(126 days)
The O-arm™ O2 Imaging System is a mobile x-ray system, designed for 2D and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16 cm, 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 and 2D imaging. The O-arm™ O2 Imaging System consists of two main assemblies that are used together: The Image Acquisition System (IAS) and The Mobile View Station (MVS). The two units are interconnected by a single cable that provides power and signal data. The 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™ O2 Imaging System operates off standard line voltage within the following voltages: VAC 100, 120 or 240, Frequency 60Hz or 50Hz, Power Requirements 1440 VA.
The Medtronic O-arm™ O2 Imaging System with 4.3.0 software introduces three new features: Medtronic Implant Resolution (MIR) (referred to as KCMAR in the document), 3D Long Scan (3DLS), and Spine Smart Dose (SSD). The device's performance was evaluated through various studies to ensure substantial equivalence to the predicate device (O-arm™ O2 Imaging System 4.2.0 software) and to verify that the new features function as intended without raising new safety or effectiveness concerns.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implicit from Study Design/Results) | Reported Device Performance |
|---|---|---|
| Spine Smart Dose (SSD) | Clinical equivalence to predicate 3D acquisition modes (Standard and HD) by board-certified neuroradiologists. | Deemed clinically equivalent to O-arm™ O2 Imaging System 4.2.x Standard and Predicate High-Definition modes by board-certified neuroradiologists in a blinded review of 100 clinical image pairs. |
| SSD Image Quality (Bench Testing) | Meet system-level requirements for 3D Line pair, Contrast, MTF, Uniformity, and Geometric accuracy. | Met all system-level requirements. |
| SSD Navigational Accuracy (Bench Testing) | Meet system-level requirements in terms of millimeters. | Met all system-level requirements. |
| Medtronic Implant Resolution (KCMAR) | Clinical utility of KCMAR images to be statistically better than corresponding non-KCMAR images from the predicate device by board-certified radiologists. | Statistically better clinical value when compared to corresponding images from the Predicate Device (O-arm O2 Imaging System version 4.2.0) under specified indications. |
| KCMAR Metal Artifact Reduction (Bench Testing) | Qualitative comparison to demonstrate metal artifact reduction between non-KCMAR and KCMAR processed images. | Demonstrated metal artifact reduction. |
| KCMAR Implant Location Accuracy (Bench Testing) | Quantitative assessment of implant location accuracy in millimeters and degrees to meet system requirements. | Met all system-level requirements. |
| 3D Long Scan (3DLS) Clinical Utility | Clinical utility of Standard 3DLS and SSD 3DLS to be statistically equivalent to the corresponding Standard acquisition mode available in the predicate system by board-certified radiologists. | Statistically equivalent clinical utility when compared to the corresponding Standard acquisition mode available in the predicate system (version 4.2.0). |
| 3DLS Image Quality (Bench Testing) | Meet system-level requirements for 3D Line pair, Contrast, MTF, and Geometric accuracy. | Met all system-level requirements. |
| 3DLS Navigational Accuracy (Bench Testing) | Meet system-level requirements in terms of millimeters. | Met all system-level requirements. |
| Usability (3DLS, SSD, KCMAR) | Pass summative validation with critical tasks and new workflows for intended users in simulated use environments. | Passed summative validation, providing objective evidence of safety and effectiveness for intended users, uses, and environments. |
| Dosimetry (SSD, 3DLS) | Confirm dose accuracy (kV, mA, CTDI, DLP) meets system-level requirements for new acquisition features. | All dosimetry testing passed system-level requirements. |
2. Sample Size for the Test Set and Data Provenance
- Spine Smart Dose (SSD) Clinical Equivalence:
- Sample Size: 100 clinical image pairs.
- Data Provenance: "Clinical" images, suggesting retrospective or prospective clinical data. No specific country of origin is mentioned.
- KCMAR Clinical Equivalence:
- Sample Size:
- Initial study: 40 image pairs from four cadavers (small, medium, large, and extra-large habitus).
- Subsequent study: 33 image pairs from two cadavers (small and extra-large habitus).
- Data Provenance: Cadavers (ex-vivo data). No country of origin specified.
- Sample Size:
- 3D Long Scan (3DLS) Clinical Utility:
- Sample Size: 45 paired samples from acquisitions of three cadavers (small, medium, and extra-large habitus). Two cadavers were instrumented with pedicle screw hardware.
- Data Provenance: Cadavers (ex-vivo data). No country of origin specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Spine Smart Dose (SSD) Clinical Equivalence: "board-certified neuroradiologist" (singular, implied one, but could be more based on typical study designs not explicitly stated as count of 1). The document mentions "board-certified neuroradiologist involving 100 clinical image pairs".
