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510(k) Data Aggregation
(149 days)
T.I.M.S. receives image data, acquired from various sources, including but not limited to 1.7.M.B. 1000.vos mage digital angiography and flourography, secondary capture devices (frame grabbers), scanners (digitizers) or other imaging sources. Images and data can be viewed, stored, transmitted (communicated), processed at the workstation, physician's vicwou, or other clinical application and distributed across networks or the world wide web for viewing.
The T.I.M.S. Teleradiology system is a general purpose software designed for the acquisition/capture/view/archival and transmission of medical images. The software operates on "off the shelf" hardware using a Windows 95 or higher platform. It is designed to capture, acquire, send, receive, archive and display patient images and data, using the DICOM communication standard. T.I.M.S. can be installed on a PC in the hospital, via a web-browser, and on a local LAN or WAN, and includes teleradiology, connectivity and display features. It employs the latest internet security techniques, including 128 bit encryption.
The provided text describes a 510(k) summary for the T.I.M.S. Teleradiology System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting specific performance studies or acceptance criteria with detailed results.
Therefore, many of the requested categories for device performance and study details cannot be filled from the given text. The document asserts that the device is substantially equivalent to predicate devices with the same intended use and does not offer any new functions requiring new performance data.
Here's a breakdown based on the provided information:
Acceptance Criteria and Reported Device Performance
Given that the submission is for substantial equivalence and states, "This device does not offer any new functions that have not received previous clearance from the Agency," it implies that the implicit acceptance criteria are met by demonstrating equivalence to the predicate devices, which are already deemed safe and effective. No specific quantitative performance metrics or acceptance criteria are listed in the document for the T.I.M.S. system itself.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (Implicit from Substantial Equivalence) |
|---|---|
| Adheres to industry-standard DICOM 3 protocol | Not explicitly stated but implied through adherence to DICOM 3 |
| Operates on standard "off the shelf" hardware and system configurations | Operates on standard "off the shelf" hardware using a Windows 95 or higher platform |
| Utilizes lossy/lossless image compression libraries substantially equivalent to previously cleared devices | Uses lossy/lossless image compression libraries believed to be substantially equivalent to those in previously cleared devices |
| Provides means for medical professionals to view images generated by medical scanning devices on a personal computer or workstation | Provides means for medical professionals to view images on a personal computer or workstation |
| Safety features such as password protection for operation and against unauthorized use | Passwords are required for operation and to protect against unauthorized use |
| System failures (e.g., partial/failed transmissions) allow for image/data recovery via re-transmission after correction | In device failures which might result in partial or failed transmissions, the images and or data may be recovered by re-transmission after correcting the problems |
Details of the Study Proving Device Meets Acceptance Criteria
The document does not describe a specific performance study (clinical or analytical) to demonstrate the T.I.M.S. system meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that if the predicate devices met certain safety and effectiveness standards, and the T.I.M.S. device has the same intended use and technological characteristics (or differences that do not raise new questions of safety and effectiveness), then it is considered to meet those same standards.
Therefore, the following information cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance: Not applicable, as no dedicated performance study is described.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: This device is a general teleradiology system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing AI assistance would not be relevant and is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a general teleradiology system with human intervention inherent in its use.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study is detailed.
- The sample size for the training set: Not applicable, as no algorithm training is mentioned for a diagnostic function.
- How the ground truth for the training set was established: Not applicable.
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