(201 days)
The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuro-angiographic cases.
The Advantage 3D XR is an X-ray imaging software option that allows the interactive display of a structure from any point of view. This is accomplished by constructing a 3D model from images taken during a single Digital Subtracted Angiography (DSA) rotation (200 degrees). A spin acquisition is performed with an LC gantry system using a specific mode (predefined start and stop positions). The data is available for diagnosis on the acquisition system and may be sent to the Advantage Windows workstation. Within 10 minutes, a 3D construction of the vasculature is available and the Navigator software package (K954355) is used to interactively create views of this object. The software allows the ability to make measurements ( length and volume) on the 3D structure. The gantry angles for each view are displayed and the physician may use them to make a DSA acquisition on the patient to get an optimized 2d image of the desired viewpoint.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, the performance is described through the successful validation and clinical use, implying that the device generates "3D information from an X-ray spin sequence" and that "the 3D construction of the vasculature is available" for diagnosis and measurement. The primary acceptance criterion seems to be the successful demonstration of the device's ability to perform its stated function and the absence of identified hazards that are not controlled by a risk management plan.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to construct a 3D model from DSA rotational angiography images. | "Within 10 minutes, a 3D construction of the vasculature is available." The device successfully generates "3D information from an X-ray spin sequence." |
| Availability of interactive display and views of the 3D object. | "The Navigator software package (K954355) is used to interactively create views of this object." |
| Ability to make measurements (length and volume) on the 3D structure. | "The software allows the ability to make measurements (length and volume) on the 3D structure." |
| Control of potential hazards (wrong measurements, misdiagnosis). | Potential hazards are "controlled by a risk management plan including: a Hazard Analysis, a Software Development and Validation Process, and external validations of the algorithms by different research hospitals to assess the validity of the 3D information." |
| Optimized for neuro-angiographic cases. | "The product is optimized for neuro-angiographic cases." |
| Substantial equivalence to predicate device (Advantage Windows 3D with Navigator Option). | FDA determined the device is "substantially equivalent" to the predicate for the stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions two types of clinical sites and examinations:
- Morphometer Sites: More than 200 examinations were done using a morphometer device at Hopital Ponchaillou, Rennes, France and HCL, Lyon, France.
- LC Angiographic System Gantry Sites: 250 examinations were performed at Hopital Pontchaillou, Rennes, France and CHU Saint-Julien, France.
Combining these, a total of over 450 examinations were performed for the clinical validation.
- Data Provenance: The data is prospective clinical data collected from two countries: France (Hopital Ponchaillou, Rennes; HCL, Lyon; CHU Saint-Julien).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document states "external validations of the algorithms by different research hospitals to assess the validity of the 3D information." It also mentions "A publication from Pr Picard, CHU Saint-Julien, France is available." and "medical publications on the obtained results are available in Attachment #9."
However, the document does not specify the exact number of experts used to establish ground truth for the test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It only implies involvement of medical professionals at the research hospitals.
4. Adjudication Method for the Test Set:
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It only refers to "external validations" and "medical publications."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The focus is on the standalone performance and capabilities of the 3D reconstruction software itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are essentially standalone performance evaluations of the algorithm. The "successful validation" using morphometer and LC angiographic system gantry, producing 3D constructions and measurements, describes the algorithm's direct output. The statement "Within 10 minutes, a 3D construction of the vasculature is available" and the ability to make measurements directly reflect the algorithm's standalone capability.
7. The Type of Ground Truth Used:
The document implies a form of expert consensus and clinical assessment as the ground truth. The "external validations of the algorithms by different research hospitals to assess the validity of the 3D information" and the "medical publications on the obtained results" suggest that the output of the 3D reconstruction was clinically reviewed and found to be valid and useful by medical experts in determining patient anatomy. It's not explicitly stated as pathology or outcomes data in this summary.
8. The Sample Size for the Training Set:
The document does not specify the sample size used for the training set. The described studies focus on the validation of the device.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established. This detail is typically part of development and internal validation, which is not detailed in this summary of safety and effectiveness.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.