The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent.

Experience in the market with the HF100H may make us aware of other possible applications. This unit may be eventually married with stands for permanent or semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications.

Device Description

The MinXray HF100H is a compact, self-contained high frequency X-ray unit consisting of the control, X-ray generator, and beam limiting device. Tube voltage (KV) and exposure time are variable and selected by the operator. Tube current is fixed at 20 mA.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for the MinXray HF100H High Frequency Diagnostic X-ray Unit, submitted in 1997. This document focuses on demonstrating substantial equivalence to a predicate device (MinXray HF80H), rather than establishing new performance criteria or conducting a comprehensive study with acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and sample sizes for performance evaluation (as would be typical for AI/software-controlled devices) is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" as applied to novel device performance is not explicitly stated in this document. Instead, the submission aims to demonstrate substantial equivalence to a predicate device. The performance is reported by comparing features and stating that "radiographs of the same patient produced on either device were essentially identical."

Feature	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (MinXray HF100H)
X-ray output	Similar to MinXray HF80H (10mA @ 50-80kV)	20 mA @ 40-100 kV in 2 kV steps (Improved/Higher)
Timer	Similar to MinXray HF80H (0.08-3.98 sec)	0.08-2.00 sec (Within range or adjusted)
X-ray generator	Constant potential, 45 kHz, Full-wave rectified	Constant potential, 60 kHz, Full-wave rectified (Improved/Higher frequency)
Line voltage adjustment	Automatic, dynamic	Automatic, dynamic (Equivalent)
X-ray tube	Toshiba D-102 or equiv.	Toshiba D-124K or equiv. (Similar but newer model)
Focal spot size	1.0 mm	1.2 mm (Slight difference, but considered equivalent for general radiography)
Total filtration	3.2 mm Al equivalent	3.2 mm Al equivalent (Equivalent)
Collimator	Advantech R-70ET or equiv.	Advantech R-70ET or equiv. (Equivalent)
Exposure cord	8 feet (2.44 meters)	8 feet (2.44 meters) (Equivalent)
Exposure switch	Two-stage, deadman type	Two-stage, deadman type (Equivalent)
Power cord	10 feet (3.05 meters)	10 feet (3.05 meters) (Equivalent)
Overload protection	Thermal, built-in	Thermal, built-in (Equivalent)
Size (tubehead/control)	6.5" W, 7.5" H, 14.5" L	9.5" W, 8.75" H, 15.35" L (Different, but still compact and portable)
Weight	27.5 lbs (12.5 kgs)	40.9 lbs (18.6 kgs) (Heavier, but still portable)
Control display	Digital	Digital (Equivalent)
Image Quality	Radiographs essentially identical to predicate (HF80H)	Radiographs essentially identical to predicate (HF80H)

Note: The "acceptance criteria" here are implicitly defined by the performance characteristics of the legally marketed predicate device (MinXray HF80H). The new device is considered acceptable if its performance is "substantially equivalent" in terms of safety and effectiveness for the intended use. In some cases, performance is improved (e.g., higher output, higher generator frequency), which is generally viewed positively.

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

Sample Size for Test Set: Not specified. The document states "Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical." This implies a comparison was made, but the number of patients or images is not provided.
Data Provenance: Not specified, but given the context of medical device preproduction testing, it would generally involve internal testing data. The country of origin is not mentioned. The study would be prospective in the sense that radiographs were specifically produced for comparison during preproduction.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It can be inferred that qualified personnel (e.g., radiologic technologists, possibly radiologists) would have evaluated the image quality, but no details are given.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The statement "radiographs... were essentially identical" suggests a subjective comparison, but no formal adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This type of study focuses on evaluating diagnostic accuracy and reader performance, commonly used for AI-based diagnostic aids. This 1997 submission for a conventional X-ray unit does not involve an AI component or complex diagnostic performance evaluation in this manner.

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

Standalone Performance: Not applicable. The MinXray HF100H is a physical X-ray generating device, not an algorithm or software. The document explicitly states: "The subject device is not software controlled."

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" here is the visual quality and diagnostic utility of the radiographs produced by both the new device and the predicate device. The claim is that they are "essentially identical," implying that they provide comparable diagnostic information. This is a subjective assessment of image quality by human observers, rather than an objective "ground truth" derived from pathology or clinical outcomes for specific diagnoses.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware X-ray generator, not an AI model that requires a training set.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this hardware device.

