The MinXray HF100H+™ - is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

Device Description

MinXray HF100H+1M is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of xrays must be observed by the operator.

AI/ML Overview

Here's an analysis of the provided text regarding the MinXray HF100H+™ High Frequency Diagnostic X-Ray Unit, structured to address your specific questions about acceptance criteria and study details:

The provided documentation details a 510(k) premarket notification for an X-ray unit, which is a hardware device. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to existing predicate devices, rather than establishing clinical performance metrics in the way AI/software devices typically would for diagnostic accuracy. Therefore, many of your requested points regarding AI device studies (like expert consensus, MRMC studies, training sets, etc.) are not applicable to this submission.

I will answer the questions based on the information available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this submission are primarily focused on demonstrating that the new device, MinXray HF100H+™, performs as safely and effectively as its predicate devices and meets relevant technical standards. The "reported device performance" is a comparison of its technical specifications to those predicates.

Characteristic / Acceptance Criteria	MinXray HF100H+™ (Modified device) Performance	Assessment
Intended Use: "Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays." (Same as Predicates)	SAME as HF100H (Predicate K973712)	Meets - Consistent with predicate device.
Size/weight: (Compared to HF100H)	SAME as HF100H	Meets - Consistent with predicate device.
Energy Source: (Compared to HF100H)	SAME as HF100H	Meets - Consistent with predicate device.
Mounting method: (Compared to HF100H)	SAME as HF100H	Meets - Consistent with predicate device.
User Interface: (Compared to HF120/60H)	SAME as HF120/60H (Predicate K040046)	Meets - Consistent with predicate device.
Exposure switch: (Compared to HF100H)	SAME as HF100H	Meets - Consistent with predicate device.
Controls: (Compared to HF120/60H)	SAME as HF120/60H	Meets - Consistent with predicate device (software-based, 2 CPUs).
Construction: (Compared to HF100H)	SAME as HF100H	Meets - Consistent with predicate device.
High Voltage Energy Source: (Compared to HF100H)	SAME as HF100H (High frequency (60kHz) inverter)	Meets - Consistent with predicate device.
Line Voltage adjustment: (Compared to HF100H)	SAME as HF100H	Meets - Consistent with predicate device.
Exposure times: (Specific ranges/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)	Different from HF100H (0.08 - 4.00 sec), but similar in range and steps to HF120/60H (0.01-5.0 sec range) with some specific changes (e.g., max 4.0 sec vs 5.0 sec). The document implies this is acceptable relative to the predicates.
Tube potential (kV): (Compared to HF100H)	SAME as HF100H (40 - 100kV 2kVstep)	Meets - Consistent with predicate device.
kV steps: (Compared to HF100H)	31 (2kV-step)	Meets - Consistent with HF100H, different from HF120/60H (41 steps), but within an acceptable performance range for a diagnostic X-ray.
Tube current (mA): (Specific ranges)	30mA (40-60kV)25mA (62-80kV)20mA (82-100kV)	Different from both HF100H (20mA constant) and HF120/60H (variable mA). This is a technical difference, but accepted as safe and effective.
mA steps: (Compared to HF100H)	SAME as HF100H (Constant)	Meets - Consistent with predicate device.
X-ray tube: (Compared to HF100H)	SAME as HF100H (Toshiba D-124S)	Meets - Consistent with predicate device.
Anode heat Storage: (Compared to HF100H)	SAME as HF100H (20,000HU)	Meets - Consistent with predicate device.
Focal Spot Size: (Compared to HF100H)	SAME as HF100H (1.2 mm)	Meets - Consistent with predicate device.
mAs: (Specific ranges)	0.6-120mAs	Different from HF100H (1.6-80mAs) and HF120/60H (0.6-202mAs). This is a technical difference, but accepted as safe and effective.
Total filtration: (Compared to HF120/60H)	SAME as HF120/60H (3.2mm AL equivalent)	Meets - Consistent with predicate device.
Collimator: (Compared to HF100H)	SAME as HF100H	Meets - Consistent with predicate device.
Source to Skin Distance (SSD): (Compared to HF100H)	SAME as HF100H (300 mm)	Meets - Consistent with predicate device.
Performance Standard: (21CFR 1020.30)	SAME as HF100H	Meets - Complies with required standard.
Electrical safety: (UL2601, IEC60601-1)	SAME as HF100/60H (and UL listed)	Meets - Complies with required safety standards.

