(118 days)
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery.
The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing and measuring spinal alignment assessment images at various time points during surgery as well as planning spinal surgical procedures. The IntraOp Alignment System is intended for use with patients aged 18 years and older.
The subject IntraOp Alignment (IOA) System consists of an optical tracking sensor, touchscreen computer, a mobile cart (stand) including an extension arm, and an electronics box with frame grabber, ports for video cables, power cables and external storage devices.
The subject IntraOp Alignment System is a software-based system that from one end interfaces with a mobile C-arm fluoroscope through a video cable and a frame capture device to receive fluoroscopic images as they are acquired, and from the other end connects to an optical position tracking sensor to track the position and orientation of a C-arm in real-time. By using subject IntraOp Alignment System along the side of mobile C-arm fluoroscopy equipment, the user of the system can combine multiple fluoroscopic images, as they are being acquired, into stitched long bi-planar radiographic images for intraoperative visualization and assessment. The user is required to identify the location of the spine in both bi-planar views to scale the image content and provide information regarding the depth of the operative anatomy. The user can then use the measurement tools available on the subject IntraOp Alignment System to visualize and assess the spinal alignment for intraoperative planning of the surgical procedure.
The subject IntraOp Alignment System has an optional capability to connect to a hospitalprovided Wi-Fi to import pre-operatively planned alignment parameters from an Alphatec cloud database. The subject IntraOp Alignment System also has the capability to export the post-operative alignment parameters to the cloud database.
The subject IntraOp Alignment System sits outside the sterile field and is provided non-The subject device is intended for use by trained healthcare professionals, and sterile. appropriately trained clinical and non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by trained non-clinical personnel.
The provided document is a 510(k) summary for the Alphatec Spine, Inc. IntraOp Alignment System. It describes the device's indications for use, technological comparison to predicate devices, and performance testing. However, it explicitly states: "Determination of substantial equivalence is not based on an assessment of clinical performance data."
Therefore, the document does not provide details about a study evaluating the device's performance against clinical acceptance criteria. It mentions "Verification testing to confirm that the system meets the accuracy specifications" and "Verification testing to verify that the following features: image stitching, C-arm tracking and spinal alignment measurements meet performance specifications" as nonclinical performance tests.
Given this limitation, I cannot provide a complete answer to all parts of your request. I will provide the information that is available in the document.
1. A table of acceptance criteria and the reported device performance
The document mentions that nonclinical performance testing was conducted to confirm the system meets accuracy specifications for image stitching, C-arm tracking, and spinal alignment measurements. However, it does not provide the specific numerical acceptance criteria or the reported device performance metrics from these tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As the document explicitly states that substantial equivalence is not based on clinical performance data, it likely refers to technical verification testing on phantoms or simulated data, but the details of such test sets are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied. The document explicitly states that "Determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document refers to "nonclinical performance testing" which included "Verification testing to confirm that the system meets the accuracy specifications" and "Verification testing to verify that the following features: image stitching, C-arm tracking and spinal alignment measurements meet performance specifications". While these tests would assess the algorithm's performance, the document does not explicitly state whether this was a standalone (algorithm only) evaluation versus an integrated system test. It mentions the "IntraOp Alignment System" which includes software and hardware components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for its nonclinical performance testing.
8. The sample size for the training set
The document does not provide information on a training set, as it primarily focuses on device comparison for substantial equivalence rather than AI/machine learning model development specifics.
9. How the ground truth for the training set was established
The document does not provide information on a training set or how its ground truth was established.
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May 22, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a circular seal with an eagle emblem, representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION."
Alphatec Spine, Inc. % Unnati Bhuptani Sr. Regulatory Affairs Specialist 1950 Camino Vida Roble CARLSBAD, CA 92008
Re: K240199
Trade/Device Name: IntraOp Alignment System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, LLZ Dated: January 24, 2024 Received: April 22, 2024
Dear Unnati Bhuptani:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K240199
Device Name IntraOp Alignment System
Indications for Use (Describe)
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery.
The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing and measuring spinal alignment assessment images at various time points during surgery as well as planning spinal surgical procedures. The IntraOp Alignment System is intended for use with patients aged 18 years and older.
| 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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Image /page/3/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, and the rest of the letters are dark blue. There is a green swoosh above the letters "tec". The letters are all lowercase.