- KCMAR Clinical Equivalence: "Board-certified radiologists" (plural).
- 3D Long Scan (3DLS) Clinical Utility: "Board-certified radiologists" (plural).
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes a "blinded review" for SSD and "clinical utility scores (1-5 scale)" for KCMAR and 3DLS, implying individual assessments that were then potentially aggregated or statistically compared.
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
The studies for SSD, KCMAR, and 3DLS involved multiple readers (board-certified radiologists/neuroradiologists) evaluating images.
- SSD: Compared "O-arm™ O2 Imaging System 4.3.0 SSD images" to "O-arm™ O2 Imaging System 4.2.x Standard and Predicate High-Definition modes." The outcome was clinical equivalence, not an improvement in human reader performance with AI assistance. It states the SSD leverages Machine Learning technology to reduce noise.
- KCMAR: Compared images reconstructed "without KCMAR feature" to images "with KCMAR feature." The outcome was "statistically better" clinical value for KCMAR. This indicates that the feature itself (which uses an algorithm for metal artifact reduction) resulted in better images, which would indirectly benefit the reader, but it doesn't quantify an improvement in human reader performance directly.
- 3DLS: Compared "Standard 3DLS and SSD 3DLS" to "corresponding Standard acquisition mode." The outcome was "statistically equivalent clinical utility." This specifically relates to the utility of the scan modes, not an AI-assisted interpretation by readers.
Therefore, while MRMC-like studies were conducted to assess the performance of the features, the focus was on the characteristics of the images produced by the device (clinical equivalence/utility/better value) rather than quantifying an effect size of how much human readers improve with AI versus without AI assistance in their diagnostic accuracy or efficiency.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, aspects of standalone performance were evaluated through bench testing.
- SSD Bench Testing: Evaluated image quality parameters (3D Line pair, Contrast, MTF, Uniformity, Geometric accuracy) and navigational accuracy.
- KCMAR Bench Testing: Qualitatively compared metal artifact reduction and quantitatively assessed implant location accuracy.
- 3DLS Bench Testing: Verified system-level requirements for image quality (3D Line pair, Contrast, MTF, Geometric accuracy) and navigational accuracy.
These bench tests assess the algorithmic output directly against defined performance metrics, independent of human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Clinical Equivalence/Utility for SSD, KCMAR, 3DLS: Ground truth was established by expert assessment/consensus from board-certified neuroradiologists/radiologists providing clinical utility scores and making equivalence/superiority judgments.
- Bench Testing: Ground truth was based on phantom measurements and objective system-level requirements for image quality, geometric accuracy, and navigational accuracy.
8. The Sample Size for the Training Set
The document states that the Spine Smart Dose (SSD) feature "leverages Machine Learning technology with existing O-arm™ images to achieve reduction in dose..." However, it does not specify the sample size of the training set used for this Machine Learning model.
9. How the Ground Truth for the Training Set was Established
For the Spine Smart Dose (SSD) feature, which uses Machine Learning, the document mentions "existing O-arm™ images." It does not explicitly state how the ground truth for these training images was established. Typically, for such denoising or image enhancement tasks, the "ground truth" might be considered the higher-dose, higher-quality images, with the ML model learning to reconstruct a similar quality image from lower-dose acquisitions. The document implies that the model's output (low-dose reconstruction) was then validated against expert opinion for clinical equivalence.
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June 21, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Navigation, Inc % Anamika Patel Senior Regulatory Affairs Specialist 200 Beaver Brook Rd BOXBOROUGH, MA 01719
Re: K240465
Trade/Device Name: O-arm™ O2 Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: February 16, 2024 Received: May 23, 2024
Dear Anamika Patel:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K240465
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 and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16 cm, 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) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| I. Company: | Medtronic Navigation, Inc. (Boxborough)200 Beaver Brook RdBoxborough, MA 01719 USA |
|---|---|
| Contact: | Anamika Patel (Primary)Senior Regulatory Affairs SpecialistPhone: (857) 264-9186Fax: (978) 698-6090e-mail: anamika.d.patel@medtronic.comJason Bridgeo (Alternate)Principal Regulatory Affairs SpecialistPhone: (508) 963-9532Fax: (978) 698-6090 |
- II. Date Summary Prepared: February 16, 2024
- III. Device Trade Name: O-arm™ O2 Imaging System
Common Name: Interventional Fluoroscopic X-ray System
Classification Name: 892.1650 - Image Intensified Fluoroscopic X-ray System
e-mail: jason.k.bridgeo@@medtronic.com
IV. Device Classification: Class II
- V. Product Code: Primary OWB Secondary - OXO, JAA
- VI. Predicate Device: K200074 O-arm™ O2 Imaging System 4.2.0 software
- VII. Product Description: The O-arm™ O2 Imaging System is a mobile x-ray system that provides 3D and 2D imaging. O-arm O2™ Imaging System was originally cleared for market under the original 510(k) K151000 and subsequently via special 510(k) K173664 and traditional 510(k) K200074. The device is classified under primary product code OWB (secondary product codes OXO, JAA) Regulation 21 CFR 892.1650.
