(263 days)
Not Found
No
The document describes standard image processing techniques (recursive filtering and edge enhancement) and does not mention AI, ML, or related terms.
No.
The device is used to provide visualization that aids physicians and surgeons during therapeutic treatment, but it is not a therapeutic device itself.
Yes
The device is intended to aid physicians and surgeons during diagnostic procedures, as stated in the 'Intended Use / Indications for Use' section.
No
The device description explicitly details hardware components such as a mini C-arm with a CMOS flat panel detector and X-ray source, a wireless footswitch, battery packs, a charger, and an optional monitor cart with a monitor, keyboard, and printer. This indicates it is a hardware system with integrated software, not a software-only device.
Based on the provided information, the Smart-C device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Smart-C is an X-ray system designed for "real time general fluoroscopic visualization of adult and pediatric patients" to aid physicians and surgeons during "diagnostic procedures, therapeutic treatment, or surgical procedures." This involves imaging the human body directly.
- Device Description: The description details a "mini C-arm X-ray system" with an "X-ray source monoblock" and a "CMOS flat panel detector" for "image acquisition." This is consistent with an in-vivo imaging device.
- Input Imaging Modality: The input modality is "Fluoroscopic X-ray," which is used for imaging inside the living body.
- Anatomical Site: The specified anatomical sites are "limbs, extremities, or shoulders," which are parts of the human body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The Smart-C does not perform this function.
The Smart-C is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smart-C is a mini C-arm X-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.
Product codes
OXO, JAA
Device Description
The Smart-C is an ultra-portable, battery-powered, mobile fluoroscopic mini C-arm system. The main component is a mini C-arm that consists of a CMOS flat panel detector aligned with an X-ray source monoblock to be used for image acquisition. The system can be hand-transported for imaging at the point of care. The primary operator workstation is a tablet computer that receives the images from the C-arm via wireless transfer protocol. The system includes a wireless footswitch to initiate image acquisition, making the entire system cord-free during operation. It comes with 2 battery packs, a table-top battery charger, and a tablet docking station.
An optional Monitor Cart is provided as an accessory. The Smart-C monitor cart includes a 27" full-color touchscreen monitor, a keyboard for data entry, a printer for hard-copy of the x-ray images, and a battery charger for the Smart-C battery packs. The whole cart is battery-powered, to provide a completely cord-free user experience.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
limbs, extremities, or shoulders
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures in orthopedics and emergency medicine.
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
A Qualified Expert Evaluation of the image quality of the Smart-C was performed by independent physicians utilizing images obtained from anthropomorphic phantoms. An additional Image Quality Performance test was completed using image quality phantoms for contrast and spatial resolution. Dynamic image resolution was assessed using rotation of a phantom with 2 lead dots.
The clinical utility of the Smart-C was demonstrated by performing a Clinical Imaging Evaluation. Cadaver subjects were chosen to represent the range of extremity imaging, including shoulders. To represent a range of imaging conditions the testing was performed in both standard fluoro and in low-dose mode. Image enhancement algorithms like recursive filtering and edge enhancement were evaluated, and suitable conditions determined for their use. Patient positioning considerations for adult patients were considered in a separate usability study.
To address the special needs of neonatal and infant patients, a Pediatric Imaging Usability Evaluation was performed. This included the additional consideration of patient positioning for these very small size subjects. The Smart-C is not indicated for wholebody imaging of pediatric patients, so this study was limited to extremity positioning.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Imaging Evaluation (Bench Testing and Clinical)
Sample Size: Not explicitly stated for each study, but involved anthropomorphic phantoms, image quality phantoms, and cadaver subjects.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- Bench Testing: Qualified Expert Evaluation by independent physicians found good image quality. Image Quality Performance test completed for contrast, spatial resolution, and dynamic image resolution. The Smart-C system meets design input and user needs as demonstrated by system verification and validation testing, including hazard mitigation. Complies with applicable IEC series of x-ray performance standards (IEC60601-2-54) and 21CFR Subchapter J performance standards.
- Clinical Testing: Clinical Imaging Evaluation using cadaver subjects demonstrated clinical utility across a range of extremity imaging and conditions (standard and low-dose fluoro). Pediatric Imaging Usability Evaluation was performed for neonatal and infant patients (extremity positioning).
