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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.

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syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, 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. Note: Web-based image distribution is not intended for reporting.

syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, 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. Note: Web-based image distribution is not intended for reporting. syngo.plaza is a "software only"-system. which will be delivered on DVD to be installed on common IT hardware, matching the syngo.plaza hardware requirements. syngo.plaza will be installed by Siemens implementation engineers. The integration into customer specific 17 environments is offered based on professional services. Updates / upgrades are offered based on service contracts and fulfilled by trained service technicians.

The provided text describes the Siemens syngo.plaza VB10A, a Picture Archiving and Communication System (PACS), and its substantial equivalence to a predicate device (syngo.plaza VA20A). It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This type of submission generally does not include extensive clinical studies or detailed performance metrics against specific acceptance criteria. Instead, it relies on demonstrating similar technical and functional characteristics to a previously cleared device.

Therefore, many of the requested details regarding acceptance criteria, specific performance metrics, and detailed study information are not present in the provided document, as they are not typically required for a 510(k) submission for a PACS device of this nature. The information below is extracted or inferred from the provided text where possible, and explicitly states where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for aPACS device, "acceptance criteria" are primarily related to functional equivalence, adherence to standards, and safety. There are no quantitative diagnostic performance metrics presented for the device itself in this document. The "performance" is largely described in terms of functional parity with the predicate device and adherence to listed standards.

Note: This document does not contain quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) for image interpretation, as the device is a PACS for display and management, not a diagnostic algorithm that provides an output needing validation against clinical outcomes. The "study" here is primarily a series of verification and validation activities against engineering and regulatory standards, and a comparison against a predicate device.

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

The document describes non-clinical testing including Unit Test Level, Integration Test Level, and System Test Level performed for newly developed components and the complete system. This implies testing against technical specifications and requirements, rather than a "test set" of patient data in the clinical sense for performance evaluation.

• Sample Size for Test Set: Not specified. The document does not refer to a "test set" in terms of patient cases or images for evaluating diagnostic performance. Testing was for software functionality, safety, and adherence to standards.
• Data Provenance: Not applicable/Not specified. As this is primarily software verification and validation, there is no mention of country of origin for clinical data or whether it was retrospective or prospective. The testing would have involved simulated data, test cases designed to check functionalities, and potentially a range of DICOM images to ensure compatibility and correct display/processing.

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)

• Number of Experts: Not applicable/Not specified. Since this is a PACS system and the application is for functional equivalence, there is no mention of expert radiologists establishing ground truth for diagnostic purposes within this 510(k) summary. The "ground truth" for software functionality would be the defined specifications and expected behavior, tested by software engineers and quality assurance personnel.

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

• Adjudication Method: Not applicable. Given that the testing is focused on software functionality, safety, and adherence to standards, the concept of "adjudication" for a clinical test set is not present in this document.

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

• MRMC Study: No. The document does not describe any MRMC comparative effectiveness study where human readers utilized AI. The device is a PACS system, not an AI-powered diagnostic aide.

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

• Standalone Performance Study: No. This device is a PACS and its function is to display, process, and manage medical images for human interpretation, not to provide standalone diagnostic outputs. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

• Type of Ground Truth: Not applicable/Not specified for clinical outcomes. For the software verification and validation, the "ground truth" would be the documented functional requirements, design specifications, and expected outputs of the software features (e.g., correct image display, accurate measurements, proper storage, and retrieval). There is no mention of clinical ground truth (like pathology or outcomes data) being used to evaluate the device's performance in a diagnostic capacity.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As the device is a PACS system and not an AI/ML algorithm that requires training data in the diagnostic sense, there is no mention of a "training set."

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

• Ground Truth for Training Set: Not applicable. See point 8.

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syngo plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo.plaza also supports storage and archiving of 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. Note: Web-based image distribution is not intended for reporting. In the U.S.A., syngo.plaza is not intended for the reporting of digital mammography images.

syngo. plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo.plaza also supports storage and archiving of 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 post processing applications. syngo.plaza is a "software only"-system, which will be delivered on CD-ROM / DVD or also preconfigured on hardware. syngo.plaza will be installed by Siemens service engineers. Defined Hardware requirements are to be met. The herewith described syngo.plaza supports DICOM formatted images and objects.

This 510(k) summary for syngo.plaza is quite brief and primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for a new or significantly modified feature. It is a PACS system, and the submission emphasizes its functionality as a medical diagnostic and viewing workstation, along with its integration capabilities.

Therefore, much of the requested information regarding acceptance criteria and performance studies for a device meeting specific quantitative performance metrics is not explicitly stated in this document. The submission focuses on verification and validation (V&V) against established standards for software development and medical devices.

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

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

The document does not provide a table of acceptance criteria with reported device performance in the manner typically seen for devices that perform a specific diagnostic measurement or AI-driven analysis. The "acceptance criteria" here refer to the successful completion of software verification and validation (V&V) activities and the demonstration of substantial equivalence.

The closest statement to an acceptance criterion is:

• "After completion of the system test and comparison of the test results with the software release acceptance criteria, Siemens is of the opinion, that syngo.plaza is substantially equivalent to and performs as well as the predicate device."

This implies that the overall system performance as a PACS met internal "software release acceptance criteria" to demonstrate substantial equivalence to the predicate device. However, these criteria are not detailed in terms of specific quantitative metrics (e.g., sensitivity, specificity, processing time).

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

This information is not provided in the document. The non-clinical testing discussion focuses on software V&V against standards, not on clinical performance testing with a specific test set of medical images from patients.

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)

This information is not provided. As there's no mention of a clinical test set with ground truth, there's no information about experts.

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

This information is not provided.

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

There is no mention of an MRMC study or any study evaluating human reader improvement with or without AI assistance. This submission describes a PACS system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation.

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

There is no mention of a standalone algorithm performance study. The device is a PACS system, which is inherently a human-in-the-loop system for image display, processing, reading, and reporting.

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

This information is not provided. Given the nature of the device (PACS), the "ground truth" for V&V would likely involve ensuring accurate image display, processing functions, data integrity, and compliance with standards, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as would be relevant for machine learning or AI models with learned parameters. The software V&V process for a PACS does not typically involve a training set.

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

This information is not provided.

Summary of what is present:

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device and successful completion of software V&V against specified standards (DICOM, JPEG, SMPTE, ISO 14971, IEC 60601-1-4, IEC 60601-1-6, HL7, IEC 62304). The "reported device performance" is that it "performs as well as the predicate device" and successfully passed these V&V activities.
• Study: The "study" referenced is the non-clinical testing which comprises "software verification and validation (Unit Test Level, Integration Test Level and System Test Level)." This is a demonstration of adherence to quality systems and regulatory standards, not a comparative clinical performance study.
• Key focus: The submission's primary goal is to demonstrate substantial equivalence to an existing PACS device (Siemens VO 1190). It is a "software only"-system delivered on CD-ROM/DVD or preconfigured hardware, meeting defined hardware requirements, and supporting DICOM formatted images and objects.

In conclusion, the provided document describes a PACS system and its regulatory submission focused on substantial equivalence based on software V&V. It does not contain the detailed quantitative performance metrics, test set characteristics, or AI-specific study designs that are typically requested when evaluating advanced diagnostic algorithms or AI-powered devices.

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