(84 days)
AMALGA PACS is a device that receives medical images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
The Amalga™ System handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
The device is a computer hardware and software medical image picture archiving and communications system. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
This document is a 510(k) summary for the Amalga™ PACS system. It is a pre-market notification to the FDA to demonstrate substantial equivalence to a predicate device. As such, it does not contain the kind of detailed study information typically found in a clinical trial report or a scientific publication.
Therefore, for the information requested:
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A table of acceptance criteria and the reported device performance
- This document does not specify quantitative acceptance criteria or reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy). The submission is focused on demonstrating substantial equivalence in function and safety, not on specific performance thresholds.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe a test set or clinical study data. It is a regulatory submission for a Picture Archiving and Communication System (PACS), which primarily handles image storage, communication, processing, and display. Performance claims are typically related to technical specifications (e.g., image resolution, transfer speeds, storage capacity) rather than diagnostic accuracy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no test set or ground truth establishment is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no test set or adjudication process is described.
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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 is mentioned. This device is a PACS, which is a foundational infrastructure for managing medical images. It does not incorporate AI for diagnostic assistance that would be evaluated in such a study. The document states that a "physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," emphasizing that human interpretation remains central.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The Amalga™ PACS is an image archiving and communication system, not a diagnostic algorithm that would have standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no ground truth is described.
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The sample size for the training set
- Not applicable, as this device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- Not applicable.
Summary of what the document does provide regarding acceptance and proof:
- Acceptance Criteria (Implied): The implied acceptance criteria for this 510(k) submission are that the Amalga™ PACS system is substantially equivalent to its predicate device (Mediface (PiView) PACS, K010259) in terms of intended use, technological characteristics, and safety.
- Study/Proof: The "study" here is the regulatory submission itself, which primarily consists of:
- Comparison to Predicate Device: A detailed comparison of the Amalga™ PACS to the Mediface (PiView) PACS, demonstrating similar technological characteristics (both are computer hardware and software medical image PACS).
- Hazard Analysis: The text mentions that "the submission contains the results of a hazard analysis and the potential hazards have been classified as Minor." This is part of demonstrating safety.
- Compliance with Standards: The system "has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey."
In essence, the "proof" is the argument laid out in the 510(k) summary (and supporting documentation not provided here) that the new device is functionally and safely comparable to an already legally marketed device, thus meeting the criteria for substantial equivalence. It is not a clinical performance study as would be expected for a diagnostic or AI-powered device.
§ 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).