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510(k) Data Aggregation
(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 Aquilion LB is a multi-slice helical CT system, consisting of a gantry, patient couch and console. The system generates up to 32 axial slices per second using a selectable slice-thickness multi-row detector.
This document is a 510(k) Summary for the Toshiba Aquilion LB CT Scanner. It's a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, not a performance study report with explicit acceptance criteria and device performance table. Therefore, much of the requested information regarding specific acceptance criteria and detailed study results is not present in this document.
However, based on the document's content, here's what can be inferred or stated about the device and its regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The entire submission implies that the acceptance criterion is "substantial equivalence" to the predicate device (Aquilion MS-16 CT scanner, K022050) in terms of intended use, technological characteristics, and safety and effectiveness. This is achieved by demonstrating that the new device does not raise new questions of safety or effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, image resolution values) are reported in this summary. The document states that the device is "designed to produce cross-sectional images of a human body by reconstruction of xray transmission data... These images have been proven to be clinically useful..." without providing quantitative performance data for this specific device model.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred from Submission) |
|---|---|
| Substantially equivalent to predicate device (Aquilion MS-16 CT scanner, K022050) regarding: | The device employs the same technological characteristics as the predicate, differing only in subassembly component composition. |
| - Intended Use | The device employs no intended uses that are not in cleared devices already found in the marketplace. |
| - Technological Characteristics | Both systems use high-frequency x-ray controllers, detect x-ray transmission data with an x-ray detector, and reconstruct data with a computer to produce 2D/3D black and white images. |
| - Safety and Effectiveness | Designed and manufactured under Quality System Regulations (21 CFR § 820). Meets Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33) and conforms to applicable parts of IEC-60601 Medical Device Safety standards. No new safety or effectiveness concerns are raised. |
| Production of clinically useful cross-sectional images for specified indications for use (e.g., spine/head injuries, tumors, soft tissue lesions, abdominal/pelvic malignancies, etc.) | The device produces images proven to be clinically useful for the listed indications. (No specific performance data provided for this device model, relying on equivalence to predicate and general CT utility). |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided: This document describes a regulatory submission for substantial equivalence based on technological characteristics and compliance with standards, not a clinical performance study with a test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not Applicable / Not Provided: No test set or ground truth establishment by experts is described in this regulatory summary.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided: No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. This is a submission for a traditional CT scanner.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No. This document pertains to a physical CT scanner, not an algorithm, and does not describe standalone performance testing as typically understood for AI/software devices.
7. The Type of Ground Truth Used:
- Not Applicable / Not Provided: Ground truth, in the context of clinical performance studies, is not described in this regulatory submission. The "truth" being established is that the device is substantially equivalent to a predicate, not clinical accuracy against a "ground truth" diagnosis.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided: As this is an application for a CT scanner and not an AI/ML device, a "training set" in that context is not relevant or mentioned.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Not Provided: See point 8.
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(14 days)
The TSX-101A CT Scanners are indicated for head and whole body computed tomography applications.
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
The Aquilion TSX101A/A and TSX-101A/C CT Scanner Systems are composed of a gantry, patient table, image acquisition hardware and software, an operator console and associated accessories. Materials and construction are similar to the Aquilion CT Scanner Multi-slice 16 (CGS-31A) [K022050] and the TSX-101A/7 Aquilion Super 4 CT Scanner [K031469], and are compliant with IEC60601-1 and associated collateral and particular standards, and applicable sections of 21 CFR Subchapter J.
The provided text is a 510(k) summary for the Toshiba Aquilion Multislice CT Scanners (TSX-101A/A and TSX-101A/C). This document describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.
Crucially, this document does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical performance study would for an AI/CAD device. This is a Computed Tomography (CT) scanner, which is a medical imaging device, not an AI or CAD software that produces diagnostic interpretations or measurements.
The "Summary of Studies" section in the K033418 510(k) document states:
"These devices have been evaluated for electrical, mechanical, and radiation safety. Furthermore they conform to applicable medical device safety and performance standards."
This indicates that the studies conducted were primarily focused on safety and engineering standards compliance rather than clinical performance metrics like sensitivity, specificity, or reader improvement with AI.
Therefore, for many of your requested points, the answer based on this document will be that the information is not applicable or not provided.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable/Not Provided. This document does not describe specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic task or algorithm performance. The device is a CT scanner, and the evaluation focuses on its safety and conformance to general engineering and radiation safety standards.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable/Not Provided. The document does not describe a "test set" in the context of clinical performance evaluation for a diagnostic algorithm. The evaluations were for electrical, mechanical, and radiation safety of the hardware.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable/Not Provided. There is no mention of experts establishing ground truth for a clinical test set, as this was not a clinical performance study of a diagnostic algorithm.
4. Adjudication Method for the Test Set
Not Applicable/Not Provided. Since there was no clinical test set for diagnostic performance, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention an MRMC comparative effectiveness study. This type of study is typically done for AI/CAD devices to evaluate reader performance with and without AI assistance, which is outside the scope of a CT scanner's hardware safety and performance evaluation.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No. The document does not describe a standalone performance study. This is a hardware device (CT scanner) and does not have a standalone algorithm for diagnostic interpretation in the sense of AI/CAD software.
7. Type of Ground Truth Used
Not Applicable/Not Provided. There is no mention of ground truth in the context of diagnostic accuracy, as the studies focused on safety and functional compliance of the CT scanner hardware.
8. Sample Size for the Training Set
Not Applicable/Not Provided. This device is a CT scanner, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established
Not Applicable/Not Provided. As there is no training set mentioned, this point is not applicable.
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