(48 days)
Medsynapse PACS Software is a WEB software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices. secondary capture devices, scanners. imaging gateways, etc.). Images and data can he captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
Medsynapse is a web PACS, which allows distribution of images within and outside the Hospital using networking technology. It does not require installation of any software and can be operated directly from the browser providing ease of use from anywhere.
The provided document is a 510(k) summary for the Medsynapse PACS Software. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, performance data from a clinical or technical study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such studies.
Instead, the document focuses on:
- Device Description: What the Medsynapse PACS Software is, its function as a web-based PACS for image distribution, and its technological characteristics (minimum hardware/software requirements for server and client).
- Indications for Use: How the device is intended to be used (receiving, capturing, storing, communicating, processing, and displaying digital images and data from various sources). It also explicitly states limitations for mammographic image review.
- Substantial Equivalence Claim: The device claims substantial equivalence to the Voyager PACS System (K062062).
- Performance Statement: A general statement about "bench testing (software validation and risk analysis)" indicating "no new issues of safety or effectiveness."
Therefore, many parts of your request cannot be fulfilled as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Device Performance
The document states that the results of "bench testing (software validation and risk analysis)" show that the device "poses no new issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device."
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Poses no new issues of safety. |
| Effectiveness | Poses no new issues of effectiveness. |
| Substantial Equivalence | Deemed substantially equivalent to the predicate device (Voyager PACS System, K062062). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only mentions "bench testing (software validation and risk analysis)," which typically refers to in-house technical testing, not necessarily clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document does not describe any test set where ground truth established by experts would be relevant (e.g., a clinical validation study).
4. Adjudication method for the test set
- This information is not provided. There's no mention of a test set requiring adjudication in the context of expert review.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was mentioned or performed. This device is a PACS software, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies general software validation and risk analysis ("bench testing") but does not detail a "standalone" performance study in the context of diagnostic accuracy for an algorithm. The device itself is an image management system, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. Given the nature of "bench testing," the "ground truth" would likely be adherence to technical specifications, software functionality, and data integrity, rather than clinical ground truth from patient data.
8. The sample size for the training set
- Not applicable. This device is a PACS software, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a PACS software, not a machine learning model that requires a training set with established ground truth.
§ 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).