(87 days)
uPACS™ is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environement.
uPACS is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for connection to and use with FDA cleared ultrasound imaging equipment which provides video output and is cleared for operation and use in the patient environment.
In the uPACS standard configuration, an FDA approved ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC). Images captured by the scanner are displayed on the monitor of the PC along with any text that is typed on the PC keyboard. The ultrasound image and patient text data can be stored on a CD-ROM in the PC, and images can be exported to an FDA approved printer by the PC.
uPACS enables users to perform the following system functions:
- View live images from user provided FDA approved ultrasound scanners or other NTSC or PAL video sources;
- Capture single-frame images from ultrasound scanners or other NTSC or PAL video sources;
- Obtain text data directly from captured images;
- Edit text and image data before permanent storage;
- Review stored images on the system and on CD-ROM;
- Display up to four images at a time for review;
- Place notations directly on images;
- Archive images using CD-ROM;
- Export images to diskette and user provided printer(s);
- Provide a means for user training and proficiency demonstration;
- Assign security privileges to specific users in accordance with clinical access criteria.
This document is for an older device, uPACS™ from 1996, and does not contain the level of detail regarding acceptance criteria and performance studies that would be expected in a modern 510(k) submission.
Based on the provided text, the following information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The determination of substantial equivalence is not based on an assessment of performance data." This explicitly indicates that specific quantitative acceptance criteria and reported device performance metrics are not provided in this submission. The 510(k) for uPACS™ relies on demonstrating substantial equivalence to predicate devices (Intrascan® and Instrascan II) based on technological characteristics and intended use, rather than detailed performance comparisons.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as performance data and ground truth establishment are not described.
4. Adjudication method for the test set:
- Not applicable as performance data and ground truth establishment are not 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:
- No MRMC comparative effectiveness study is mentioned. This device is a Picture Archiving System (PACS) and does not inherently involve AI in its described functionality of archiving and presenting ultrasound images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is for archiving and presenting images, not for stand-alone diagnostic interpretation by an algorithm.
7. The type of ground truth used:
- Not applicable as performance data and ground truth establishment are not described.
8. The sample size for the training set:
- Not applicable as no AI/algorithm training is described for this device.
9. How the ground truth for the training set was established:
- Not applicable as no AI/algorithm training is described for this device.
Summary based on provided text:
The submission explicitly states that "The determination of substantial equivalence is not based on an assessment of performance data." This means the 510(k) for uPACS™ did not include a study demonstrating specific acceptance criteria or quantitative performance metrics. Instead, it focused on establishing substantial equivalence to predicate devices (Intrascan and Instrascan II) based on intended use and technological characteristics. Therefore, most of the requested information regarding performance studies, sample sizes, expert involvement, and ground truth establishment is not present in this document.
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(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.