- Physician Feedback: Clinical images obtained with the Smart-C were "at least as good as the predicate device." No new concerns regarding patient positioning, including for neonatal and infant patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Orthoscan Mobile DI Mini C-arm, 510(k) # K113708
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
September 27, 2019
Turner Imaging Systems, Inc. % D. Clark Turner, Ph.D. President and CEO 1119 South 1680 West OREM UT 84058
Re: K190024
Trade/Device Name: Smart-C"™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OXO, JAA Dated: August 26, 2019 Received: August 28, 2019
Dear Dr. Turner:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Smart-C TM
Indications for Use (Describe)
The Smart-C is a mini C-arm X-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.
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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Tab 5
510(k) Summary
Submission # K190024
Smart-C X-ray Imaging System
26 August 2019
Submitter:
| Name: | Turner Imaging Systems, Inc. |
|---|---|
| Address: | 1119 S 1680 W |
| Orem, UT 84058 | |
| Official Correspondent: | Clark Turner, Acting Director of Quality and Regulatory Affairs |
| Telephone No: | 801-796-2951 |
| Email: | cturner@turnerinnovation.com |
Proposed Device:
| Trade Name: | Smart-C TM |
|---|---|
| Common/Usual Name: | Fluoroscopic X-ray System, Mobile |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Primary Product Code: | OXO |
| Secondary Product Code: | JAA |
| Regulatory Standard: | 21CFR 892.1650 |
Predicate Device:
| Orthoscan Mobile DI Mini C-arm, 510(k) # K113708, manufactured by Orthoscan. | |
|---|---|
| Common/Usual Name: | Fluoroscopic X-ray System, Mobile |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Product Codes: | OXO and JAA |
| Regulatory Standard: | 21CFR 892.1650 |
Description: The Smart-C is an ultra-portable, battery-powered, mobile fluoroscopic mini C-arm system. The main component is a mini C-arm that consists of a CMOS flat panel detector aligned with an X-ray source monoblock to be used for image acquisition. The system can be hand-transported for imaging at the point of care. The primary operator workstation is a tablet computer that receives the images from the C-arm via wireless transfer protocol. The system includes a wireless footswitch to initiate image acquisition, making the entire system cord-free during operation. It comes with 2 battery packs, a table-top battery charger, and a tablet docking station.
An optional Monitor Cart is provided as an accessory. The Smart-C monitor cart includes a 27" full-color touchscreen monitor, a keyboard for data entry, a printer for hard-copy of the x-ray images, and a battery charger for the Smart-C battery packs. The whole cart is battery-powered, to provide a completely cord-free user experience.
- Intended Use: The Smart-C is a mini c-arm X-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid
4
physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.
| Table 1. Comparison with predicate device: | ||
|---|---|---|
| Characteristic
or Property | Predicate Device
OrthoScan Mobile DI, K113708 | Turner Imaging Systems Smart-C |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Regulation number: 21 CFR 892.1650
Regulation name: Image-intensified
Fluoroscopic x-ray system
Regulatory Class: II
Product Code: OXO and JAA | Regulation number: 21 CFR 892.1650
Regulation name: Image-intensified
Fluoroscopic x-ray system
Regulatory Class: II
Product Code: OXO and JAA |
| Intended Use | The OrthoScan Mobile DI [1000-0005]
is a mini c-arm X-ray system designed
to provide the physician with general
fluoroscopic visualization of the patient
including, but not limited to, surgical
orthopedic procedures and critical and
emergency care procedures in hospital,
emergency care, critical care, clinical,
or physician office environments. The
Mobile DI is capable of generating,
processing, capturing, saving and
transmitting fluoroscopic images of
patient extremities for the purpose of
diagnostic imaging. In addition, the
portability of the OrthoScan Mobile DI
provides for ease of use in athletic team
venues, and military units. | The Smart-C is a mini C-arm X-ray system
designed to provide physicians with real
time general fluoroscopic visualization of
adult and pediatric patients. It is intended to
aid physicians and surgeons during
diagnostic procedures, therapeutic
treatment, or surgical procedures of the
limbs, extremities, or shoulders including
but not limited to, orthopedics and
emergency medicine. The Smart-C is
