(113 days)
The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
The O-arm® O2 Imaging System is compatible with certain image guided surgery systems.
The O-arm® O2 Imaging System is a mobile x-ray system that provides 3D imaging as well as 2D fluoroscopic imaging. It was originally cleared for market in 2005 via K050996. Additional submissions were made in 2006 (K060344) and 2009 (K092564). The device is classified under primary product code OWB (secondary OXO, JAA) , ref 21 CFR 892.1650.
O-arm® O2 Imaging System, also referred to as “O-arm® O2”, adds an extended field of view imaging mode that offers twice the lateral field of view as the prior design to provide clinicians further visualization options in larger anatomic regions and anatomical structures. It accomplishes this task with essentially the same hardware design as described within.
The system consists of two parts: the O-arm® Image Acquisition System (IAS), comprising of a x-ray generator, amorphous silicon flat panel x-ray detector and the x-ray control user interface and the Mobile View Station (MVS), comprising of the image processors, a user interface for image and patient handling and viewing monitor.
The O-arm® O2 Imaging System consists of two main assemblies that are used together during fluoroscopic imaging:
• The Mobile View Station (MVS)
• The Image Acquisition System (IAS)
The two units are interconnected by a single cable that provides power and signal data. The O-arm® IAS has an internal battery pack that provides power for motorized transportation and gantry positioning. In addition the battery pack is used to power the X-ray tank. The MVS has an internal UPS to support its function when mains power is disconnected.
The O-arm® operates off standard line voltage within the following voltages:
• VAC 100, 120 or 240
• Frequency 60Hz; 50Hz
• Power Requirements 1440 VA
The provided text describes the O-arm® O2 Imaging System and its substantial equivalence to a predicate device, the O-arm® 1000. The information given does not detail specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) that would typically be presented for an AI/ML device, nor does it describe a study specifically designed to prove the device meets such criteria in the context of an AI/ML product.
Instead, the document details performance testing related to electrical safety, electromagnetic compatibility, radiation protection, and software/hardware verification, which are standard for medical imaging devices. It also mentions an "Image Quality Assessment" and a "Cadaver Image Pair Study" for comparison with the predicate device, but without specific acceptance criteria or detailed results of those studies in terms of quantitative performance metrics.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not discernible from the provided text, as the submission appears to focus on demonstrating substantial equivalence to a predicate device through engineering and safety testing rather than a clinical performance study with specific AI-related metrics.
Here is the information that can be extracted or reasonably inferred from the provided text, formatted as requested where possible:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are largely related to compliance with electrical, safety, radiological, and software/hardware engineering standards, and demonstrating image quality comparable to the predicate device. Specific quantitative performance metrics with defined acceptance thresholds (e.g., for diagnostic accuracy, sensitivity, specificity) are not explicitly stated in the provided document. The device performance is generally reported as "will perform as intended" or "meets all prescribed design inputs" through compliance testing and comparative studies.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Compliant with AAMI/ANSI ES 60601-1:2012 |
| Electromagnetic Compatibility | Compliant with IEC 60601-1-2:2007 |
| Radiation Protection | Compliant with IEC 60601-1-3:2008, IEC 60601-2-28:2010, IEC 60601-2-43:2010 |
| Software Verification | Verification and Validation testing confirmed software perform as intended |
| Hardware Verification | Hardware requirements identified for the system perform as intended |
| Image Quality Assessment | Quantitative image quality assessment in comparison to the predicate O-arm® 1000 device was conducted. (Specific results/metrics not provided) |
| Dosimetry | Dosimetry measurements for various modes documented. (Specific results/metrics not provided) |
| Usability | Usability Testing conducted according to FDA guidance. Users conducted imaging functions under simulated use conditions. |
| Clinical Utility | O-arm® Cadaver Image Pair Study evaluated clinical utility compared to predicate O-arm® 1000 and reference Artis Zeego device. (Specific results/metrics not provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- The "O-arm® Cadaver Image Pair Study" is mentioned, which implies a test set of cadaver images. However, the specific sample size (number of cadavers or images) for this study is not provided.
- For other engineering and safety tests, the "test set" would refer to the device itself or components under various test conditions, not patient data.
- Data Provenance:
- The "O-arm® Cadaver Image Pair Study" used cadaver images. Further details on the origin (e.g., country) or whether they were retrospective/prospective are not provided.
