The AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs (182 kg).

Device Description

The Mobius Airo is a Mobile Intraoperative Computed Tomography (CT) System. The Airo has a large-diameter bore designed for intraoperative use; the main features include a 107cm bore, with a 51.2cm field of view (FOV). The Airo has two modes of operation; transport and scanning (both helical and axial in patient mode). In its scanning mode, translation along the longitudinal axis is achieved through movement of the gantry along the length of the system base (rather than through movement of the patient support table).

The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array (that includes detector modules that consist of a layered Cadmium Tungstate (CdWO4) and Photodiode Array). Each detector module includes a 32 x 16 pixel scintillator array that produces scintillation events responsive to irradiation by X-rays. The Airo also includes a collimator, control computer, communications link, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and a DC brushless servo drive system (translation).

The power system consists of batteries which provide system power while unplugged from a standard power outlet (e.g., during transport of the System and also during scanning). The base has retractable rotating caster wheels and electrical drive system can be easily moved to different locations.

In addition, the System has the necessary safety features such as emergency stop button, X-ray indicators, interlocks, patient alignment lasers, and 110 percent X-ray timer. The software helical and axial reconstruction algorithms are both based on an exact filtered-back projection.

AI/ML Overview

The provided text describes the Mobius Imaging AIRO® Computed Tomography (CT) X-ray System and its substantial equivalence to a predicate device (Airo Mobile CT System – K131431). However, the document does not contain explicit acceptance criteria and a detailed study proving the device meets those criteria in a format that directly addresses all the requested information categories.

Instead, it focuses on demonstrating substantial equivalence through a comparison of technological characteristics and a summary of non-clinical tests.

Here's an attempt to extract and infer the requested information based on the provided text, while also noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific performance metrics and their corresponding reported device performance values. The closest information is the comparison table of technological characteristics to the predicate device, implying that equivalence to the predicate's performance serves as an acceptance criterion for these features.

Feature	Acceptance Criteria (Implied: Match Predicate)	Reported Device Performance (AIRO CT System - subject of this 510(k))
Technological Characteristics (Main Features)
Aperture (cm)	107	107
Image Field of View (cm)	51.2	51.2
Detector Material	Solid State CdWO4	Solid State CdWO4
Detector Configuration	32 x 2.0mm	32 x 2.0mm
Spatial Resolution for Sharpest Clinical Algorithm (lp/cm at 2%)	6.9	6.9
X-ray Tube Type	Rotating Anode	Rotating Anode
Heat Storage (MHU)	1.7	1.7
X-ray Tube Cooling	Liquid (50% Water, 50% Propylene Glycol)	Liquid (50% Water, 50% Propylene Glycol)
X-ray Fan Angle (deg)	45	45
Max X-ray Power (kW)	32	32
Rotating Speed (seconds)	2	2
Gantry Weight (kg)	1068	1068
Transfer of electric current	Data Dock system	Data Dock system
Mechanism to translate Gantry	Rails on Mobile Base System	Rails on Mobile Base System
Wireless	No	No
Mobile	Yes (motorized)	Yes (motorized)
Battery System	Yes (LiFePO4)	Yes (LiFePO4)
Wheels (casters)	Wheels (3 inch)	Wheels (3 inch)
Input Voltage	1 phase 100-240 volt	1 phase 100-240 volt
Input Power Max	1.5 kW	1.5 kW
PACS/DICOM 3.0	Yes	Yes
2D Scout	Yes	Yes
Bolus tracking	No	No
Dynamic Scan	No	No
Axial/Helical	Helical	Axial and Helical
Tube Modulation Feature	No	Yes (Helical only)
MPR	Yes	Yes
3D Viewing	No	No
Patient Table Option	Yes (Trumpf table column integrated with base)	Yes (Trumpf table column integrated with base)
Scan Motion	Scanner Moves	Scanner Moves
Laser Alignment	Patient Alignment	Patient Alignment
X-ray warning lights	Yes	Yes
110% X-ray Timer	Yes	Yes
Emergency Stop	Yes	Yes
Internal Lead Shield	Yes	Yes
External Lead Curtains	No	No
Operator X-ray On Switch	Yes	Yes
Quality Test Phantom	Yes	Yes
Login ID/password	Yes	Yes
Administrator Privileges	Yes	Yes
Dose Display	Yes	Yes
Dose Report/Audit	Yes	Yes
Protocol Override Protection	Yes	Yes
Protocols by weight/body region	Yes	Yes
QA Test Report	Yes	Yes
Quality Test Phantom	Yes - Included	Yes - Included
Operating System	Microsoft Windows	Microsoft Windows
Biocompatibility	N/A	N/A
EM Emissions	ETL Testing	ETL Testing
Sterility	N/A	N/A
Chemical Safety	N/A	N/A
Thermal Safety	ETL Testing	ETL Testing
IEC EN 60601 Electrical Safety Testing	ETL Testing	ETL Testing
IEC EN 60601 Mechanical Safety Testing	ETL Testing	ETL Testing
Where Used	Mobile or Fixed Radiology, ICU, ED, Surgical, Clinic, Office	Mobile or Fixed Radiology, ICU, ED, Surgical, Clinic, Office
Anatomical Site	That which can be imaged in 51.2cm FOV and 107cm Aperture	That which can be imaged in 51.2cm FOV and 107cm Aperture
New Features/Software Changes	Acceptance Criteria (Implied: Safe & Effective)	Demonstrated Performance (Implied: Passed Testing)
Sequential Axial Scanning Mode	Safe and effective performance	Tested and found safe/effective
Tube Current Modulation Feature (Helical only)	Safe and effective performance	Tested and found safe/effective
Metal Artifact Reduction Algorithm (NMAR)	Safe and effective performance	Tested and found safe/effective

