(42 days)
The syngo Aortic ValveGuide software is an add-on option to InSpace 3D software with an enhanced algorithm to display the aortic root and to visually assist the physician by placing the C-arm in an orthogonal position to the aortic root plane.
The syngo Aortic ValveGuide software is intended for imaging soft tissues (heart) for diagnosis, surgical planning, interventional procedures and treatment follow-up.
This software is also designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)
The syngo Aortic ValveGuide software is an add-on to the 510(k) cleared InSpace 3D software and a workflow improvement. This software visually assists the physician in localizing the aortic root plane by exact C-arm adiustment. The Inspace 3D application was originally cleared under Premarket Notification K011447 on 08/03/2001.
syngo Aortic ValveGuide software offers fast and precise 3D image viewing information of the aortic root anatomy during the procedure, thus providing excellent viewing support of the aortic root plane.
This software modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
Here's an analysis of the provided 510(k) summary for the "syngo Aortic ValveGuide Software" regarding acceptance criteria and study details:
Summary of Acceptance Criteria and Device Performance (Based on Provided Document):
The provided 510(k) summary (K113027) for the syngo Aortic ValveGuide Software is a "Special 510(k) Submission" and largely focuses on demonstrating substantial equivalence to a predicate device (InSpace 3D, K011447) rather than presenting new performance studies with quantitative acceptance criteria. The submission states that the new software is an "add-on" and a "workflow improvement" that does not affect the intended use or alter its fundamental scientific technology.
Therefore, the acceptance criteria and detailed performance reporting typically found in a traditional 510(k) for a novel device are not explicitly present in this document. The "acceptance criteria" in this context are primarily around demonstrating that the new software maintains the safety and effectiveness of the predicate device and that its enhancements achieve the stated workflow improvements without introducing new risks.
Since specific quantitative acceptance criteria and performance data are not provided in this summary, the table below reflects the stated purpose of the software modification as its "performance goal" and the basis for acceptance as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary Statements) |
|---|---|
| Safety and Effectiveness Equivalence to Predicate | "syngo Aortic ValveGuide is intended for similar indications as cleared in the predicate Inspace 3D." |
| "The functionality of syngo Aortic ValveGuide Software is similar to the predicate device." | |
| Workflow Improvement (Enhanced Algorithm for Aortic Root) | "This software visually assists the physician in localizing the aortic root plane by exact C-arm adjustment." |
| "syngo Aortic ValveGuide software offers fast and precise 3D image viewing information of the aortic root anatomy during the procedure, thus providing excellent viewing support of the aortic root plane." | |
| No Alteration of Intended Use or Fundamental Scientific Technology | "This software modification does not affect the intended use of the device nor does it alter its fundamental scientific technology." |
| Risk Management and Hazard Control | "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." |
| Compliance with Industry Standards and Practices | "Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document is a Special 510(k) focusing on software modifications and equivalence. It does not mention a specific "test set" in the context of a new clinical study with a defined sample size for performance evaluation of the new features. Instead, it relies on the established performance of its predicate device, InSpace 3D. The "verification and validation testing" mentioned typically refers to internal software testing rather than a clinical performance study.
- Sample Size (Test Set): Not specified for the new "syngo Aortic ValveGuide" features in this document.
- Data Provenance: Not specified for a new test set. The predicate device, InSpace 3D, would have undergone its own clearance process (K011447) which might have involved clinical data, but this is not detailed for the new add-on.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a clinical study requiring expert-established ground truth for a test set. The ground truth for the predicate device (InSpace 3D) would have been established at its original clearance (K011447) but is not detailed here for the new add-on.
4. Adjudication Method for the Test Set:
Not applicable, as no specific clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission's focus is on demonstrating substantial equivalence and workflow improvement through technical modification and internal verification/validation, not a direct comparison of reader performance with and without the AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
The syngo Aortic ValveGuide Software is an "add-on to InSpace 3D" and is "not a stand-alone software." The description indicates it "visually assists the physician," implying human-in-the-loop operation. Therefore, a standalone algorithm-only performance study, in the sense of an AI model making independent decisions, is not relevant or described. The "performance" is about how well it assists the physician.
7. The Type of Ground Truth Used:
For the "syngo Aortic ValveGuide Software" specifically, in this Special 510(k), no new clinical ground truth establishment is described. The device is for "imaging soft tissues (heart) for diagnosis, surgical planning, interventional procedures and treatment follow-up" and to "assist physicians in the diagnosis and treatment of vessel malformations." The implicit ground truth for such clinical applications would typically be clinical outcomes, pathology, or expert consensus based on established diagnostic criteria, but this is related to the intended use and predicate device, not a new comparative study for this add-on.
8. The Sample Size for the Training Set:
Not applicable. The document describes a software "add-on" with an "enhanced algorithm" but does not characterize it as a machine learning/AI model requiring a dedicated training set in the modern sense. It refers to "software development, verification and validation testing," which would use internal datasets for testing the software's functionality and accuracy, but not a "training set" for a learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set for a machine learning algorithm is mentioned.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.