Study Description:
The study proving the device meets the acceptance criteria is a "bench and user testing" comparison to predicate devices, focusing on demonstrating substantial equivalence in safety and effectiveness. The conclusion states "the results of bench and user testing indicates that the new device is as safe and effective as the predicate device."

2. Sample size used for the test set and the data provenance

Sample size for the test set: Not explicitly stated in the document. "Bench and user testing" is mentioned, implying internal testing and perhaps observation of performance. There is no information regarding a specific dataset of X-ray images or clinical cases used for testing.
Data provenance: Not applicable in the context of an X-ray hardware device. The "testing" refers to the device itself, not patient data. "Bench testing" implies laboratory conditions, and "user testing" would likely involve qualified personnel operating the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this submission. This is a hardware device focusing on general X-ray production, not a diagnostic AI algorithm that interprets images or requires expert ground truth for image interpretation. The "testing" here assesses technical performance and adherence to safety and function standards.

4. Adjudication method for the test set

This question is not applicable to this submission. Adjudication methods are typically used for assessing disagreements in image interpretation or clinical outcomes, which is not the subject of this hardware device submission.

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

This question is not applicable to this submission. An MRMC study is relevant for AI-powered diagnostic tools designed to assist human readers. This device is a general-purpose diagnostic X-ray unit.

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

This question is not applicable to this submission. This is a standalone hardware X-ray machine. There is no algorithm for image interpretation described or evaluated.

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

This question is not applicable to this submission in the context of diagnostic accuracy. "Ground truth" for this device would refer to its technical specifications matching design parameters and fulfilling performance standards (e.g., producing X-rays at specified kV and mA settings, meeting safety requirements). The "bench testing" would verify these physical and electrical performance points.

8. The sample size for the training set

This question is not applicable to this submission. This device is an X-ray hardware unit, not an AI model that requires a training set.

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

This question is not applicable to this submission, as there is no training set for an AI model.

Summary

{0}------------------------------------------------

K052721

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

September 24, 2005 510(k) Summary

1. Identification of the Device: Proprietary-Trade Name: MinXray HF100H+™ High Frequency Diagnostic X-Ray Unit" Classification Name: Mobile X-ray system, Product Code 90 1ZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit.

1. Equivalent legally marketed devices This product is similar in function to the MinXray HF100H K973712 and MinXray HF120/60H PowerPlus™ K040046
1. Indications for Use (intended use) The MinXray HF100H+™ is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
1. Description of the Device: MinXray HF100H+1M is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of xrays 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.