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

The document lists "Image Phantom Data," "Historical Clinical Image Data Reconstruction Comparison," and "Offline Reconstruction Clinical Image Comparison (for NMAR feature)" as non-clinical tests. However, it does not specify the sample size for these test sets, nor the country of origin or retrospective/prospective nature of any clinical image data used.

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

The document mentions "Independent Review Analysis for Diagnostic Image Quality" but does not provide details on the number of experts, their qualifications, or how they established ground truth.

4. Adjudication method for the test set

The document does not describe any adjudication method used for establishing ground truth for the test set.

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 document describes a CT X-ray system, not an AI-assisted diagnostic tool that would typically involve human reader improvement. Therefore, no MRMC comparative effectiveness study was done in the context of human reader improvement with AI.

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

The document specifies "Image Quality Metrics," "Image Phantom Data," and "Historical Clinical Image Data Reconstruction Comparison" as tests. These tests assess the device's technical performance and image quality, which are indicative of standalone (algorithm only) performance. However, specific metrics and results are not provided. The phrase "Offline Reconstruction Clinical Image Comparison (for NMAR feature)" also suggests standalone evaluation of the algorithm.

7. The type of ground truth used

For objective metrics like spatial resolution, phantom data likely served as ground truth. For "Historical Clinical Image Data Reconstruction Comparison" and "Offline Reconstruction Clinical Image Comparison," the ground truth would likely be the original clinical images from the predicate device (K131431) or accepted diagnostic standards derived from them, to ensure the modified device's images are comparable. The document also mentions "Independent Review Analysis for Diagnostic Image Quality," which suggests expert review/consensus was involved in parts of the evaluation.

8. The sample size for the training set

This document primarily describes the substantial equivalence of a medical imaging device (CT scanner). While it mentions reconstruction algorithms and a Metal Artifact Reduction (MAR) algorithm, it does not provide information on a "training set" as would be typical for machine learning-based AI devices. The focus is on the device's hardware and software performance characteristics in comparison to a predicate.

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

As no training set is explicitly mentioned or detailed for an AI component in the conventional sense, this information is not applicable/provided. The ground truth relevant to the device's performance evaluation would be related to its imaging capabilities, not the training of a diagnostic AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element above them.

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

April 19, 2016

Mobius Imaging, LLC % Ms. Norma LeMay Regulatory Affairs Contractor 2 Shaker Road SHIRLEY MA 01464

Re: K160126

Trade/Device Name: AIRO® Computed Tomography (CT) X-ray System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 7, 2016 Received: March 8, 2016

Dear Ms. LeMay:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mechon D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160126

Device Name

AIRO® Computed Tomography (CT) X-ray System

Indications for Use (Describe)

Contraindications:

Airo is contraindicated as the principal means of guidance during invasive procedures when real-time imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the Mobius Imaging logo at the top, with the words "IMAGING Now You See" below it. The logo consists of an orange circle and the word "Mobius" in black letters. Below the logo is the text "510(k) Summary" in a large, bold font. The text is centered on the page.

This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.