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)
This information is not provided in the document. The text does not describe a process for establishing ground truth, especially not with expert readers, for the comparative image quality or clinical utility studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study, particularly in the context of human readers improving with AI assistance, is not described in the document. The "O-arm® Cadaver Image Pair Study" is a comparative study of the device's images against a predicate and reference, not a study of human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an imaging system (hardware and associated software for image acquisition and reconstruction), not a standalone AI algorithm for interpretation. Therefore, a "standalone" AI algorithm performance study as typically understood is not applicable in this context. The closest would be the "Image Quality Assessment," which directly evaluates the system's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for any of its comparative or image quality studies. For an "Image Quality Assessment," the ground truth might be based on physical phantoms with known properties or established image quality metrics. For the "Cadaver Image Pair Study," the ground truth for "clinical utility" would likely refer to the ability to visualize specific anatomical structures or metallic objects, but how this was objectively established is not detailed.
8. The sample size for the training set
The device described is an imaging system (hardware and software) that performs 2D fluoroscopic and 3D imaging and image reconstruction. It is not presented as a machine learning inference algorithm that would typically undergo a "training" phase with a large dataset. Therefore, a "training set sample size" is not applicable in the context of this device description.
9. How the ground truth for the training set was established
As the device is an imaging system and not explicitly described as an AI/ML inference algorithm, the concept of a "training set" and its "ground truth" establishment is not applicable from the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
Medtronic, Inc. Medtronic Navigation, Inc. (Littleton) % Mr. Rishi Sinha Prinicipal Regulatory Affairs Specialist 300 Foster Street LITTLETON MA 01460
Re: K151000
Trade/Device Name: O-arm® O2 Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO and JAA Dated: June 30, 2015 Received: July 2, 2015
Dear Mr. Sinha:
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.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting 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) NA K151000
Device Name O-arm® O2 Imaging System
Indications for Use (Describe)
The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
The O-arm® O2 Imaging System is compatible with certain image guided surgery systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter: | Medtronic Navigation, Inc. (Littleton)300 Foster StreetLittleton, MA 01460 |
|---|---|
| Contact Person: | Rishi Sinha (Primary)Principal Regulatory Affairs SpecialistPhone: (269) 903-4373Fax: (269) 353-5924E-mail: rishi.k.sinha@medtronic.comPaul Smolenski (Alternate)Senior Regulatory Affairs ManagerPhone: (978)698-6065Fax: (978)698-6090E-mail: paul.d.smolenski@medtronic.com |
| Date Summary Prepared: | June 30th, 2015 |
| Device Trade Name: | Medtronic O-arm® O2 Imaging System |
| Common Name: | Interventional Fluoroscopic X-ray System |
| Device Classification: | Class II |
| Product Code: | Primary: OWBSecondary: OXO, JAA |
| Classification Name: | 892.1650 - Image Intensified Fluoroscopic X-ray System, Mobile |
| Predicate Device: | K092564 - Medtronic O-arm® Imaging System |
| Device Description: | The O-arm® O2 Imaging System is a mobile x-ray system that provides3D imaging as well as 2D fluoroscopic imaging. It was originally clearedfor market in 2005 via K050996. Additional submissions were made in2006 (K060344) and 2009 (K092564). The device is classified underprimary product code OWB (secondary OXO, JAA) , ref 21 CFR892.1650.O-arm® O2 Imaging System, also referred to as “O-arm® O2”, adds anextended field of view imaging mode that offers twice the lateral field ofview as the prior design to provide clinicians further visualization optionsin larger anatomic regions and anatomical structures. It accomplishesthis task with essentially the same hardware design as described within.The system consists of two parts: the O-arm® Image Acquisition System(IAS), comprising of a x-ray generator, amorphous silicon flat panel x-raydetector and the x-ray control user interface and the Mobile View Station(MVS), comprising of the image processors, a user interface for imageand patient handling and viewing monitor.The O-arm® O2 Imaging System consists of two main assemblies thatare used together during fluoroscopic imaging: |
| • The Mobile View Station (MVS) | |
| The two units are interconnected by a single cable that provides powerand signal data. The O-arm® IAS has an internal battery pack thatprovides power for motorized transportation and gantry positioning. Inaddition the battery pack is used to power the X-ray tank. The MVS hasan internal UPS to support its function when mains power isdisconnected. | |
| The O-arm® operates off standard line voltage within the followingvoltages:• VAC 100, 120 or 240• Frequency 60Hz; 50Hz• Power Requirements 1440 VA | |
