(164 days)
The FLAATZ 600 Series (FLAATZ 600/601) is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
The FLAATZ 600 Series (FLAATZ 600/601) is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The FLAATZ 600 Series (FLAATZ 600/601) system includes a Detector Panel, Case, Grid, Power Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Power Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
The FLAATZ 600 Series (FLAATZ 600/601) is a digital X-ray detector with some changes compared to its predicate device, the FLAATZ 560. The primary modification is the change in data communication methods to Ethernet & Wireless. There are no changes to the product performance specifications or intended use.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for clinical performance or a direct comparison table against such criteria. Instead, it focuses on demonstrating substantial equivalence to the predicate device, FLAATZ 560, primarily by showing equivalent image quality and technical performance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Diagnostic Equivalency to Predicate Device | "FLAATZ 600 Series (FLAATZ 600/601) produces diagnostic images of equivalent quality as the predicate device (FLAATZ 560)" |
| DQE (Detective Quantum Efficiency) Performance | "The proposed FLAATZ 600 Series (FLAATZ 600/601) has similar performance in terms of DQE" (evaluated according to IEC 62220-1:2003 Standard) |
| MTF (Modulation Transfer Function) Performance | "The proposed FLAATZ 600 Series (FLAATZ 600/601) has similar performance in terms of [...] MTF" (evaluated according to IEC 62220-1:2003 Standard) |
| Safety and EMC Standards Compliance | "FLAATZ 600 Series is in accordance with Safety, EMC and DICOM standards (IEC 606001-1:2005, IEC 60601-1- 2:2007 and NEMA PS 3.1-3.20:2011)" and "The FLAATZ 600 Series (FLAATZ 600/601) has also met applicable Electro Magnetic Compatibility (EMC) requirements." |
| Compliance with FDA Guidance for Solid State X-ray Imaging | "The FLAATZ 600 Series (FLAATZ 600/601) has been evaluated as per FDA's 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' and has shown good performance, substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical study tested for "eight body parts (Chest, Shoulder, L-Spine L, L-Spine_AP, Hand, Forearm, Foot and Knee)". The exact number of images or patient cases for each body part is not specified in the provided text.
- Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A MRMC comparative effectiveness study, in the sense of evaluating human reader performance with and without AI assistance, was not performed, nor is it applicable here. This device is an X-ray detector, not an AI-powered diagnostic aid for radiologists. The clinical study aimed to demonstrate diagnostic equivalency of the new detector to a predicate detector.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a form of standalone performance evaluation was done through non-clinical testing of technical parameters.
- Non-Clinical Testing: DQE and MTF were evaluated according to IEC 62220-1:2003 Standard. These are objective measures of image quality for the device itself.
- Clinical Testing: The clinical study to investigate diagnostic equivalency (comparing images from the new device to the predicate device) can be considered a standalone assessment of the device's image output, without human-in-the-loop diagnostic assistance being part of its intended use.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was established by comparing the images produced by the FLAATZ 600 Series to those of the predicate device (FLAATZ 560) to assess "diagnostic equivalency." This implies a comparison of perceived diagnostic quality by potentially expert readers, but the explicit nature of this "ground truth" (e.g., expert consensus on specific findings, pathology, or outcomes) is not detailed. It is more focused on the quality of the image for diagnosis rather than the correctness of a specific diagnosis derived from the image.
For the non-clinical testing (DQE, MTF), the ground truth is established by the specifications and methodologies outlined in the IEC 62220-1:2003 Standard for X-ray detector performance.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI/Machine Learning device that requires a training set. It's a hardware device (X-ray detector).
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.