Adjusting Instrument Regulation Number: n/a Regulation Name: n/a Regulatory Class: unclassified Product Code: LXM Dated: August 14, 2002 Received: August 15, 2002

Dear Ms. Koeneman;

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 reguirements 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 - Ms. Deborah F. Koeneman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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/dsma/dsmamain.html

Sincerely yours,

Stypt Rurler

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

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Frye Adjusting Instrument Premarket Notification

Indications for Use Enclosure

510(k) Number: K011238

Device Name: _________________________________________________________________________________________________________________________________________________________________ Frye Adjusting Instrument

Indications for Use: The Frye Adjusting Instrument is indicated for chiropractic adjustment of the spine and extremities.

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

Concurrence of CRDH, Office of Device Evaluation (ODE)

Prescription Use	X
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(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices

510(k) Number	K021238
Over-the Counter Use

Regulation Number and Section

N/A