AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM

• K Number: K072606
• Device Name: AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
• Manufacturer: TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
• Date Cleared: 2007-10-02 ( 15 days)
• Product Code: JAK
• Regulation Number: 892.1750
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can then be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

Device Description

The TSX-301A/2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.

AI/ML Overview

This 510(k) premarket notification for the Toshiba Aquilion ONE TSX-301A/2 CT System does not contain the information needed to answer your request about acceptance criteria and a study proving device performance.

Here's why and what information is missing:

This submission is a "modification to existing device" and focuses on demonstrating substantial equivalence to a predicate device (TSX-301A Aquilion ONE CT System). The document covers:

• Device Description and Intended Use: Clarifies what the device is and what it's used for (whole body CT, volume data acquisition, dynamic and perfusion studies).
• Technological Characteristics, Safety & Effectiveness Concerns: States that the device uses similar materials/processes as the predicate, produces ionizing radiation, and complies with quality system regulations and applicable standards (21 CFR § 820, 21 CFR § 1020.30 and 1020.33, IEC 60601 series).
• Substantial Equivalence: Asserts similarity to the predicate device.
• FDA Clearance Letter: Confirms the FDA's review and determination of substantial equivalence.
• Indications for Use: Specifies the clinical applications (acquiring and displaying cross-sectional volumes of the whole body, including whole organs).

Missing Information (and why it's typically not in a 510(k) for this type of device/submission):

Consumer-facing acceptance criteria and detailed clinical performance studies proving specific image quality or diagnostic accuracy are generally not included in a 510(k) submission for a CT scanner, especially for a modification or an upgrade of an existing, already-cleared technology.

For general purpose X-ray CT systems, the "acceptance criteria" are primarily related to:

• Compliance with Federal Diagnostic X-ray Equipment Standards: This refers to technical performance standards related to radiation safety, dose, image uniformity, spatial resolution, contrast resolution, noise, etc., which are typically verified through engineering tests and phantom studies, not human clinical studies demonstrating diagnostic accuracy. The document explicitly states compliance with 21 CFR 1020.30 and 1020.33.
• Safety Standards: Compliance with electrical safety and other relevant IEC standards (IEC 60601 series) is also mentioned.
• Substantial Equivalence: The primary clinical "proof" in a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often relies on similarity in design, materials, and intended use, along with non-clinical performance data (e.g., phantom studies) if there are minor changes.

Therefore, I cannot provide the requested table and study details because the provided 510(k) summary does not contain performance metrics, clinical study design, or results related to human diagnostic efficacy or specific "acceptance criteria" in the way you've framed them (e.g., sensitivity, specificity, reader improvement).

To directly answer your numbered points based on the absence of this information in the document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states compliance with general regulatory and safety standards, but no specific performance metrics like sensitivity/specificity or other diagnostic efficacy criteria are listed or reported from a clinical study.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance is mentioned as part of this submission for demonstrating performance beyond technical compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is mentioned.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware CT scanner, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is a hardware CT scanner, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

§ 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.