(126 days)
Yes
The "Mentions AI, DNN, or ML" section explicitly states that the "Spine Smart Dose feature leverages Machine Learning technology".
No.
The device is an imaging system designed to provide 2D and 3D information of anatomic structures, primarily for diagnostic and surgical guidance, rather than for direct treatment or therapy.
Yes
The "Intended Use" section states that the device is designed for "2D and 3D imaging for adult and pediatric patients... to be used where a physician benefits from 2D and 3D information of anatomic structures and objects." Imaging for information about anatomic structures is a form of diagnosis.
No
The device description explicitly states it is a "mobile x-ray system" consisting of two main hardware assemblies (Image Acquisition System and Mobile View Station) with physical interconnections, batteries, and power requirements. While it includes software features like "Spine Smart Dose" that leverage machine learning, the core device is a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "mobile x-ray system, designed for 2D and 3D imaging... intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects". This describes an imaging device used in vivo (within the living body) to visualize internal structures.
- Device Description: The description details an "x-ray system" with components like an "Image Acquisition System (IAS)" and a "Mobile View Station (MVS)". This aligns with the description of an imaging device, not a device used to examine specimens in vitro (outside the living body).
- Input Imaging Modality: The input modality is "X-ray", which is an in vivo imaging technique.
- Anatomical Site: The device is used to image "anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects; spine". These are all in vivo anatomical locations.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) obtained from the human body in vitro to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA
Device 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.
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)
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-ray, Cone Beam CT
Anatomical Site
Anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects., spine
Indicated Patient Age Range
adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16 cm
Intended User / Care Setting
Physician, surgeons, spine representatives, and radiation technologists.
Care setting is implicit for a mobile x-ray system used by aforementioned users, likely in an operating room or similar clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Spine Smart Dose Clinical Equivalence Design Validation:
Blinded review by board-certified neuroradiologist involving 100 clinical image pairs.
Description of annotation protocol: Not Found
KCMAR Clinical Equivalence Design Validation:
3D O-arm acquisitions reconstructed using the predicate device without KCMAR feature and the same acquisitions reconstructed using the subject device with KCMAR feature were compared for their clinical equivalence. Board-certified radiologists provided clinical utility scores (1-5 scale) for the 40 image pairs from four cadavers acquired using Standard 3D imaging mode. The cadavers were of small, medium, large, and extra-large habitus. In the subsequent study, board-certified radiologists provided clinical utility scores for the 33 image pairs from two cadavers acquired using other 3D imaging modes (Low Dose, HD, and SSD). The cadavers were of small and extra-large habitus.
3D Long Scan Clinical Utility Validation:
Board-certified radiologists provided clinical utility scores (1-5 scale) for Standard, Standard 3DLS, and SSD 3DLS acquisitions of three cadavers. The cadavers were of small, medium, and extra-large habitus, and two of the cadavers were instrumented with pedicle screw hardware. Paired statistical equivalence testing of the clinical utility scores was performed between (1) the Standard (predicate) and Standard 3DLS mode, and (2) the Standard (predicate) and SSD 3DLS mode. Each test was performed on 45 paired samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Spine Smart Dose Clinical Equivalence Design Validation
Study Type: Blinded clinical review
Sample size: 100 clinical image pairs
Key Results: O-arm™ O2 Imaging System 4.3.0 SSD images were deemed clinically equivalent to O-arm™ O2 Imaging System 4.2.x Standard and Predicate High-Definition modes. The dose of the SSD images reviewed in this study were approximately ¼ the dose of the corresponding Standard images. This clinical and cadaver image pair validation study demonstrated that the clinical value of the O-arm O2 4.3 SSD images is clinically equivalent when compared to corresponding images from the Predicate Device (O-arm O2 4.2.0 Imaging System) under the specified indications.
Spine Smart Dose Bench Testing
Study Type: Phantom testing
Key Results: All the bench testing demonstrated Spine Smart Dose met all the system level requirements for Image Quality (3D Line pair, Contrast, MTF, Uniformity and Geometric accuracy) and Navigational accuracy in terms of millimeters.
KCMAR Clinical Equivalence Design Validation
Study Type: Clinical utility assessment by board-certified radiologists.
Sample Size: 40 image pairs from four cadavers (Standard 3D), 33 image pairs from two cadavers (other 3D modes).
Key Results: This cadaver image pair validation study demonstrated that the clinical value of the KCMAR image with the O-arm O2 Imaging System version 4.3.0 is statistically better when compared to corresponding images from the Predicate Device (O-arm O2 Imaging System version 4.2.0) under the specified indications.
