(213 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 pediatic populations when imaging limbs/extremittes, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
The OrthoScan TAU Mini C-Arm is a mobile fluoroscopic mini Carm 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 proposed device provides the option of three CMOS flat panel detector sizes and identical X-ray source HVPS monoblock generator assembly with continuous or pulsed operation for image acquisition. The C-arm supports the CMOS FPD, X-Ray controls, collimator, high voltage generator with a fixed SID imaging. The C-arm and support arm which is connected to the mobile workstation platform are mechanically balanced allowing the operator precise positioning and locking of the vertical, horizontal, orbital and rotational movements at various angles and distances when imaging the patient's anatomical structures. The main workstation platform that supports the C-arm assembly contains the power control system, image processing system, system software, monitor display control and main user interface controls. The combination of C-Arm and workstation provides the clinician with a stable platform to obtain precise angles for localizing the patient's anatomical structures and visualization of pathology during live fluoroscopic imaging. The touch screen interface and keyboard provide user concise selectable imaging, X-ray technique control, entry of patient demographics and related procedural information. The workstation supports both an optional wired or wireless fluoroscopic footswitch allowing optimal positioning for the clinician. The optional connector interface panel of the OrthoScan TAU Mini C-Arm provides convenient connection of peripheral devices such as thermal video printers, image storage devices (USB) and DICOM fixed wire and wireless network interfaces.
The provided text is a 510(k) Summary for the OrthoScan TAU Mini C-Arm, which is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on non-clinical testing to support the claim of substantial equivalence, rather than a full clinical study with specific acceptance criteria and performance metrics typically seen for novel devices or AI/software as a medical device (SaMD) where performance improvement is a key claim.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment, which are standard for AI/SaMD studies, are not explicitly provided in this document as it pertains to a traditional medical imaging device (C-arm) that primarily demonstrates substantial equivalence to existing technology.
However, I can extract the information that is present regarding device performance and the "study" conducted to support substantial equivalence.
Here's a breakdown of what can be inferred or directly stated from the document, and what is missing due to the nature of this 510(k) submission for an imaging device, not an AI algorithm:
Acceptance Criteria and Reported Device Performance
The document doesn't present a table of "acceptance criteria" in the traditional sense of specific numerical thresholds for diagnostic performance (e.g., sensitivity, specificity, AUC) that an AI algorithm would be tested against. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed through "image comparison" and "dose assessment" to show that the new device performs "as intended" and provides "similar image quality with new IDR filter" at "lower entrance dose level" compared to the predicate.
The table below summarizes the comparative technological characteristics which are used to argue substantial equivalence, and indirectly imply performance. The primary "performance" studied here is image quality and dose reduction, not diagnostic accuracy of an AI.
Table of Performance Comparison (Excerpted and Reinterpreted from the Provided Document)
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (OrthoScan TAU Mini C-Arm) | Comparison to Predicate, Comments to Differences (Why it's "Acceptable") |
|---|---|---|---|
| Image Quality / Detector | |||
| Detector Technology | medical grade GadOx (T1)/CMOS solid state X-ray detector | medical grade CsI(T1)/CMOS solid state X-ray detector | All Detectors of the TAU Mini C-Arm are of similar design Technology and Scientific principal to that of the Predicate (K133174) They share the advantages of SSXI image receptors. |
| Detector Resolution | 1.5 k x 1.5 k | TAU 2020 = 2.0k x 2.2 k | |
| TAU 1515 = 1.5 k x 1.5 k | |||
| TAU 1512 = 2.0 k x 1.5 k | Substantially Equivalent. The proposed device has added the ability of a larger FOV for Physician. These changes do not raise new safety or effectiveness concerns. | ||
| Field of View (Full) | 5.5" x 5.5" | TAU 2020 = 8" x 8" | |
| TAU 1515 = 5.5" x 5.5" | |||
| TAU 1512 = 5.5" x 4.3" | Substantially Equivalent. The proposed device has added the ability of a larger FOV for Physician. These changes do not raise new safety or effectiveness concerns. | ||
| Field of View (Collimated Mag) | 4.3" x 4.3" | TAU 2020 = 4" x 4" | |
| TAU 1515 = 4.3" x 4.3" | |||
