(117 days)
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac
The proposed Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station (MVS).
This document is a 510(k) summary for the Philips Zenition 90, which is an Image-Intensified Fluoroscopic X-Ray System. The summary asserts substantial equivalence to a predicate device (Zenition 70, K212813) rather than proving performance against specific acceptance criteria for a novel device or AI algorithm.
Therefore, many of the requested details, such as those related to acceptance criteria for device performance, sample sizes for test and training sets for an AI algorithm, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable in the context of this 510(k) summary. The document does not describe a study proving the device meets acceptance criteria in the way one would for a software or AI/ML device. Instead, it demonstrates compliance with recognized standards and substantial equivalence to a predicate device.
However, I can extract the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the typical sense for a new AI/software function. Instead, it compares the proposed device (Zenition 90) features and specifications to those of the predicate device (Zenition 70) to establish substantial equivalence. The "acceptance criteria" here appear to be adherence to the predicate device's performance characteristics or recognized industry standards.
| Feature/Component | Acceptance (Predicate Zenition 70) | Reported Performance (Proposed Zenition 90) | Conclusion (Relative to Acceptance) |
|---|---|---|---|
| Indications for Use | Radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates. Used in health care facilities inside and outside the operating room, sterile and non-sterile. Applications: Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac. | Radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients (including neonates). Used in health care facilities inside and outside the operating room, sterile and non-sterile. Applications: Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac. | Substantially Equivalent. The inclusion of neonates is justified by compliance with FDA guidance "Pediatric information for x-ray imaging device premarket notifications." The device is deemed safe and effective despite this expanded indication. |
| C-arm motions and brakes | Manual | Motorized (3 axis: angulation, rotation, longitudinal) with electromagnetic brakes. | Similar and Substantially Equivalent. (Added advantage, simplifies workflow, no impact on safety/effectiveness). |
| X-ray Generator | Peak output power: 15 kW | Peak output power: 15kW/25kW options. kV range similar. | Similar and Substantially Equivalent. Different make of generators but similar technology, energy source, and output. No impact on safety and effectiveness. |
| X-ray tube | Model: RTM 780 H (Type RO-0306), Focal spot: dual (0.3 & 0.6), Target angle: 10°, Anode heat content: 225kJ, Max anode cooling rate: 550W, Nominal anode input power: 15kW. | Same model, focal spot, target angle, anode heat content, max anode cooling rate. Nominal anode input power: 15kW/25kW (for 25kW version). | Same and Substantially Equivalent. From the same supplier. |
| Monoblock: Oil circulation | Active oil circulation with AC Pump | Active oil circulation with DC Pump | Same and Substantially Equivalent. Similar heat performance, no significant difference in safety and clinical performance. DC pump helps with better oil circulation and lower power consumption. |
| Monoblock heat content | 1350kJ | 1350kJ | Same and Substantially Equivalent. |
| Safety mechanisms | Thermal Switch | Thermal Switch | Same and Substantially Equivalent. |
| Fluoro time | 296W for 60mins | 296W for 60mins | Same and Substantially Equivalent. |
| Flat Panel Detector | Frame rate: 30fps, Zoom modes: Overview + 2 zoom, Detector size: 207x207mm/301x301mm (square), Pixel pitch: 154µm, Image matrix: 1344x1344/1000x1000, DQE: 77% | Same frame rate, zoom modes, detector sizes, pixel pitch, image matrix, and DQE. | Same and Substantially Equivalent. Uses the same FPD cleared in the predicate device. |
| Imaging Processing | Xres-3 | Xres-3 | Same and Substantially Equivalent. |
| Anti Scatter Grid | Removable grid (square), Transmission: 70% | Removable grid (square), Transmission: 70% | Same and Substantially Equivalent. |
| Radiation safety features | Collimation, Anti-scatter grid, Fluoroscopy modes, Pulsed fluoroscopy, Recording and storing fluoro runs, Last image hold, Real-time dose monitoring. | Same radiation safety features. | Same and Substantially Equivalent. |
| Beam Limiting Device | Square (but round in zooming/rotation) | Square (but round in zooming/rotation) | Same and Substantially Equivalent. |
| Geometry | Hammerhead design, Size: 206x82x162 cm, Weight: 332 Kg, Stand-U/I: 15.3" touch screen. | New design stand. Size: 206x82x162 cm, Weight: 400 kg (Motorized) / 375 Kg (Non-motorized), Stand-U/I: 15.3" touch screen. | Similar and Substantially Equivalent. New stand design offers benefits like lower C-arm operating forces and provision for additional UI monitor, improving maneuverability and ease of use. Increased weight due to motorization is accepted as it simplifies workflow and improves user experience without impacting clinical workflow. |
| System architecture | PC Based Win 10 | PC Based Win 10 | Same and Substantially Equivalent. |
| Ionizing radiation | System uses X-ray for imaging | System uses X-ray for imaging | Same and Substantially Equivalent. Same X-ray technology. |
| Laser Alignment tool | Tube Laser Aiming Device (Model: 4598 008 4322x) | Tube Laser Aiming Device (Model: 4598 008 4322x) | Same and Substantially Equivalent. |
| DICOM connectivity | DICOM connectivity workflow | DICOM connectivity workflow | Same and Substantially Equivalent. |
| Security features | Various listed features including patient data export, network transfer, local user account management, audit trail, white listing, disk encryption, FIPS 140-2. | Same listed security features, potentially with different implementation for network time sync. | Same and Substantially Equivalent. |
| Room Interface | External x-ray Lamp and power indication interface | External x-ray Lamp and power indication interface | Same and Substantially Equivalent. |
| Audible signals | Speaker with volume control added in the Stand. | Speaker with volume control added in the Stand. | Same and Substantially Equivalent. |
| Wired Footswitch and remote control unit | Same | Same | Same and Substantially Equivalent. |
| Automatic Vascular Outlining (AVO) | Manual Outlining | Manual and automatic outlining | Similar and Substantially Equivalent. Automatic outlining is an added ease-of-use feature, with manual adjustment still available. No significant difference in safety and effectiveness. |
| Injector interface | Manual Injection with user-added X-ray delay from an injector device possible. | Integrated injector interface where user can add needed X-ray delay based on Injection volume. Manual Injection is also possible. | Similar and Substantially Equivalent. Added provision for external integrated injector interface. No change in clinical workflow or significant difference in safety and effectiveness. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses non-clinical performance testing and non-clinical validation testing for the device's intended use, claims, safety measures, instructions, and usability. It does not specify sample sizes of imaging data for a test set, nor the provenance of such data (e.g., country of origin, retrospective/prospective). This is because it is not a submission for a new AI/ML algorithm that requires clinical image data validation for its performance metrics. Instead, it relies on demonstrating compliance with recognized standards for the x-ray system as a whole.
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. As this is not an AI/ML algorithm submission requiring ground truth for image interpretation, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of image interpretation that would require an adjudication method.
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. This is not an AI-assisted interpretation device that would involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software algorithm, but a complete x-ray system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth for image interpretation is described or required for this type of submission.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML algorithm.
9. 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.