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510(k) Data Aggregation
(69 days)
IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR).
Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and cleared by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Contraindications: Lossy compressed images and digitized film screen images must not be reviewed for primary image interpretations.
IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations.
In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards. Stored files are transmitted using a network and can be viewed or manipulated using InteleViewer viewing software.
This document is a 510(k) premarket notification for the IntelePACS™ device. It asserts substantial equivalence to a predicate device (IntelePACS, Model Version 3.X.X, K083520). The primary purpose of this document is to demonstrate that the new device does not raise new questions of safety or efficacy compared to the predicate.
Here's an analysis of the provided text in relation to acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device as a Picture Archiving and Communications System (PACS) and outlines its functionalities and technical characteristics in comparison to a predicate device. The acceptance criteria are broadly focused on demonstrating that the new IntelePACS™ performs equivalently to its predicate and that any differences do not impact safety or efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance (IntelePACS™ Subject Device) |
|---|---|
| Intended Use Equivalence: Acquire, view, edit, and store radiographs and related patient images, with the same user types (radiologists). | Same as predicate; no difference. |
| Technical Characteristics Equivalence: Performance across various functions (network, monitor, user interaction, import/export, acquisition devices, imaging interfaces, image organization, search, storage, viewing, measurement, annotation, operations, security, DICOM 3.0 compatibility, generator control, RAW/post-image data processing, thumbnail viewing, image reset, panning, magnify glass, fit image). | Same as predicate for all these functionalities; no difference. |
| Operating System Compatibility: Workstation and Server OS updates (Windows 7 64-bit Professional, Red Hat Enterprise Linux 6 64-bit x86) are validated to ensure no impact on safety or efficacy. | Confirmed: "The system has been tested and validated... and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified." |
| Hardware Performance: Updated Server Memory (16GB vs 8GB), Server Database (Sybase and PostgreSQL), Workstation Processor (Intel 6-core Xeon Processor 3.2GHz vs Intel Core 2 Duo 2Ghz), and Workstation Memory (6GB vs 2GB) are validated to ensure no impact on safety or efficacy. | Confirmed: "The system has been tested and validated... and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified." |
| Software Feature Equivalence: Inclusion of "Blackford Registration" (K142337) does not affect image or intended use and has no impact on safety or efficacy. | Confirmed: "The difference is a user preference and does not directly affect the image or intended use... no impact on safety or efficacy and that no additional risks have been identified." |
| Overall Safety and Efficacy: The new device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. | Confirmed: "Any difference between the two devices does not affect safety or efficacy." and "The modification to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices." |
| Manufacturing Standards Compliance: Manufactured in accordance with voluntary standards. | Confirmed: "The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey." |
| Verification and Validation: All input, output, and actions performed by the software in each operational mode are assessed and tested. | Confirmed: "The complete IntelePACS™ configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification Test Plan was designed to evaluate all input functions, output functions, and actions performed by the IntelePACS™ software in each operational mode and followed the process documented in the Validation Test Plan." |
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. It mentions "in-house testing criteria" and "all verification and validation activities" but without specific numbers of images, studies, or scenarios.
The data provenance is implied to be retrospective as the testing is described as "in-house testing criteria" and "assessment at the factory." There is no mention of prospective data collection or specific countries of origin for the data, other than the company being based in Montreal, Quebec, Canada.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. It clarifies that "A physician, providing ample opportunity for competent human interprets images and information being displayed and printed," implying that medical professionals are the end-users responsible for interpretation, but this doesn't detail their role in testing or establishing ground truth for the device's performance validation.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set. It mentions "designated individuals performed all verification and validation activities" but does not detail how discrepancies or consensus were managed.
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, an MRMC comparative effectiveness study was not done. This 510(k) notification is for a Picture Archiving and Communications System (PACS), which is infrastructure software for managing and viewing medical images. It is not an AI algorithm designed to interpret images or assist human readers in diagnosis. Therefore, there is no discussion of human reader improvement with or without AI assistance, or any effect size.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done in the context of an AI algorithm providing diagnostic interpretations. The device itself (IntelePACS™) is a standalone system in the sense that it performs its functions (image capture, storage, distribution, manipulation, viewing) without continuous human interaction for each specific task in its backend processing. However, it is not an AI algorithm whose performance is measured in terms of diagnostic accuracy without human intervention. The device's primary function is to enable human clinicians to view and interpret images.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The document does not specify the type of ground truth used for its validation. Given its nature as a PACS system, the "ground truth" for its testing would likely relate to the accurate storage, retrieval, display fidelity, manipulation functionality, and network performance of medical images, rather than diagnostic outcomes or pathology reports. The testing would ensure that the digital images are handled correctly and consistently to allow accurate human interpretation.
8. The Sample Size for the Training Set:
This document is for a PACS system, not an AI/ML algorithm that requires a training set. Therefore, the concept of a "training set" does not apply to the described device or its validation within this 510(k) summary.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for this device, a method for establishing its ground truth is not applicable and therefore not described.
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