| TAU 1512 = 4.3" x 3.3" | Substantially Equivalent. The proposed device has added the ability of a larger Field of view for the Physician. These changes do not raise new safety or effectiveness concerns. | ||
| Detector Size | 15.0 x 15.0 (cm) | TAU 2020 = 20 x 20 cm | |
| TAU 1515 = 15 x 15 cm | |||
| TAU 1512 = 15 x 12 cm | Substantially Equivalent. The proposed device has added the ability of a larger Field of view for the Physician. The difference does not affect the safety or efficacy of the device. | ||
| DQE | 70% (implied for predicate, not explicitly stated as a value) | TAU 2020 = 70% | |
| TAU 1515 = 70% | |||
| TAU 1512 = 70% | Identical. The difference does not affect the safety or efficacy of the device. | ||
| Grayscale Resolution | 16 bit (65,536 shades of gray) | 16 bit (65,536 shades of gray) | Identical. |
| Dose Reduction | |||
| Pediatric Dose Reduction IDR | NO | YES | IDR unique set of features and functions. Pediatric Dose reduction and special features for pediatric population. Dose assessment and image comparison of dose reduction for pediatric confirmed similar image quality with new IDR filter. The difference does not affect the safety or efficacy of the device. See Substantially Equivalent. |
| Adult Dose Reduction IDR | NO | YES | IDR unique set of features and functions for Adult population. Dose assessment and image comparison of dose reduction confirmed similar image quality with new IDR filter. The difference does not affect the safety or efficacy of the device. Substantially Equivalent. |
| Beam Pre-filter | Predicate has 2.5mm AL | 0.1mm Cu (Yes) | Although not identical, New Device X-ray beam pre-filter helps reduce skin entrance dose by adding additional filtration of Cu. |
| Collimator | Fixed Aperture @ Fixed SID (Normal, Mag) | TAU 1512/1515 Fixed Aperture @ Fixed SID (Normal, Mag) | |
| TAU 2020 Stepless Collimator with Fixed SID (4 Leaf, 2 Axis) | Although not Identical both have similar intended use of collimating X-ray beam providing compliance with the regulations. Substantially Equivalent. |
Study Details (as inferable from the 510(k) Summary)
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Images: 330 individual images arranged in 20 groups of image sets.
- Data Provenance: The study involved images taken from "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." This means the data is synthetic/phantom-based, not from human patients. The country of origin is not specified, but given the FDA submission, it's presumed to be a controlled laboratory setting. The study is inherently non-clinical (not retrospective or prospective on human subjects).
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: 1 Radiologist.
- Qualifications: "a board-certified Radiologist." No specific years of experience or sub-specialty are explicitly mentioned beyond board certification.
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Adjudication Method for the Test Set:
- There is no mention of an adjudication method (like 2+1 or 3+1). The evaluation was "conducted by a board-certified Radiologist." This implies a single reader assessment for comparison.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document explicitly states: "OrthoScan TAU mobile fluoroscopic mini C-arm system did not require live human clinical studies to support substantial equivalence... Therefore, OrthoScan conducted a lab test image comparison study employing the use of anthropomorphic phantoms..." The study was a "lab test image comparison study" and involved a "Radiologist performed an assessment of 330 individual images." This is not an MRMC study.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this is a device clearance, not an AI algorithm. The device aims to provide better image quality at lower dose, which indirectly can improve human interpretation, but this was not quantified in an MRMC study.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a medical imaging device (C-arm), not an AI algorithm. The "performance" being evaluated is the direct image output of the device itself and its dose characteristics, not a diagnostic output from an automated algorithm.
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The Type of Ground Truth Used:
- Phantom-based comparison with expert assessment. The "ground truth" for image quality and dose reduction in this context is established by the comparative assessment of images generated using standardized phantoms and evaluated by a qualified radiologist in conjunction with laboratory performance data (e.g., on dose). There's no "pathology" or "outcomes data" ground truth as this is a technical assessment of an imaging device.
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The Sample Size for the Training Set:
- Not applicable. This is a medical device, not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The device's design and software are developed through engineering and quality processes, not through autonomous learning from a dataset.
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How the Ground Truth for the Training Set was Established:
- Not applicable due to the reasons stated above.
§ 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.