(80 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
INFX-8000V, V6.40, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table. This system offers an optional hybrid (aSi/CMOS) 12 inch flat panel detector (TFP-1200C) to provide high definition (HD) imaging.
This document describes the premarket notification (510(k)) for the Toshiba Medical Systems Corporation's INFX-8000V, V6.40, an image-intensified fluoroscopic X-ray system. The submission aims to demonstrate substantial equivalence to a predicate device (INFX-8000V, V6.35, K162614).
Acceptance Criteria and Device Performance:
The document doesn't explicitly list "acceptance criteria" in a typical quantitative clinical trial sense with specific metrics for disease detection or diagnostic accuracy (e.g., sensitivity, specificity). Instead, the acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to a cleared predicate device. This is achieved by proving that the modified device's performance is equal to or better than the predicate device, especially regarding imaging performance, and that the changes do not introduce new safety issues or alter the intended use.
The reported device performance presented focuses on technical and physical characteristics, rather than diagnostic efficacy with human-in-the-loop studies.
Here's a table summarizing the implicit acceptance criteria based on the information provided and the reported device performance:
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1 and collateral standards | Conforms to applicable parts of IEC60601-1, -2-28, -2-43. |
| Compliance with Federal Diagnostic X-ray Equipment Standard | Conforms to 21 CFR Subchapter J. Radiation output does not exceed 88mGy/min. | |
| Risk Mitigation | All known risks mitigated to an acceptable level via design controls. | |
| Imaging Performance Equivalence/Improvement | Spatial Resolution | Equivalent or improved compared to predicate. |
| Low Contrast Resolution | Equivalent or improved compared to predicate. | |
| Dynamic Range | Equivalent or improved compared to predicate. | |
| Artifacts | Equivalent or improved compared to predicate. | |
| Contrast | Equivalent or improved compared to predicate. | |
| Functionality | Live Zoom in HD Mode (with TFP-1200C) | Not allowed in HD mode; requires FOV of 6" or greater. |
| Dose Tracking (with TFP-1200C) | Toshiba XDIF-DTS802 Dose Tracking System incorporated. | |
| Substantial Equivalence | No new indications for use | Confirmed: Indications for Use remain the same. |
| No new intended use | Confirmed: Intended Use remains the same. | |
| Basic system configuration unchanged | Confirmed. | |
| Method of operation unchanged | Confirmed. | |
| Base software unchanged | Confirmed (minor software changes to support hardware are acknowledged). | |
| Manufacturing process unchanged | Confirmed. |
Study Information:
-
Sample sizes used for the test set and the data provenance:
- The document describes "Bench Testing" conducted to compare the modified system to the predicate device. However, it does not specify the sample size for this test set (e.g., number ofphantoms, or measurements taken).
- The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. It's implied to be internal testing conducted by Toshiba Medical Systems Corporation, likely in Japan (given TMSC's location). This type of testing is generally prospective in nature for a 510(k) submission, where new measurements are taken with the modified device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission focuses on technical and physical performance metrics (spatial resolution, contrast, etc.) rather than diagnostic accuracy involving human interpretation. Therefore, there is no mention of experts being used to establish a "ground truth" for interpretations of images from the test set. The ground truth for technical performance would be established by physical measurements and engineering specifications, not expert consensus on clinical images.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned as the testing performed was bench testing on physical and technical performance, not human-in-the-loop diagnostic accuracy studies.
-
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:
- No MRMC comparative effectiveness study was performed or is mentioned. This device is an X-ray system, not an AI-powered diagnostic tool. The submission is for a hardware modification (new detector) and supporting software updates to an existing X-ray system. Therefore, it does not involve AI assistance for human readers in the diagnostic process.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is a physical imaging system, not a software algorithm that performs diagnostic analysis. The "bench testing" evaluated the system's inherent imaging capabilities.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the tests performed was based on objective physical measurements and engineering specifications for parameters like spatial resolution, low contrast resolution, dynamic range, artifacts, and contrast. It was not based on expert clinical consensus, pathology, or outcomes data, as those are typically relevant for diagnostic accuracy claims.
-
The sample size for the training set:
- This submission describes a modification to an existing X-ray imaging system. There is no mention of a "training set" in the context of machine learning or AI. The system's operation is based on known physics and engineering principles, not a learned algorithm from a training dataset.
-
How the ground truth for the training set was established:
- As there is no training set for a machine learning algorithm, this question is not applicable.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.