(19 days)
The Liebel-Flarsheim Direct Digital Imaging System is a solid state detector X-ray system that facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/surgery. The system may be used for urological, gastroenterological, and gynecological treatment, planning and diagnostic procedures. It is intended to replace fluoroscopic images formerly obtained through image intensifier technology. Not intended for mammography applications.
The Liebel-Flarsheim Direct Digital Imaging System is a radiographic and fluoroscopy examination' table with the X-ray tube over the table and the detector underneath the patient table. The table top can be moved longitudinally and laterally as well as vertically. The imaging system and table top can be rotated in the Trendelenburg and reverse-Trendelenburg positions. The system is a modified version of the Hydra Vision Urological X-Ray System (marketed as Hydra Vision Plus DR System). The modification features a multipurpose (radiography and fluoroscopy) solid state digital detector in place of the Image Intensifier and CCD camera for image acquisition. The table design remains unchanged.
Here's a summary of the acceptance criteria and study information for the Liebel-Flarsheim Direct Digital Imaging System based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Safety Testing | Electrical Safety | Satisfactory (conformance to IEC 60601-1, IEC 60601-1-1) |
| Mechanical Safety | Satisfactory (conformance to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-32) | |
| Electromagnetic Compatibility (EMC) | Satisfactory (conformance to IEC 60601-1-2 3rd edition 2007 - 03) | |
| Performance Testing | Contrast Resolution | Meets required specifications |
| Maximum Entrance Exposure | Meets required specifications | |
| Maximum Viewable Image | Meets required specifications | |
| Motion Imaging Performance | Meets required specifications | |
| Substantial Equivalence | Comparison to Predicate Device (Hydra Vision Urological X-Ray System) | Confirmed. Device does not raise new significant issues of safety, effectiveness, or performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or image datasets. The performance evaluation appears to be based on functional testing of the device's technical capabilities rather than a clinical study with a patient cohort. Therefore, information on data provenance (country of origin, retrospective/prospective) and sample size for a test set of patient data is not applicable/provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As the evaluation was functional testing of the device's technical performance and not a clinical study assessing image interpretation against a ground truth, this information is not applicable/provided.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described. The comparison is made at a technological level between the new device and its predicate, not between human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device is an imaging system (hardware and associated software for image acquisition and processing), not an AI algorithm for image analysis. Therefore, a standalone algorithm performance study is not applicable. The "performance data" described refers to the functional performance of the imaging system itself.
7. The Type of Ground Truth Used
For the functional performance criteria (contrast resolution, exposure, viewable image, motion imaging), the "ground truth" would be the expected technical specifications or standards that the device is designed to meet. For instance, contrast resolution would be measured against established technical benchmarks or the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware imaging system. There is no mention of an AI model or "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.