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The Omnisonics Resolution® Endovascular System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

The Resolution Endovascular System is a portable ultrasound energy system for the treatment of thrombosed synthetic dialysis access grafts. The System is comprised of two major components: (1) the sterile, single use Resolution Therapeutic Kit, and (2) the multi-use Generator. Required accessories include the Resolution Delivery Catheter and a commercially available hemostasis valve.

The provided text is a 510(k) summary for the OmniSonics Resolution® Endovascular System. This document asserts substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for a new device's performance. Therefore, detailed information on acceptance criteria and a specific study proving those criteria are not available in this text.

However, based on the information provided, we can infer some aspects relevant to your request, especially regarding the claim of "substantial equivalence" and the types of testing typically involved in such a submission.

Here's an attempt to answer your questions based on the provided FDA documents. Please note that many details are not explicitly stated in this summary and would typically be found in the full 510(k) submission, which is not provided.

Based on the provided 510(k) Summary (K052428) for the Resolution Endovascular System:

The document states that the Resolution Endovascular System is substantially equivalent to the predicate device, the Resolution® Thrombectomy System – K041705. It does not present a de novo study with specific acceptance criteria and performance data for a new device but rather relies on the equivalence to a previously cleared device. Therefore, a table of acceptance criteria and reported device performance specific to a new study is not provided in these documents.

The core of this submission is the assertion: "The technological characteristics of the applicant device are substantially equivalent to the predicate device with respect to device classification, intended use, indication for use, target population, product design, materials, packaging, labeling, sterilization and product performance."

The "Support of Substantial Equivalence" section mentions: "product performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device." However, no specific details about this "product performance testing" (e.g., criteria, results, methodology, sample sizes) are included in this summary.

Here's an attempt to answer your numbered questions based on the limited information:

1. A table of acceptance criteria and the reported device performance:

• Not explicitly provided. The 510(k) summary does not contain a table of acceptance criteria or reported device performance for a new study. Instead, it asserts "substantial equivalence" to a predicate device based on unspecified "product performance testing." To gain market clearance via a 510(k), the new device must perform at least as well as the predicate device, meaning its performance would meet the unstated acceptance criteria established for the predicate device.

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

• Not explicitly provided. The 510(k) summary does not mention specific sample sizes for any test set or the provenance of data. Substantial equivalence typically relies on bench testing, material characterization, and potentially animal or limited human factor studies, but no details are given here.

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

• Not applicable/Not explicitly provided. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic devices). The Resolution Endovascular System is an interventional device for treating thrombosed grafts, and the "product performance testing" would likely involve engineering and functional assessments rather than expert-derived ground truth.

4. Adjudication method for the test set:

• Not applicable/Not explicitly provided. Adjudication methods are usually for clinical trials involving human review of outcomes or data, which is not detailed in this 510(k) summary.

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:

• Not applicable. The device is an Endovascular System (medical device for treatment), not primarily a diagnostic or AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned.

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

• Not applicable. This question pertains to AI/algorithm performance. The Resolution Endovascular System is a physical medical device; there's no mention of an algorithm or AI component in this 510(k) summary.

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

• Not explicitly provided. For "product performance testing" of a physical device, ground truth would typically refer to established engineering standards, material specifications, and functional targets (e.g., clot removal efficiency, flow rates, durability) that are compared to the predicate device's known performance. No specific details are given.

8. The sample size for the training set:

• Not applicable/Not explicitly provided. "Training set" is typically used for machine learning models. As this is a physical medical device, not an AI/ML product, this concept does not apply in the context of this 510(k) summary.

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

• Not applicable/Not explicitly provided. See point 8.

In summary: The provided FDA 510(k) documents are for a medical device cleared through the substantial equivalence pathway. They assert that "product performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device" but do not provide the detailed results, acceptance criteria, methodologies, or sample sizes of such testing. This information would typically be found in the full 510(k) submission, which is not included in the provided text.

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