(58 days)
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, blood 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.
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
The Aquilion (TSX-101A) 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 "slice" of the body. As is common with today's CT Scanner, the Aquilion has the capability to acquire volumetric (helical) data by initiating table movement during data This data can be reconstructed per the operator's preference, to include three acquisition. dimensional rendering of the patient data. Additionally the TSX-101A is capable of CT Fluoroscopy, which is used on other Toshiba CT scanners and has received previous market clearance from the Agency. This device incorporates a standard x-ray tube and a solid state 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.
The provided text is a 510(k) summary for the Aquilion CT Scanner (TSX-101A). It does not contain information about a study proving the device meets specific acceptance criteria in the way described in your request.
The document is a premarket notification (510(k)) to the FDA, demonstrating substantial equivalence to a predicate device, not a performance study report with acceptance criteria.
Therefore, I cannot provide the requested information in the format because the submission is about regulatory clearance based on substantial equivalence, rather than a clinical or performance study with defined acceptance criteria and results.
Here's a breakdown of what can be inferred from the document regarding the device and its regulatory clearance:
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A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific performance metrics with acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no dedicated performance study with a test set is described.
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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 applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 applicable. This device is a CT scanner, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable, as this is hardware, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Summary of Device and Regulatory Clearance (from the provided text):
- Device Name: Aquilion CT Scanner, TSX-101A
- Intended Uses: Produce cross-sectional images of a human body by reconstruction of x-ray transmission data. Clinically useful for diagnosing various conditions including spine and head injuries, tumors, blood clots, soft tissue lesions, gastrointestinal lesions, malignancies, and musculoskeletal degeneration.
- Technological Characteristics: Employs slip ring technology for continuous rotation of x-ray tube and detector, volumetric (helical) data acquisition, and CT Fluoroscopy. Uses a standard x-ray tube and solid-state filled x-ray detector. Microprocessor-based computer, hard disk storage, and display electronics are mature technologies.
- Predicate Device: Toshiba TSX-011A, Xpress (K903701/A)
- Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition."
- Standards Conformance: IEC-60601 (Medical Device Safety) and NEMA-PS3 (DICOM Standard), alongside Quality System Regulations (21 CFR § 820).
The 510(k) process is about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate device. It typically does not involve a detailed performance study with acceptance criteria in the manner you describe for a novel AI or diagnostic device.
§ 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.