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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."

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The ArtPIX DRF is a digital image acquisition system to be used with integrated solid state detector, during radiography or fluoroscopy x-ray examination, to capture digitalize, review images according to DICOM protocol to be sent through network connection.

This device is not intended for mammography use.

The modified ArtPIX DRF is a dynamic digital radiography system including fluoroscopy and radiography capabilities.

The system application is based on Windows 10 operating system. The object-oriented software performs real-time image processing (based on parallel computing), and full procedures storage. The DICOM 3.0 IHE compliant connectivity provides the tools to transmit patient demographics, examinations and image data in digital format.

Parameters for X-ray exposure, review, post-processing operations and filming can be set up from a single console, significantly increasing clinical efficiency.

The modified ArtPix DRF operates in connection with the dynamic Pixium 2121, 3030, 4343 flat panel detectors and 2430, 3543 portable flat panel detectors (made by Thales of Moirans, France).

The modified ArtPix DRF is intended for OEMs and Integrators that will integrate the product with their R&F table as a digital supplement.

The provided text describes a Special 510(k) submission for the ArtPIX DRF, which is a modification of a previously cleared device, the Duet DRF (K103038). This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the predicate device, implying that extensive, new clinical studies for acceptance criteria may not be performed if the changes do not introduce new safety or effectiveness concerns.

Based on the provided information, I can extract the following:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a way you might expect for a new device submission. Instead, it details that the modified ArtPIX DRF's performance and technological characteristics are substantially equivalent to its predicate device, the Duet DRF K103038. The acceptance criteria for the modified device are implicitly inferred from the performance characteristics of the predicate device and the new, integrated components, as well as adherence to various industry standards.

Here's an attempt to infer and present the acceptance criteria and device performance based on the comparison:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes verification and validation (V&V) activities, which are typically technical assessments rather than extensive clinical studies. It mentions "software unit tests," "software test document," "system bench tests," and "measuring the image quality." It also states, "The (positive /negative) results were documented in the test document."

However, there is no specific sample size mentioned for a test set (e.g., number of patients or images). The data provenance is also not specified, as these appear to be internal design validation activities rather than
a clinical trial. The testing was performed by "CMT Medical Technologies Ltd." which is an Israeli company, so the testing data would likely originate from their facilities. The nature of the changes (integration of new, already cleared FPDs and hardware/software upgrades) suggests that rigorous clinical testing with human subjects was not deemed necessary for substantial equivalence given the predicate.

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)

The document does not mention using experts (e.g., radiologists) to establish ground truth for a test set. This is consistent with a "Special 510(k)" for device modifications where clinical performance is demonstrated via substantial equivalence to a predicate device and technical performance testing, rather than new clinical evaluations requiring expert reads.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is mentioned, as no expert-based ground truthing or clinical study requiring adjudication is detailed.

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 MRMC comparative effectiveness study was done. The device is an image acquisition and processing system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is a digital image acquisition system with software for image processing and handling. Its performance is inherently linked to its ability to capture, digitize, review, and format images. The "system performance of the modified ArtPix DRF was validated by measuring the image quality." This would include the performance of the integrated detectors and the processing algorithms. While not explicitly called "standalone algorithm performance," the technical tests on image quality and system functionality without human interpretation are part of the stated V&V.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the verification and validation activities appears to be based on technical performance specifications, industry standards (e.g., DQE, pixel pitch), and expected functional behavior of the system components. For image quality, it would be measured parameters against documented specifications. There's no indication of ground truth established by expert consensus, pathology, or outcomes data, as this was not a clinical efficacy study.

8. The sample size for the training set

The document discusses device modifications and V&V testing, not the development of a machine learning or AI algorithm that would typically require a "training set." Therefore, no training set size is applicable or mentioned.

9. How the ground truth for the training set was established

As there is no mention of a training set or an AI/ML algorithm within the modifications described, this information is not applicable and not provided. The software modifications described primarily relate to supporting new hardware, updating the operating system and user interface, and incorporating previously cleared processing algorithms or standard DICOM functions.

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