(152 days)
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion Prime has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
The Aquilion PRIME TSX-303A/A and /B, v6.00 are 80-row CT Systems and the TSX-303A/F, v6.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.
This document is a 510(k) premarket notification for a Computed Tomography (CT) system, the Aquilion PRIME, v6.00. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might expect for a novel AI-powered diagnostic device.
Therefore, the information regarding "acceptance criteria" and the "study that proves the device meets the acceptance criteria" is framed within the context of demonstrating equivalence and safety/effectiveness for a hardware/software update to an existing CT system, rather than a standalone performance study with clinical endpoints.
Here's an attempt to extract the closest available information based on your request, acknowledging that the format and detail for a conventional "acceptance criteria" study are not fully present in this type of submission.
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and meeting regulatory standards for CT systems. The "reported device performance" is described in terms of improved imaging properties and diagnostic quality.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | The device (Aquilion PRIME, TSX-303A/A, 303A/B and 303A/F, v6.00) is determined to be substantially equivalent to the predicate device (Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00, K130645). Modifications include a new detector that meets the specifications of the current detector and addition of previously cleared optional software features. The method of operation, base software, and manufacturing process remain unchanged. |
| Detector Performance: | The modified system's detector sensitivity and noise properties showed improvement in both studies. |
| Image Quality Metrics: | Additional image quality metrics (utilizing phantoms) demonstrated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number, contrast-to-noise ratio, and uniformity performance. |
| Diagnostic Quality: | Representative diagnostic images (brain, chest, abdomen, peripheral exams) were obtained and reviewed, demonstrating that the device produces images of diagnostic quality and performs as intended. |
| Safety and Standards: | Conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] and various IEC, NEMA, and internal quality system standards (e.g., IEC60601-1 series, ISO 13485, 21 CFR § 820). The device is concluded to be safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a number of patients or cases. The document mentions "representative diagnostic images" but does not quantify them.
- Data Provenance: Not specified. It's likely that the "representative clinical images" were obtained during internal testing or pilot sites, but no details on country or retrospective/prospective nature are provided.
3. 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)
- Number of Experts: "an American Board Certified Radiologist" (singular).
- Qualifications of Experts: "American Board Certified Radiologist." No specific experience level (e.g., 10 years) is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: "Reviewed by an American Board Certified Radiologist." This implies a single reader review, so no adjudication method (like 2+1 or 3+1) was used.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a CT system itself, not an AI-assisted diagnostic tool designed to improve human reader performance. Its purpose is to demonstrate the fundamental image quality and safety of the CT scanner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable in the context of this submission. The device is a CT scanner, which inherently produces images for human interpretation. The "software options" mentioned (SEMAR, SURESubtraction Ortho, Dual Energy System Package) are image processing algorithms that enhance the raw CT data, but the "performance" as described (image quality metrics, diagnostic quality) still relates to the final image presented for a human in the loop. There is no "algorithm only" performance study in the sense of an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for evaluating image quality appears to be based on:
- Phantom measurements: For spatial resolution, CT number, contrast-to-noise ratio, and uniformity performance.
- Expert opinion: The "American Board Certified Radiologist" reviewing representative diagnostic images for diagnostic quality. This functions as the human expert assessment indicating the images are fit for interpretation.
8. The sample size for the training set
- Not applicable/provided. This document describes a new version of an existing CT scanner, not a novel machine learning algorithm that requires a separate training set. The "software options" mentioned were previously cleared and their development (including any training data if applicable) would have been part of their original 510(k) submissions.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.