(133 days)
The RFVision 9.9D is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The RFVision 9.9D allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details.
RFVision 9.9 D is an advanced remote controlled 90/90 Digital RF system with floating table top for radiographic and fluoroscopy procedures. Reliable, time tested generator. High quality image intensifier and digital imaging system improves diagnostic capabilities assures filmless operations and smooth integration in digital PACS environment.
The provided text is a 510(k) summary for the RFVision 9.9D Image Intensified Fluoroscopic System. It does not contain any information regarding specific acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, or expert qualifications) for proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K061173, CPIVision Digital Imaging System). The "Safety and Effectiveness, comparison to predicate device" section broadly states: "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices." However, it does not elaborate on what those tests were, what specific criteria they measured, or what the results were.
The "Substantial Equivalence Chart" primarily lists characteristics that are "SAME" as the predicate device, such as intended use, performance standard (21 CFR 1020.30), generator, and electrical safety. This indicates that the device is deemed effective and safe because it is similar to an already approved device, not because it underwent independent testing against new, specific performance criteria.
Therefore, I cannot provide the requested table or answer most of the specific questions as the necessary information is not present in the provided document.
Here's what I can extract or infer based on the document's content, with many fields remaining blank due to lack of information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Safety & Effectiveness | "as safe and effective as the predicate devices" (K061173) | "as safe and effective as the predicate devices" |
| Intended Use | Same as predicate | Same as predicate (High resolution, digital imaging for general fluoroscopy, interventional fluoroscopy, angiography, cardiac imaging; replaces conventional film; allows viewing/enhancement of digital fluoroscopic images; acquires high-resolution digital spot images) |
| Performance Standard | 21 CFR 1020.30 | Complies with 21 CFR 1020.30 |
| Electrical Safety | IEC-60601, UL listed | Complies with IEC-60601, CSA listed |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, only generally referred to as "bench, test laboratory and clinical testing." No mention of country of origin or whether data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document indicates "user testing data" but provides no details on how "ground truth" (if applicable in this context) was established or by whom.
4. Adjudication method for the test set
- Not specified.
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
- No MRMC study information is provided. This device is an image-intensified fluoroscopic system, not explicitly an AI-assisted device in the context of this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This is a hardware imaging system, not an algorithm being evaluated without human interaction.
7. The type of ground truth used
- Not specified. Given the nature of a fluoroscopic system, "ground truth" would likely relate to image quality assessment, radiation dose, system reliability, and functional performance rather than diagnostic accuracy like in an AI algorithm. No details are given.
8. The sample size for the training set
- Not applicable/Not specified. There is no mention of a "training set" as this is a hardware device submission, not an AI/ML algorithm submission that would typically involve training data.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As above, no training set is mentioned.
§ 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.