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510(k) Data Aggregation
(126 days)
syngo.CT Coronary Analysis; syngo.CT Vascular Analysis
syngo.CT Coronary Analysis is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/ thick, maximum intensity projection (MP) thin/thick, inverted MP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization tools allow for characterization (geometry (length, lumen diameter, cross section area, stenosis grade) and appearance (HU values)) of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP think, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified lesions in blood vessels and evaluation and follow-up of any such lesion. These visualization/processing/evaluation tools allow for characterization (geometry (length, lumen diameter, cross section area, stenosis grade) and appearance (HU values)) of vascular lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
syngo.CT Coronary Analysis is an image analysis post-processing software application designed to support evaluation of the vessels of the heart. This submission describes the following modifications that were made to predicate device syngo.CT Coronary Analysis (K100637, clearance date 5/26/2010):
- Support of software version SOMARIS/8 VB30 which supports the following functionality:
a. Coronary Tracing Quality Improvement
b. Rapid Results Technology Support for Curved Vessel Ranges - Update 510(k) Information
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stencils calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and kev images), the software package is designed to support the physician in confirming the presence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
syngo.CT Vascular Analysis is a post-processing software application to support evaluation of the large vessels of the body. This submission describes the following modifications that were made to predicate device syngo.CT Vascular Analysis (K112020, clearance date 08/18/2011):
- Modified Indications for Use Statement
- Support of software version SOMARIS/8 VB30 which supports the following functionality:
a. Rapid Results Technology Support for curved vessel ranges
b. Bone Removal Quality Improvement
c. Vessel Tracing Quality Improvement - Update 510(k) Information
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified lesions in blood vessels and evaluation, documentation and follow-up of any such lesion. These visualization/processing/evaluation tools allow for characterization of vascular lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
This Siemens 510(k) summary for syngo.CT Coronary Analysis and syngo.CT Vascular Analysis describes modifications to existing cleared devices rather than a completely new device. Therefore, the performance studies primarily focus on demonstrating that the modified features maintain or improve performance compared to their predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For syngo.CT Coronary Analysis: Coronary Tracing Quality Improvement | |
| Centeredness of the Centerlines | "the derived centerlines were assessed in comparison to the predicate device to demonstrate an improvement in the ability of the subject device application to more accurately follow the vessels in the lumen." |
| Tracing of branches (Clinically relevant and irrelevant) | "demonstrated an increased sensitivity and specificity" |
| Coverage of Centerlines | "improved vessel coverage for the subject device tracing feature in comparison to the predicate device." |
| For syngo.CT Vascular Analysis: Vessel Tracing Quality Improvement | |
| Detection rate of a predetermined set of vessels | "demonstrated that the subject device had a higher level of traced vessels in comparison to the predicate device, which supports an improvement of vessel tracing quality in comparison to the predicate device." |
| General Software Performance (Both Devices) | |
| Software specifications met acceptance criteria | "The testing supports that all software specifications have met the acceptance criteria." |
| Conformance to performance standards (DICOM, IEC 62304, ISO 14971, IEC 62366-1, AAMI / ANSI ES60601-1) | "Siemens claims conformance to the following performance standards" (lists all mentioned standards). |
| Risk control implemented to mitigate identified hazards | "The Risk Analysis was completed and risk control implemented to mitigate identified hazards." |
2. Sample Size Used for the Test Set and Data Provenance
- syngo.CT Coronary Analysis: "a sampling of centerlines from a predetermined number of datasets were evaluated." The exact number of datasets is not specified.
- syngo.CT Vascular Analysis: "a predetermined set of vessels was evaluated." The exact number of vessels or datasets is not specified.
- Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin. However, given that these are modifications to existing software, it's likely that existing clinical CT angiography datasets were used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a ground truth for these performance tests. The evaluation appears to be based on comparing algorithmic performance (e.g., centerline accuracy, branch tracing, vessel coverage) against the predicate device's performance or predefined internal metrics, rather than expert-derived ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the studies are focused on comparing the algorithmic performance of the modified device against its predicate, rather than human review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The studies described are non-clinical performance (bench) testing, comparing the improved algorithms against their previous versions.
6. Standalone Performance Study
Yes, standalone (algorithm-only) performance testing was conducted for the specific improved features.
- For syngo.CT Coronary Analysis, improvements in "Centeredness of the Centerlines," "Tracing of branches," and "Coverage of Centerlines" were evaluated.
- For syngo.CT Vascular Analysis, the "detection rate of a predetermined set of vessels" was evaluated.
These evaluations focused on the direct output of the algorithms.
7. Type of Ground Truth Used
The ground truth used for these specific performance tests appears to be internal algorithmic metrics and comparisons to the predicate device's performance.
- For centerline centeredness, it implies an ideal path for the vessel lumen against which the derived centerlines are compared.
- For branch tracing and coverage, it implies an objective definition of "clinically relevant" and the actual anatomical presence of branches and overall vessel extent.
- For vessel tracing, it implies whether a vessel that is anatomically present and expected to be traced was indeed traced.
This ground truth is not explicitly stated as expert consensus, pathology, or outcomes data, but rather as an internal standard or objective measure of algorithmic output.
8. Sample Size for the Training Set
The document does not provide information about the sample size used for the training set. These are modifications to existing software, and the description focuses on verification and validation of the changes, not the initial development of the underlying algorithms.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established.
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(82 days)
SYNGO.CT CORONARY ANALYSIS
Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets.
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion.
These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets.
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a formal table or list quantifiable performance metrics with specific thresholds. Instead, it refers to general safety and effectiveness concerns and the device's intended use, which is to support physicians in confirming the presence or absence of coronary lesions, and evaluating and documenting them.
The document highlights the device's functionality and visualization tools, implying that these capabilities are what define its "performance." However, no numerical performance data (e.g., sensitivity, specificity, accuracy for lesion detection or quantification) is presented.
2. Sample Size for the Test Set and Data Provenance
The provided text does not include information about the sample size used for a test set, nor does it specify the data provenance (country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not include information about the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The provided text does not include information about any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The provided text does not explicitly describe a standalone (algorithm-only) performance study with quantifiable results. The description of the device focuses on its role as an "image analysis software package" designed to "support the physician," implying a human-in-the-loop workflow rather than a fully autonomous application.
7. Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used for any evaluation. Given the context of coronary analysis, likely ground truth would involve either invasive coronary angiography (ICA) or expert consensus readings by cardiologists/radiologists. However, this is not confirmed in the document.
8. Sample Size for the Training Set
The provided text does not include any information about the sample size used for a training set. The document is a 510(k) summary, which often focuses on substantial equivalence to predicate devices and general safety/effectiveness, rather than detailed algorithmic training and validation specifics.
9. How Ground Truth for the Training Set Was Established
The provided text does not describe how ground truth for any training set was established.
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