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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular, Other (Specify) Intravascular

The EndoSonics Resolve option for the Oracle Imaging system is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide an alternative 2D display of ultrasound information. This additional display information is provided in addition to the standard 2D echo image. Information collected during uniform withdrawal of the imaging catheter from the artery is presented in a longitudinal display. The Resolve option also provides a computer assisted boundary detection function which helps identify boundaries within the image, which the operator must explicitly accept or correct before measurements can be performed on these boundaries.

This 510(k) summary for the EndoSonics Resolve Option for the Oracle InVision Intravascular Imaging System does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is the core requirement for 510(k) clearance.

However, based on the provided text, we can infer some aspects related to the device's function and potentially implied "acceptance criteria" through its description and comparison to predicate devices. It is crucial to understand that this is an interpretation based on limited information, and not explicit performance data.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, explicit quantitative acceptance criteria for image analysis software are rarely presented in the summary itself. Instead, the focus is on functional equivalence and safety.

Study Details (Based on the Provided Text)

Unfortunately, the provided 510(k) summary does not describe a specific scientific study with a defined test set, ground truth, or expert review process to demonstrate the performance of the "Resolve Option" software in terms of its longitudinal display or boundary detection capabilities.

The primary "study" or justification for clearance in a 510(k) is the demonstration of substantial equivalence to predicate devices. This typically involves:

1. Comparison of Indications for Use: The Resolve option is for "diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide an alternative 2D display...", which is considered equivalent to existing systems.
2. Comparison of Technological Characteristics: The software adds an "alternative 2D display" and "computer assisted boundary detection." The key argument is that the acoustic output remains unchanged.
3. Performance Data (if applicable): For software features like "computer assisted boundary detection," robust clinical performance studies might be expected in more recent submissions, but this document (1998) does not detail one. The implicit 'performance' is that the operator can accept or correct the boundaries successfully.

Given this, the following points can be addressed with the available information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. There is no mention of a test set for evaluating the performance of the "Resolve Option" features (longitudinal display, boundary detection).
   • Data Provenance: Not specified. No country of origin or whether data was retrospective/prospective is mentioned, as no specific performance study is detailed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No ground truth establishment process for a test set is described. The "ground truth" for the identified boundaries is ultimately the operator's explicit acceptance or correction, transforming the computer-assisted function into a user-controlled measurement tool.

3. Adjudication method for the test set:

   • Not applicable. No test set or adjudication process is described. The "adjudication" for boundary detection is the singular operator's decision to accept or correct.

4. 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. This type of study is not mentioned or described in the 510(k) summary. The "computer assisted boundary detection function" is presented as an aid that the operator validates, rather than a system designed to improve human reader performance through a comparative effectiveness study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. The description explicitly states the "operator must explicitly accept or correct before measurements can be performed." This indicates the device is not intended for standalone use for final measurements. Its function is to "help identify boundaries," implying an assistance role.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for algorithm performance validation. As mentioned, for the boundary detection feature, the "ground truth" for measurement purposes is established by the operator's explicit acceptance or correction of the computer-identified boundaries. For the overall system, the ground truth for "substantial equivalence" is its clinical utility as perceived by comparison to predicate devices, rather than a specific pathological or outcomes benchmark for the added software features.

7. The sample size for the training set:

   • Not specified. As no detailed algorithmic development or validation study is provided, the training set size for the boundary detection algorithm (if it was a machine learning algorithm, which is unlikely for 1998 in this context) is unknown.

8. How the ground truth for the training set was established:

   • Not specified. As no training set or algorithm development details are provided, the method for establishing its ground truth is unknown.

Conclusion:

The provided 510(k) summary for the EndoSonics Resolve Option primarily serves to demonstrate substantial equivalence to existing devices for market clearance. It describes the new functional features (longitudinal display and computer-assisted boundary detection) but does not include a detailed scientific study with defined acceptance criteria, test sets, ground truth establishment, or expert reviews to quantify the performance of these features. The "acceptance criteria" are largely implicit in the claim of substantial equivalence and the design that requires operator validation for boundary detection.

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