The DIGISCAN 2 PLUS recording system may be used for all radiographic exposures for which conventional cassettes are used, such as pediatrics, trauma, bone, neuro, GI, mobile radiography and vascular radiography.

Device Description

The DIGISCAN 2 PLUS is an X-ray recording medium used for routine radiographic examinations. Instead of utilizing conventional radiographic screens (e.g. silver halide), the DIGISCAN 2 PLUS system employs phosphor plate technology. The system may be used for all radiographic exposures in which conventional cassettes are used, such as GI, and vascular radiography. The processed radiographic images may be sent to a hardcopy device, or an archive.

The DIGISCAN 2 PLUS will be made commercially available in three models: the DIGISCAN 2H PLUS, DIGISCAN 2C PLUS and the DIGISCAN 2T PLUS. The DIGISCAN 2H PLUS and 2C PLUS systems essentially differ only in throughput time, cassette use/reuse time and cassette formats. Unlike the 2H PLUS and 2C PLUS, the DIGISCAN 2T PLUS is a thoracic imaging system that operates on the basis of phosphor plate technology and is configured with a generator, an overhead tube support with synchronization control, and an integrated X-ray tube.

The DIGISCAN 2 PLUS basic systems are comprised of an ID station, an X-ray reader and a diagnostic workstation. The ID station is an interactive station through which the trained healthcare professional may enter patient data and other exposure data. Included in the ID station configuration is a barcode reader and label printer for easy cassette identification. The X-ray reader reads out the radiographic information retained within the storage phosphor plates. The signal is then digitized and sent to an interactive diagnostic workstation (MagicView) where further postprocessing may be performed by a radiologist.

AI/ML Overview

This document is a 510(k) Summary for the Siemens DIGISCAN 2 PLUS, a digital luminescence radiography system. It is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device).

Based on the provided text, there is no information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics typically associated with AI/CAD devices (e.g., sensitivity, specificity, AUC).

Here's an analysis of the provided text in relation to your requested information:

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

No specific acceptance criteria or performance metrics (e.g., sensitivity, specificity, AUC, accuracy) are reported in this document. The document describes the device and its intended use, but does not present performance data in terms of diagnostic accuracy or reader improvement.

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 document does not describe a clinical study with a test set that would evaluate diagnostic performance. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.

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 test set or ground truth establishment process is described in this document.

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

Not applicable. No test set or ground truth establishment process with 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

No MRMC comparative effectiveness study was done or reported. This device is a digital radiography system, not an AI/CAD system designed to assist human readers in interpretation. Therefore, there's no mention of human reader improvement with or without AI assistance.

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

Not applicable. This device is a digital radiography system, not an AI algorithm. Its "performance" would relate to image quality, throughput, and functionality compared to conventional film or its predicate device, not standalone diagnostic accuracy.

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

Not applicable. No clinical study involving ground truth establishment is described. The "ground truth" for this filing is substantial equivalence to a predicate device, meaning it performs as intended and is as safe and effective.

8. The sample size for the training set

Not applicable. This document describes a medical device (a digital radiography system) and its regulatory filing, not an AI/ML model for which a training set would be relevant.

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

Not applicable. As above, this is not an AI/ML model document.

Summary of Document's Purpose:

This 510(k) Summary serves to establish substantial equivalence for the SIEMENS DIGISCAN 2 PLUS to a previously cleared device (SIEMENS DIGISCAN 2, K924459). The primary arguments for substantial equivalence are:

Intended Use: The DIGISCAN 2 PLUS has the same intended use as conventional cassettes and its predicate device.
Technological Characteristics: It employs phosphor plate technology, similar to its predicate. Enhancements include increased throughput capacity and data management abilities, and it utilizes newly cleared X-ray readers (Fuji AC-3, Fuji 9000, Fuji 9501 which were cleared under K944046/S1).
Safety and Effectiveness Concerns: The document states that instructions for use ensure safe and efficacious operation, the device does not directly contact patients, and its wide dynamic range reduces patient dosage.

The provided text does not contain any data from clinical performance studies that would typically involve acceptance criteria, test sets, ground truth, or expert readers to evaluate diagnostic accuracy. Its focus is on demonstrating that the new device is fundamentally similar to a previously approved device.

Summary

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SIEMENS

JUN 1 8 1996

955457

510(k) SUMMARY

GENERAL INFORMATION: I. Establishment: • Address:

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ. 08830

· Registration Number:
·Contact Person:

2240869

Kathleen Rutherford Manager, Regulatory Submissions Telephone Number: (908) 321- 4779 TELEFAX Number: (908) 321 - 4841

Date of Summary Preparation:

Device Name: · Trade Name:

·Common Name:

· Classification Name:

November 27, 1995

DIGISCAN 2 PLUS

Digital Luminescence Radiography System

System, Image Processing: CFR: 90 LLZ.

·Classification:

Performance Standards:

21 CFR, Subchapter J

Class II

SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE II. SUBSTANTIAL EQUIVALENCE DETERMINATION.

Performance Standards:

All components to which the above referenced performance standards apply are certified to conform with 21 CFR Subchapter J.

Device Description:

The DIGISCAN 2 PLUS will be made commercially available in three models: the DIGISCAN 2H PLUS, DIGISCAN 2C PLUS and the DIGISCAN 2T PLUS. The

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SIEMENS

DIGISCAN 2H PLUS and 2C PLUS systems essentially differ only in throughput time, cassette use/reuse time and cassette formats. Unlike the 2H PLUS and 2C PLUS, the DIGISCAN 2T PLUS is a thoracic imaging system that operates on the basis of phosphor plate technology and is configured with a generator, an overhead tube support with synchronization control, and an integrated X-ray tube.

Intended Use:

Technological Characteristics:

General Safety and Effectiveness Concerns:

Instruction for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and efficacious manner. The DIGISCAN 2 PLUS is a recording medium which does not come in direct contact with the patient, nor does it control the delivery of energy, the administration of parenteral drugs, or life sustaining functions. In addition, the wide dynamic range of the system minimizes the occurrence of over and under exposures, which concomitantly reduces the applied patient dosage.

Substantial Equivalence:

The SIEMENS DIGISCAN 2 PLUS is substantially equivalent to the SIEMENS DIGISCAN 2 which was described in K924459, and received FDA clearance on 12/17/92. The DIGISCAN 2 PLUS has been designed with increased throughput capacity and data management abilities compared to the predicate device DIGISCAN 2.

The X-ray readers configured with the DIGISCAN 2 PLUS systems are the Fuji AC-3, Fuji 9000 and the Fuji 9501 manufactured by FUJI Photo Company, Ltd.. The X-ray readers are new high throughput readers which were the subject of premarket notification K944046/S1 and received FDA clearance on May 11, 1995.

Ketlea Rutherford
Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions

11/27/95

Date

Siemens Medical Systems, Inc.

Imaging Systems Group

186 Wood Avenue South Iselin, NJ 08830

Tel: (908) 321-4500 Fax: (908) 494-2250

Regulation Number and Section

N/A