(84 days)
The SPY Analysis Toolkit is a separate companion software application to the SPY Intra-operative Imaging System and is intended as a display, analysis, and comparison tool for the interpretation of SPY images by trained healthcare professionals including cardiovascular, plastic & reconstructive, and organ transplant surgeons.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images. The SPY Analysis Toolkit is a complement to the SPY procedures.
The SPY® Analysis Toolkit is a separate companion application to the SPY Intraoperative Imaging System's (SPY System) software, which is currently cleared for use in cardiovascular, plastic and reconstruction, and organ transplant surgeries. The Analysis Toolkit is capable of working cooperatively, as an accessory plug-in feature, with the SPY software or standalone on a physician's desktop computer. The Analysis Toolkit is not real-time.
Novadaq's SPY System allows surgeons (including cardiovascular, plastic and reconstructive, and transplant) to produce real-time images of blood vessels, surrounding tissue and related perfusion of those tissues/organs during various types of surgeries. The Analysis Toolkit provides a set of clinical image analysis tools and makes them available to clinicians for either intra-operative post image acquisition or retrospective analysis. The ultimate goal of analysis will be to provide surgeons with another parameter, in addition to standard of care information, including data from other imaging modalities, for use in pre-operative decision-making and post-operative evaluation of results as an input to post-operative care.
The SPY Analysis Toolkit is a plug-in module to the SPY Imaging Device and does not have any control over the device or the previously cleared software. The SPY Analysis Toolkit is an accessory software feature designed and developed to work with images acquired on the SPY System, models SP2000 and SP2001. The SPY Analysis Toolkit has no capability to modify in any way the underlying images previously acquired intraoperatively by the SPY System. The resolution and the quality of the images captured by the SPY System and analyzed by the SPY Analysis Toolkit remain the same.
The SPY Analysis Toolkit application is for viewing, manipulation, measurement and comparison of medical image sequences produced at single or multiple time-points by the SPY System. Entire image time-sequences are processed for viewing using a variety of analytical algorithms that provide visual or numerical results.
The Analysis Toolkit can also accept DICOM and AVI images independent of the SPY device for post-operative analysis.
The provided text describes the SPY Analysis Toolkit, its intended use, and its equivalence to predicate devices, but it does not contain information about specific acceptance criteria, a scientific study with a test set, or detailed performance metrics. The document is a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence rather than reporting on a clinical or performance study with acceptance criteria.
The "Testing" section mentions that the device was "designed and developed with the input from experienced SPY System users," and "scanned image datasets from the various disciplines were used as input for testing of the software functionalities in accordance with the Software Development Plan." It also states that "A full description of the software functionality, device hazard analysis, software requirements, and verification and validation protocols and testing can be found in Section 16 - Software, of this submission." However, these details are not provided in the excerpt.
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.
Here's a breakdown of what can be extracted or inferred from the given text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot be created. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) nor does it report specific performance metrics against such criteria. The document focuses on "substantial equivalence" to predicate devices based on intended use and technological characteristics rather than quantitative performance.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The text mentions "Scanned image datasets from the various disciplines were used for testing," but no specific number or size of these datasets is provided.
- Data Provenance: Not explicitly stated. It mentions "datasets from the various disciplines," implying a medical context, but no country of origin is given. It is likely retrospective as it refers to "scanned image datasets."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: The device was "designed and developed with the input from experienced SPY System users," which included "all disciplines currently cleared to use the SPY System, in cardiovascular, plastic and reconstructive, organ transplant surgeries." This implies the "experts" were practicing surgeons in these fields. However, their specific role in establishing "ground truth" for a test set is not detailed.
4. Adjudication method for the test set:
- Not explicitly stated. The document does not describe any specific adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No such study is described or referenced. The document indicates the SPY Analysis Toolkit is "a complement to the SPY procedures" and that "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images." This suggests the tool is an aid, but no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document implies the software is not intended for standalone, unsupervised diagnosis. It explicitly states: "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images." and "Device output and analysis is not real-time and is only used to indicate the appropriateness of a referral or surgical decision."
7. The type of ground truth used:
- Not explicitly stated. Given the context of a medical imaging analysis tool, ground truth would typically come from clinical diagnosis, pathology reports, or expert consensus, but the document does not specify.
8. The sample size for the training set:
- Not mentioned. The document refers to "scanned image datasets... used for testing," but does not distinguish between training and testing sets, nor does it provide sample sizes for either.
9. How the ground truth for the training set was established:
- Not mentioned.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).