Search Results

syngo .plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital mages, including mammographic images. It supports the physician in diagnosis and treatment planning

For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used

syngo .plaza also supports DICOM Structured Reports

In a comprehensive imaging suite, syngo .plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer-specific workflows

syngo .plaza optionally uses a variety of advanced postprocessing applications

syngo®.plaza is a "software only"-system, to be installed on common IT hardware, matching the syngo®.plaza hardware requirements.

The provided document is a 510(k) summary for the medical device syngo®.plaza. It states that No clinical studies were carried out for syngo®.plaza, all performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device. Therefore, a table of acceptance criteria and reported device performance related to clinical studies and elements like sample size, ground truth, and expert adjudication are not applicable as no such studies were conducted.

Instead, the document details non-clinical performance testing based on various international standards for software verification and validation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable as no clinical studies with specific performance metrics (sensitivity, specificity, AUROC, etc.) and acceptance criteria were performed. The equivalence is established through non-clinical testing aligned with the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable, as no clinical test set was used. The performance testing was non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable, as there was no test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical studies were carried out for syngo®.plaza".

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device "syngo®.plaza" is a Picture Archiving and Communication System (PACS) and is intended for use by a physician in diagnosis and treatment planning. It is not an AI algorithm that functions in a standalone capacity without "human-in-the-loop". Its purpose is to display, process, read, report, communicate, distribute, store, and archive digital images to support the physician.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies with a ground truth were performed.

8. The Sample Size for the Training Set

Not applicable, as the document describes a PACS system and does not refer to an AI algorithm that requires a training set in the conventional sense. The focus is on software verification and validation against established standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as above.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of non-clinical performance testing activities conducted for software verification and validation.

• Study Title/Description: Software verification and validation activities for syngo®.plaza VB30.

• Methodology: The testing was carried out according to a set of international and industry standards, including:

  • ISO 14971:2007 (Medical devices – Application of risk management to medical devices)
  • IEC 62304 Edition 1.1 2015-06 (Medical device software – Software life cycle processes)
  • IEC 82304-1 Edition 1.1 2016-10 (Health software – Part 1: General requirements for product safety)
  • IEC 62366-1 Edition 1.0 2015-02 (Medical devices – Part 1: Application of usability engineering to medical devices)
  • NEMA PS3 / ISO 12052:2017 (DICOM)
  • ISO / IEC 10918-1:1994 + TC 1:2005 (JPEG)
  • ISO / IEC 15444-1:2005 + TC 1:2007 (JPEG 2000)
  • IEEE 3333.2.1:2015
  • ISO / HL7 21731:2014 (HL7 Version 2.x)

• Acceptance Criteria (Implied): The device (syngo®.plaza VB30) must perform as well as the predicate device (syngo®.plaza VB10A) and comply with the listed standards. Changes from the predicate were evaluated for safety and effectiveness impact, with the conclusion being "This update does not impact or change the safety and effective use of the product" for most listed differences.

• Reported Device Performance: "After comparison of the test results with the software release acceptance criteria, Siemens Healthcare GmbH is of the opinion, that syngo®.plaza VB30 is substantially equivalent to and performs as well as the predicate device syngo®.plaza VB10A." This statement confirms the device met its non-clinical acceptance criteria by demonstrating substantial equivalence and performance comparable to the predicate.

Ask a specific question about this device