| Indications for Use: | The O-arm® O2 Imaging System is a mobile x-ray system designed for2D fluoroscopic and 3D imaging for adult and pediatric patients weighing60lbs or greater and having an abdominal thickness greater than 16cm,and is intended to be used where a physician benefits from 2D and 3Dinformation of anatomic structures and objects with high x-rayattenuation such as bony anatomy and metallic objects. |
| The O-arm® O2 Imaging System is compatible with certain image guidedsurgery systems. |
- The Image Acquisition System (IAS) •
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| Substantial Equivalence: | O-arm® O2 is substantially equivalent to the following device: | |
|---|---|---|
| · K092564 – O-arm® Imaging System |
| Subject Device | Predicate | |
|---|---|---|
| O-arm® O2 Imaging System | O-Arm® 1000 Imaging System(K092564) | |
| Classification | Class 2 | Class 2 |
| Product Code | OXO; 892.1650 | OXO; 892.1650 |
| Indications for Use | The O-arm® O2 Imaging System isa mobile x-ray system designed for2D fluoroscopic and 3D imaging andis intended to be used where aphysician benefits from 2D and 3Dinformation of anatomic structuresand objects with high x-rayattenuation such as bony anatomyand metallic objects.The O-arm® Imaging System iscompatible with certain ImageGuided Surgery Systems. | The O-arm® Imaging System is amobile x-ray system designed for2D fluoroscopic and 3D imagingand is intended to be used wherea physician benefits from 2D and3D information of anatomicstructures and objects with highx-ray attenuation such as bonyanatomy and metallic objects.The O-arm® Imaging System iscompatible with certain ImageGuided Surgery systems. |
Table 1: O-arm® O2 Predicate Device Comparison Table
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| Subject Device | Predicate | |
|---|---|---|
| O-arm® O2 Imaging System | O-Arm® 1000 Imaging System (K092564) | |
| Cone Beam CT | The O-arm® O2 Imaging System is a mobile cone-beam x-ray system with isocentric motion options. It allows 3D image reconstruction using a 360 degree rotation of the x-ray source and detector within closed gantry. | The O-arm® Imaging System is a mobile cone-beam x-ray system with isocentric motion options. It allows 3D image reconstruction using a 360 degree rotation of the x-ray source and detector within closed gantry. |
| Detector Technology | 40 x 30 cm (RoHS compliant, Flat-Panel Detector using a Csl scintillation) | 40 x 30 cm (Flat-Panel Detector using a CsI scintillation) |
| Generator Technology | 32 kW, RoHS compliant generator with improved electrical interface. | 32kW Generator |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic |
| 3D Imaging (20 cm FOV) | Full Fan (20cm FOV) scan acquisition | Full Fan (20cm FOV) scan acquisition |
| 3D Imaging Protocols (20 cm FOV) | Available presets:1. Standard 3D2. HD3D (High Definition)3. Enhanced Cranial4. Low Dose 3D | Available presets:1. Standard 3D2. HD3D (High Definition)3. Enhanced Cranial |
| 3D Imaging (40 cm FOV) | Half-fan single scan acquisition | No 3D Imaging at 40cm FOV |
| 3D Imaging Protocols (40 cm FOV) | Available presets:1. HD3D (high definition) equivalent to 750 projections | No 3D Imaging at 40cm FOV |
Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the O-arm O2 Imaging System device to establish substantial equivalence of the O-arm O2 Imaging System and verify that device will perform as intended meeting all of the design inputs.
- AAMI/ANSI ES 60601-1:2012 Medical Electrical Equipment -● Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: . General requirements for safety; Electromagnetic Compatibility -Requirements and Tests (2/2014)
- IEC 60601-1-3:2008 - Medical Electrical Equipment - Part 1-3:General Requirements for Basic Safety and Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment (1/2014)
- IEC 60601-2-28:2010 Medical electrical equipment part 2: . Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (8/2013)
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- . IEC 60601-2-43:2010 – Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (3/2010)
- Software Verification and Validation testing verifying the software requirements perform as intended
- . Hardware verification ensuring the hardware requirements identified for the system perform as intended.
- The Dose Setting Guidance for Extra-small Patient Size determines ● recommended dose settings (kVp/mA pairs) for an extra-small patient population to help the end user when imaging such patients.
- . The Image Quality Assessment of the O-arm® O2 System provides a quantitative image quality assessment of the O-arm® O2 system in comparison to the predicate O-arm® 1000 device.
- . The Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm O2 System.
- . The Usability Testing was conducted according to the FDA quidance Applying Human Factors and Usability to Optimize Medical Device Design. Users conducted a series of imaging functions under simulated use conditions.
- The O-arm® Cadaver Image Pair Study evaluates the clinical utility ● of the images obtained using the O-arm® O2 Imaging System compared to the images obtained using the predicate O-arm® 1000 and the reference Artis Zeego device.
All performance testing was conducted to ensure the product meets all prescribed design inputs.
Conclusion: The O-arm® O2 system is similar in technological characteristics, imaging performance and indications for use as the predicate devices listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that O-arm® O2 does not raise new risks of safety and effectiveness when compared to the predicates.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.