1. Submitter:

Mobius Imaging, LLC 2 Shaker Road, Suite F100 Shirley, MA 01464 USA

Contact: Norma LeMay Regulatory Affairs Consultant Telephone: 978-391-9644 Email: nlemay@mobiusimaging.com

Date of Preparation: March 7, 2016

2. Device Name & Regulatory Classification:

Proprietary or Trade Name: AIRO® Computed Tomography (CT) X-ray System Classification Name: Computed Tomography X-ray System Product Code: 90 JAK Device Classification: Class II Regulation Number: 21 CFR 892.1750

3. Predicate Device(s):

The legally marketed device to which substantial equivalence is being claimed is as follows:

. Airo Mobile CT System – Premarket Notification K131431 (cleared on September 26, 2013, product code 90 JAK)

4. Device Description:

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5. Indications for Use:

The AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients weighing over 400 lbs (182 kg).

Contraindications:

AIRO is contraindicated as the principal means of guidance during invasive procedures when realtime imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.

6. Comparison of Technological Characteristics with the Predicate Device:

As detailed in Section 12 of this 510(k) Premarket Notification, the modified Airo CT System, for its intended use, is of comparable type in design, material, functionality, technology and is considered substantially equivalent to its baseline device Airo CT System (K131431, cleared on September 26, 2013) based on the following comparison.

Most importantly, the differences noted below and/or in the comparison table raise no new issues of safety or effectiveness based on all testing performed and presented in this 510(k) submission:

Sequential Axial Scanning Mode
Tube Current Modulation Feature (Helical only)
. Metal Artifact Reduction Algorithm

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Model Name	Airo® CT System	Airo® CT System
	(subject of this 510(k)	(K131431)
Technological Characteristics
Indications for Use	The AIRO is intended to beused for X-ray computedtomography applications foranatomy that can be imaged inthe 107cm aperture excludingpediatric patients and patientsweighing over 400 lbs (182 kg).Airo is contraindicated as theprincipal means of guidanceduring invasive procedureswhen real-time imaging isneeded (e.g., CT Fluoroscopy).In addition, the physician mustverify navigation accuracyusing an adequate verificationmethod when used withNavigation Systems duringsurgical procedures.	The AIRO is intended to be usedfor non-contrast X-ray computedtomography applications foranatomy that can be imaged inthe 107cm aperture excludingpediatric patients and patientsweighing over 400 lbs (182 kg).Airo is contraindicated as theprincipal means of guidanceduring surgical procedures. Thephysician must verify navigationaccuracy using knownanatomical landmarks or anequivalent verification methodwhen used in surgicalprocedures.
Aperture (cm)	107	107
Image Field of View (cm)	51.2	51.2
Detector Material	Solid State CdWO4	Solid State CdWO4
Detector Configuration	32 x 2.0mm	32 x 2.0 mm
Spatial Resolution for SharpestClinical Algorithm (Ip/cm at 2%)	6.9	6.9
X-ray Tube Type	Rotating Anode	Rotating Anode
Heat Storage (MHU)	1.7	1.7
X-ray Tube Cooling	Liquid (50% Water, 50%Propylene Glycol)	Liquid (50% Water, 50%Propylene Glycol)
X-ray Fan Angle (deg)	45	45
Max X-ray Power (kW)	32	32
Rotating Speed (seconds)	2	2
Gantry Weight (kg)	1068	1068
Transfer of electric current	Data Dock system	Data Dock system
Model Name	Airo® CT System(subject of this 510(k)	Airo® CT System(K131431)
Technological Characteristics
Mechanism to translate Gantry	Rails on Mobile Base System	Rails on Mobile Base System
Wireless	No	No
Mobile	Yes (motorized)	Yes (motorized)
Battery System	Yes (LiFePO4)	Yes (LiFePO4)
Wheels (casters)	Wheels (3 inch)	Wheels (3 inch)
Input Voltage	1 phase 100-240 volt	1 phase 100-240 volt
Input Power Max	1.5 kW	1.5 kW
PACS/DICOM 3.0	Yes	Yes
2D Scout	Yes	Yes
Bolus tracking	No	No
Dynamic Scan	No	No
Axial/Helical	Axial and Helical	Helical
Tube Modulation Feature	Yes (Helical only)	No
MPR	Yes	Yes
3D Viewing	No	No
Patient Table Option	Yes (Trumpf table columnintegrated with base)	Yes (Trumpf table columnintegrated with base)
Scan Motion	Scanner Moves	Scanner Moves
Laser Alignment	Patient Alignment	Patient Alignment
X-ray warning lights	Yes	Yes
110% X-ray Timer	Yes	Yes
Emergency Stop	Yes	Yes
Internal Lead Shield	Yes	Yes
External Lead Curtains	No	No
Operator X-ray On Switch	Yes	Yes
Quality Test Phantom	Yes	Yes
Model Name	Airo® CT System(subject of this 510(k)	Airo® CT System(K131431)
Technological Characteristics
Login ID/password	Yes	Yes
Administrator Privileges	Yes	Yes
Dose Display	Yes	Yes
Dose Report/Audit	Yes	Yes
Protocol Override Protection	Yes	Yes
Protocols by weight/body region	Yes	Yes
QA Test Report	Yes	Yes
Quality Test Phantom	Yes - Included	Yes - Included
Operating System	Microsoft Windows	Microsoft Windows
Biocompatibility	N/A	N/A
EM Emissions	ETL Testing	ETL Testing
Sterility	N/A	N/A
Chemical Safety	N/A	N/A
Thermal Safety	ETL Testing	ETL Testing
IEC EN 60601 Electrical SafetyTesting	ETL Testing	ETL Testing
IEC EN 60601 Mechanical SafetyTesting	ETL Testing	ETL Testing
Where Used	Mobile or Fixed Radiology, ICU,ED, Surgical, Clinic, Office	Mobile or Fixed Radiology, ICU,ED, Surgical, Clinic, Office
Anatomical Site	That which can be imaged in51.2cm FOV and 107cmAperture	That which can be imaged in51.2cm FOV and 107cmAperture