Characteristic	Minxray HF100H(K973712)	MinXray HF120/60H(K040046)	MinXray HF100H+(Modified device)
Intended Use :	Intended for use by aqualified/trained physicianor technician on both adultand pediatric subjects fortalking diagnostic x-rays.	SAME as HF100H	SAME as HF100H
Size/weight	406 x 222 x 241 mm18.6kgs	413 x 224 x 29.2 mm17.51 kgs	SAME as HF100H
Energy Source	100-140V 50-60 HzAC3.0kVA	100-260V 50-60HzAC3.5KVA	SAME as HF100H
Characteristic	Minxray HF100H(K973712)	MinXray HF120/60H(K040046)	MinXray HF100H+(Modified device
Mountingmethod	Unit is usually mounted toa MinXray XGS MKIIIPortable Stand	SAME as HF100H	SAME as HF100H
User Interface	Up-Down pushbuttons forkVp selections andexposure time selectionswith LED indictors	Up-Down pushbuttons forkVp selections andexposure time selectionswith LED indictors andmAs indicators	SAME as HF120/60H
Exposure switch	Dual-stage,deadman type	SAME as HF100H	SAME as HF100H
Controls	Analog/digital,no software	Software based, 2 CPUs.	SAME as HF120/60H
Construction	Monobloc HF agenerator, Medical fullbridge inverter system	SAME as HF100H	SAME as HF100H
High VoltageEnergy Source	High frequency (60kHz)inverter	High frequency (40kHz)inverter	SAME as HF100H
Line Voltageadjustment	Automatic, dynamic	SAME as HF100H	SAME as HF100H
Exposure times	(199)(in 0.01 sec. Steps)0.08 - 4.00 sec	0.01-0.2 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)1.0-5.0 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)1.0-4.0 sec(in 0.1 sec. Steps)
Tube potential(KV)	40 - 100kV 2kVstep	40 - 120kV 2kVstep	SAME as HF100H
kV steps	31(2kV-step)	41(2kV-step)	31(2kV-step)
Tube current(mA)	20mA	60/42mA(40-50kV)50/35mA(52-60kV)45/31.5mA(62-70kV)38/26.6mA(72-80kV)33/23.1 mA(82-90kV)30/21 mA(92-100kV)20/14mA(102-120kV)	30mA(40-60kV)25mA(62-80kV)20mA(82-100kV)
mA steps	Constant	0.01-0.1 sec. (Hi mA)0.11-5.0 sec. (Low mA)	SAME as HF100H
X-ray tube	Toshiba D-124S	SXR-130 Focus x 1.2	SAME as HF100H
Anode heatStorage	20,000HU	65,000HU	SAME as HF100H
Focal SpotSize	1.2 mm	SAME as HF100H	SAME as HF100H
mAs	1.6-80mAs	0.6-202mAs	0.6-120mAs
Total filtration	4.2mm AL equivalent	3.2mm AL equivalent	SAME as HF120/60H
Characteristic	Minxray HF100H(K973712)	MinXray HF120/60H(K040046)	MinXray HF100H+(Modified device)
Collimator	Advantech R72Continuously adjustablelight beam type withcentral x-ray indicator	SAME as HF100H	SAME as HF100H
Source to SkinDistance (SSD)	300 mm	SAME as HF100H	SAME as HF100H
PerformanceStandard	21CFR 1020.30	SAME as HF100H	SAME as HF100H
Electrical safety	UL2601, IEC60601-1	SAME Plus UL listed	SAME as HF100/60H

1. Substantial Equivalence Chart, MinXray MinXray HF100H+TM

{1}------------------------------------------------

{2}------------------------------------------------

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of MinXray that the MinXray HF100H+™ 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. Safety is further assured by Underwriters Laboratories testing and listing.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized emblem that resembles an eagle or bird with three curved lines representing its wings or feathers. The emblem is black, and the text is also in a dark color, likely black or a dark shade of blue.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2005

MinXray, Inc. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K052721

Trade/Device Name: MinXray HF100H+™ Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: IZL Dated: September 24, 2005 Received: September 30, 2005

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 the enorologics to teenay man date of the Medical Device Amendments, or to devices that have been rear 20, 1710, the closedance 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 do not require approval controls provisions of the Act. The general controls provisions of the Act include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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 FI>A 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.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manteang your antial equivalence of your device to a legally premarket nothication. The I DA miding or bacements of the may of the 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 th you desire specific advice for your de results.
contact the Office of Compliance at one of the following numbers, based on the regulation number 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 Also, please note the regulation enation on your responsibilities under the Act from the 807.97). Tou may obtain other general more.
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/industry/support/index.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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

K052721

Device Name:

Indications For Use:

The MinXray HF100H+™ - is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

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)

David A. Seppam

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ..

Page 1 of 1

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.