KCMAR Bench Testing
Study Type: Phantom studies
Key Results: All the bench testing demonstrated KCMAR met all the system level requirements.
3D Long Scan Clinical Utility Validation
Study Type: Clinical utility assessment by board-certified radiologists.
Sample Size: 45 paired samples (each test) from three cadavers.
Key Results: This cadaver clinical utility study demonstrated that the clinical utility of the Standard 3DLS and SSD 3DLS with the O-arm O2 Imaging System version 4.3.0 is statistically equivalent when compared to the corresponding Standard acquisition mode that is available in the predicate system (version 4.2.0).
3D Long Scan Bench Testing
Study Type: Phantom testing
Key Results: All the bench testing demonstrated 3D Long Scan met all the system level requirements for Image Quality (3D Line pair, Contrast, MTF and Geometric accuracy) and Navigational accuracy in terms of millimeters.
Usability
Study Type: Summative validation
Key Results: The 3DLS, SSD, and KCMAR features passed summative validation. Results of the summative validations provided objective evidence the O-arm O2 Imaging System with 4.3.0 software is safe and effective for the intended users, uses, and use environments.
Dosimetry
Study Type: Dosimetry studies
Key Results: All the dosimetry testing passed the system level requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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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3
510(k) Summary
| I. Company: | Medtronic Navigation, Inc. (Boxborough)
200 Beaver Brook Rd
Boxborough, MA 01719 USA |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Anamika Patel (Primary)
Senior Regulatory Affairs Specialist
Phone: (857) 264-9186
Fax: (978) 698-6090
e-mail: anamika.d.patel@medtronic.com
Jason Bridgeo (Alternate)
Principal Regulatory Affairs Specialist
Phone: (508) 963-9532
Fax: (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.
4
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:
5
| Feature/ Attribute | Subject Device
O-arm O2 Imaging System
4.3.0 Software | Predicate
O-arm O2 Imaging
System 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 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 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
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 O-arm™ O2
Imaging System is
compatible with certain
Image Guided Surgery
Systems. | Identical |
| 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™ 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. | Identical |
| Detector Technology | 40 x 30 cm (RoHS
compliant, Flat-Panel
Detector using a CsI
scintillation) | 40 x 30 cm (RoHS
compliant, Flat-Panel
Detector using a CsI
scintillation) | Identical |
| Feature/ Attribute | Subject Device
O-arm O2 Imaging System
4.3.0 Software | Predicate
O-arm O2 Imaging
System 4.2.0 Software | Discussion |
| Generator Technology | 32 kW, RoHS compliant
generator with improved
electrical interface. | 32 kW, RoHS compliant
generator with improved
electrical interface. | Identical |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic | Identical |
| 2D Imaging | Automatically stitched 2D
Radiographic (Long Film) | Automatically stitched 2D
Radiographic (Long Film) | Identical |
| 3D Imaging (20 cm
FOV) | Full Fan (20cm FOV) scan
acquisition | Full Fan (20cm FOV) scan
acquisition | Identical |
| 3D Imaging Protocols
(20 cm FOV) | Available presets:
- Standard 3D
- HD3D (High Definition)
- Enhanced Cranial
- Low Dose 3D
- SpineSmart Dose | Available presets:
- Standard 3D
- HD3D (High
Definition) - Enhanced Cranial
- Low Dose 3D | Added new preset called
SpineSmart Dose (See below for
details) in our subject device |
| 3D Imaging (40 cm
FOV) | Half-fan single scan
acquisition | Half-fan single scan
acquisition | Identical |
| 3D Imaging Protocols
(40 cm FOV) | Available presets: - HD3D (high definition)
equivalent to 750
projections | Available presets: - HD3D (high
definition) equivalent to
750 projections | Identical |
| System Software | Version 4.3.0 | Version 4.2.0 | Equivalent, with the addition of
4.3.0 features (KCMAR, SSD
and 3DLS) described in
Section 3 Device Description. |
| Known Component
Metal Artifact
Reduction
( | | | |
| 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 Scan
Protocol | 3D Long Scan
The 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 Film
The 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 Dose
SSD 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 dose
In 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 Smart
Dose Clinical
Equivalence
Design
Validation | The Spine Smart Dose (SSD) feature uses a
sparse image acquisition, an FDK
reconstruction and a machine learning
denoising algorithm to provide images of
the spine at significantly lower dose