intended to be used on a table or other hard
flat surface. It may also be used with the
optional support stand. |
| Electrical: | | |
| Power | Must be plugged in to AC Mains | C-arm: Rechargeable lithium ion battery;
22.2VDC; 3.5AHr |
| | | Tablet: Rechargeable lithium ion battery;
14.8VDC; up to 3.7AHr |
| | | Monitor Cart: Rechargeable Battery,
LiFePO4, 24VDC, 40AHr, plug into AC
mains to charge battery |
| | | Footswitch: Alkaline AA Battery; 1.5VDC |
| X-ray Source | Fixed anode, beryllium window
Focal spot: 0.05mm
Voltage range: 40 to 78 kV
Current range: 40 to 160 μA
Exposure: Continuous
Duty Cycle: Continuous | Fixed anode, tungsten filament
Focal spot: 0.03-0.05mm
Voltage range: 40 to 80 kV
Current range: 65 to 370 μA
Exposure: Pulsed, 10FPS, 40ms per frame
Duty cycle: 1 min. of fluoroscopy per 5
min. |
| Image Receptor | Type: CMOS Flat Panel | Type: CMOS Flat Panel |
| Characteristic
or Property | Predicate Device
OrthoScan Mobile DI, K113708 | Turner Imaging Systems Smart-C |
| | Scintillator:
Full Field: 15cm x 12cm
Limited Field: 11cm x 8cm
Pixel Size: 75 microns
Array Size: 1.5k x 2k | Scintillator: Cesium Iodide
Full Field: 15cm x 15cm
Limited Field: 10cm dia. circle
Pixel Size: 99 microns
Array Size: 1.5k x 1.5k |
| Electrical Safety
and EMI
Standards | ANSI/AAMI std IEC60601-1
IEC60601-1-2 | ANSI/AAMI std IEC60601-1
IEC60601-1-2 |
| Mechanical/Physical: | | |
| C-arm Physical
Dimensions | C-arm:
Inside depth: 23 cm (9 in)
Free space: 35 cm (13.8 in)
Height: 64 cm (25 in)
Width: 29 cm (11.4 in)
Outside depth: 49 cm (19.2 in) | C-arm:
Inside depth: 31 cm (12.2 in)
Free space: 34 cm (13.5 in)
Height: 53 cm (21 in)
Width: 20 cm (8 in)
Outside depth: 46 cm (18 in) |
| Field of view | Normal mode: 15 cm x 12 cm
Magnification mode: 11 cm x 8 cm | Primary collimation: 15 cm x 15 cm
Secondary collimation: 10 cm diameter |
| Source to
Detector
distance (SDD) | 45 cm | 45 cm |
| Minimum
Source to Skin
Distance (SSD) | 10 cm, 19 cm with spacer cone | 10 cm, 20 cm with head extension |
| Weight | C-arm and power supply: 19.5 kg (43
lb.) | C-arm + battery: 7.3 kg (16 lb.)
Tablet: 1.5 kg (3 lb.) |
| Imaging, Display, and Software: | | |
| Monitor | 20.1 inch monochrome LCD | Tablet: 13" full color touchscreen LCD with
1920 x 1080 resolution
Monitor on Accessory Stand: 27" full color
touchscreen LCD monitor with 1920 x 1080
resolution |
| Image Transfer | Wired | Wireless image transfer:
IEEE 802.11AC with WPA2 encryption,
5GHz band, 80MHz bandwidth, MAC
Address filtering and restricted to a single
IP address. Beacon type handshake to
verify communication every 100-200 msec. |
| Data Standard | DICOM | DICOM |
| Image Storage | 12,000 images | 80,000 images |
| Removable Data
Storage | USB Port | USB Port |
| Hard Copy | Thermal Printer | Thermal Printer (optional) |
| Characteristic
or Property | Predicate Device
OrthoScan Mobile DI, K113708 | Turner Imaging Systems Smart-C |
| Device | | |
| Imaging
Features | 1 Main/2 Reference Windows
Auto x-ray technique control
Noise and motion reduction
Auto/manual brightness and contrast
control
Negate
Swap
Save and autosave
Last image hold
Edge enhancement
Zoom & Pan
Image rotation
Image flip/invert
Cine | 1 Main/1 Reference Window
Auto x-ray technique control
Noise and motion reduction
Auto/manual brightness and contrast control
Negate
Swap
Save and autosave
Last image hold
Edge enhancement
Zoom & pan
Image rotation
Image flip/invert
Automatic Sequence Record
Metal Detection |
| Support | Can be placed on a hard surface or
optional cart mounted. | Place on a table or other hard flat surface, or
optional cart mounted. |
| Software | Windows operating system and
Windows-like user interface. | Windows operating system with
touchscreen user interface. |
| PACS
Connectivity | Wireless | Wireless |
| X-Ray Performance | | |
| Performance
Standards | 21CFR1020.30
21CFR1020.32
IEC60601-1-3
IEC60601-2-28
IEC60601-2-54 | 21CFR1020.30
21CFR1020.32
IEC60601-1-3
IEC60601-2-28
IEC60601-2-54 |
5
6
Discussion: The Smart-C and the Mobile DI both use the same fundamental scientific technology of generating fluoroscopic x-ray images using an x-ray source monoblock and flat-panel xray imaging detector in a fixed C-arm configuration. The mechanical arrangement between these components is almost identical. One difference is the main power source being a Li-ion battery pack in the Smart-C and standard mains power supply for the Mobile DI. The safety and efficacy considerations of battery power for the Smart-C are considered and mitigated through the Risk Analysis and design mitigations.
