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510(k) Data Aggregation
(87 days)
SHINA SYSTEMS LTD.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy. The 3Di indications for use have been modified to include viewing of Mammography images.
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di indications for use have been modified to include viewing of Mammography images.
The provided text describes the 3Di device, a PACS workstation that now includes the viewing of Mammography images. The submission focuses on demonstrating substantial equivalence for this added functionality.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Quality of Mammography imaging is unsubstantially different or equivalent to DICOM source mammographic data (for accurate viewing) | The quality of Mammography imaging was validated by comparing the device imaging output to the DICOM source mammographic data. The comparison results demonstrate that the 3Di and the DICOM source mammographic data are substantial equivalent in terms of image quality. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "comparison results" without detailing the number of mammography images or studies included in this comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. It only mentions that the device is "intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis".
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set. The validation was based on a direct comparison of image quality.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The submission focuses on the equivalency of image quality for mammography viewing, not on the impact of the AI on human reader performance or diagnostic accuracy.
6. Standalone Performance Study
No standalone (algorithm only without human-in-the-loop performance) study is explicitly detailed. The validation described is a comparison of image output quality of the device against the DICOM source, rather than an algorithmic diagnostic performance study.
7. Type of Ground Truth Used
The "ground truth" for the validation seems to be the DICOM source mammographic data itself. The device's output was compared directly against this source data to ensure visual fidelity and quality. This indicates a technical ground truth related to image rendering, rather than a clinical ground truth like pathology or expert consensus on disease presence.
8. Sample Size for the Training Set
The document does not provide any information about a training set since the validation focuses on image quality comparison, not on a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or related ground truth establishment is mentioned in the context of this 510(k) submission.
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(30 days)
SHINA SYSTEMS LTD.
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.
The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di has been modified to include the 3Di CScore -option, which is intended to process CT cardiac studies for CT Calcium scoring.
Here's a breakdown of the acceptance criteria and the study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a validation study for the 3Di CScore feature by comparing its output to a predicate device. It doesn't explicitly state numerical "acceptance criteria" in the format of a predefined threshold. Instead, it states the goal of the validation and the outcome of the comparison.
| Criterion Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Calcium Scoring Output | The 3Di CScore output should be "very similar" to the output of the Philips Brilliance workstation (the predicate device). | "The comparison results demonstrate that the 3Di and the Brilliance are very similar in terms of calcium scoring." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. The study is described as a comparison against a predicate device's output, rather than against expert consensus on a dataset.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. The study is a direct comparison of algorithmic outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted or described. The study focuses on the device's algorithmic output compared to a predicate device's algorithmic output, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a standalone performance assessment was done in the sense that the 3Di CScore's calculated calcium scores were compared directly to the Philips Brilliance workstation's calculated calcium scores. This is a comparison of two algorithmic outputs.
7. The Type of Ground Truth Used
The "ground truth" for the test set appears to be the output of a legally marketed predicate device (Philips Brilliance workstation) for calcium scoring. This is a comparative validation, where the predicate device serves as the reference standard.
8. The Sample Size for the Training Set
The document does not provide the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Given the nature of the validation (comparison to a predicate device), it's possible that the 3Di CScore's development involved internal reference standards or existing clinical data, but the details are not outlined here.
Ask a specific question about this device
(49 days)
SHINA SYSTEMS LTD.
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.
The 3Di indications for use are processing of Cardiac CT angiography studies, including coronaries analysis, cardiac functional assessment and CT colonoscopy.
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications.
Here's an analysis of the provided 510(k) summary regarding the 3Di device, addressing your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state acceptance criteria in a quantitative or pass/fail threshold manner. Instead, it describes a comparative study against a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| General functionality of image reformatting (various modalities) | "results of the two devices are very similar" |
| Reliability of orientation annotations displayed | "results of the two devices are very similar" |
| Correctness of measurements | "results of the two devices are very similar" |
| Image quality | "results of the two devices are very similar" |
| Cardiac analysis Graphs and Results | "results of the two devices are very similar" |
| Colon analysis results | "results of the two devices are very similar" |
| Overall Safety and Effectiveness (compared to predicate) | "substantial equivalent in terms of safety and effectiveness to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for the comparative performance study. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The 510(k) summary does not provide information on the number of experts or their qualifications. The study described is a comparison of the 3Di device against a predicate device (Philips Brilliance) rather than establishing ground truth against expert consensus.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe an adjudication method. The study appears to be a direct comparison of the 3Di's output with the predicate device's output across various functions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The comparison is between two devices, not human readers with and without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance assessment was effectively done. The summary states: "Its performance has been validated by comparison to the performance of the Philips Brilliance predicate device." This implies an evaluation of the algorithm's output directly against the predicate device's output, without human intervention in the loop during this specific performance validation.
7. Type of Ground Truth Used
The "ground truth" for this study was the performance and output of the legally marketed predicate device (Philips Brilliance). The comparison aimed to demonstrate "substantial equivalence" to this established device, rather than to a clinical ground truth like pathology or patient outcomes.
8. Sample Size for the Training Set
The 510(k) summary does not provide information on the sample size used for the training set. Given the submission date (2010) and the description of the device as a PACS workstation with visualization tools, it's possible that traditional "training sets" in the modern machine learning sense might not have been explicitly documented or emphasized in the same way as they would be for deep learning-based AI devices today. The device focuses on visualization and manipulation tools, which might rely more on established graphics algorithms than on data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established
The 510(k) summary does not provide information on how ground truth was established for any training set. If internal validation or verification was performed during development, this information is not detailed in the provided text.
Ask a specific question about this device
(44 days)
SHINA SYSTEMS LTD.
The system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.
The CardioCT (CCT) is a software application for viewing, evaluating and functionally analyzing cardiac CT images. The application is an interactive tool for radiologists and cardiologists and is used to visualize coronary anatomy, assess the state of the coronary arteries and execute functional analyses of the heart. This is accomplished by segmenting the heart tissues and coronary arteries and performing detailed evaluations of the coronary arteries and ventricular functions.
The supplied text is a 510(k) summary for the CardioCT device. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Identifying the device (CardioCT) and its manufacturer (Shina Systems Ltd.).
- Stating its intended use (viewing, evaluating, and functionally analyzing cardiac CT images for radiologists and cardiologists).
- Claiming substantial equivalence to a predicate device (Philips Medical Systems Inc.'s Comprehensive Cardiac Analysis (CCA) module).
- Providing the FDA's clearance letter, regulation number, and product code.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The requested information regarding specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies is not present in this 510(k) summary.
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