K240199 - 510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| A. | SUBMITTER: | Alphatec Spine, Inc. |
|---|---|---|
| 1950 Camino Vida Roble | ||
| Carlsbad, CA 92008 | ||
| Phone: (760) 432-9286 | ||
| Fax: (760) 431-0289 | ||
| Contact Person: | Unnati Bhuptani | |
| Sr. Regulatory Affairs Specialist | ||
| Alphatec Spine, Inc. | ||
| Contact Phone: (760) 356-6711 | ||
| Date Summary Prepared: | January 24, 2024 |
B. DEVICE
| Trade Name: | IntraOp Alignment System |
|---|---|
| Common or Usual Name: | Interventional Fluoroscopic X-ray System |
| Classification Name: | Image-Intensified Fluoroscopic X-ray System(21 CFR §892.1650) |
| Regulatory Class: | Class II |
| Product Code: | OWB |
| Subsequent Codes: | JAA. LLZ |
C. LEGALLY MARKETED PREDICATE DEVICES
| Primary Predicate | |
|---|---|
| Trade Name: | Nuvasive® LessRay® with Enhanced Tracking |
| 510(k) number: | K170800 |
| 510(k) Clearance Date: | August 18, 2017 |
| Common or Usual Name: | Interventional Fluoroscopic X-ray System |
| Classification Name: | Image-Intensified Fluoroscopic X-ray System(21 CFR §892.1650) |
| Regulatory Class: | Class II |
| Product Code: | OWB |
| Subsequent Codes: | JAA, LLZ |
| Additional Predicate | |
| Trade Name: | ATEC Alignment App |
| 510(k) number: | K211987 |
| 510(k) Clearance Date: | October 29, 2021 |
| Common or Usual Name: | System, Image Processing, Radiological |
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| Classification Name: | Medical image management and processing system(21 CFR §892.2050) |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | LLZ |
| Reference Devices: | |
| Trade Name: | NuVasive® NuvaLine® |
| 510(k) number: | K192435 |
| 510(k) Clearance Date: | September 5, 2019 |
| Common or Usual Name: | System, Image Processing, Radiological |
| Classification Name: | Medical image management and processing system(21 CFR §892.2050) |
| Regulatory Class: | Class II |
| Product Code: | LLZ |
D. DEVICE DESCRIPTION
The subject IntraOp Alignment (IOA) System consists of an optical tracking sensor, touchscreen computer, a mobile cart (stand) including an extension arm, and an electronics box with frame grabber, ports for video cables, power cables and external storage devices.
The subject IntraOp Alignment System is a software-based system that from one end interfaces with a mobile C-arm fluoroscope through a video cable and a frame capture device to receive fluoroscopic images as they are acquired, and from the other end connects to an optical position tracking sensor to track the position and orientation of a C-arm in real-time. By using subject IntraOp Alignment System along the side of mobile C-arm fluoroscopy equipment, the user of the system can combine multiple fluoroscopic images, as they are being acquired, into stitched long bi-planar radiographic images for intraoperative visualization and assessment. The user is required to identify the location of the spine in both bi-planar views to scale the image content and provide information regarding the depth of the operative anatomy. The user can then use the measurement tools available on the subject IntraOp Alignment System to visualize and assess the spinal alignment for intraoperative planning of the surgical procedure.
The subject IntraOp Alignment System has an optional capability to connect to a hospitalprovided Wi-Fi to import pre-operatively planned alignment parameters from an Alphatec cloud database. The subject IntraOp Alignment System also has the capability to export the post-operative alignment parameters to the cloud database.
The subject IntraOp Alignment System sits outside the sterile field and is provided non-The subject device is intended for use by trained healthcare professionals, and sterile. appropriately trained clinical and non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by trained non-clinical personnel.
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Image /page/5/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is dark blue. There is a small trademark symbol in the upper right corner of the logo. The logo is simple and modern.
This submission seeks to establish that the IntraOp Alignment System is substantially equivalent to the primary predicate, Nuvasive® LessRay® with Enhanced Tracking (K170800), and additional predicate ATEC Alignment App (K211987) with respect to indications for use (IFU), intended use. technology, and performance specifications.
E. INDICATIONS FOR USE
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery.
The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing and measuring spinal alignment assessment images at various time points during surgery as well as planning spinal surgical procedures.
The IntraOp Alignment System is intended for use with patients aged 18 years and older.
