(30 days)
The OEC Olympus Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
The OEC Olympus Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the xray imaging components at various angles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCR's. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets and DICOM 3.0. An auxiliary connection is provided for a angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.
Here's an analysis of the provided text regarding the OEC Olympus Mobile Fluoroscopy System, focusing on the requested information about acceptance criteria and studies.
It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validation studies and acceptance criteria in the same way a full design validation report would. Therefore, much of the requested information about explicit acceptance criteria and a detailed study proving performance against them is not directly present in this document. The document primarily focuses on regulatory compliance and substantial equivalence to existing devices.
Nonetheless, I will extract what can be inferred and explicitly stated from the provided text.
Acceptance Criteria and Device Performance Study for OEC Olympus Mobile Fluoroscopy System
Based on the provided 510(k) Summary for the OEC Olympus Mobile Fluoroscopy System, the device's acceptance is primarily based on meeting established product standards and demonstrating substantial equivalence to predicate devices, rather than a specific, detailed performance study with explicit acceptance criteria provided in this summary.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of quantitative performance-based acceptance criteria (e.g., image resolution, contrast-to-noise ratio) and corresponding measured device performance. Instead, its "acceptance criteria" are implied through adherence to recognized safety and performance standards for medical electrical equipment and diagnostic x-ray systems.
| Category | Acceptance Criteria (Inferred from standards and equivalence) | Reported Device Performance (Implied) |
|---|---|---|
| Safety & Performance | Adherence to product safety and performance requirements established in standards such as: |
- 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems)
- ANSI/NFPA 70 & 99 (National Electrical Code and Standard for Health Care Facilities)
- UL 60601, CSA-C22.2 No. 601.1-M90 (Medical Electrical Equipment Safety)
- IEC 60601 series (General Safety, EMC, Radiation Protection, Programmable Systems, HV/X-ray Generators, X-ray Tube/Source, Associated X-ray Equipment)
- 93/42/EEC - Annex 1 (Essential Requirements of the Medical Devices Directive) | The system is
designed in accordancewith these standards. The FDA's clearance (K041932) implies that the device has met the safety and performance requirements outlined by these standards, which are considered sufficient for market approval based on the 510(k) pathway. |
| Functional Equivalence | Functional equivalence to predicate devices: - OEC 9800 Plus Digital Mobile Imaging System (K021049)
- OEC 9800 E/CV+ Digital Mobile Systems (K024012) | The OEC Olympus Mobile Fluoroscopy System is stated to be
substantially equivalentto the listed predicate devices. This indicates that its intended use, design principles, energy source, performance, safety, and effectiveness are comparable, and it does not raise new questions of safety and effectiveness. |
| Clinical Utility | Ability to provide fluoroscopic and spot-film images during diagnostic, surgical, and interventional procedures, for applications like cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care, and emergency room procedures. | The device isdesigned to providethese images for the stated clinical applications. The substantial equivalence claim, implicitly, refers to the ability to meet the same clinical imaging needs as the predicate devices. No specific quantitative clinical outcome data or reader performance metrics are provided in this summary to "prove" this utility beyond the design statement and equivalence claim. |
2. Sample Size Used for the Test Set and Data Provenance:
The 510(k) summary does not describe a specific "test set" in the context of an algorithm or AI performance evaluation. This document pertains to a traditional medical device (an X-ray system), not an AI/ML software device. Therefore, concepts like "test set sample size" and "data provenance" for algorithm validation are not applicable or provided here.
The "testing" mentioned would typically refer to engineering verification and validation testing to ensure compliance with the listed standards and specifications, rather than a clinical performance study with a 'test set' of medical images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the 510(k) summary as it is for an X-ray imaging system, not an AI/algorithm-based diagnostic tool requiring expert ground truth for image interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers with vs. without AI Assistance:
This information is not applicable and not provided. The device is an image acquisition system, not an AI-assisted diagnostic software. There is no AI component described in this summary that would involve human readers being assisted or compared with AI.
6. If a Standalone (algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and not provided. The device is an X-ray system, not a standalone algorithm.
7. The Type of Ground Truth Used:
This information is not applicable and not provided for an X-ray system. The "ground truth" for an imaging system usually relates to its ability to accurately visualize anatomical structures, and its performance is assessed against technical specifications (e.g., spatial resolution, contrast resolution, dose) and compliance with standards.
8. The Sample Size for the Training Set:
This information is not applicable and not provided as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided as this is not an AI/ML device.
Summary of what's provided for acceptance/proof of performance:
The acceptance and proof of performance for the OEC Olympus Mobile Fluoroscopy System, as presented in this 510(k) summary, hinge on two primary aspects:
- Compliance with Recognized Standards: The device is designed in accordance with a comprehensive list of national and international safety and performance standards for diagnostic X-ray systems and medical electrical equipment (e.g., 21 CFR 1020.30-32, ANSI/NFPA, UL, CSA, IEC 60601 series, 93/42/EEC). The underlying assumption is that adherence to these standards ensures the device is safe and performs as intended.
- Substantial Equivalence to Predicate Devices: The submission explicitly states that the OEC Olympus Mobile Fluoroscopy System is substantially equivalent to two previously cleared GE OEC Mobile Imaging Systems (K021049 and K024012). This means that its indications for use, fundamental technology, and performance characteristics are similar enough to existing legally marketed devices that it does not raise new questions of safety and effectiveness.
The document does not delve into specific quantitative performance metrics or clinical study results to "prove" the device's acceptance against detailed diagnostic outcome criteria. Such detailed performance data, if collected, would typically be part of internal design validation documentation rather than summarized in a 510(k) for a device of this nature and era.
§ 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.