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VIII. Modified Device: O-arm™ O2 Imaging System with 4.3.0 software.
This submission for the O-arm™ O2 Imaging System 4.3.0 software release introduces the following features:
- . Medtronic Implant Resolution (MIR)
- . 3D Long Scan (3DLS)
- . Spine Smart Dose (SSD)
These features are described in more detail in the Substantial Equivalence section.
The O-arm™ O2 Imaging System consists of two main assemblies that are used together:
- . The Image Acquisition System (IAS)
- . The Mobile View Station (MVS)
The two units are interconnected by a single cable that provides power and signal data. The 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™ O2 Imaging System operates off standard line voltage within the following voltages:
- . VAC 100, 120 or 240
- . Frequency 60Hz or 50Hz
- Power Requirements 1440 VA .
IX. Indications for Use:
The O-arm™ O2 Imaging System is a mobile x-ray system designed for 2D and 3D imaging for adult and pediatric patients weighing 60lbs 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 Oarm™ O2 Imaging System is compatible with certain image guided surgery systems.
X. Substantial Equivalence:
O-arm™ O2 Imaging System with 4.3.0 software is substantially equivalent to the following device: K200074 - O-arm™ O2 Imaging System 4.2.0 software.
The unmodified device (predicate - K200074) and the modified device are compared in table below:
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| Feature/ Attribute | Subject DeviceO-arm O2 Imaging System4.3.0 Software | PredicateO-arm O2 ImagingSystem 4.2.0 Software | Discussion |
|---|---|---|---|
| Classification | Class II | Class II | Identical |
| Product Code | OWB, OXO and JAA | OWB, OXO and JAA | Identical |
| Indications for Use | The O-arm™ O2 ImagingSystem is a mobile x-raysystem designed for 2D and3D imaging for adult andpediatric patients weighing60lbs or greater and havingan abdominal thicknessgreater than 16cm and isintended to be used where aphysician benefits from 2Dand 3D information ofanatomic structures andobjects with high x-rayattenuation such as bonyanatomy and metallic objects.The O-arm™ O2 ImagingSystem is compatible withcertain Image GuidedSurgery Systems. | The O-arm™ O2Imaging System is amobile x-ray systemdesigned for 2D and 3Dimaging for adult andpediatric patientsweighing 60lbs or greaterand having an abdominalthickness greater than16cm and is intended tobe used where aphysician benefits from2D and 3D informationof anatomic structuresand objects with high x-ray attenuation such asbony anatomy andmetallic objects.The O-arm™ O2Imaging System iscompatible with certainImage Guided SurgerySystems. | Identical |
| Cone Beam CT | The O-arm™ O2 ImagingSystem is a mobile cone-beam x-ray system withisocentric motion options. Itallows 3D imagereconstruction using a 360-degree rotation of the x-raysource and detector withinclosed gantry. | The O-arm™ O2 ImagingSystem is a mobile cone-beam x-ray system withisocentric motion options.It allows 3D imagereconstruction using a360-degree rotation of thex-ray source and detectorwithin closed gantry. | Identical |
| Detector Technology | 40 x 30 cm (RoHScompliant, Flat-PanelDetector using a CsIscintillation) | 40 x 30 cm (RoHScompliant, Flat-PanelDetector using a CsIscintillation) | Identical |
| Feature/ Attribute | Subject DeviceO-arm O2 Imaging System4.3.0 Software | PredicateO-arm O2 ImagingSystem 4.2.0 Software | Discussion |
| Generator Technology | 32 kW, RoHS compliantgenerator with improvedelectrical interface. | 32 kW, RoHS compliantgenerator with improvedelectrical interface. | Identical |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic | Identical |
| 2D Imaging | Automatically stitched 2DRadiographic (Long Film) | Automatically stitched 2DRadiographic (Long Film) | Identical |
| 3D Imaging (20 cmFOV) | Full Fan (20cm FOV) scanacquisition | Full Fan (20cm FOV) scanacquisition | Identical |
| 3D Imaging Protocols(20 cm FOV) | Available presets:1. Standard 3D2. HD3D (High Definition)3. Enhanced Cranial4. Low Dose 3D5. SpineSmart Dose | Available presets:1. Standard 3D2. HD3D (HighDefinition)3. Enhanced Cranial4. Low Dose 3D | Added new preset calledSpineSmart Dose (See below fordetails) in our subject device |
| 3D Imaging (40 cmFOV) | Half-fan single scanacquisition | Half-fan single scanacquisition | Identical |
| 3D Imaging Protocols(40 cm FOV) | Available presets:1. HD3D (high definition)equivalent to 750projections | Available presets:1. HD3D (highdefinition) equivalent to750 projections | Identical |