F. TECHNOLOGICAL COMPARISON TO PREDICATES
The subject device was compared to the predicate device in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this 510(k), between the subject device and the predicate device, does not impact substantially equivalence, or safety and effectiveness. Table 1 below provided a detailed analysis of the substantial equivalence of the following device characteristics: indications for use, device functionalities. C-arm tracking, algorithms and accuracy specifications.
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| Attribute | Predicate Devices | Reference Device | Subject Device | SE Discussion | |
|---|---|---|---|---|---|
| Nuvasive® LessRay® with EnhancedTracking (K170800) | ATEC Alignment App(K211987) | NuVasive® NuvaLine®(K192435) | IntraOp Alignment System | ||
| Indications for Use | NuVasive® LessRay® with EnhancedTracking is intended for use in anyapplication where a fluoroscopeincorporated to aid in diagnosis andtreatment of disease. | The ATEC Alignment App assistshealthcare professionals in viewing,measuring, and storing images as well asplanning orthopedic surgeries. The appallows the healthcare professional toperform generic and specialtymeasurements of the images, and to plansurgical procedures. The app includestools for measuring anatomicalcomponents for implant selection andoffers the possibility to share data amongATEC Alignment App users. The app isfor planning use only and is not intendedfor primary diagnostic use. | NuVasive NuvaLine is a medical devicesoftware application intended to assisthealthcare professionals in capturing,viewing, measuring, and storage anddistribution of spinal alignment assessmentimages at various time points in patientcare. Online synchronization of thedatabase allows healthcare professionalsand service providers to convenientlyperform and review spinal alignmentassessments of images by featuringmeasurement tools on various platforms.Clinical judgment and experience arerequired to properly use the software. | The IntraOp Alignment System is intendedfor use in applications where a mobile C-arm fluoroscope is incorporated to aid indiagnosis and treatment during spinalsurgery.The IntraOp Alignment System is alsointended to assist healthcare professionalsin viewing, storing and measuring spinalalignment assessment images at varioustime points during surgery as well asplanning spinal surgical procedures.The IntraOp Alignment System is intendedfor use with patients aged 18 years andolder. | The subject device indications for use aresame as the primary predicate,Nuvasive® LessRay® with EnhancedTracking (K170800) for the imagestitching functionality. The indicationsfor use for use are also identical to theadditional predicate ATEC AlignmentApp (K211987) for the spinal alignmentassessments functionality. CompletedV&V testing successfully demonstratedthat the risks related to the differences inthe indications for use between thesubject device and primary predicatehave been mitigated and do not affect thesafety and effectiveness of the device.Therefore, the subject device can beconsidered substantially equivalent to theprimary predicate, Nuvasive® LessRay®with Enhanced Tracking (K170800) andadditional predicate, ATEC AlignmentApp (K211987). |
| Regulation Number | §892.1650 | §892.2050 | §892.2050 | §892.1650; | Same |
| Product Code | OWB, JAA, LLZ | LLZ | LLZ | OWB, JAA, LLZ | Same |
| Device Class | II | II | II | II | Same |
| Device Classification Name | Interventional Fluoroscopic X-RaySystem | System, Image Processing, Radiological | System, Image Processing, Radiological | Interventional Fluoroscopic X-Ray System | Same |
| Device Functionalities | Image Acquisition, Enhancement andDisplay :• Software based device used toprovide computer display systemsinterfaced to fluoroscope through avideo cable. The images producedby the fluoroscope are transmittedthrough a cable to a frame captureboard in the computer where theimages are enhanced and thendisplayed on the monitor.• Enhanced images are displayed on acomputer monitor at the same timethat the corresponding original | Measurement:• Spinal alignment assessments ofimages | Measurement:• Spinal alignment assessments ofimages | Image Acquisition, Processing,Stitching, and Display:• Software based system that fromone end interfaces with a mobile C-arm fluoroscope through a videocable and a frame capture device toreceive fluoroscopic images as theyare acquired.• As the images are being acquired,the user of the system can combinemultiple fluoroscopic images, intostitched long bi-planar radiographicimages for intraoperative | Substantially Equivalent. The imagestitching feature of the subject device issimilar in function to the primarypredicate. Nuvasive® LessRay® withEnhanced Tracking (K170800). Thevisualization and spinal alignmentassessment feature of the subject device issimilar in function to the additionalpredicate, ATEC Alignment App(K211987). |
