Search Results

The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature.

The Ruby XL System is comprised of a platinum embolization coil attached to a composite delivery pusher, and the Penumbra Detachment Handle. The coil/delivery pusher is packaged separately from the Penumbra Detachment Handle.

The provided document is a 510(k) Pre-Market Notification for the Ruby XL System, a vascular embolization device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on a clinical or performance study in the way an AI/ML device would.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, data provenance, expert ground truth, MRMC study, standalone performance) is not applicable to this document.

This submission focuses on bench-top performance testing, biocompatibility, and shelf-life, establishing substantial equivalence based on the device's physical characteristics, materials, and mechanical performance compared to a predicate embolization coil system. No AI/ML components are mentioned or evaluated in this regulatory filing.

Here's a breakdown of what is provided and why the AI/ML-specific questions are not applicable:

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

• This document does not present acceptance criteria in the typical sense of numerical thresholds for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various bench-top performance tests (Dimensional/Visual, Packaging, Radiopacity, Friction, Fatigue Resistance, Torsional Resistance, Stiffness, Simulated Use, Corrosion, Tensile, MRI Compatibility) and states that these tests were "used in support of the subject device to determine substantial equivalence."
• No specific reported numerical performance values are given for these tests beyond the general statement that they substantiate the device's performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as no AI/ML test set was used. The "test set" here would refer to the physical devices undergoing bench-top testing. Data provenance is not relevant for physical device testing in this context.

3. 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)

• Not applicable. Ground truth, in the AI/ML context, refers to expert labeling or an objective standard against which an algorithm's output is compared. For this device, "ground truth" would be the established physical and mechanical properties and material standards. No human experts are described as defining a "ground truth" for a test set of images or data to evaluate an algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/ML ground truth, which is not part of this submission.

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. This is a physical medical device (embolization coil system), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant.

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

• No. This is a physical medical device.

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

• Not applicable for an AI/ML context. The "ground truth" for this device's performance is established engineering and material science standards and physical measurements.

8. The sample size for the training set

• Not applicable as no AI/ML algorithm was trained.

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

• Not applicable as no AI/ML algorithm was trained.

Summary based on the provided document:

The Ruby XL System is a medical device (vascular embolization device), not a software/AI/ML product. The 510(k) submission demonstrates substantial equivalence to a predicate device (Penumbra Coil System and POD System) based on:

• Indications for Use: The subject device is indicated for arterial and venous embolizations in the peripheral vasculature, which is a subset of the predicate's indications.
• Design and Materials: The document states "SAME" for various material and construction attributes, coil dimensions, detachment mechanism, sterilization method, and method of supply, indicating identical or highly similar characteristics to the predicate.
• Non-Clinical Safety and Performance Data: Bench-top testing (e.g., Dimensional, Packaging, Radiopacity, Friction, Fatigue, Stiffness, Simulated Use, Corrosion, Tensile, MRI Compatibility) and Biocompatibility testing were performed. These tests are the "study" that substantiates the device's performance and safety, leading to the determination of substantial equivalence. The document explicitly states "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."

Therefore, the requested AI/ML specific criteria and study details are not relevant to this 510(k) submission for a physical medical device.

Ask a specific question about this device