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The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orienation of tissues during specific opinical applications. These include general abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy.

Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

HRI 2000 Ultrasound System

This document is a 510(k) premarket notification from 1997 for the HRI 2000 Ultrasound System and its associated transducers. As such, it does not contain the detailed information requested for acceptance criteria and a study proving device performance in the context of AI/ML or clinical efficacy.

The FDA 510(k) clearance process primarily establishes substantial equivalence to a predicate device, focusing on safety and technological characteristics rather than requiring new clinical efficacy studies. The document only lists the indications for use for different transducers.

Therefore, I cannot provide the requested information from the provided text.

Here's a breakdown of why this information is not present in the document:

• Acceptance Criteria and Reported Device Performance (Table 1): The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, dice score) that would be relevant for an AI/ML device, nor does it present a table of reported device performance against such criteria. The "performance" mentioned in a 510(k) for an ultrasound system typically refers to its imaging capabilities (e.g., resolution, penetration) which are qualitatively compared to a predicate, not quantified against acceptance metrics in a study.
• Sample Size for Test Set and Data Provenance: This information is not included as the document is not describing a study to establish performance metrics for an AI/ML algorithm.
• Number and Qualifications of Experts for Ground Truth: Not applicable, as there's no mention of a ground truth creation process for a performance study.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of such a study. The document predates widespread AI in medical imaging, and its purpose is not to evaluate human reader improvement with AI.
• Standalone Performance Study: No standalone algorithm performance study is described, as the device is an ultrasound system, not an AI algorithm.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable, as there's no AI algorithm being trained.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does provide:

• Device Name: HRI 2000 Ultrasound System and several transducers (GA-3.5, TV-6.5, TR-6.5, PV-12.5).
• Indications for Use: General real-time two-dimensional diagnostic ultrasound imaging for specific clinical applications (general abdominal, small organ, gynecological and urological, vascular and cardiac anatomy). The separate forms (Pages 4-7) detail the applicable modes of operation (A, B, M, CWD, Color Doppler, etc.) for each transducer across various clinical applications.
• Regulatory Class: Class II.
• Submission Type: 510(k) Premarket Notification.
• Clearance Date: May 29, 1997.
• Acoustic Output Requirement: The FDA states that a post-clearance special report containing acoustic output measurements based on production line devices is required. This is a safety requirement, not a performance efficacy study.

In essence, this document grants market clearance for a conventional ultrasound imaging system based on its substantial equivalence to previously marketed devices, without requiring the types of performance studies associated with AI/ML devices.

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