(88 days)
The intended use of the device is to allow storage and retrieval of medical images for purposes of assisting in the diagnosis and/or treatment of diseases.
The ImageACCESS® system is a complete clinical image management system providing direct capture, retrieval, storage, and transmission of images, reports and patient demographics. These images include, but are not limited to, Flat film Radiology, computer Tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET). Images from such devices are directly recorded/retrieved on/from optical disk recorders.
This document is a 510(k) premarket notification for the StorCOMM ImageACCESS system, which is a clinical image management system. The provided text primarily focuses on the administrative aspects of the 510(k) submission and FDA approval, rather than detailed performance study results or acceptance criteria for a new device.
Therefore, many of the requested categories about acceptance criteria and detailed study information cannot be extracted from this document as they are not present. This submission is for substantial equivalence to an existing device (K931454) and not for a novel device that requires extensive clinical performance studies as would be expected for, say, a new diagnostic algorithm.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document is a 510(k) summary for an image management system, not a diagnostic device with specific performance metrics like sensitivity or specificity. No acceptance criteria or performance data for such metrics are provided. The "performance" described is its function as an image management system (capture, retrieve, storage, transmission).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No information on a "test set" in the context of diagnostic performance is mentioned. The device is a system for managing images, not for performing diagnostic tests on images itself.
3. 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)
- Cannot be extracted. This document does not describe studies that require expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. Not applicable, as no test set requiring adjudication is described.
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
- Cannot be extracted. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be extracted. This is an image management system, not an algorithm, so standalone performance in the sense of a diagnostic algorithm is not relevant or described.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be extracted. Not applicable, as no diagnostic performance study establishing ground truth is described.
8. The sample size for the training set
- Cannot be extracted. This is not a machine learning or AI device that would typically have a training set.
9. How the ground truth for the training set was established
- Cannot be extracted. Not applicable, as no training set or ground truth for it is described.
In summary, the provided 510(k) document pertains to an image management system and emphasizes its substantial equivalence to a previously cleared device. It does not contain the detailed performance study information typically found for novel diagnostic devices, especially those incorporating AI or requiring clinical validation against a "ground truth."
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.