(28 days)
The Dornier Genesis with Windows 7 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 Genesis with Windows 7 is an Image Intensified Fluoroscopic X-ray System. The Genesis with Windows 7 consists of the following components: an x-ray generator and tube housing image detector (flat panel or Image Intensifier), monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.
The provided text describes a Special 510(k) Summary for the Dornier Genesis with Windows 7, an image-intensified fluoroscopic x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance studies in the way you've outlined for an AI/device performance study.
Here's an analysis based on the information provided, highlighting what is and is not present concerning your request:
The core of this document is a 510(k) submission seeking clearance for a modification to an existing medical device. The primary "study" proving the device meets its acceptance criteria is the demonstration of substantial equivalence to a legally marketed predicate device. The acceptance criteria for this type of submission are typically adherence to recognized standards and a demonstration that the changes do not introduce new safety or effectiveness issues.
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) is provided, nor is there reported device performance in those terms. The "acceptance criteria" here are broad regulatory compliance and substantial equivalence to a predicate device.
The "performance data" section lists recognized testing standards that Dornier MedTech America, Inc. states the device complies with:
| Acceptance Criteria (Implied) | Reported Device Performance (Compliance) |
|---|---|
| Safety (General) | IEC 60601-1: Medical electrical equipment. Part 1: General requirements for safety (2005). |
| Electromagnetic Compatibility | IEC 60601-1-2: Medical electrical equipment. Part 1-2: General requirements for safety; Electromagnetic compatibility-requirements and tests (2007). |
| Radiation Protection (Diagnostic X-ray) | IEC 60601-1-3: Medical electrical equipment. Part 1: General requirements for safety; general requirements for radiation protection in diagnostic X-ray equipment (2008). |
| Usability | IEC 60601-1-6: Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability (2008). |
| Safety (High Voltage Generators) | IEC 60601-2-7: Medical electrical equipment. Part 2-7: Particular requirements for the safety of high voltage generators of diagnostic X-ray generators (1998). |
| Safety (X-ray Source & Tube Assemblies) | IEC 60601-2-28: Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (2010). |
| Safety & Performance (Radiography/Radioscopy) | IEC 60601-2-54: Medical electrical equipment. Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (2009). |
| Digital Imaging and Communications | NEMA PS 3.1-3.20 - Digital imaging and Communications in Medicine (DICOM) Set |
| Risk Management | ISO 14971 (Risk analysis performed, no new risks or hazards after mitigation) |
| Design Verification & Validation | Design verification and validation tests performed to meet final design requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes compliance with standards and risk analysis, not a clinical performance study with a specific test set of patient data. The modification is primarily a software platform upgrade (Windows XP to Windows 7), implying that the core imaging hardware's performance characteristics are considered unchanged.
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)
This information is not provided. As there's no mention of a clinical test set for diagnostic performance, there's no discussion of ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
An MRMC study was not mentioned or indicated. The device is an imaging system, not an AI-assisted diagnostic tool in the typical sense of generating interpretations or assisting human readers with diagnostic tasks. The change is an operating system upgrade.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm is not mentioned or indicated. This is not an algorithmic diagnostic device, but rather an imaging system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Ground truth for diagnostic performance is not applicable in the context of this 510(k) summary, as it's not a diagnostic algorithm undergoing validation of its diagnostic accuracy. The ground truth for the engineering tests mentioned would be the specified requirements of the standards (e.g., specific measurement readings, functional tests).
8. The sample size for the training set
This information is not provided. This device is not an AI/machine learning product that requires a training set for model development.
9. How the ground truth for the training set was established
This information is not provided. This is not applicable to the device described.
§ 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.