The MinXray HFP24 and HFP40 is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. These units are specifically designed for podiatric and extremity applications.

Device Description

MinXray HFP24 and HFP40 are x-ray units which operate from 120 V 50-60~ AC. They utilize a newly designed high frequency inverter designed to be mounted on a stand. The usual safety precautions regarding the use of x-rays must be observed by the operator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MinXray HFP24 and HFP40 High Frequency Diagnostic X-Ray Units. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical studies with specific acceptance criteria that would typically be associated with new efficacy claims or significant changes in intended use.

Therefore, the requested information elements related to robust clinical studies, such as specific performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable in this context.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to existing predicate devices. This involves showing that the new device has the same intended use and either the same technological characteristics or, if technological characteristics are different, that these differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic / Criteria	Predicate Device (MinXray HF100H+ K052721) Baseline	Study Device (MinXray HFP24/40) Performance	Acceptance/Equivalence Rationale
Intended Use	For diagnostic x-rays on adult/pediatric subjects, specifically podiatric and extremity applications.	SAME	The new device shares the identical intended use as the predicate device.
Safety & Effectiveness	Safe and effective (as previously cleared in K052721).	As safe and effective as predicate device.	"The results of bench and user testing indicates that the new device is as safe and effective as the predicate device." This is the general acceptance criteria for a 510(k), demonstrated by comparing technological characteristics and functionality. Specific clinical efficacy metrics are not detailed because no new claims are made.
Technological Characteristics (Comparison to Predicate)			The most detailed "performance" is a direct comparison of specifications. Differences identified (e.g., size/weight, energy source, exposure times, kV range, mA, focal spot size, X-ray tube) are presented with the implicit claim that these differences do not alter the fundamental safety or effectiveness for the stated intended use. The acceptance is that these differences are not significant enough to warrant a new clinical review for safety and efficacy beyond the substantial equivalence framework. For example: - Size/weight: Modified device is generally smaller/lighter, presented as an improvement without new safety concerns. - Energy Source: Different kVA, but still within typical medical device operation and tested for safety. - kV steps, mA: Modified kV range (50-70kV) and mA (10 mA) are specific to the "podiatric and extremity applications" noted in the intended use, and are therefore considered appropriate subsets of the predicate's capabilities. - Focal Spot Size: 0.8 mm (Modified Device) vs. 1.2 mm (Predicate). A smaller focal spot generally improves image resolution. This is considered a technological improvement that does not raise new safety concerns. - Exposure Times: Adjusted range (e.g., 1.0-2.0 sec vs. 1.0-4.0 sec) within acceptable limits for the intended use. - X-ray tube: Different model (SNMIF XDT-S70 vs. Toshiba D-124S), but deemed suitable through bench testing and compliance with performance standards.

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

Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical images or patients. The evaluation appears to be based on bench testing and "user testing" of the physical device, comparing its specifications and functional performance to the predicate devices. This typically involves engineering verification and validation (V&V) activities.
Data Provenance: The data provenance is from bench testing and "user testing" conducted by the manufacturer, Mikasa X-Ray Co., LTD. (Japan) and their distributor MinXray, Inc (USA). The nature of "user testing" in this context likely refers to usability and functional validation, not a formal clinical trial with patient data. It is retrospective in the sense of comparing against established predicate device performance and existing standards.

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

This is not applicable for a 510(k) submission based on substantial equivalence of an X-ray unit. There is no mention of a clinical "test set" requiring expert radiographic interpretation to establish ground truth for diagnostic accuracy, as the device is not an AI diagnostic tool or making new diagnostic claims. The "experts" involved would be the engineers and quality assurance personnel performing the bench and user testing, verifying the technical specifications and safety.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical "test set" with diagnostic findings requiring ground truth, there is no need for an adjudication method.

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

No, an MRMC study was not done. This device is an X-ray generator, not an AI-powered diagnostic software. Therefore, questions regarding AI assistance or improvements in human reader performance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is hardware (an X-ray unit), not a software algorithm.

7. The Type of Ground Truth Used

For the purpose of this 510(k), the "ground truth" is primarily based on technical specifications, functional performance, and safety standards as verified through engineering tests and comparison to the predicate devices. Compliance with these technical ground truths (e.g., accurate kV output, appropriate filtration, physical dimensions, safety interlocks) constitutes the basis for demonstrating safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models, so there is no "training set."

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

Not applicable. As there is no training set.

Summary

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5 2006 APR

11060566

EXHIBIT 2

Mikasa X-Ray Co., LTD. (Manufacturer) 13-2, Hongo 3-chome Bunkyo-Ku, Tokyo 113-0033 Japan Tel 81-3-3813-3911 Fax 81-3-3813-4420

MinXray, Inc (Initial Distributor) 3611 Commercial Ave. Northbrook, IL 60062 Tel 847-564-0323 Fax 847-564-9040 Contact: Keith Kretchmer

February 25, 2006 510(k) Summary

l . Identification of the Device:

Proprietary-Trade Name: MinXray HFP24 and HFP40 High Frequency Diagnostic X-Ray Units

Classification Name: Mobile X-ray system, Product Code 90 IZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit.

