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510(k) Data Aggregation
(87 days)
AQUILION PRIME, V5.00
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/2, v5.00 is an 80-row CT System and the TSX-303A/6, v5.00 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Toshiba Aquilion PRIME CT system (K130645):
The submission K130645 is for a modification of an already cleared device (Aquilion Prime CT System, K120710). As such, the purpose of the submission is to demonstrate that the modified device is substantially equivalent to the predicate device and that the modifications do not adversely affect its safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of distinct "acceptance criteria" against which a device's performance is strictly measured in a pass/fail manner with specific quantitative thresholds. Instead, it describes a comparative evaluation against a predicate device and relies on an image quality metrics study using phantoms to show substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness (General) | "Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use." (Section 18) Adherence to various IEC, NEMA, and FDA standards (Section 16). |
| Functional Equivalence to Predicate (Changes) | The modifications (X-ray tube substitution, smaller gantry, increased gantry tilt, new gantry scan switch, breath-hold indication, optional software) do not change the indications for use or intended use. (Section 18) The method of operation, base software, and manufacturing process remain unchanged from the cleared device. (Section 15) |
| Image Quality Equivalence to Predicate | "The modified system was also evaluated according to an image quality metrics study, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and noise properties." (Section 17) |
| Software Performance (Moderate Level of Concern) | Software Documentation for a Moderate Level of Concern, per FDA guidance, is included. (Section 17) "successful completion of software validation" (Section 18) |
| Performance Standard (Radiation Emitting Products) | "This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]" (Section 10). "This device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020." (Section 16). |
| Quality System Compliance | "The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards." (Section 16) |
| Intended Use & Indications for Use Equivalence to Predicate | "The modifications incorporated into the Aquilion PRIME TSX-303A/2 and 303A/6, v5.00 do not change the indications for use or the intended use of the device." (Section 18) "This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head." (Section 14 & Indications for Use page) |
| Technical Specifications (e.g., X-ray tube, Gantry dimensions/angles) | Performance data matches predicate for X-ray tube capacity, maximum/continuous cooling rates. (Section 15 table) Gantry size is smaller, tilt angle is increased, and new features added as described in the comparison table. These are engineering design changes, and their implementation is covered by the overall safety and effectiveness assessment and testing. (Section 15 table) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of patient cases. The testing mentioned is an "image quality metrics study, utilizing phantoms." Phantoms are standardized test objects, not patient data.
- Data Provenance: Not applicable as patient data was not used for this specific substantial equivalence claim. The testing involved phantoms.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts/Qualifications: Not applicable. Ground truth for phantom-based image quality metrics is established by physical measurements and computed reference values within the phantom, not by expert interpretation.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "image quality metrics study, utilizing phantoms" involves objective measurements (e.g., spatial resolution, CT number, CNR, noise properties) comparing the modified device to the predicate, rather than human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
- MRMC Study: No, an MRMC comparative effectiveness study was not performed or mentioned in this submission. This is not a study assessing human reader performance with or without AI assistance. It's a technical modification to a CT scanner.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. This submission is about a CT hardware and software system, not a diagnostic AI algorithm that operates standalone. The image quality metrics study is a technical performance assessment of the system.
7. The Type of Ground Truth Used:
- Ground Truth: For the "image quality metrics study, utilizing phantoms," the ground truth is established by the known physical properties of the phantoms and the expected scientific principles of CT imaging. This allows for objective quantification of spatial resolution, CT number accuracy, contrast-to-noise ratio, and noise properties.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This document describes a modification to an existing CT system and its validation through phantom studies and adherence to standards. It does not refer to the development of a machine learning algorithm that would require a distinct "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning algorithm.
Summary of the Study:
The primary study mentioned to demonstrate that the device meets implied acceptance criteria is an "image quality metrics study, utilizing phantoms." This study compared the modified Aquilion PRIME CT system to its predicate device (TSX-302A/2, Aquilion Prime CT System) to demonstrate substantial equivalence in key image quality parameters.
Key Findings: The study validated that the subject device is substantially equivalent to the predicate device with regard to:
- Spatial resolution
- CT number
- Contrast-to-noise ratio (CNR)
- Noise properties
This type of technical study, along with bench testing, software validation, risk management, and compliance with applicable standards (IEC, NEMA, FDA), was considered sufficient by the manufacturer and the FDA to conclude that the modified device is safe and effective and substantially equivalent to the predicate.
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