(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.
§ 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.