(23 days)
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.
syngo.CT Cardiac Planning includes tools that support the clinician at different steps during diagnosis, including reading and reporting. The user has full control of the reported measurements and images and is able to choose the appropriate function suited for their clinical need. Features included in this software that aid in diagnosis can be grouped in the following categories:
- . Basic reading: commodity features that are commonly available on CT cardiac postprocessing workstations
- Advanced reading: additional features for increased user support during CT cardiac ● postprocessing.
This document, K200515, describes Siemens' syngo.CT Cardiac Planning software. It states that the submission aims to clear an "error correction that return the Cardiac Planning software to its original specifications" and mentions that there are "no differences between the subject device and the predicate device" and no "new features or modification to already cleared features." Based on this, a full comparative effectiveness study with human readers (MRMC) or a standalone (algorithm only) performance study against clinical ground truth is not expected or provided. The document focuses on verification and validation demonstrating that the software performs as intended after the error correction, aligning with the original cleared specifications.
Given the nature of this 510(k) submission, the provided text does not contain information about specific acceptance criteria related to clinical performance metrics (like sensitivity, specificity, accuracy) or a study proving the device meets these criteria in the typical sense for a new AI/ML device. Instead, the "acceptance criteria" discussed are largely related to software verification and validation, ensuring the corrected software meets its design specifications and maintains substantial equivalence to the predicate device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of performance acceptance criteria (e.g., sensitivity, specificity, or specific measurement accuracy thresholds) for the device's diagnostic capabilities. Instead, it refers to:
| Acceptance Criteria Type | Reported Device Performance (Summary) |
|---|---|
| Software Specifications | - All software specifications met. |
| Corrective Measures | - Corrective measures implemented meet predetermined acceptance values. |
| Verification & Validation | - Functions work as designed, performance requirements and specifications met. - All hazard mitigations fully implemented. |
| Risk Management | - Risk analysis performed (ISO 14971 compliant). - Risk control implemented to mitigate identified hazards. |
The "Correction of the measurement algorithm" for "Measurement Tools" within the TAVI Feature is the specific area where a change was made and subsequently verified. The performance reported is that this correction brings the software back to its "original specifications" and achieves "substantially equivalent" performance to the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size of a test set (e.g., number of patient cases) used for clinical performance evaluation. The testing described is primarily focused on software verification and validation, rather than a clinical performance study with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of clinical performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as a clinical performance study with a test set requiring expert ground truth is not detailed in this submission. The focus is on software function and correction verification.
4. Adjudication Method for the Test Set:
Not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not mentioned. The submission's core purpose is to demonstrate that an error correction maintains the device's original cleared specifications, not to show improvement over human readers.
6. Standalone (Algorithm Only) Performance Study:
A standalone (algorithm only) performance study (e.g., measuring diagnostic accuracy independent of a human user) was not conducted and is not described. The document pertains to an error correction in existing, cleared software.
7. Type of Ground Truth Used:
The document implies a ground truth based on the original design specifications and expected behavior of the syngo.CT Cardiac Planning software (K170221). The testing confirmed that the corrected measurement algorithm performs according to these original specifications, which serve as the implicit "ground truth" for the verification activities. There is no mention of external clinical ground truth (e.g., pathology, outcomes data) for validating a diagnostic claim in this submission.
8. Sample Size for the Training Set:
Not applicable. This submission is for an error correction to an existing software product, not the development of a new algorithm that would involve a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned or implied for this submission.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.