The Mobilett Mira is a radiographic system designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

Device Description

The Mobilett Mira is a mobile X-ray system with a solid state detector. The system is designed to provide X-ray imaging for healthcare professionals. Cable less operation and motor-driven movements are supported with build in rechargeable batteries. The mobile generator is positioned at bedside and the X-ray system is directed to the anatomical area to be imaged. The image detector is placed perpendicular to the central beam behind the anatomical area of interest. The system features a collimator with a light field that mimics the x-ray field to limit the field of exposure to the area to be imaged. Exposure may be released via remote control. The image data acquired by the detector are sent wireless to the mobile unit.

The Mobilett Mira is a modification of the Mobilett XP originally cleared under Premarket Notification K033238 on 11/14/2003. The modification consists of a rotatable suspension arm, a solid state image detector, digital image acquisition system and a 35KW generator. This modified Mobilett XP will be marketed under the trade name Mobilett Mira. The modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study proving device performance:

Unfortunately, the provided text for the Siemens Mobilett Mira 510(k) submission does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than presenting a detailed performance study with acceptance criteria.

Therefore, many of your requested items cannot be directly extracted from this document. However, I can infer some general aspects based on the nature of a 510(k) submission for an X-ray system.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance (Based on available information)

Since a formal performance study with explicit acceptance criteria is not detailed, the "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating that the modified device (Mobilett Mira) is as safe and effective as the predicate device (Mobilett XP / XP hybrid) and other similar cleared components (Ysio solid-state detector).

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from 510(k) context)	Reported Device Performance (Inferred from 510(k) claims)
Safety: Device operates without undue electrical, mechanical, and radiation hazards.	* "Several safety features including visual and audible warnings are incorporated into the system design."
	* "Mobilett Mira is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed."
	* "Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing."
Effectiveness: Device performs its intended functions for X-ray imaging, providing images of diagnostic quality.	* "Designed to provide X-ray imaging for healthcare professionals."
	* "The solid state imaging detector replaces the conventional cassette with film/screen combination." (Implies equivalent or improved imaging capability)
Intended Use: Device maintains the same intended use as the predicate device.	* "The Mobilett Mira is intended for the same indications for use as the predicate Mobilett XP / XP hybrid."
Technological Characteristics: Modifications (rotatable suspension arm, solid-state detector, digital acquisition, 35KW generator) do not negatively impact safety or effectiveness and are either cleared in predicate devices or minor modifications to existing components.	* "These modifications are 510(k) cleared in the mentioned predicate devices."
	* "Several of the components used in the Mobilett Mira are either commercially available with current Siemens systems or include minor modifications to existing components."
Substantial Equivalence: Device is equivalent to predicate devices regarding indications for use, fundamental scientific technology, and performance.	* "The modification does not affect the intended use of the device nor does it alter its fundamental scientific technology."
	* "It is Siemens opinion, that the Mobilett Mira is substantially equivalent to the Mobilett XP."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. A 510(k) for a hardware modification like this typically relies on engineering testing, compliance with standards, and comparison to existing cleared devices rather than a clinical "test set" of patient data in the way an AI algorithm might. The document doesn't mention any specific patient data test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Since no specific patient data test set is described, there's no mention of experts establishing ground truth for such a set. Engineering and safety testing would involve qualified engineers and technicians.

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

Not applicable / Not provided. There is no described test set of patient data requiring adjudication.

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, a MRMC study was not done, and is not applicable. This device is a mobile X-ray system, not an AI-powered diagnostic tool. The submission is for a hardware modification, not a software algorithm that assists human readers.

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

Not applicable. This is a hardware device, not an algorithm.

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

Not applicable in the context of patient data. For hardware modifications, "ground truth" would relate to engineering specifications, performance measurements against established standards (e.g., radiation output, image quality metrics like spatial resolution, contrast-to-noise ratio), and compliance with safety regulations. These would be assessed through bench testing and verification/validation activities, not typically through clinical "ground truth" patient data in a 510(k) for such a device.

8. The sample size for the training set

Not applicable. This device is hardware; it does not involve a training set for an AI algorithm.

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

Not applicable. This device is hardware; it does not involve a training set for an AI algorithm.

Summary

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Special 510(k) Submission: Mobilett Mira

510(k) Summary: Mobilett Mira

SEP 1 9 2011

Company: Siemens Medical Systems. Inc. 1 Valley Stream Parkway Malvern, PA 19355

111912

Date Prepared: June 30, 2011

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

General Information: 1.

lmporter / Distributor: Siemens Medical Solutions, Inc.

51 Valley Stream Parkway, E-50 Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

Siemens S.A. Parque Empresarial La Carpetana, Avenida Leonardo da Vinci, 15 E-28906 Getafe (Madrid), Spain Headquarters: Siemens AG Wittelsbacherplatz 2 D-80333 Munich 2, Germany Establishment Registration Number: 1000342169

2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway G-01 Malvern, PA 19355 Phone: (610) 448 -3536 Fax: (610) 448-1787 Email: patricia.d.jones@siemens.com

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K111912
Page 2 of 3

SIEMEN

Special 510(k) Submission: Mobilett Mira

1. Device Name and Classification: Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
  Mobilett Mira Mobile X-ray System Radiology 21 CFR §892.1720 Class II IZL

4. Device Description:

5. Intended Use:

6. Substantial Equivalence:

The Mobilett Mira is substantially equivalent to the following devices:

Predicate DeviceName andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Mobilett XPMobilett XP hybrid	K033238	11/14/2003	• Indications for use• X-ray Generator• X-ray tube
Ysio	K081722	08/22/2008	• Solid State detector• Imaging system

Siemens Medical Systems, Inc.

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KII 912

SIEMENS

7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The modified Mobilett XP will be marketed under the trade name Mobilett Mira. The modifications consist of a rotatable suspension arm, a solid state image detector, digital image acquisition system and a 35KW generator. These modifications are 510(k)cleared in the mentioned predicate devices. Several of the components used in the Mobilett Mira are either commercially available with current Siemens systems or include minor modifications to existing components.

8. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Mobilett Mira is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

9. Conclusion as to Substantial Equivalence:

The Mobilett Mira is intended for the same indications for use as the predicate Mobilett XP / XP hybrid. The solid state imaging detector replaces the conventional cassette with film/screen combination. The portfolio of accessories is the same as with the predicate Mobilett XP. It is Siemens opinion, that the Mobilett Mira is substantially equivalent to the Mobilett XP.

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Image /page/3/Picture/0 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Patricia D. Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355

Re: K111912

SEP 1 9 2011

Trade/Device Name: Mobilett Mira Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: August 29, 2011 Received: August 30, 2011

Dear Ms. Jones:

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 (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 (OS) regulation (21 CFR, Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket noutication. 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/ReportalProblem/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,

Mary Patel

Mary S. Pastel, Sc.D. 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 Form

510(k) Number (if known): _ K | | 19 | 2 __

Device Name: Mobilett Mira

Indications for Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Jordant D. O'Hern

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111912

Page 1 of

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.