(236 days)
The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.
The MiniCAT is a dedicated X-ray imaging device that acquires a 360-degree rotation x-ray sequence of images. The MiniCAT consists of both software and hardware components. The software is used for image acquisition, processing, and viewing and consists of the following main functional units patient database, study (scan) acquisition, study reconstruction, study view, report generation, and file saving. The software also controls the hardware components of the device. The major hardware components include the X-ray source, scanning arm (motor), and detector.
This submission is for a special 510(k) to address reported software failures in the MiniCAT device, specifically regarding a forced 10-minute delay between scans, running the software as a Windows shell, a daily calibration date checking function, and DICOM image unique identifiers compliance. This is a modification to a previously cleared device (K032243). The focus of the performance data is on software verification and validation, as the changes are software-only and do not raise new questions of safety or effectiveness regarding the core imaging performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Software Requirements (Implicit): | Software Verification and Validation Results: |
| Prevent scanning during "dwell" time. | A forced 10-minute delay has been added between scans to prevent the user from scanning during the "dwell" time. |
| Software stability and environment compatibility. | The software has been modified to run as a Windows shell. |
| Ensure daily calibration is performed. | The software includes a daily calibration date checking function that displays a warning message to the user prior to scanning, if the calibration has not yet been performed that day. |
| Compliance with DICOM standard for UIDs. | The DICOM image unique identifiers (UIDs) have been brought into compliance with the DICOM standard. |
| Overall safe and effective function for intended use. | "The Xoran MiniCAT computed tomography x-ray system met all requirements and functions as intended. Thus, the modified MiniCAT is safe and effective for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of clinical image evaluation, nor does it mention data provenance (e.g., country of origin, retrospective or prospective) for such a test set. This submission is for software modifications, and the "performance data" section focuses on software verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The provided text does not mention the use of experts to establish a ground truth for a test set. The submission focuses on software functionality rather than diagnostic performance assessed by human readers.
4. Adjudication Method for the Test Set
The provided text does not mention an adjudication method. As no expert review or test set is described, adjudication would not be applicable within the scope of this regulatory submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement
An MRMC comparative effectiveness study was not done or at least not reported in this submission. The submission is for software modifications to an existing device, not for a new device requiring a comprehensive clinical performance evaluation with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study of the algorithm's diagnostic capabilities (without human-in-the-loop) was not explicitly described for this software modification. The performance data focuses on verification and validation of the software changes themselves. The core imaging algorithm's standalone performance would have been assessed in the initial 510(k) for the MiniCAT (K032243).
7. The Type of Ground Truth Used
For the software modifications, the "ground truth" was programmatic and functional:
- Compliance with specifications: The "forced 10-minute delay" was verified to correctly implement the delay.
- Operating system compatibility: "Running as a Windows shell" was verified for correct integration.
- Warning message functionality: The "daily calibration date checking function" was verified to display the warning under the correct conditions.
- DICOM standard adherence: "DICOM image unique identifiers (UIDs) have been brought into compliance" was verified against the DICOM standard.
There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for diagnostic performance, as that was not the scope of this specific software modification submission.
8. The Sample Size for the Training Set
The provided text does not mention a training set or its sample size. This submission is about software modifications, not the development or training of a new AI/machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
Since there is no mention of a training set, there is no information on how its ground truth was established.
§ 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.