(24 days)
The Orthoscan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including when imaging limbs/extremities, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
The proposed modifications to Orthoscan, Inc. TAU Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan TAU 2.0, for distinction from predicate Orthoscan TAU) retain identical function as the predicate TAU Mini C-arm (K183220) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders, knees, and Hips. The system consists of C-arm support attached to the image workstation.
The changes to the Orthoscan TAU series of Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU mini C-Arm K183220. The proposed modifications to the predicate encompass the implementation of an optional IGZO 15 cm x 15 cm Flat Panel Detector (FPD) in the 15x12cm and 15x15cm device detector sizes, a new LINUX based operating system and related software, image processing board revisions and a revised Power Manager Board for AC to DC conversion that will distribute 24Vdc via a medical grade DC power supply. The proposed device incorporates software architecture and other improvements that replicate the features and functions of the predicate device and improve image clarity without increasing dose levels.
This FDA 510(k) summary describes the modified Orthoscan TAU Mini C-arm (Orthoscan TAU 2.0) and its substantial equivalence to its predicate device (Orthoscan TAU Mini C-arm, K183220). The device is an image-intensified fluoroscopic x-ray system.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner for specific benchmarks. Instead, it focuses on demonstrating substantial equivalence to the predicate device by comparing technological characteristics and asserting overall safety and effectiveness.
The document highlights differences in the modified device (Orthoscan TAU 2.0) compared to the predicate (Orthoscan TAU):
- Optional IGZO Flat Panel Detector (FPD): The predicate used CMOS detectors. The modified device offers CMOS or optional IGZO for 15x12cm and 15x15cm sizes.
- Reported Performance: "Substantially Equivalent. The introduction of the optional IGZO technology was found to be equal in safety and effectiveness including image quality (Essential Performance). IGZO sensor technology demonstrates equal/better image quality to that of the predicate... and provides slightly improved image quality at equal dose values as the predicate."
- Linux-based Operating System: The predicate used Windows 8.1 Embedded.
- Reported Performance: "Substantially Equivalent operating system was shown to support nearly identical workflows to achieve the same basic functionality with new proposed device software application. During verification and validation activities this change did not raise any safety and/or effectiveness concerns. The difference does not affect the safety or efficacy of the device."
- Revised Power Manager Board: For AC to DC conversion.
- Reported Performance: "Substantially Equivalent. The AC to DC conversion will provide intrinsic value through risk reduction such as leakage, while standardizing distribution of 24Vdc."
- Software Architecture (OrthoTouch Application vs. OrthoMini Application):
- Reported Performance: "Software architecture design is Substantially Equivalent to that of the predicate device... The OrthoTouch Application provides the main user interface to Orthoscan fluoroscopic X-Ray products, identical to OrthoMini, application. OrthoTouch on LINUX operating system performs equal to OrthoMini."
- Graphical User Interface (GUI):
- Reported Performance: "Substantially Equivalent GUI application are nearly Identical in workflows to achieve the same basic functionality with new proposed device software application. During verification and validation activities this change did not raise any safety and/or effectiveness concerns. The difference does not affect the safety or efficacy of the device."
- Minor Differences in Detector Specifications (Pixel Spacing, Dynamic Range, DQE) for IGZO:
- Reported Performance: These differences "do not affect the safety or efficacy of the device."
The overall "acceptance criteria" seem to be the demonstration of substantial equivalence to the predicate device, ensuring at least the same level of safety and effectiveness, including image quality.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The "test set" for the image quality comparison consisted of:
- "Numerous Image comparison sets"
- Images from "Anthropomorphic (PMMA material) phantoms"
- Images from "anatomical simulation phantoms"
- Sample Size: The exact number of images or phantoms in the "numerous image comparison sets" is not specified.
- Data Provenance: The study was a retrospective lab test image comparison study conducted by Orthoscan, Inc. (the manufacturer). There is no mention of country of origin for the data; it was an internal company lab study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: One expert.
- Qualifications: A "board-certified Radiologist." No details on years of experience or specialization are provided beyond this.
- Ground Truth Establishment: The radiologist performed an "assessment of individual images arranged in groups of image sets." Their conclusion served as the basis for the ground truth regarding image quality comparison between the modified and predicate devices.
4. Adjudication Method for the Test Set
- Adjudication Method: None mentioned or implied. Only one radiologist was involved in the assessment, so there was no multi-reader consensus or adjudication process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The study involved a single radiologist's assessment of image sets from phantoms.
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: The device is a fluoroscopic X-ray system, not an AI algorithm in the context of standalone performance studies typically seen for AI/ML devices. The "algorithm" here refers to image processing within the device. The performance assessment was based on visual evaluation of the output images by a human expert. Therefore, a standalone algorithm-only performance study in the way it's usually defined for AI software was not conducted or described. The performance tested was for the integrated device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for image quality was established by expert consensus (albeit by a single expert) and comparison of visual characteristics ("image quality") based on images of "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." The expert's conclusion stated "the image quality at same or similar patient dose rates will result in a slight improvement in patient care (images) for the proposed modified TAU device over the Predicate device."
8. The Sample Size for the Training Set
- Training Set Sample Size: This submission is for a medical device (Mini C-arm X-ray system), not an AI/ML software. It describes modifications to an existing device, including a new operating system and detector options. There is no mention of a training set in the context of machine learning. The device itself is not presented as an AI-powered diagnostic tool requiring a separate training process for its core functionality.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.
§ 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.