A significant difference between the 2 devices is the use of a standard computer and imaging monitor for the Mobile DI, and the use of a Tablet Computer with integrated touchscreen display as the primary workstation for the Smart-C. To evaluate the substantial equivalence of the tablet computer/display with a standard imaging monitor, we referred to the FDA Guidance Display Devices for Diagnostic Radiology. In addition to the display data, a Qualified Expert Evaluation of the diagnostic ability of the tablet display device was performed by 2 independent board-certified physicians. The conclusion of the expert evaluators is that the image quality of the tablet is diagnostic in all presented cases, and thus substantially equivalent to a standard surgical monitor for the intended use of the Smart-C device.
7
Another significant difference between the units is that the Smart-C uses WiFi technology to wirelessly transfer the images from the x-ray detector to the Tablet computer for display and processing. This allows the display device to be positioned independently of the Smart-C. and within the physicians preferred field of view. This improves the workflow and ease of imaging. FDA guidance documents used in the development of the device include Radio Frequency Wireless Technology in Medical Devices, and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Summary Reports were prepared to show how the Smart-C complies with these guidance documents.
Summary Bench Testing
A Qualified Expert Evaluation of the image quality of the Smart-C was performed by independent physicians utilizing images obtained from anthropomorphic phantoms. An additional Image Quality Performance test was completed using image quality phantoms for contrast and spatial resolution. Dynamic image resolution was assessed using rotation of a phantom with 2 lead dots.
In addition to the image quality bench studies, system verification and validation testing including hazard mitigation has been performed to demonstrate the Smart-C system meets design input and user needs.
The Smart-C system has been tested to show compliance with the applicable IEC series of x-ray performance standards, including IEC60601-2-54. It also meets all applicable 21CFR Subchapter J performance standards.
Summary Clinical Testing
The clinical utility of the Smart-C was demonstrated by performing a Clinical Imaging Evaluation. Cadaver subjects were chosen to represent the range of extremity imaging. including shoulders. To represent a range of imaging conditions the testing was performed in both standard fluoro and in low-dose mode. Image enhancement algorithms like recursive filtering and edge enhancement were evaluated, and suitable conditions determined for their use. Patient positioning considerations for adult patients were considered in a separate usability study.
To address the special needs of neonatal and infant patients, a Pediatric Imaging Usability Evaluation was performed. This included the additional consideration of patient positioning for these very small size subjects. The Smart-C is not indicated for wholebody imaging of pediatric patients, so this study was limited to extremity positioning.
Based on physician feedback, the clinical images obtained with the Smart-C were at least as good as the predicate device. There were no new concerns regarding patient positioning, including for neonatal and infant patients.
- Conclusion: The Smart-C and the predicate device both have the same intended use to provide physicians with real-time fluoroscopic visualization of anatomy of extremities. Thev meet the same recognized performance and safety standards, and to conform to FDA guidance regarding solid-state x-ray imaging systems. The designs are based on the same modern technologies using a compact monoblock x-ray generator and flat-panel x-ray
8
detector, operating at similar power levels. Differences in technological characteristics (battery power, wireless image transfer, tablet display, and wireless footswitch) have been evaluated for safety hazards utilizing risk management activities and risk analysis. The design mitigations were successfully tested during verification and validation. The Smart-C has been evaluated by numerous physicians and surgeons for image quality and usability on anthropomorphic phantoms, image quality phantoms, and cadaver subjects in clinical settings. They determined that it performs at least as well as the predicate device, and that it is efficacious for the intended uses.
We conclude that the Smart-C is of comparable type and substantially equivalent to the predicate device Orthoscan Mobile DI (K113708) and is safe and effective for its intended use.