(181 days)
The SIEMENS Flat Panel Detector, in both the THORAX FD and the MULTIX FD systems, allows acquisition of x-ray exposures without the use of conventional film/screen systems. The THORAX FD system is a stand alone automated chest unit, while the MULTIX FD is a universal radiographic x-ray system. The MULTIX FD and THORAX FD both allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.
The SIEMENS Flat Panel Detector is a scintillator-photodetector device. The Flat Panel Detector is used in two different configurations which allow acquisition of radiographic exposures. The two configurations in which the detector is used are the vertical position, marketed as the THORAX FD, and the horizontal position, marketed as the MULTIX FD. Both x-ray system configurations utilize the digital capabilities of the detector, in conjunction with other system components, to produce radiographic images of various anatomical regions of the body. The SIEMENS Flat Panel Detector, in the THORAX FD and the MULTIX FD configurations, allows acquisition of exposures without the use of conventional film/screen systems. This process is done via semiconductor sensors which facilitate direct conversion of x-ray quanta into digital image data.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Radiographic images comparable to standard film images | "The results from the studies showed that the digital images were comparable to film." |
| Diagnostic imaging quality equal to or better than film/screen | "This clinical outcome supported the diagnostic imaging quality of the digital system as being equal to or better than film/screen." |
| Substantial equivalence to predicate devices (DIGISCAN 2, THORAMAT, Multix TOP/PRO) | The FDA granted clearance based on substantial equivalence to the listed predicate devices. |
Note: The document doesn't explicitly state numerical acceptance criteria (e.g., a specific AUC or sensitivity threshold). Instead, the acceptance criteria are implicitly defined by the goal of demonstrating 'comparability' and 'equal or better diagnostic imaging quality' relative to standard film/screen systems and substantial equivalence to established predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: The clinical study was carried out in Regensburg, Germany. The text does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The document only mentions "The results from the studies showed that the digital images were comparable to film." without detailing how this comparison was adjudicated by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: The document does not explicitly state that a multi-reader multi-case (MRMC) comparative effectiveness study was performed in the described clinical study. It mentions a "clinical study" where "digital images were comparable to film," but the methodology isn't detailed enough to confirm an MRMC design.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as the device described is a direct-conversion digital X-ray detector, not an AI assistance tool for human readers. The comparison is between the output of the digital detector and traditional film/screen, not between human readers with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, in essence, the "clinical study" described focuses on the direct output of the digital system ("digital images") compared to standard film, without explicitly detailing human interpretation in the loop of that comparison. The diagnostic quality of the system's images was assessed.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used appears to be the diagnostic quality of standard film images. The study aimed to determine if the digital images were "substantially equivalent to standard film images" and if their "diagnostic imaging quality... [was] equal to or better than film/screen." This implies that the standard clinical diagnostic interpretation of film images served as the reference.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. The device is hardware (a flat panel detector) for image acquisition. The description does not indicate the use of machine learning or an "algorithm" requiring a training set in the modern sense. The "clinical study" mentioned here is for performance validation, not for training an AI model.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI algorithm.
§ 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.