(263 days)
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.
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.
The provided text describes the 510(k) premarket notification for the Smart-C™ X-ray Imaging System and its comparison to a predicate device, the Orthoscan Mobile DI Mini C-arm. The document focuses on demonstrating substantial equivalence, rather than a traditional AI/ML performance study with specific acceptance criteria metrics like sensitivity, specificity, or AUC.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of explicit performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for a medical AI device cannot be fully extracted from this document. This is because the Smart-C is an imaging device, not an AI/ML algorithm that interprets images. The "performance" discussed relates to image quality and usability, compared to a predicate device, rather than diagnostic accuracy of an algorithm.
However, I can extract information related to the device's evaluation methods and the qualitative assessment of its performance against the predicate, which serves as its "acceptance criteria" for substantial equivalence.
Here's an attempt to answer the questions based on the available text, with caveats where the specific details are not provided:
Device: Smart-C™ X-ray Imaging System
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated as quantitative performance metrics (e.g., specific image resolution values to be met). Instead, the performance is evaluated against the predicate device and relevant standards to demonstrate substantial equivalence. The "acceptance" is qualitative: that the device's image quality and usability are "at least as good as" the predicate device and meet applicable safety and performance standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Image Quality: "Diagnostic ability" and "image quality" equivalent to a standard surgical monitor/predicate device. | 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." Additionally, "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.""Based on physician feedback, the clinical images obtained with the Smart-C were at least as good as the predicate device." |
| Safety and Efficacy: Compliance with relevant standards and guidance documents. | The device "meets the same recognized performance and safety standards, and to conform to FDA guidance regarding solid-state x-ray imaging systems." It has been tested for compliance with "applicable IEC series of x-ray performance standards, including IEC60601-2-54" and "all applicable 21CFR Subchapter J performance standards." Risk analysis and design mitigations were successfully tested. |
| Usability: Equivalent or improved workflow/ease of imaging, given differences like wireless technology and battery power. | The wireless image transfer "improves the workflow and ease of imaging." "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." Pediatric Imaging Usability Evaluation was performed for neonatal and infant patients. "There were no new concerns regarding patient positioning, including for neonatal and infant patients." "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." |
| Technical Equivalence: Fundamental scientific technology and core components similar to predicate. | Both devices "use the same fundamental scientific technology of generating fluoroscopic x-ray images using an x-ray source monoblock and flat-panel x-ray imaging detector in a fixed C-arm configuration." Designs are "based on the same modern technologies using a compact monoblock x-ray generator and flat-panel x-ray detector, operating at similar power levels." |
2. Sample sizes used for the test set and the data provenance
- Test Set (Clinical Imaging Evaluation):
- Sample Size:
- "Cadaver subjects were chosen to represent the range of extremity imaging, including shoulders." (Specific number not provided).
- A "Pediatric Imaging Usability Evaluation was performed" for "neonatal and infant patients." (Specific number of subjects not provided).
- For the tablet display evaluation, "all presented cases" were evaluated (number of cases not specified).
- "Anthropomorphic phantoms" and "image quality phantoms" were also used.
- Data Provenance: Not explicitly stated (e.g., country of origin). The evaluation involved "clinical" settings using cadavers. The pediatric study was also an "Evaluation," implying a simulated or controlled setting, not necessarily retrospective or prospective patient data from a real clinic.
- Sample Size:
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts:
- Tablet Display Evaluation: "2 independent board-certified physicians."
- Image Quality Evaluation (Smart-C): "independent physicians" (number not specified).
- General Evaluation: "numerous physicians and surgeons" (number not specified).
- Qualifications of Experts: "board-certified physicians" for the display evaluation. For other evaluations, they are referred to simply as "physicians" or "physicians and surgeons."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For the tablet display evaluation, it states, "The conclusion of the expert evaluators is that the image quality of the tablet is diagnostic in all presented cases..." This suggests that both experts agreed, or their consensus was sufficient. No formal adjudication method like "2+1" or "3+1" is described.
- For other aspects, "physician feedback" was used, implying a qualitative assessment rather than a structured adjudication process for ground truth.
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
- No MRMC comparative effectiveness study was done with AI assistance. This device is an X-ray imaging system, not an AI-powered diagnostic algorithm. The evaluations were performed to establish image quality and usability of the device itself compared to a predicate device, not to evaluate human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The Smart-C is a piece of hardware (fluoroscopic X-ray system) that produces images for human interpretation, not a standalone diagnostic algorithm. Its "performance" refers to the quality of the images it generates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the evaluations was primarily expert judgment/consensus regarding image diagnostic quality and usability. This was based on:
- "Anthropomorphic phantoms" and "image quality phantoms" (for objective image quality measures like contrast and spatial resolution).
- "Cadaver subjects" (for clinical imaging evaluation and simulating patient positioning).
- "Neonatal and infant patients" (for pediatric usability evaluation, likely simulated or using models).
- Physicians' informal "feedback" and "conclusion" on images and usability.
8. The sample size for the training set
- Not applicable. This document describes the evaluation of a medical imaging device, not the development or training of an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As a hardware medical imaging device, there is no AI/ML training set or associated ground truth establishment process in the context of this FDA submission.
