(16 days)
The OEC 9800 Plus Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
The OEC 9800 Plus is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus, which supports the x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices.
This 510(k) summary describes a legacy device that was submitted in 2002. At that time, the FDA's requirements for clinical performance studies and acceptance criteria were different than what they are today. The provided document focuses primarily on demonstrating substantial equivalence to a predicate device, adherence to safety standards, and providing a description of the device and its intended use. It does not contain information related to specific acceptance criteria, a clinical study with detailed performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods in the way a modern submission would.
Therefore, I cannot fully answer your request based on the provided text. The document does not include a table of acceptance criteria and reported device performance because such performance studies for demonstrating efficacy in the modern sense were not generally required for this type of device at that time, especially when demonstrating substantial equivalence.
Here's an analysis of what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not define specific performance acceptance criteria (e.g., in terms of sensitivity, specificity, or image quality metrics) that were then measured and reported. The "performance" described is largely functional equivalence to the predicate and compliance with safety standards rather than clinical efficacy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: No test set or clinical performance data is mentioned. The submission is based on substantial equivalence to a predicate device and compliance with safety standards.
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 Available: Since no test set or clinical study is described, there's no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: 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 Available: No MRMC study was done, nor is AI assistance relevant to this device from 2002. This device is an X-ray imaging system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available: This question is not applicable. The device is a fluoroscopic imaging system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: No clinical ground truth is described.
8. The sample size for the training set
- Not Available: No training set is applicable to this type of device submission.
9. How the ground truth for the training set was established
- Not Available: Not applicable.
What the document does provide regarding "acceptance criteria" and "study":
The "study" in this context is the 510(k) Pre-market Notification process, which demonstrates "substantial equivalence" to a legally marketed predicate device. The "acceptance criteria" are implied to be:
- Substantial Equivalence: The OEC 9800 Plus is substantially equivalent to the GE OEC Medical Systems OEC 9800 Digital Mobile Imaging System (the predicate). This is the primary "acceptance criterion" for a 510(k) submission.
- Safety Compliance: The device is designed in accordance with established product safety requirements outlined in various national and international standards (e.g., Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30-32), ANSI/NFPA 70 & 99, UL 2601, CSA-C22.2 No. 601.1-M90, IEC 60601 series, 93/42/EEC Annex 1). Testing against these standards would have been part of the internal validation process.
- Indications For Use: The device performs its intended fluoroscopic and spot-film imaging functions for diagnostic, surgical, and interventional procedures, matching the predicate.
- Technological Characteristics: The device shares similar technological characteristics (e.g., high-voltage x-ray generator, x-ray tube, image intensifier, digital image processing, image storage, video displays, C-arm design) with the predicate.
In summary, the provided document is a 510(k) summary from 2002 for an X-ray imaging system. It demonstrates substantial equivalence and compliance with safety standards rather than clinical performance based on quantitative metrics from a clinical study with defined acceptance criteria and ground truth, as typically seen for AI/ML-enabled devices today.
§ 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.