(28 days)
The Luminos Agile is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
Luminos Agile may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
Luminos Agile is a floor-mounted universal fluoroscopic x-ray diagnostic system (R/F system), that was developed for tableside examinations in combination with an Explorator. The modification is to replace the Image Intensifier / TV Camera with a solid state detector (flat panel/digital imager). The Explorator houses the flat panel solid state detector.
This modified AXIOM SIRESKOP SD will be marketed under the trade name Luminos Agile. The modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
Luminos Agile may be configured as a single tube system, with an under table tube or a dual tube system which features an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically. The dual x-ray tube configuration provides a quick change between under table and over table exposure modes. The under table tube is used for fluoroscopy and radiographic exposures taken with the Digital Imaging System. The over table tube is suspended from an overhead tube support for exposures with a table Bucky or Bucky wall stand, either with film cassettes or solid state detector. The digital images produced by the solid state detector are recorded and displayed by the Fluorospot COMPACT digital imaging system. The table design remains unchanged while the new imaging chain is based on the AXIOM Luminos dRF described in premarket notification K062623 which received FDA Clearance on August 22. 2007.
The provided text describes the Siemens Luminos Agile, a floor-mounted universal fluoroscopic x-ray diagnostic system. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study methodologies (MRMC, standalone, training set details) is not available in the provided text. The document is primarily a regulatory submission to establish equivalence for market clearance.
Here's a breakdown of the information that can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for a 510(k) submission generally revolve around demonstrating "substantial equivalence" to a legally marketed predicate device in terms of intended use, technology, and safety/effectiveness. This does not involve setting specific performance thresholds (e.g., sensitivity, specificity) for a new clinical study.
- Reported Device Performance: Not provided in terms of quantitative clinical performance metrics (e.g., diagnostic accuracy, image quality scores). The document states that the modification (replacing an Image Intensifier/TV Camera with a solid state detector) "does not affect the intended use of the device nor does it alter its fundamental scientific technology." It also mentions that "the Luminos Agile is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed," and that Siemens adheres to industry practices to minimize hazards. This is general safety and functionality assurance rather than quantifiable performance for acceptance.
| Aspect | Acceptance Criteria (Not explicitly stated/Quantified) | Reported Device Performance (Not explicitly stated/Quantified) |
|---|---|---|
| Overall Equivalence | Substantial equivalence to predicate devices (AXIOM Luminos TF and AXIOM Luminos dRF) in terms of intended use, safety, and effectiveness. | The device is deemed substantially equivalent, as per the FDA clearance letter. The modification (flat panel detector) does not alter intended use or fundamental technology. |
| Safety | Meet recognized industry safety practices; minimize electrical, mechanical, and radiation hazards. | Safety features include visual and audible warnings, continuous monitoring, system blockage on error, and error display. All equipment undergoes final performance testing. |
| Intended Use | Perform as a universal diagnostic imaging system for radiographic and fluoroscopic studies, including general R/F, angiography, and pediatric examinations. | The device is intended for these uses and is considered equivalent to predicates for these indications. |
| Technological Equivalence | The new imaging chain and components should be equivalent to or minor modifications of existing Siemens systems. | X-ray generation, control, flat detector (Pixium 5100), and digital imaging system (Fluorospot Compact) are identical to those in the AXIOM Luminos dRF. |
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/Not Provided. The document is a 510(k) submission asserting substantial equivalence. It does not describe a new clinical study with a "test set" in the context of diagnostic performance. The testing mentioned (final performance testing) refers to engineering/system validation, not a clinical trial with patient data for performance evaluation.
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/Not Provided. As there is no described clinical test set for diagnostic performance, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. See point 3.
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. This document describes an X-ray system, not an AI-powered diagnostic algorithm. An MRMC study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided. No clinical ground truth is described as having been established for testing diagnostic performance in this document. The ground truth for regulatory clearance in a 510(k) is typically the established safety and effectiveness of the existing predicate device(s).
8. The sample size for the training set
- Not Applicable/Not Provided. This is a hardware system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. See point 8.
§ 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.