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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
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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 WOrem, 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
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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: | ||
|---|---|---|
| Characteristicor Property | Predicate DeviceOrthoScan Mobile DI, K113708 | Turner Imaging Systems Smart-C |
|---|---|---|
| Classification | Regulation number: 21 CFR 892.1650Regulation name: Image-intensifiedFluoroscopic x-ray systemRegulatory Class: IIProduct Code: OXO and JAA | Regulation number: 21 CFR 892.1650Regulation name: Image-intensifiedFluoroscopic x-ray systemRegulatory Class: IIProduct Code: OXO and JAA |
| Intended Use | The OrthoScan Mobile DI [1000-0005]is a mini c-arm X-ray system designedto provide the physician with generalfluoroscopic visualization of the patientincluding, but not limited to, surgicalorthopedic procedures and critical andemergency care procedures in hospital,emergency care, critical care, clinical,or physician office environments. TheMobile DI is capable of generating,processing, capturing, saving andtransmitting fluoroscopic images ofpatient extremities for the purpose ofdiagnostic imaging. In addition, theportability of the OrthoScan Mobile DIprovides for ease of use in athletic teamvenues, and military units. | The Smart-C is a mini C-arm X-ray systemdesigned to provide physicians with realtime general fluoroscopic visualization ofadult and pediatric patients. It is intended toaid physicians and surgeons duringdiagnostic procedures, therapeutictreatment, or surgical procedures of thelimbs, extremities, or shoulders includingbut not limited to, orthopedics andemergency medicine. The Smart-C isintended to be used on a table or other hardflat surface. It may also be used with theoptional 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 ACmains to charge battery | ||
| Footswitch: Alkaline AA Battery; 1.5VDC | ||
| X-ray Source | Fixed anode, beryllium windowFocal spot: 0.05mmVoltage range: 40 to 78 kVCurrent range: 40 to 160 μAExposure: ContinuousDuty Cycle: Continuous | Fixed anode, tungsten filamentFocal spot: 0.03-0.05mmVoltage range: 40 to 80 kVCurrent range: 65 to 370 μAExposure: Pulsed, 10FPS, 40ms per frameDuty cycle: 1 min. of fluoroscopy per 5min. |
| Image Receptor | Type: CMOS Flat Panel | Type: CMOS Flat Panel |
| Characteristicor Property | Predicate DeviceOrthoScan Mobile DI, K113708 | Turner Imaging Systems Smart-C |
| Scintillator:Full Field: 15cm x 12cmLimited Field: 11cm x 8cmPixel Size: 75 micronsArray Size: 1.5k x 2k | Scintillator: Cesium IodideFull Field: 15cm x 15cmLimited Field: 10cm dia. circlePixel Size: 99 micronsArray Size: 1.5k x 1.5k | |
| Electrical Safetyand EMIStandards | ANSI/AAMI std IEC60601-1IEC60601-1-2 | ANSI/AAMI std IEC60601-1IEC60601-1-2 |
| Mechanical/Physical: | ||
| C-arm PhysicalDimensions | 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 cmMagnification mode: 11 cm x 8 cm | Primary collimation: 15 cm x 15 cmSecondary collimation: 10 cm diameter |
| Source toDetectordistance (SDD) | 45 cm | 45 cm |
| MinimumSource to SkinDistance (SSD) | 10 cm, 19 cm with spacer cone | 10 cm, 20 cm with head extension |
| Weight | C-arm and power supply: 19.5 kg (43lb.) | 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 with1920 x 1080 resolutionMonitor on Accessory Stand: 27" full colortouchscreen LCD monitor with 1920 x 1080resolution |
| Image Transfer | Wired | Wireless image transfer:IEEE 802.11AC with WPA2 encryption,5GHz band, 80MHz bandwidth, MACAddress filtering and restricted to a singleIP address. Beacon type handshake toverify communication every 100-200 msec. |
| Data Standard | DICOM | DICOM |
| Image Storage | 12,000 images | 80,000 images |
| Removable DataStorage | USB Port | USB Port |
| Hard Copy | Thermal Printer | Thermal Printer (optional) |
| Characteristicor Property | Predicate DeviceOrthoScan Mobile DI, K113708 | Turner Imaging Systems Smart-C |
| Device | ||
| ImagingFeatures | 1 Main/2 Reference WindowsAuto x-ray technique controlNoise and motion reductionAuto/manual brightness and contrastcontrolNegateSwapSave and autosaveLast image holdEdge enhancementZoom & PanImage rotationImage flip/invertCine | 1 Main/1 Reference WindowAuto x-ray technique controlNoise and motion reductionAuto/manual brightness and contrast controlNegateSwapSave and autosaveLast image holdEdge enhancementZoom & panImage rotationImage flip/invertAutomatic Sequence RecordMetal Detection |
| Support | Can be placed on a hard surface oroptional cart mounted. | Place on a table or other hard flat surface, oroptional cart mounted. |
| Software | Windows operating system andWindows-like user interface. | Windows operating system withtouchscreen user interface. |
| PACSConnectivity | Wireless | Wireless |
| X-Ray Performance | ||
| PerformanceStandards | 21CFR1020.3021CFR1020.32IEC60601-1-3IEC60601-2-28IEC60601-2-54 | 21CFR1020.3021CFR1020.32IEC60601-1-3IEC60601-2-28IEC60601-2-54 |
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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.
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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
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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.
§ 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.