In summary: This 510(k) submission is a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device based on technical specifications and a general assertion of comparable image quality. It does not employ the structured study designs, performance metrics, and "ground truth" definitions that are typical for AI/software-controlled devices.

Summary

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EXHIBIT A

510(k) Summary of Safety and Effectiveness

DEC 1 2 1997

Identification of the Device 1.

Classification Name: 90 IZL per 21 CFR 892.1720

Common/Usual Name: Portable general purpose diagnostic X-ray unit.

Proprietary Trade Name: MinXray HF100H High Frequency Diagnostic X-ray Unit

Equivalent legally marketed device 2.

This product is similar in design and function to the MinXray HF80H High Frequency Diagnostic X-ray Unit (K945707).

3. Indications for Use (intended use)

Experience in the market with the HF100H may make us aware of other possible This unit may be eventually married with stands for permanent or applications. semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use with the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.

Description of the device 4.

Safety and Effectiveness, comparison to predicate device 5.

The MinXray HF100H is substantially equivalent to the MinXray HF80H in safety and effectiveness. Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical. The following chart compares the new and predicate devices.

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6. Substantial Equivalence Chart

Feature	MinXray HF100H (new device)	MinXray HF80H (predicate)
X-ray output	20 mA @ 40-100 kVin 2 kV steps	10 mA @ 50-80 kVin 5 kV steps
Timer	0.08-2.00 sec.192 steps	0.08-3.98 sec.195 steps
X-ray generator	Constant potential, 60 kHzFull-wave rectified	Constant potential, 45 kHzFull-wave rectified
Line voltage adjustment	Automatic, dynamic	Automatic, dynamic
X-ray tube	Toshiba D-124K or equiv.	Toshiba D-102 or equiv.
Focal spot size	1.2 mm	1.0 mm
Total filtration	3.2 mm Al equivalent	3.2 mm Al equivalent
Collimator	Advantech R-70ET or equiv.	Advantech R-70ET or equiv.
Exposure cord	8 feet (2.44 meters)	8 feet (2.44 meters)
Exposure switch	Two-stage, deadman type	Two-stage, deadman type
Power cord	10 feet (3.05 meters)	10 feet (3.05 meters)
Overload protection	Thermal, built-in	Thermal, built-in
Size (tubehead/control)	9.5" (24.1 cm) W,8.75" (22.2 cm) H,15.35" (39 cm) L+ skin guards	6.5" (16.5 cm) W,7.5" (19 cm) H,14.5" (27.94 cm) L+ skin guards
Weight	40.9 lbs (18.6 kgs)	27.5 lbs (12.5 kgs)
Control display	Digital	Digital

7. Conclusion

Since there are no new indications for use, nor are there any new potential hazards, and preproduction testing showed that radiographs of the same patient produced on either device were essentially identical, MinXray is of the opinion that the devices are substantially equivalent.

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Manufacturer's Statement of Substantial Equivalence 8.

STATEMENT OF INDICATIONS FOR USE:

The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. These uses are typical of the predicate device, the MinXray HF80H.

CLAIMS REGARDING DEVICE FEATURES, PERFORMANCE, OR SAFETY:

This product is similar in design and function to the MinXray HF80H high frequency diagnostic X-ray unit (K945707).

This notification contains all of the information required by 21 CFR 807.87. A completed copy of the "DRAERD Premarket Notification 510(k) Screening Checklist" is attached.

The subject device conforms to the following mandatory standards:

Performance Standard: 21 CFR 1020.30 Diagnostic X-ray Systems

The subject device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. If the subject device is a kit, all of the contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)s. The kit contains no drug or biologic product.

The subject device is not software controlled.

TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(j)):

I certify that, in my capacity as President of MinXray, Inc., I believe, to the best of my knowledge, that the above statements and all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

Keith R. Krettenhir

Keith R. Kretchmer President

4/26/97
Data

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 1997

Keith R. Kretchmer President MinXRay, Inc. 3611 Commercial Avenue Northbrook, IL 60062-1822 Re: K973712 MinXray HF100H High Frequency Diagnostic X-Ray Unit Dated: December 5, 1997 Received: December 8, 1997 Regulatory Class: II 21 CFR 892.1720/Procode: 90 IZL

Dear Mr. Kretchmer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 80) and additionally 809.10 for in vitr' diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT B

Indications for Use (intended use)

The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the diagnotic rational depice that the safety and effectiveness of the two models are substantially equivalent.

Experience in the market with the HF100H may make us aware of other possible This unit may be eventually married with stands for permanent or applications. semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.