| Attribute | Predicate Devices | Reference Device | Subject Device | SE Discussion | |
| Nuvasive® LessRay® with EnhancedTracking (K170800) | ATEC Alignment App(K211987) | NuVasive® NuvaLine®(K192435) | IntraOp Alignment System | ||
| • image is displayed on thefluoroscope monitor(s).• Serves only as an image displaywhich is in addition to thefluoroscope's standard imagedisplay device. Device is passive, inthat the operation depends only onthe video output of the fluoroscope,and it does not transmit any signalsor images to the fluoroscope. | visualization and spinal alignmentassessments.• Serves only as an image display whichis in addition to the fluoroscope'sstandard image display device. Deviceis passive, in that the operation dependsonly on the video output of thefluoroscope, and it does not transmitany signals or images to thefluoroscope.Spinal Alignment Measurements:• After bi-planar images are acquired,they are calibrated by the user usingthe established tools available onIntraOp Alignment Systemsoftware.• The user can place measurementtools for spinal alignmentassessments. | ||||
| C-arm Tracking | • When tracking is enabled, willautomatically choose the Baselinewhen the fluoroscope is near thelocation and orientation that theBaseline was initially taken.• When tracking is enabled, requireshardware components in order tomount the off-the-shelf trackinghardware to the C-arm and to theoperating table.• When tracking is enabled, requiresthe use of an off-the-shelf trackingsystem in order to track the 6 DOFlocation of the C-arm relative to theoperating table.• When tracking is enabled, visualcues are provided which help guidethe user in positioning the C-armback to where a prior Baseline wastaken. | N/A | N/A | • IntraOp Alignment System uses off-the-shelf tracking sensor and reflectivetracking markers to track the 6 DOFlocation of the C-arm relative totracking sensor.• The reflective tracking markers areattached on the mobile C-arm and areregistered and calibrated on the IntraOpAlignment System after its initialapplication on the C-arm.• The IntraOp Alignment System GUIguides the user regarding theplacement of the C-arm over theoperative anatomy and tracks the C-arm position relative to the trackingsensor using the reflective markers. | Substantially Equivalent. |
| Tracking Options | • Electromagnetic or optical | N/A | N/A | • Optical | Substantially Equivalent |
| Algorithms | • Image quality improvement usingaveraging algorithm | Patient parameters and calculations basedon published literature | Various spinal assessment algorithms | • Image quality improvement bydistortion removal using C-Armcalibration data | Substantially Equivalent. The imagestitching algorithm of the subject device issimilar in function to the primary |
| Attribute | Predicate Devices | Reference Device | Subject Device | ||
| Nuvasive® LessRay® with EnhancedTracking (K170800) | ATEC Alignment App(K211987) | NuVasive® NuvaLine®(K192435) | IntraOp Alignment System | SE Discussion | |
| • Contrast and brightnessenhancement with simultaneousreduction of random noise | • Image stitching using C-Arm positioncoordinates• Depth correction based on user input• Various spinal assessment algorithms | predicate, Nuvasive® LessRay® withEnhanced Tracking (K170800). Thespinal alignment assessment algorithm ofthe subject device is similar in function tothe additional predicate, ATECAlignment App(K211987). |
Table 1: Comparison for Substantial Equivalence
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PERFORMANCE DATA G.
Nonclinical performance testing demonstrates that the subject IntraOp Alignment System meets the functional, system, and software requirements. The following testing was conducted:
- Verification testing to confirm that the system meets the accuracy specifications ●
- Verification of the workflow to confirm that the system performs according to ● specifications
- Verification testing to verify that the following features: image stitching, C-arm tracking and spinal alignment measurements meet performance specifications
EMC and Electrical Safety Testing of the IntraOp Alignment System was performed to ensure all functions of the system and its accessories are electrically safe and comply with recognized electrical safety standards.
Clinical Information
Determination of substantial equivalence is not based on an assessment of clinical performance data.
H. CONCLUSION
The information provided in this submission demonstrates that the subject device does not pose additional risk to safety and effectiveness when compared to the predicate device. The subject device, IntraOp Alignment System, is substantially equivalent to the primary predicate, Nuvasive® with Enhanced Tracking (K170800), and additional predicate ATEC Alignment App (K211987).
§ 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.