(69 days)
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical)
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blodd clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
The Auklet is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "clice" of the body. As is common with today's CT Scanner, the Auklet has the capability to acquire volumetric (helical) data by initiating table movement during data acquisition. This data can be reconstructed per the operator's preference, to include three dimensional rendering of the patient data. This device incorporates a standard x-ray tube and xenon gas filled x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.
This 510(k) submission for the Toshiba Auklet CT Scanner (TSX-003A) focuses on demonstrating substantial equivalence to a predicate device (Toshiba TSX-002A, Xvision [K941745]). As such, the submission primarily describes the device's technical characteristics and intended use, aligning with the predicate. It does not include a study with acceptance criteria and reported device performance in the way a clinical performance study would typically be presented for novel devices or highly complex algorithms.
Here's a breakdown of why this information isn't present in the provided text and what can be inferred:
Since this is a submission for a CT scanner, the "device performance" refers to the scanner's ability to produce images, and "acceptance criteria" relate to its safety and effectiveness, usually demonstrated through technical specifications and comparisons to a legally marketed predicate.
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail metrics in a table. For CT scanners, acceptance criteria would typically involve technical specifications like spatial resolution, contrast resolution, noise levels, dose output, scan times, image reconstruction speed, and safety features. These are usually established through national/international standards and regulatory guidance.
- Reported Device Performance: The document states, "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition." This implies that its performance is equivalent to the predicate. The performance of the predicate device (Toshiba TSX-002A, Xvision [K941745]) would have been established through its own 510(k) clearance process, where it demonstrated its ability to produce clinically useful images.
2. Sample size used for the test set and data provenance:
- Not applicable in the context of this 510(k). This submission is for a medical imaging hardware device (CT scanner), not a diagnostic algorithm that analyzes medical images. Therefore, there isn't a "test set" of patient data in the typical sense for evaluating algorithm performance.
- Data Provenance: Not relevant here.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. No ground truth establishment related to interpreting images by experts is mentioned, as this is a hardware device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is typically performed for AI/CAD devices to assess how the AI impacts human reader performance. It is not relevant for a CT scanner hardware submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for a CT scanner's performance is its technical ability to acquire and reconstruct images that accurately represent the internal structures of the body, which is assessed through engineering tests and phantom studies, rather than clinical ground truth like pathology.
8. The sample size for the training set:
- Not applicable. This refers to a dataset used to train an algorithm. This is a hardware device.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided 510(k) summary is for a CT scanner hardware device (Auklet CT Scanner, TSX-003A). The regulatory pathway for such a device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Toshiba TSX-002A, Xvision [K941745]) by showing similar technological characteristics and intended use. Therefore, the detailed methodologies for acceptance criteria and performance evaluation typically found in submissions for AI/CAD-driven diagnostic software are not present or applicable here.
The crucial information provided in this document is:
- Technological Characteristics are the same as the predicate.
- Intended Uses are the same as the predicate.
- The device incorporates standard technologies (slip ring, x-ray tube, xenon gas detector, microprocessor, hard disk storage).
These points are used to support the claim of substantial equivalence, which is the "study" in this context. The FDA's clearance letter confirms their agreement with this substantial equivalence, allowing the device to be marketed.
§ 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.