(24 days)
The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.
The Dornier Nautilus is an Image Intensified Fluoroscopic X-ray System with a flat panel image receptor system. The Nautilus consists of the following components: an X- ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics for the imaging chain.
The Dornier Nautilus is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted under the table on a fixed arm. A flat panel detector is mounted above the patient table. The flat panel used is a Varex model 4343DXV. These Varex 4343 series have been used in similar cleared devices (K192541). The Varex flat panel system uses Cesium lodide as the image scintillator which is identical to that used in the predicate device. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position. The captured images are processed and can be stored in the users DICOM system.
The provided text describes the Nautilus, an image intensified fluoroscopic x-ray system. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.
The "Performance Data" section primarily addresses adherence to electrical safety and electromagnetic compatibility (EMC) standards, and software verification and validation. These are crucial for the safety and basic functionality of the device, but they are not the typical performance metrics associated with demonstrating the clinical efficacy or diagnostic accuracy of an imaging system compared to a ground truth or a human reader.
Here's a breakdown of what is and isn't present, based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria Mentioned: The text implicitly states acceptance criteria by listing the standards that the Nautilus was tested against (e.g., IEC 60601-1, IEC 60601-1-2). The "Performance Data" states that "Performance testing confirmed that the Nautilus met the requirements of the following standards."
- Reported Device Performance: The document only reports conformance to these safety and software standards, not specific performance metrics in terms of image quality, diagnostic accuracy, or clinical outcomes. There are no numerical results (e.g., contrast-to-noise ratio, spatial resolution, diagnostic sensitivity/specificity) provided.
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. No clinical or diagnostic performance test set is described. The testing mentioned is for electrical safety, EMC, and software, which typically involves engineering tests, not patient data sets.
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. No ground truth establishment for diagnostic performance is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No diagnostic performance test set requiring adjudication 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
- No. The document explicitly states: "Clinical testing is not necessary for the subject system Nautilus, based on the same basic technology as the predicate device and based on existing minor differences." This indicates that an MRMC study or any clinical effectiveness study was not performed or deemed necessary for this 510(k) submission. There is no AI assistance mentioned, so no effect size for human readers with AI vs. without AI assistance can be provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an imaging system (fluoroscopic x-ray system) and not an AI algorithm. Its performance is evaluated fundamentally in conjunction with a human operator / clinician interpreting the images. No standalone algorithm performance is applicable or discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No diagnostic ground truth is mentioned. The "ground truth" for the non-clinical tests would be the requirements defined by the referenced international standards for electrical safety, EMC, and software quality.
8. The sample size for the training set
- Not Applicable. As no AI algorithm or diagnostic performance study is described, there's no training set for such a purpose.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Device Acceptance and Study as Described in the Document:
The Nautilus device's acceptance is based on its substantial equivalence to a predicate device (Dornier Genesis K151485) and its demonstrated conformance to established international standards for:
- Electrical Safety: IEC 60601-1, EN 60601-1-6, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54
- Electromagnetic Compatibility (EMC): IEC 60601-1-2
- Usability: EN 60601-1-6, IEC 62366-2
- Software Verification and Validation: Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern).
The study that "proves the device meets the acceptance criteria" is non-clinical testing (bench testing) against these referenced standards. No clinical studies, human reader studies, or diagnostic performance studies with explicit acceptance criteria (e.g., sensitivity/specificity thresholds) and corresponding test results are provided in this submission document. The rationale provided for not conducting clinical testing is that the device uses "the same basic technology as the predicate device and based on existing minor differences."
§ 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.