(17 days)
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.
The main function of this system is to perform fluoroscopy /radiography of the interventional angiography system. Using the fluorescent scintillation effect of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis treatment.
The provided text is a 510(k) summary for the Toshiba America Medical Systems INFX-8000V with 56 inch Monitor. This document is a pre-market notification to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria. Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is largely not present in this type of regulatory submission.
The document primarily focuses on:
- Device Description and Intended Use: The system performs fluoroscopy/radiography for interventional angiography, specifically for diagnostic and interventional procedures involving cardiac, abdominal, and lower limb blood vessels.
- Substantial Equivalence: It claims substantial equivalence to its predicate device, the INFX-8000V (K081582). This means it asserts that the new device is as safe and effective as the predicate, which has already been cleared for market.
- Safety Standards: Compliance with Quality System Regulations (21 CFR § 820, ISO 13485) and applicable parts of IEC60601-1 and 21 CFR §1020 is stated.
- Regulatory Clearance: The FDA's letter (K112054) confirms the finding of substantial equivalence.
Therefore, based only on the provided text, I cannot extract the information required to populate the table and answer the specific study-related questions. The document does not describe a performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the INFX-8000V with 56 inch Monitor. This information would typically be found in a separate performance study report, which is not included here.
However, I can extract what is provided regarding the device and its regulatory clearance.
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the given 510(k) summary. A 510(k) submission generally asserts substantial equivalence to a predicate device based on similar design, intended use, and technological characteristics, rather than presenting a de novo performance study against specific acceptance criteria. The document states compliance with general safety and performance standards (e.g., IEC60601-1, 21 CFR §1020), which serve as a baseline for all such devices, but not specific diagnostic performance metrics or acceptance thresholds for the device itself.
2. Sample size used for the test set and the data provenance:
Not applicable/Not provided. The document does not describe a test set or a performance study involving patient data to demonstrate the device's diagnostic accuracy or performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. As no test set performance study is described, there is no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Not provided. No test set 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. The device is described as a "Solid State X-Ray Imager" and "diagnostic X-ray system," not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant in this context and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. The device is a hardware imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided. No performance study necessitating ground truth is described.
8. The sample size for the training set:
Not applicable/Not provided. The device is a hardware imaging system and does not mention any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established:
Not applicable/Not provided. No training set is described.
§ 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.