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510(k) Data Aggregation
(59 days)
MediLab
MediLab is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediLab displays and manages diagnostic quality DICOM images. MediLab is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediLab is not intended for diagnostic use on mobile devices.
Contraindications: MediLab is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
The MediLab is a DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediLab is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediLab enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software.
The provided text describes the MediLab device, its intended use, and compares it to predicate devices. However, it does not explicitly state acceptance criteria in a quantitative manner or detail a specific study proving the device meets said criteria for diagnostic performance.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (ZeeroMED View, IMPLANTER DENTAL PLANNING SOFTWARE, and aPROMISE X) based on intended use, technical characteristics, and functionalities as a medical image management and processing system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or diagnostic performance metrics for the MediLab device. The comparison focuses on feature similarity with predicate devices. The closest to "performance" mentioned is "Performance Testing (Measurement Accuracy) was conducted on the MediLab system to determine measurement accuracy when performing the various distance and area measurements." However, the results of this testing, or any specific acceptance criteria for these measurements, are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of diagnostic performance metrics. | "Performance Testing (Measurement Accuracy) was conducted on the MediLab system to determine measurement accuracy when performing the various distance and area measurements." |
| Functionality (e.g., DICOM image loading, display operations, user authentication, report generation) | "Subject device has similar features and functionality as the predicate and reference devices." |
| Safety and Effectiveness | "The non-clinical performance test data and software verification and validation demonstrate that the MediLab system performs comparably to and it is as safe and effective as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. The document mentions "Non-clinical product evaluation to demonstrate safety and effectiveness was conducted" and "Performance Testing (Measurement Accuracy) was conducted," but it does not specify the details of the test data (sample size, origin, retrospective/prospective nature).
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)
This information is not provided in the text. The document does not mention any expert review or ground truth establishment process for diagnostic performance validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text, as no details of a diagnostic performance study are given.
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
There is no indication in the text that an MRMC comparative effectiveness study was conducted. The MediLab device is described as a medical image management and processing system and a diagnostic/analysis tool, not specifically an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication in the text that a standalone algorithm performance study was conducted. The device is presented as a medical image viewer and management system for use by qualified medical personnel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the text, as no diagnostic performance study details are given.
8. The sample size for the training set
The document describes "Software Verification and Validation" and mentions "software requirements and specifications, design architecture, risk analysis and software validation and verification." However, it does not mention a "training set" or "training data" in the context of an AI/ML device. The MediLab is described as a DICOM image viewer and processor, not as a device utilizing machine learning for diagnostic interpretations.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of an AI/ML algorithm, this information is not applicable and therefore not provided in the text.
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