Search Results

The Wireless/Wired DR-ID 1200SDK System is intended to capture for display radiographic images of human anatomy . It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The DR-ID 1200SDK System is not intended for mammography, fluoroscopy, tomography, and angiography applications.

The subject device DR-ID 1200SDK is a detector/software system, previously cleared as a component of the predicate FDR D-EVO II (K142003). The x-ray generator, necessary for a fullyoperational radiographic system, is not part of the subject device is designed as an alternative system added in FDR D-EVO II Flat Panel Detector System (DR-ID 1200) made by FUJIFILM. The subject device does not include imaging processing unit FDX Console (DR-ID 300CL) but the function of console is combined by system integrators. Both the subject device and predicate device are indicated for general purpose radiography. The software package is unchanged from the predicate, however the SW name was changed from DR-ID 1200MC (K142003) to DR-ID 1200SDK.

The document provided is a 510(k) premarket notification for a medical device called the DR-ID 1200SDK System. This notification aims to demonstrate "substantial equivalence" to a predicate device, the FDR D-EVO II Flat Panel Detector System (DR-ID 1200).

Crucially, this document states "No clinical study has been performed." Therefore, there is no acceptance criteria or study data that proves the device meets acceptance criteria in the traditional sense of a clinical performance study with human subjects.

Instead, the submission relies on non-clinical performance data and a comparison of technological characteristics to demonstrate substantial equivalence to a previously cleared device.

Here's an breakdown based on your request, even though a clinical study report is not available:

1. Table of acceptance criteria and the reported device performance

Since no clinical study was performed, there are no specific clinical acceptance criteria or reported device performance metrics in the context of diagnostic accuracy (e.g., sensitivity, specificity) for human interpretation. The "performance" data refers to compliance with established non-clinical standards and the device's physical/technical specifications being "Same" as the predicate device.

Differences from Predicate (and rationale for substantial equivalence):

• Removal of imaging processing unit FDX Console (DR-ID 300CL), optional Docking Stand (DR-ID 1200DS), and optional Fujifilm Access Point: These are considered minor modifications that "do not affect the indications for use, the fundamental scientific technology, safety and effectiveness, and image quality." The device is intended to be integrated with system integrators' consoles.
• Removal of memory exposure mode: This function allows storing images in the detector memory without an immediate connection to the processing unit. The document states "Even if this function is not supported, images can be sent to the image processing unit; thus the change does not affect the indications for use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• No clinical test set was used.
• The "performance data" refers to non-clinical tests based on regulatory standards. The provenance of such testing data (location, retrospective/prospective) is not specified but would typically be internal testing by the manufacturer.

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. No clinical test set with ground truth established by experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set requiring expert adjudication was used.

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 MRMC study was done. This device is a digital X-ray detector system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is hardware (detector) and associated software for image acquisition, not an AI algorithm for standalone diagnosis or detection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No clinical ground truth was established as no clinical study was performed. The "ground truth" for the non-clinical tests would be the established engineering and physics standards for detector performance.

8. The sample size for the training set

• Not applicable. This device is a digital X-ray detector system, not an AI algorithm that requires a training set in the AI/ML sense.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Ask a specific question about this device