"HCMI X-Ray" High Frequency Chiropractic Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position.

Device Description

The "HCMI X-Ray" is a chiropractic radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. The standard system includes the high voltage generator, control panel, a Model S-82RM Tube Stand, and HC-172-F wall mount cassette holder. The tube stand employs a Toshiba tube head and a certified Eureka collimator. A radiographic table, one of several models, is optional. A wall stand with bucky is optional.

AI/ML Overview

Acceptance Criteria and Study for "HCMI X-Ray" High Frequency Chiropractic Radiographic System

This device, the "HCMI X-Ray" High Frequency Chiropractic Radiographic System, is seeking substantial equivalence to a predicate device, the Bennett X-Ray Radiographic System (K952672). Therefore, the acceptance criteria are not in terms of specific performance metrics against a defined standard for accuracy, sensitivity, or specificity, but rather relate to demonstrating its safety and effectiveness are equivalent to the predicate device.

The study presented focuses on demonstrating this equivalence through various testing methodologies.

1. Table of Acceptance Criteria (Implicit for Substantial Equivalence) and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Intended Use Equivalence: The device's intended use must be the same as the predicate device.	"SAME" - Intended for general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts, performed by a qualified doctor or technician, with the patient sitting, standing, or lying prone/supine.
Performance Standard Compliance: The device must meet the same applicable federal performance standards.	"SAME" - Complies with 21 CFR 1020.30.
Electrical Safety Compliance: The device must meet the same electrical safety standards.	"SAME, plus tested for EMC compatibility" - Complies with Underwriters Laboratories Standard UL-2601(IEC-60601) and IEC 60601, and additionally, tested for EMC compatibility.
Technological Characteristics Equivalence: The device must have few technological differences from the predicate device that do not raise new questions of safety or effectiveness.	The document implies equivalence through the "SAME" statements and the "few technological differences" conclusion. Specific technical details like mA, kVp, and Max KW ranges are provided and would have been compared to the predicate.
Overall Safety and Effectiveness Equivalence: The device must be demonstrated to be as safe and effective as the predicate device.	"The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices."

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

The provided document refers to "bench and user testing" for safety and effectiveness. However, no specific sample sizes for tests (e.g., number of test images, number of test subjects) are mentioned. Similarly, there is no information provided regarding data provenance (e.g., country of origin of the data, retrospective or prospective nature).

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

The document does not specify the number of experts used for any aspect of the testing, nor does it provide any details about their qualifications. The "user testing" mentioned generally implies evaluation by end-users (qualified/trained doctors or technicians), but without further detail.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of rigorous adjudication is typically associated with studies evaluating diagnostic accuracy, which is not the primary focus of this submission, which aims for substantial equivalence based on safety and functional similarity.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. This type of study, especially one evaluating the improvement of human readers with AI assistance, is not relevant given the device is a standard X-ray system and not an AI-powered diagnostic tool.

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

A standalone algorithm performance study was not conducted, nor would it be applicable to this device, which is an X-ray imaging system, not an algorithmic diagnostic tool.

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

The concept of "ground truth" as typically understood in diagnostic performance studies (e.g., expert consensus, pathology) is not explicitly mentioned or applied in this submission. The evaluation focuses on equivalence of the X-ray system itself (e.g., image quality, radiation output, electrical safety) rather than the accuracy of diagnoses made using images from the system. The "user testing" would have assessed the functional aspects and usability of the device, likely against anticipated positive outcomes of general radiographic examinations, rather than a specific disease diagnosis ground truth.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a conventional X-ray system, not a machine learning or AI-driven device that requires a training set for algorithm development.

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

As there is no training set for this device, there is no information on how ground truth would have been established for it.

Summary

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OCT 2 2 2002

EXHIBIT 2 510(k) Summary of Safety and Effectiveness

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KC22737

August 9, 2002 Contact: Katrina Moulder, Official Correspondent

1. Identification of the Device: Proprietary-Trade Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System Classification Name: Stationary X-Ray System, Product Code 90 KPR Common/Usual Name: Stationary X-Ray System
Equivalent legally marketed devices This product is similar in function and 2. design to the Bennett X-Ray Radiographic System K952672
1. Indications for Use (intended use) : "HCMI X-Ray" High Frequency Chiropractic Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position
Description of the Device: The "HCMI X-Ray" is a chiropractic radiographic 4. high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. The standard system includes the high voltage generator, control panel, a Model S-82RM Tube Stand, and HC-172-F wall mount cassette holder. The tube stand employs a Toshiba tube head and a certified Eureka collimator. A radiographic table, one of several models, is optional. A wall stand with bucky is optional.

HCMI 100 kHz Generators with Anatomical Programming:

Model	mA Range	kVp Range	Max KW
HF-300	25-300	40-125	30
HF-600	25-600	40-125	37.5
HF-3SE	25-300	40-125	30

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1. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

Characteristic	Bennett X-RayRadiographic SystemK952672	"HCMI X-Ray"High FrequencyChiropracticRadiographicSystem
Intended Use:	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.	SAME
PerformanceStandard	21 CFR 1020.30	SAME
Electrical safety	Electrical Safety perUnderwriters LaboratoriesStandard UL-2601(IEC-60601) and IEC 60601,Underwriters Laboratories	SAME, plus tested forEMC compatibility

1. Substantial Equivalence Chart, "HCMI X-Ray" High Frequency Chiropractic Radiographic System

7. Conclusion

After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Health Care Manufacturing, Inc. that the "HCMI X-Ray" High Frequency Chiropractic Radiographic System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Health Care Mfg., Inc. % Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K022737

Trade/Device Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: August 14, 2002 Received: August 19, 2002

Dear Mr. Kamm:

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 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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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-459
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21 CFR 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number K (222

Device Name: "HCMI X-Ray" High Frequency Chiropractic Radiographic System

Indications for Use: "HCMI X-Ray" High Frequency Chiropractic Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over the Counter Use (Per 21 CFR 801.109)

Nancy C. Hodgdon

(Division Sign-Off) Dession of Reproductive, Abdominal, are Padiological Devices 5 : (k) Number _______________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.