(81 days)
uPACS™ Version 1.7 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 Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for capturing, storage, archiving 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. uPACS Version 1.7 can also accept images stored on magneto-optical (MO) disks, captured remotely, in video output form.
Here's an analysis of the provided text regarding the uPACS™ Version 1.7 device and its acceptance criteria and study information:
Analysis of Provided Text:
The provided document is a 510(k) Summary for the uPACS™ Version 1.7 device from 1996. It primarily focuses on demonstrating substantial equivalence to predicate devices, not on providing performance data or clinical study results for acceptance criteria.
Response to Each Requested Item:
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A table of acceptance criteria and the reported device performance
Based on the provided text, no specific acceptance criteria (metrics, thresholds, etc.) or quantitative performance data (sensitivity, specificity, accuracy, etc.) are reported for uPACS™ Version 1.7. The submission explicitly states: "The determination of substantial equivalence is not based on an assessment of performance data."
Therefore, a table cannot be constructed from the given information.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No information about a test set sample size or data provenance is provided. The document does not describe any performance testing that would involve such a set.
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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)
No information about expert involvement in establishing ground truth for a test set is provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information about an adjudication method for a test set is provided.
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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 information about an MRMC comparative effectiveness study is provided. The device is described as an archiving system for video ultrasound images, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No information about standalone algorithm performance testing is provided. The submission focuses on the device's capability to capture, store, archive, and present images, not on diagnostic performance.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No information about any type of ground truth used is provided, as no performance study is detailed.
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The sample size for the training set
No information about a training set sample size is provided. The device predates the common application of machine learning/AI where training sets are typically used for diagnostic algorithms.
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How the ground truth for the training set was established
No information regarding a training set or its ground truth establishment is provided.
Summary of Device and Regulatory Context from the Text:
The uPACS™ Version 1.7 is a software-controlled microprocessor-based archiving system for video ultrasound images. Its primary functions include viewing live images, capturing single-frame images, importing images, editing text and image data, reviewing stored images, placing notations, archiving on CD-ROM, and exporting images.
The 510(k) submission successfully achieved clearance by demonstrating substantial equivalence to predicate devices (Intrascan and Instrascan II). Critically, the submission explicitly states that this determination of substantial equivalence was not based on an assessment of performance data. This implies that the regulatory assessment focused on the device's technological characteristics, intended use, and safety features being comparable to existing cleared devices, rather than requiring new clinical performance studies.
§ 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.