(52 days)
The Siregraph T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-ray Systems are devices intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. Both systems have medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract, lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
Siregraph T.O.P. is a universal fluoroscopic X-ray diagnostic system with an overtable X-ray tube assembly. Two versions are available: Siregraph T.O.P. 33 for use with an undertable spot film device, and Siregraph T.O.P. 40 for use in Digital Fluoroscopy. Both systems are operated either via the patient support table or a remote control console.
This document describes a 510(k) submission for the Siregraph T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-ray Systems by Siemens Medical Systems, Inc. The submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a novel device.
Therefore, much of the requested information regarding acceptance criteria, specific performance studies, sample sizes, expert ground truthing, and training sets is not available in the provided text because the 510(k) process for this type of device typically relies on demonstrating equivalence to existing technology which has already established its safety and effectiveness.
Here's what can be extracted and inferred based on the provided text, with explicit notes on what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a new device. The acceptance criteria for a fluoroscopic X-ray system in a 510(k) submission are generally that it performs as intended and is substantially equivalent to predicate devices without raising new questions of safety or effectiveness. This implies meeting industry standards and regulatory requirements for image quality, dose, and functionality typical for such systems at the time of submission (1997).
- Reported Device Performance: The document states that the Siregraph T.O.P. systems have the "same technological characteristics as the predicate Siregraph D3/D340." The improvements are ergonomic design, the communication network (XCS), and the use of the latest commercially available system components. This implies that the performance (e.g., image quality, dose, reliability) is expected to be at least equivalent to the predicate devices. No specific quantitative performance data (e.g., spatial resolution, contrast resolution, signal-to-noise ratio, dose measurements) are provided in this summary.
| Acceptance Criteria (Inferred from 510(k) process for this device type) | Reported Device Performance (Inferred from 510(k) claims) |
|---|---|
| Safe operation for intended use | Substantially equivalent to predicates. No new safety concerns raised. |
| Effective visualization of anatomical structures | Performs as other fluoroscopic X-ray systems, equivalent to predicates. |
| Image quality suitable for diagnostic purposes | Expected to deliver image quality equivalent to predicates (Siregraph D3/D340). |
| Meets relevant industry standards for fluoroscopic X-ray systems | Utilizes established technology and components. |
| Ergonomics and user interface improvements | Redesigned for better ergonomics. Uses new communication system (XCS). Configured with latest available components. |
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: As this is a 510(k) submission for substantial equivalence based on technological characteristics, a specific "test set" with a defined sample size for clinical performance validation (like an AI algorithm would require) is not detailed here. The submission relies on the established safety and effectiveness of the predicate devices. There is no mention of a separate study with a test set, data provenance, or retrospective/prospective nature.
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: No "test set" or ground truthing by experts, in the context of validating a diagnostic algorithm's performance, is mentioned or required for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No "test set" and thus no adjudication method is mentioned.
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: This device is a conventional fluoroscopic X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This is a conventional medical imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: As this is a 510(k) for a hardware system based on substantial equivalence, the "ground truth" is implied by the long-standing clinical use and accepted diagnostic capabilities of the predicate devices in their ability to "visualize anatomical structures by converting a pattern of X-ray into a visible image." No specific, new ground truth validation study is described.
8. The sample size for the training set
- Not Applicable / Not Provided: This is a hardware device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: This is a hardware device, not an algorithm that requires a training set or its associated ground truth establishment.
§ 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.