(68 days)
4D LV-Analysis is intended to retrieve, analyze, and store digital ultrasound images for computerized dynamic 3-dimensional image analysis. 4D LV-Analysis reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for analysis. It is intended as a digital 4D ultrasound image processing tool for cardiology.
4D LV-Analysis 3.0 is intended as software for analysis of the left ventricle in heart failure patients.
The 4D LV-Analysis® 3.0 software is a clinical application package for high performance PC platforms based on Microsoft Windows operating system standards. 4D LV-Analysis is software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images. 4D LV-Analysis is compatible with different TomTec Image-Arena™ platforms, their derivatives or any other platform that provides and supports the Generic CAP Interface. Platforms enhance the workflow by providing the database, import, export and other functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes. 4D LV-Analysis is designed for 2- and 3-dimensional morphological and functional analyses of the left ventricle. Based on three dimensional datasets a semi-automatic 3D surface model finding algorithm supports the calculation of a 4D model that represents the cavity of the LV.
From that model, global as well as regional volumetric changes can be derived. By looking at the timing of regional contractions, dyssynchrony of a ventricle can be quantified and visualized. For visualization, parametric maps are used that indicate areas with a delayed contraction.
Thus 4D LV-Analysis improves the functional analysis of the LV and presentation of findings to cardiologists and electro-physiologists and visualizes the contraction pattern of the LV to assess dyssynchrony.
The submission K110746 for TomTec Imaging Systems GmbH's "4D LV-Analysis 3.0" device provides minimal details regarding specific acceptance criteria and detailed study results. The document largely defers to internal company procedures and a general statement of clinical acceptance.
Here's an analysis based on the provided text, highlighting what is presented and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Device is safe and effective | "safe as effective, and performs as well as the predicate devices." | Vague and lacking specific metrics or thresholds. |
| Performs as well as or better than predicate devices | "performs as well as or better than the predicate devices." | No specific performance metrics or statistical comparisons are provided. |
| Compliance with internal software testing and validation protocols | "Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted." | This describes the process, not the outcome or specific acceptance criteria met. |
| Clinical acceptance of the overall product concept | "The overall product concept was clinically accepted" | This indicates a general positive reception but lacks quantifiable clinical endpoints or acceptance thresholds. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "clinical test results support the conclusion," but no details about the number of cases or patients in the clinical performance testing are provided.
- Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether the clinical data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, not explicitly mentioned. The document does not describe any study comparing human readers' performance with and without AI assistance.
- Effect Size of Improvement: Not applicable, as no such study is described.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes, implied. The device itself is software for analysis, and the claims about its performance relative to predicate devices would inherently involve evaluating its algorithmic output. However, no specific standalone performance metrics (e.g., accuracy, sensitivity, specificity for specific clinical endpoints) are provided.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified. The document refers to "overall product concept was clinically accepted" and "clinical test results," suggesting some form of clinical ground truth, but the specific nature (e.g., expert consensus, pathology, long-term outcomes, invasive measurements) is not detailed.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document mentions the device uses a "semi-automatic 3D surface model finding algorithm," which implies machine learning or model training, but gives no details about the training data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not specified.
Summary of Deficiencies in Reporting:
The 510(k) summary for K110746, typical for submissions from that era and device type, is high-level and defers significant detail to internal documentation (Chapter 16: Software, Verification and Validation Documentation). It lacks specific, quantifiable acceptance criteria and detailed reporting of clinical performance data. Key information such as sample sizes, expert qualifications, ground truth methods, and statistical performance metrics which are common in more recent AI/ML device submissions, are not present in this public summary. The claims are generalized statements about safety and effectiveness in comparison to predicate devices, without providing the underlying evidence in this document.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).