DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 by MEDICATECH USA

The MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). (Digital Diagnostic X-Ray Systems) are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures 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 MAK 1500 employs a ceiling mounted tubehead/collimator combination made by Suinsa, the NOVA . The system has one digital panel inside the universal bucky in the chest stand. It employs the Suinsa NBS-2100 Universal Bucky. The MAK 2000 uses a conventional vertical column mount and adds a Suinsa NET-4100 table. The MAK 3000, like the MAK 1500, employs a ceiling mount and universal bucky in the chest stand and adds the Suinsa NET-4100 table with a digital panel mounted inside. The digital pancl is the same one we supplied in K080582, manufactured by DRTcch Corporation (K080064) and the software is also unchanged.

AI/ML Overview

The provided text is a 510(k) summary for a Digital Diagnostic X-Ray System (MAK 1500, MAK 2000, MAK 3000) and an FDA clearance letter. It describes the device, its intended use, and its equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics.

The 510(k) summary primarily focuses on:

Identification of the Device: Proprietary-Trade Name, Classification Name, Product Codes, Common/Usual Name.
Equivalent legally marketed devices: Stating it's a modified device based on K080582.
Indications for Use: What the device is intended to be used for (diagnostic radiographic exposures of various body parts in adults and pediatrics).
Description of the Devices: Details about the components (tubehead, bucky, digital panel, software).
Safety and Effectiveness, comparison to predicate device: A general statement that "The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices."

The FDA letter confirms the substantial equivalence determination but does not delve into specific performance data or acceptance criteria.

Therefore, based solely on the provided text, I cannot complete the requested tables and sections related to acceptance criteria, detailed study information, sample sizes, expert qualifications, or ground truth establishment. The document does not contain this level of detail regarding performance studies.

Here's what I can extract and state based on the provided text, noting the missing information:

Description of Device and General Regulatory Context:

Device Name: Model MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (Stationary).
Manufacturer: MedicaTech USA
510(k) Number: K082798
Indications for Use: Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures 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.
Predicate Device: K080582 (The current device represents a variation of the tubehead mounting method described in this 510(k)).

Missing Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The document states "The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices," but no specific performance metrics, acceptance criteria, or comparative data are listed.

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

Not provided in the document. No information on a specific "test set" for performance evaluation (e.g., number of images, patient demographics, country, retrospective/prospective nature) is available.

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

Not provided in the document. There is no mention of expert reviews or ground truth establishment for a test set.

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

Not provided in the document. No adjudication method is mentioned as there is no described test set evaluation.

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/Not provided. This is a diagnostic imaging system (X-ray machine), not an AI-assisted diagnostic software. Therefore, an MRMC study comparing human readers with/without AI assistance would not be relevant to this specific device's clearance. The document does not describe any AI component.

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

Not applicable/Not provided. As stated above, this is an X-ray system, not an algorithm, so a standalone algorithm performance evaluation is not relevant or described.

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

Not provided in the document. No ground truth type is mentioned as no specific performance study is detailed.

8. The sample size for the training set:

Not applicable/Not provided. As this is a hardware X-ray system and not an AI/machine learning algorithm, there is no "training set" in the conventional sense.

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

Not applicable/Not provided. (See point 8).

Conclusion:

The provided 510(k) summary and FDA letter pertain to the substantial equivalence of a general-purpose digital X-ray system. The documentation focuses on hardware specifications, intended use, and comparison to a predicate device based on bench and standards testing for safety and effectiveness. It does not provide the detailed performance study information, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found for software algorithms or devices requiring specific diagnostic accuracy claims. For an X-ray system, "safety and effectiveness" often refers to image quality (resolution, contrast, dose), electrical safety, mechanical safety, and compliance with performance standards, rather than diagnostic accuracy metrics of a distinct algorithm.

Summary

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510(k) Summary

K082798

MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 September 8, 2008 Contact: Ashraf Stefan , CEO

OCT 2 8 2008

1. Identification of the Device: Proprietary-Trade Name: MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). Classification Name: Stationary X-ray system. Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
1. Equivalent legally marketed devices: This notification is for a MODIFIED device. The device represents a variation of the tubehead mounting method described in our 510(k) number K080582.
1. Indications for Use (intended use) These digital X-Ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures 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.
1. Description of the Devices:

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

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Medicatech USA % Mr. Daniel Kamm Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015

AUG - 9 2013

Re: K082798

Trade/Device Name: Model MAK 1500, MAK2000, MAK 3000 Digital Diagnostic X-Ray System (Stationary). (Digital Diagnostic X-Ray System) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system

Regulatory Class: II Product Code: KPR and MOB Dated: September 19. 2008 Received: October 2, 2008

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of October 28, 2008.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. 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 Parts 801 and 809): medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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	Indications for Use
510(k) Number (if known):	K082798

Device Name: Model MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). (Digital Diagnostic X-Ray Systems)

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)

Heidi Heitman

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Division Sign-Off Division of Reproductive. Abdominal. and Radiological Devi

510(k) Number K082778

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.