(around 70% lower dose to patient). In a
blinded review by board-certified
neuroradiologist involving 100 clinical | This clinical and cadaver image pair
validation study demonstrated that the
clinical value of the O-arm O2 4.3 SSD
images is clinically equivalent when
compared to corresponding images from the
Predicate Device (O-arm O2 4.2.0 Imaging
System) under the specified indications. |
| | | | |
| | image pairs, O-arm™ O2 Imaging System
4.3.0 SSD images were deemed clinically
equivalent to O-arm™ O2 Imaging System
4.2.x Standard and Predicate High-
Definition modes. The dose of the SSD
images reviewed in this study were
approximately ¼ the dose of the
corresponding Standard images. | | |
| Spine Smart
Dose Bench
Testing | Phantom testing was performed on Spine
Smart Dose feature to verify the system
level requirements for Image Quality (3D
Line pair, Contrast, MTF, Uniformity and
Geometric accuracy) and Navigational
accuracy in terms of millimeters. | All the bench testing demonstrated Spine
Smart Dose met all the system level
requirements. | |
| KCMAR
Clinical
Equivalence
Design
Validation | The 3D O-arm acquisitions reconstructed
using the predicate device without KCMAR
feature and the same acquisitions
reconstructed using the subject device with
KCMAR feature were compared for their
clinical equivalence. Board-certified
radiologists provided clinical utility scores
(1-5 scale) for the 40 image pairs from four
cadavers acquired using Standard 3D
imaging mode. The cadavers were of small,
medium, large, and extra-large habitus.
In the subsequent study, board-certified
radiologists provided clinical utility scores
for the 33 image pairs from two cadavers
acquired using other 3D imaging modes
(Low Dose, HD, and SSD). The cadavers
were of small and extra-large habitus. | This cadaver image pair validation study
demonstrated that the clinical value of the
KCMAR image with the O-arm O2 Imaging
System version 4.3.0 is statistically better
when compared to corresponding images
from the Predicate Device (O-arm O2
Imaging System version 4.2.0) under the
specified indications. | |
| KCMAR
Bench Testing | Phantom studies were used to qualitatively
compare the metal artifact reduction
between non-KCMAR and KCMAR
processed images with supported
Medtronic implants. In addition, phantom
studies were conducted to quantitatively
assess the accuracy of the implant location
in millimeters and degrees. | All the bench testing demonstrated
KCMAR met all the system level
requirements. | |
| 3D Long Scan
Clinical
Utility
Validation | Board-certified radiologists provided
clinical utility scores (1-5 scale) for
Standard, Standard 3DLS, and SSD 3DLS
acquisitions of three cadavers. The
cadavers were of small, medium, and extra- | This cadaver clinical utility study
demonstrated that the clinical utility of the
Standard 3DLS and SSD 3DLS with the O-
arm O2 Imaging System version 4.3.0 is
statistically equivalent when compared to | |
| | | | |
| | large habitus, and two of the cadavers were
instrumented with pedicle screw hardware.
Paired statistical equivalence testing of the
clinical utility scores was performed
between (1) the Standard (predicate) and
Standard 3DLS mode, and (2) the Standard
(predicate) and SSD 3DLS mode. Each test
was performed on 45 paired samples. | the corresponding Standard acquisition
mode that is available in the predicate
system (version 4.2.0). | |
| | 3D Long Scan
Bench Testing | Phantom testing was performed on the 3D
Long Scan feature to verify the system
level requirements for Image Quality (3D
Line pair, Contrast, MTF and Geometric
accuracy) and Navigational accuracy in
terms of millimeters. | All the bench testing demonstrated 3D Long
Scan met all the system level requirements. |
| | Usability | Usability for the 3DLS, SSD, and KCMAR
features was assessed in multiple formative
evaluations and tested in two summative
validations with the clinically relevant users
in simulated use environments. Summative
validation of critical tasks and new
workflows for 3DLS and SSD was
conducted with surgeons, spine
representatives, and radiation technologists.
Summative validation of KCMAR critical
tasks and new workflows was conducted
with surgeons and spine representatives. | The 3DLS, SSD, and KCMAR features
passed summative validation. Results of the
summative validations provided objective
evidence the O-arm O2 Imaging System
with 4.3.0 software is safe and effective for
the intended users, uses, and use
environments. |
| | Dosimetry | Dosimetry studies were used to confirm the
dose accuracy (kV, mA, CTDI and DLP)
for the new acquisition features including
the Spine Smart Dose and 3D Long Scan. | All the dosimetry testing passed the system
level 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.