(39 days)
The XCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand, and foot).
The xCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The xCAT™ can measure distances and thickness on two dimensional images. Images produced by the xCAT can be exported via Ethernet or onto optical media or a memory stick. The building blocks of the xCAT are a motorized scanning arm carrying an Xray source and image detector, and a computer running the xCAT software. The scanning arm facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector transforms them into three dimensional images and displays them on the computer monitor for viewing.
The provided 510(k) summary for the Xoran xCAT™ does not contain information regarding specific acceptance criteria, a study proving device performance against such criteria, or details typically found in a clinical or performance study report. The document focuses on establishing substantial equivalence to predicate devices rather than proving performance against defined metrics.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the text:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, resolution, noise levels) or report specific performance metrics for the xCAT™ beyond its intended imaging capabilities and reconstruction process.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No test set, sample size, or data provenance are mentioned, as a formal performance study against detailed acceptance criteria is not described.
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):
- Not provided. Ground truth establishment is not discussed, as there is no described test set or performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Adjudication methods are not applicable as no test set or ground truth establishment process is described.
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:
- Not provided. An MRMC study is not mentioned. The xCAT™ is described as an imaging device that produces images for human viewing and measurement, without explicit mention of AI assistance or human reader performance improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not provided. The document describes the device as producing images for viewing and measurement by a user, implying human intervention. There is no mention of a standalone algorithm performance evaluation without human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. As no performance study is detailed, the type of ground truth used is not specified.
8. The sample size for the training set:
- Not provided. The document describes the xCAT™ as an imaging device that reconstructs 3D images from X-ray sequences. It does not mention any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established:
- Not provided. This is not applicable, as no training set or AI component requiring ground truth for training is described.
Summary of what the document does provide regarding device evaluation:
The 510(k) submission establishes substantial equivalence to predicate devices (Neurologica's NL 3000 CereTom and Xoran Technologies Inc. MiniCATTM) rather than providing a detailed performance study with specific acceptance criteria. The basis for clearance is that its design, material, functionality, and technology are comparable to these existing, legally marketed devices, and it does not pose new safety or effectiveness issues.
The "study" implicitly referenced is the comparison to predicate devices, which allows the FDA to conclude that the device is substantially equivalent for its intended use. Potential hazards are stated to be controlled by a risk management system, including Hazard Analysis and Software Development and Validation Process, but no details of these processes or their outcomes are provided.
§ 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.