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7. General Safety and Effectiveness Concerns:

ldentical to its baseline device, all components of the Airo CT System are subject to Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR Part 1020.30 and

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1020.33 are certified to meet those requirements. Initial and Annual Reports are filed with the Center for Devices and Radiological Health (CDRH) according to 21 CFR 1002.10, respectively.

To minimize electrical, mechanical and radiation hazards, Mobius adheres to recognized and established industry practices. Additionally, the Airo CT System was designed and tested to the following FDA recognized International harmonized and National standards:

IEC 60601-1 Issued: 2005/01/01 Ed:3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2 Issued: 2007/03/01 Ed:3 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-3 Issued: 2008/01/22 Ed:2 Medical Elec. Equipment - P. 1: General Req. for Safety 3. Collateral Standard: General Req. for Radiation Protection in Diagnostic X-Ray Equipment
IEC 62366 Issued: 2007/10 Ed:1, Medical devices – Application of usability engineering to medical devices
IEC 60601-2-44 Issued: 2009/02/25 Ed:3 Medical Electrical Equipment - Part 2-44: Particular Requirements for the basic safety and essential performance of X-ray Equipment for computed Tomography
. IEC 61223:2004 – Evaluation and routine testing in medical imaging departments - Part 3-5 Acceptance Tests – Imaging Performance of Computed Tomography X-ray equipment
IEC 60825-1:2007 – Safety of laser products
IEC 62133:2002: Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
UL 1642:1995: Standard for Lithium Batteries

Relating to concerns regarding unintentional radiation exposure, the Airo CT System has software safeguards such as: ID password/login, dose display/reporting, safety warning to prevent excessive dose, protocol protection and required quality assurance testing.

8. Determination of Substantial Equivalence:

Summary of Non-clinical tests:

The Airo CT System complies with the voluntary harmonized standards as detailed above and in Section 9 and 17 of this 510(k) Premarket Notification. In addition, the following quality assurance measures were applied to the development of the System and performance testing was performed to support substantial equivalence:

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Risk Analysis ●
Design Reviews
Design Verification Testing
SW Unit Integration Testing
System Software Verification & Validation Testing
Image Quality Metrics
Image Phantom Data
Historical Clinical Image Data Reconstruction Comparison
. Offline Reconstruction Clinical Image Comparison (for NMAR feature)
Independent Review Analysis for Diagnostic Image Quality
Radiation/Dose Testing
Electrical Safety, Mechanical & Stability Testing
. EMI/EMC Testing

The results of all testing performed indicate that the modified Airo CT System meets the acceptance criteria and is substantially equivalent to the currently cleared baseline device (Airo Mobile CT System - K131431).

9. Conclusion:

Based upon the above considerations, including all testing presented in this 510(k) submission, Mobius considers the modified Airo CT System to be as safe, as effective, and performance is substantially equivalent to its baseline device. We also believe that the proposed modifications to the Airo CT System raise no new issues of safety and/or efficacy and the device performs as intended.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.