(61 days)
The Philips DUO DIAGNOST is a multi-functional diagnostic X-Ray system intended for Fluoroscopic. Radiographic, Angiographic, and Interventional applications.
The Philips DUO DIAGNOST is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
The Philips DUO DIAGNOST is a remote controlled multi-functional R/F system consisting of a floor-mounted tilting patient support table and an undertable spotfilm device holding an image intensifier and the TV camera. The overtable X-Ray tube is supported by a combined floor/wall-stand. The X-Ray tube can be mechanically coupled to the table for fluoroscopy or spot film work and Radiography is possible in the coupled or uncoupled The system comes with an X-Ray generator, trimode Image Intensifier, XTV mode. imaging system. Philips glass or metal X-Ray tube, and TV monitor(s). An optional multiformat camera (PMI 100) can also be added, as can a wallbucky stand, and digital spot film camera.
The provided text is a 510(k) summary for the Philips DUO DIAGNOST X-Ray system, and it primarily focuses on establishing substantial equivalence to a predicate device and outlining safety compliance.
Based on the provided text, there is no information available regarding acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of clinical performance or algorithm-based diagnostics. The document pertains to an X-ray system, not an AI/algorithm-based diagnostic device in the modern sense.
Therefore, I cannot provide the requested table or answer the specific questions related to AI/algorithm performance studies, sample sizes for test/training sets, expert involvement, or ground truth establishment.
The document states:
- Device Name: Philips DUO DIAGNOST
- Intended Use: A multi-functional diagnostic X-Ray system intended for Fluoroscopic, Radiographic, Angiographic, and Interventional applications.
- Safety Information: "This device complies with the federal X-Ray performance standards (CFR 1020.30, 31, .32) as well as with the relevant national and international standards for Electrical and Mechanical Safety (UL 2601-1, IEC 60601-1, IEC 60601-2-7, IEC 60601-2-32)."
- Substantial Equivalence: The DUO DIAGNOST is substantially equivalent to the Philips Diagnost 96 system (FDA ref. K912470).
These statements indicate that the "acceptance criteria" in this context are primarily related to compliance with established X-ray performance standards and electrical/mechanical safety standards, as well as demonstrated substantial equivalence to a legally marketed predicate device. The "study" proving this is implicitly the documentation submitted to the FDA detailing the device's design, specifications, and comparison to the predicate, along with adherence to the listed safety standards.
As the request specifically asks for details pertinent to AI/algorithm performance studies, which are not present in this 1998 510(k) submission for an X-ray machine, the following points cannot be addressed with the provided text:
- A table of acceptance criteria and the reported device performance: Not specifically outlined for clinical or algorithm performance.
- Sample sized used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: 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.