(14 days)
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table.
The provided text is a 510(k) premarket notification summary for the Toshiba INFX-8000C, an x-ray angiography system. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new AI or diagnostic algorithm.
Therefore, the document does not contain the detailed information required to fully answer your request, specifically:
- Acceptance criteria and reported device performance: There is no table of specific performance metrics or acceptance criteria for a new device function, nor is there any presented performance data. The submission is for a model number change and demonstrates equivalence.
- Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth types, training set size, or ground truth establishment for a study. These elements are typically found in a clinical study report or a more detailed technical submission for a novel diagnostic device or AI algorithm, which is not what this 510(k) summary provides.
Based on the available information, here is what can be inferred or directly stated, noting the significant lack of the requested study details:
1. A table of acceptance criteria and the reported device performance
Not applicable/Not provided in the document.
This 510(k) submission is for a model number change and asserts substantial equivalence to predicate devices, rather than presenting specific performance data against predefined acceptance criteria for a new diagnostic capability or algorithm. The document emphasizes meeting safety standards and having similar technological characteristics and intended use as the predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided in the document.
No clinical study with a test set is described. The submission focuses on demonstrating substantial equivalence for a device with a model number change.
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)
Not applicable/Not provided in the document.
No clinical study requiring expert ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided in the document.
No clinical study with a test set requiring adjudication is described.
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
Not applicable/Not provided in the document.
This submission is for an x-ray angiography system, not specifically an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided in the document.
This submission is for an x-ray system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in the document.
No ground truth data is discussed as no specific diagnostic performance study is presented.
8. The sample size for the training set
Not applicable/Not provided in the document.
No training set is discussed as no machine learning or AI algorithm development is described.
9. How the ground truth for the training set was established
Not applicable/Not provided in the document.
No training set or associated ground truth establishment is described.
Summary of Device and 510(k) Basis:
The Toshiba INFX-8000C, Infinix-CCi, and Infinix-VCi systems are described as digital x-ray systems for diagnostic and interventional angiography of blood vessels in the heart, brain, abdomen, and lower extremities.
The 510(k) submission (K081621) is primarily for a model number change and asserts substantial equivalence to existing predicate devices (GE Innova 4100; K052412 and Toshiba DFP-8000D/FPD; K052884). The basis for equivalence rests on:
- Similar intended uses.
- Similar technological characteristics, employing x-rays to generate fluoroscopic and radiographic images.
- Compliance with relevant safety and performance standards (Quality System Regulations, Federal Diagnostic Equipment Standard, IEC 60601-1, IEC 60601-2-32, IEC 60601-2-28).
No specific clinical performance study with acceptance criteria and measured performance data, as would be expected for a novel diagnostic device or AI algorithm, is detailed in this 510(k) summary. The approval is based on demonstrating that the new model number represents a device that is safe and effective because it is substantially equivalent to already cleared devices, not because it has met specific, new performance thresholds in a clinical trial.
§ 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.