(27 days)
The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.
The Cios Select can operate in four different modes, Digital Radiography, Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Theis 510(k) submission, Cios Select (VA21C) with Imagine Intensifier is a Mobile Carm X-ray System, which is a modification of the Cios Select (VA21) Image Intensifier originally cleared under Premarket Notification K210307 on March 04, 2021.
The Cios Select consists of two major units:
One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.
The second unit is the image display station with a moveable trolley for the image processing and storage system, image display, and documentation. Both units are connected to each other with a cable. The main unit is connected to the main power outlet and the trolley is connected to a data network.
The provided text describes a 510(k) premarket notification for a medical device called "Cios Select (VA21) Image Intensifier." This is a special 510(k) submission, meaning it concerns minor modifications to an already cleared predicate device (K210307). As such, the focus of the documentation is on demonstrating that the modified device remains substantially equivalent to the predicate, rather than proving novel performance.
Therefore, the document does not contain a typical "study" proving the device meets acceptance criteria in the sense of a clinical trial or performance study against specific, quantified metrics with a defined ground truth and expert review. Instead, the "acceptance criteria" are implied by compliance with safety and performance standards for an image-intensified fluoroscopic x-ray system, and the "study" is a series of verification and validation (V&V) tests to confirm that the modifications do not introduce new safety or effectiveness issues.
Based on the provided information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a special 510(k) for modifications, the "acceptance criteria" are primarily related to maintaining safety and performance equivalence to the predicate device and adhering to recognized standards. Specific quantitative performance metrics are not explicitly listed in a table format for the device's image quality or diagnostic accuracy in this submission narrative.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Performance Standards Compliance: | The Cios Select (VA21C) Imagine Intensifier has been tested to meet the requirements for conformity to multiple industry standards. |
| 21 CFR Federal Performance Standards: | Complies with 21 CFR 1020.30 (Diagnostic X-Ray System), 1020.31(h)(2)(3) (Alignment of X-ray field & spot-film cassette), 1020.32 (Fluoroscopic Equipment), 1040.10 (Laser products). |
| Electrical Safety, Performance, & EMC: | Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with: AAMI ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-3:2013, IEC 60601-1-6:2010/A1:2013, IEC 60825-1:2014, IEC 62304:2015, IEC 60601-2-28:2017, IEC 60601-2-43:2019, IEC 60601-2-54:2018, IEC 62366-1:2015, ISO 14971:2019. |
| Software Functionality & Safety: | Software documentation for a Moderate Level of Concern software included, demonstrating continued conformance with special controls. Risk analysis completed, risk control implemented. All software specifications met acceptance criteria. Verification and validation testing for software performance and regression testing performed successfully. |
| Hardware Functionality (Collimator, PC, Camera): | Collimator: The new collimator has the same functionality as the cleared predicate and does not raise new safety or effectiveness issues. |
| PC Hardware: The new mini-PC has the same functionality as the cleared predicate and does not raise new safety or effectiveness issues. | |
| Image Intensifier Camera: The camera was updated to CMOS technology (from CCD). Testing for image quality was performed and test results indicate substantial equivalence for this component. The new camera has the same functionality as the cleared predicate and does not raise new safety or effectiveness issues. | |
| Overall Equivalence to Predicate: | The device functions as intended and is as safe and effective as the predicate device. Bench testing results, including unit, subsystem, and system integration testing, evaluated the performance and functionality of new features, hardware, and software updates. All testable requirements in Engineering Requirements Specifications, Subsystem Requirements Specifications, and Risk Management Hazard keys were successfully verified and traced. All conducted testing and clinical assessments were found acceptable and do not raise any new issues of safety or effectiveness. Clinical testing was not necessary. |
| Human Factors/Usability: | Human Factor Usability Validation showed human factors are addressed in system tests (operator’s manual, clinical use tests with customer reports and feedback forms). |
| Cybersecurity: | Conforms to cybersecurity requirements, preventing unauthorized access, modifications, misuse, or denial of use. Cybersecurity statement provided, considering IEC 80001-1:2010 (responsibility for compliance for IEC 80001-1-2010 is the hospital). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of diagnostic performance involving patient data. The "tests" mentioned are non-clinical (bench testing, verification, and validation).
- Data Provenance: The study described is primarily non-clinical validation and verification. There is no indication of patient data being used for the performance evaluation in this specific 510(k) submission, as it relates to system modifications and demonstrating substantial equivalence. The predicate device's prior clearance would have relied on such data. Since clinical testing was deemed "not necessary" for this special 510(k), no patient data (retrospective or prospective, or country of origin) is specified for the current submission's performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable as this submission describes non-clinical testing for substantial equivalence, not a diagnostic performance study requiring expert ground truth for patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Not applicable for the same reason as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC study was not performed. This device is an image intensifier system (mobile C-arm X-ray), not an AI-based diagnostic algorithm that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is a medical imaging hardware system with integrated software, not a standalone AI algorithm. The performance evaluation focuses on the safety and functionality of the modified system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests described, the "ground truth" is defined by established engineering specifications, performance standards (e.g., IEC, AAMI, CFR), and functional requirements rather than medical ground truth like pathology or expert consensus on clinical cases. The tests verify that the device performs according to these engineering and regulatory specifications.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI model that underwent a separate and distinct training phase using a specific dataset. The "software" updates mentioned are for system control and image processing, not for a trainable machine learning model.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reason as above.
§ 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.