1. Equivalent legally marketed devices This product is similar in function to the MinXray P200 R24/40 (pre-amendments devices) and MinXray HF100H+ (K052721)
1. Indications for Use (intended use) The MinXray HFP24 and HFP40 is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. These units are specifically designed for podiatric and extremity applications.
1. Description of the Device: MinXray HFP24 and HFP40 are x-ray units which operate from 120 V 50-60~ AC. They utilize a newly designed high frequency inverter designed to be mounted on a stand. The usual safety precautions regarding the use of x-rays must be observed by the operator.
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 device.

6. Substantial Equivalence Chart, MinXray HFP24 and HFP40

Characteristic	MinXray P200 R24/40(pre amendments)	MinXray HF100H+(K052721)	Minxray HFP24/40(Modified Device)
Intended Use :	Intended for use by aqualified/trained physicianor technician on both adultand pediatric subjects fortaking diagnostic x-rays.	SAME	SAME
Physical characteristics
Size/weight	171 x 330.2 x 175.5 mm(P200R24) 13kgs216 x 330.2 x 190.5 mm(P200R40) 15kgs	406 x 222 x 241 mm18.6kgs	230 x 195 x 380 mm(HFP24) 9.3kgs230 x 195 x 390 mm(HFP40) 12.5kgs
Energy Source	110-130V 60Hz AC1.0kVA	100-140V 50-60 Hz 3.0kVA	100-140V 50-60Hz 1.5kVA
MountingMethod	P200R24 Stationary systemP200R40 Mobile system	Unit is usually mounted to aMinXray XGS MKIIIPortable Stand	SAME as P200R24/40
Characteristic	MinXray P200 R24/40(pre amendments)	MinXray HF100H+(K052721)	Minxray HFP24/40(Modified Device)
	Technical characteristics
User Interface	Knob for kVp selectionsand exposure timeselections	Up-Down pushbuttons forkVp selections andexposure time selectionswith LED indictors andmAs indicators	SAME as HF100H+
Exposure switch	Single-stage deadmantype	Dual-stage,deadman type	SAME as HF100H+
Controls	Analog	Software based, 2 CPUs.	SAME as HF100H+
Construction	Monobloc generator,Medical high tensiontransformer system	Monobloc HFgenerator, Medical fullbridge inverter system	SAME as HF100H+
High VoltageEnergy Source	conventional transformer	High frequency (60kHz)inverter	SAME as HF100H+
Line Voltageadjustment	manual	Automatic, dynamic	SAME as HF100H+
Exposure times	0.08-2.0 sec(16 Steps)	0.03-0.2 sec(in 0.01 sec.Steps)0.2-0.4 sec(in 0.02 sec.Steps)0.4-1.0 sec(in 0.05 sec.Steps)1.0-4.0 sec(in 0.1 sec.Steps)	0.03-0.2 sec(in 0.01 sec.Steps)0.2-0.4 sec(in 0.02 sec.Steps)0.4-1.0 sec(in 0.05 sec.Steps)1.0-2.0 sec(in 0.1 sec.Steps)
Tube potential(KV)	63kV constant	40 - 100kV 2kVstep	50 - 70kV 2kVstep
kV steps	constant	31(2kV-step)	11(2kV-step)
Tube current(mA)	12mA	30mA(40-60kV)25mA(62-80kV)20mA(82-100kV)	10 mA
X-ray tube	Toshiba D-102	Toshiba D-124S	SNMIF XDT-S70
Anode heatStorage	20,000 HU	20,000 HU	20,000 HU
Focal SpotSize	1.0 mm	1.2 mm	0.8 mm
mAs	0.96-24mAs	0.6-120mAs	0.3-20mAs
Total filtration	P200R242.7 mm AL equivalentP200R403.2 mm AL equivalent	3.2 mm AL equivalent	SAME as P200
Collimator	P200R24Advantech R72P200R40MIKASA R-200H	Advantech R72Continuously adjustablelight beam type withcentral x-ray indicator	SAME as P200
Source to SkinDistance (SSD)	P200R24: 24 inchesP200R40: 40 inches	300 mm	SAME as P200

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7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of MinXray that the MinXray HFP24 and HFP40 High Frequency Diagnostic X-Ray Units are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MinXray, Inc. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K060566

5 2006

APR

Trade/Device Name: MinXray HFP24 and HFP40 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: February 25, 2006 Received: March 7, 2006

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 (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 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 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 one of the following numbers, based on the regulation prumber at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely vours.

7 Nancy C. Higdon

Naney 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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Indications for Use

510(k) Number (if known):

Ko60566

Device Name: MinXray HFP24 and HFP40

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Nancy C hogdon
(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices 5100k) Number

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.