Search Results

The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.

The Fluorospot Compact is a PC-based, 10 bit acquisition digital imaging system where images are acquired in 10242 format. It can be configured with conventional overtable/under-table x-ray systems (e.g. commercially available Sireskop SX and Siregraph CX). Configuring the conventional systems with Fluorospot Compact provides the systems with multi-functional use capability, thus allowing trained healthcare professionals to perform x-ray imaging using conventional film or digital imaging. Upon acquiring digital images, the user can display them on the live monitor in the exam room, as well as the control room for review. Multiple digital image acquisition and storage is possible without interrupting the procedure to change film.

This submission is a 510(k) premarket notification for the Siemens Fluorospot Compact, an optional integral component of a radiographic/fluoroscopic x-ray system. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting data from a new clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria and study design are not present in the provided text.

Here is an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or report specific device performance metrics in the format of a clinical study. The submission focuses on substantial equivalence to predicate devices rather than proving performance against predefined clinical thresholds.

The key claim regarding performance is:
"The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures."

This is a statement of intended performance rather than a measurable acceptance criterion with a corresponding reported result.

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. The provided document does not describe a new clinical study with a test set of patient data. The basis for clearance is substantial equivalence to predicate devices, not performance on a new dataset.

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 new test set requiring expert ground truth establishment for a clinical study is described.

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

Not applicable. No new test set requiring adjudication is described.

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

Not applicable. There is no mention of an MRMC study or AI assistance in this submission. The device described is a digital imaging acquisition and display system for X-rays, not an AI-powered diagnostic tool.

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

The device is explicitly stated not to be a standalone device: "The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, and as such it is not considered a stand alone device." Therefore, a standalone performance study as typically understood for an AI algorithm was not performed or claimed. Its function is to acquire, record, and display images for a trained healthcare professional.

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

Not applicable. No new ground truth for a clinical study is described. The device's "ground truth" for substantial equivalence would relate to its technical specifications and image quality characteristics matching those of the predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning model or an AI algorithm that would require a training set. This is a digital imaging system.

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

Not applicable. As there is no training set for a machine learning model, ground truth establishment for it is not relevant.

Summary of Device and Basis for Clearance:

The Siemens Fluorospot Compact is a PC-based, 10-bit acquisition digital imaging system for fluoroscopic X-ray systems. It acquires images in 1024x1024 format. Its primary function is to digitally acquire, record, and display radiographic images, enabling trained healthcare professionals to perform various X-ray examinations.

The device received 510(k) clearance based on substantial equivalence to two previously cleared Siemens devices:

• Fluorospot T.O.P (K961871, cleared July 31, 1996)
• Fluorospot H (Version 2) (K914525, cleared November 19, 1991) and Fluorospot H (Version 1) (K911082, cleared May 1, 1991)

The submission states that the Fluorospot Compact has the "same technological characteristics" as these predicates, utilizing PC-based technology to acquire, store, and post-process images from an image intensifier/TV chain output of a fluoroscopic system. The FDA's letter confirms findings of substantial equivalence to these legally marketed predicates.

Ask a specific question about this device