(15 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 images 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. This device employs no intended uses that are not in cleared devices already found in the marketplace.
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
The Multislice kit is an upgrade to previously cleared CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner [K020385]. This upgrade will allow for the collection of sixteen axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high-resolution slices while maintaining the speed required to reduce anatomical motion artifacts.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "CGS-31A Multislice Upgrade Kit for Aquilion CT ScannerTSX-101A":
Based on the provided 510(k) summary and FDA clearance letter, this device is an upgrade kit for an existing CT scanner. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical performance studies with specific accuracy metrics for diagnostic tasks. The "study" here is primarily an engineering and regulatory demonstration of equivalence, not a clinical trial proving diagnostic performance against explicit acceptance criteria in the way one might expect for a new diagnostic algorithm.
Therefore, many of the requested fields related to clinical study design (sample size, ground truth, experts, MRMC, standalone performance) are not directly addressed or applicable in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|---|
| Technological Characteristics | - Employ same principles of operation as predicate device (CGS-30A). |
- Generate x-radiation from x-ray tube via high-frequency controllers.
- Detect x-ray transmission data with x-ray detector.
- Reconstruct data by computer into 2D/3D black and white images. | "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition." |
| Intended Use | - Produce cross-sectional images of the human body. - Clinically useful for diagnosis of spine/head injuries, intracranial tumors, blood clots, eye trauma, soft tissue lesions, GI lesions, abdominal/pelvic malignancies, hepatic metastases, intestinal obstructions, intra-abdominal abnormalities, musculoskeletal degeneration.
- No new intended uses beyond those already cleared for predicate devices. | "This device employs no intended uses that are not in cleared devices already found in the marketplace." (Matches predicate's intended uses). |
| Safety | - Design and manufactured under Quality System Regulations (21 CFR § 820). - Meet all applicable requirements of Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33).
- Conformance with applicable parts of IEC-60601 Medical Device Safety standards. | The submission states: "All requirements of the Federal Diagnostic Equipment Standard... will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards." |
| Performance (Imaging Capability) | Ability to collect sixteen axial slices in one scan, compared to the predicate's capability (implied standard of performance for multislice CT). | "This upgrade will allow for the collection of sixteen axial slices in one scan. This is accomplished by employing multiple solid state detectors." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable (N/A). The document describes an engineering and regulatory comparison to a predicate device, not a clinical "test set" in the context of diagnostic performance metrics against a gold standard. The assessment is based on design, technical specifications, and intended use equivalence.
- Data Provenance: N/A. No specific patient data or images were used to demonstrate performance against clinical acceptance criteria. The "data" here refers to technical specifications, safety standards compliance, and comparison to the predicate device's design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: N/A. This type of submission relies on engineering and regulatory review rather than expert clinical review of a test set to establish ground truth for diagnostic performance. Reviewers at Toshiba and the FDA assess the technical and safety claims.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. There was no clinical test set requiring adjudication.
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
- MRMC Study: No. This device is a hardware upgrade for a CT scanner, not an AI-powered diagnostic tool. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not relevant or applicable.
- Effect Size: N/A.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a CT scanner upgrade, a medical imaging acquisition system. It does not perform "algorithm only" diagnostic functions in the way an AI algorithm might. Its performance is intrinsic to the image acquisition capabilities it enables.
7. The Type of Ground Truth Used
- Type of Ground Truth: N/A. The "ground truth" for this 510(k) submission is the predicate device's established safety, effectiveness, and intended uses, as well as compliance with relevant engineering and safety standards. The new device demonstrates "substantial equivalence" to this established "truth." There is no clinical ground truth (like pathology or outcomes data) being established for a diagnostic task for this specific submission.
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. This is a hardware upgrade for a CT scanner, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: N/A. (See point 8).
Summary of the Study Proving Acceptance Criteria:
The "study" presented in this 510(k) is a demonstration of substantial equivalence to a legally marketed predicate device (CGS-30A Multislice Upgrade kit for Aquilion CT Scanner). The basis for acceptance is that the CGS-31A upgrade kit shares identical intended uses and fundamental technological characteristics with the predicate, with the primary difference being an advancement in imaging capability (collecting sixteen axial slices instead of fewer, as implied by the "Multislice Upgrade" context and the "Major difference is the number of slices" statement).
The acceptance criteria are implicitly met by:
- Stating identical intended uses to the predicate device.
- Claiming similar technological characteristics (high frequency x-ray controllers, x-ray detectors, computer reconstruction) to the predicate.
- Affirming compliance with Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33), and IEC-60601 Medical Device Safety standards.
- Highlighting the improvement in capability (16 slices) without introducing new risks or intended uses.
The "evidence" is primarily found in the declarations made by the manufacturer in the 510(k) submission regarding its design, safety standards compliance, and comparison to the predicate device. The FDA's clearance letter confirms their agreement with this assessment of substantial equivalence. This is a common approach for modifications to existing devices within the 510(k) pathway.
§ 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.