| System Software | Version 4.3.0 | Version 4.2.0 | Equivalent, with the addition of4.3.0 features (KCMAR, SSDand 3DLS) described inSection 3 Device Description. |
| Known ComponentMetal ArtifactReduction( | |||
| Feature/ Attribute | Subject Device | Predicate | Discussion |
| O-arm O2 Imaging System | O-arm O2 Imaging | ||
| 4.3.0 Software | System 4.2.0 Software | ||
| 3D Long ScanProtocol | 3D Long ScanThe 3D Long Scan feature provides functionality to specify start and end positions for acquiring two to three (depending on length) auto-registered 3D scans in combination with the IGS system. The maximum achievable length for a 3D Long scan is approximately 43.8 cm (17.24 in). The minimum scan length for a 3D Long Scan is approximately 19.2 cm (7.6 in). | 2D Long FilmThe 2D Long Film mode provides functionality for acquiring an intraoperative linear X-ray scan. In this mode, the O-arm™ O2 Imaging System scans while the gantry moves left/right along the z-axis during acquisition between the positions stored in memory presets 1 and 2. When the saved memory presets are stored at the extremes of the z-axis, the maximum length and width of a 2D Long Film image is 47 cm by 20 cm at isocenter. | Added Feature:3D Long Scan is the combination of automatic registration with navigation systems (e.g., Medtronic StealthStation), lateral access to the patient, and a navigated three-dimensional scan of 15-43cm of the patient's spine.2D Long Film was validated and FDA-cleared previously. |
| SpineSmart Dose(SSD) | SpineSmart DoseSSD mode is designed to provide an additional preset setting for standard 3D acquisitions with a lower overall dose reduction of around 70% from the standard acquisition protocols, for spinal applications. The rotor spins at 30° per second, acquires images at 30 frames per second, and captures approximately 100 projections. | Normal doseIn 3D acquisition modes, the O-arm™ O2 system IAS creates a series of pulsed x-ray exposures throughout a complete 360-degree rotation of the gantry rotor. The rotor spins at 30° per second, acquires images at 30 frames per second and captures approximately 391 projections. | Added Feature:Spine Smart Dose feature leverages Machine Learning technology with existing O-arm™ images to achieve reduction in dose on the O-arm™ O2 Imaging System. It is an algorithm designed to reduce the noise of 3D reconstructions acquired from fewer acquisitions so that clinically viable 3D images can be produced using fewer projections. |
| Testing | Testing Methodology / Parameters | Overall Results | |
| Spine SmartDose ClinicalEquivalenceDesignValidation | The Spine Smart Dose (SSD) feature uses asparse image acquisition, an FDKreconstruction and a machine learningdenoising algorithm to provide images ofthe spine at significantly lower dose(around 70% lower dose to patient). In ablinded review by board-certifiedneuroradiologist involving 100 clinical | This clinical and cadaver image pairvalidation study demonstrated that theclinical value of the O-arm O2 4.3 SSDimages is clinically equivalent whencompared to corresponding images from thePredicate Device (O-arm O2 4.2.0 ImagingSystem) under the specified indications. | |
| image pairs, O-arm™ O2 Imaging System4.3.0 SSD images were deemed clinicallyequivalent to O-arm™ O2 Imaging System4.2.x Standard and Predicate High-Definition modes. The dose of the SSDimages reviewed in this study wereapproximately ¼ the dose of thecorresponding Standard images. | |||
| Spine SmartDose BenchTesting | Phantom testing was performed on SpineSmart Dose feature to verify the systemlevel requirements for Image Quality (3DLine pair, Contrast, MTF, Uniformity andGeometric accuracy) and Navigationalaccuracy in terms of millimeters. | All the bench testing demonstrated SpineSmart Dose met all the system levelrequirements. | |
| KCMARClinicalEquivalenceDesignValidation | The 3D O-arm acquisitions reconstructedusing the predicate device without KCMARfeature and the same acquisitionsreconstructed using the subject device withKCMAR feature were compared for theirclinical equivalence. Board-certifiedradiologists provided clinical utility scores(1-5 scale) for the 40 image pairs from fourcadavers acquired using Standard 3Dimaging mode. The cadavers were of small,medium, large, and extra-large habitus.In the subsequent study, board-certifiedradiologists provided clinical utility scoresfor the 33 image pairs from two cadaversacquired using other 3D imaging modes(Low Dose, HD, and SSD). The cadaverswere of small and extra-large habitus. | This cadaver image pair validation studydemonstrated that the clinical value of theKCMAR image with the O-arm O2 ImagingSystem version 4.3.0 is statistically betterwhen compared to corresponding imagesfrom the Predicate Device (O-arm O2Imaging System version 4.2.0) under thespecified indications. | |
| KCMARBench Testing | Phantom studies were used to qualitativelycompare the metal artifact reductionbetween non-KCMAR and KCMARprocessed images with supportedMedtronic implants. In addition, phantomstudies were conducted to quantitativelyassess the accuracy of the implant locationin millimeters and degrees. | All the bench testing demonstratedKCMAR met all the system levelrequirements. | |
| 3D Long ScanClinicalUtilityValidation | Board-certified radiologists providedclinical utility scores (1-5 scale) forStandard, Standard 3DLS, and SSD 3DLSacquisitions of three cadavers. Thecadavers were of small, medium, and extra- | This cadaver clinical utility studydemonstrated that the clinical utility of theStandard 3DLS and SSD 3DLS with the O-arm O2 Imaging System version 4.3.0 isstatistically equivalent when compared to | |
| large habitus, and two of the cadavers wereinstrumented with pedicle screw hardware.Paired statistical equivalence testing of theclinical utility scores was performedbetween (1) the Standard (predicate) andStandard 3DLS mode, and (2) the Standard(predicate) and SSD 3DLS mode. Each testwas performed on 45 paired samples. | the corresponding Standard acquisitionmode that is available in the predicatesystem (version 4.2.0). | ||
| 3D Long ScanBench Testing | Phantom testing was performed on the 3DLong Scan feature to verify the systemlevel requirements for Image Quality (3DLine pair, Contrast, MTF and Geometricaccuracy) and Navigational accuracy interms of millimeters. | All the bench testing demonstrated 3D LongScan met all the system level requirements. | |
| Usability | Usability for the 3DLS, SSD, and KCMARfeatures was assessed in multiple formativeevaluations and tested in two summativevalidations with the clinically relevant usersin simulated use environments. Summativevalidation of critical tasks and newworkflows for 3DLS and SSD wasconducted with surgeons, spinerepresentatives, and radiation technologists.Summative validation of KCMAR criticaltasks and new workflows was conductedwith surgeons and spine representatives. | The 3DLS, SSD, and KCMAR featurespassed summative validation. Results of thesummative validations provided objectiveevidence the O-arm O2 Imaging Systemwith 4.3.0 software is safe and effective forthe intended users, uses, and useenvironments. | |
| Dosimetry | Dosimetry studies were used to confirm thedose accuracy (kV, mA, CTDI and DLP)for the new acquisition features includingthe Spine Smart Dose and 3D Long Scan. | All the dosimetry testing passed the systemlevel requirements. |
Comparison of the Technological Characteristics
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XI. 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 with the predicate device and verify that device will perform as intended in meeting all the design inputs:
- . AAMI/ANSI ES 60601-1 2005+A1:2012 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General requirements for safety; ● Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-3:2008 + A1:2013 Medical Electrical Equipment Part 1-3: General Requirements for Basic ● Safety and Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
- . 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
- IEC 60601-2-43:2010 + A1:2017 Medical electrical equipment Part 2-43: Particular requirements for the . basic safety and essential
- . IEC60601-1-6:2010 + A1:2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Software Verification and Validation testing verifying the software requirements perform as intended. .
- The Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm™ O2 . Imaging System with 4.3.0 software.
- . Usability Testing was conducted according to the FDA guidance 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 evaluated the clinical utility of the images obtained using the Oarm™ O2 Imaging System with 4.3.0 compared to the images obtained using the predicate O-arm™ O2 Imaging System with 4.2.0.
- FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of . Premarket Submissions."
Performance Testing Summary
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XII. Conclusion
The O-arm™ O2 Imaging System with 4.3.0 software is similar in technological characteristics, imaging performance and indications for use as the predicate device listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that O-arm™ O2 Imaging System with 4.3.0 software does not raise new risks of safety and effectiveness when compared to the predicate.
§ 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.