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The Nfocus Neuromedical Echo Distal Access Catheter Vessel is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature.

Device Description

The Echo " Distal Access Catheter is a single-stiffness catheter with an atraumatic tip at the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. The Echo Distal Access Catheter is compatible with introducer sheaths having an inner diameter of 6F or greater. A rotating hemostasis valve with side-arm adapter and a compatible guidewire are required, but not provided with the Echo catheter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Echo™ Distal Access Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through extensive clinical trials with specific acceptance criteria and detailed study designs as might be found for a novel device or a PMA submission.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training data) is not applicable or not provided in this type of regulatory document.

However, I can extract the information that is present and indicate where the requested details are not available.

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

This information is typically not presented as a formal table with acceptance criteria in a 510(k) summary for a device like a catheter. Substantial equivalence is demonstrated by comparing technological characteristics and intended use to predicate devices and showing that the new device is as safe and effective.

Characteristic	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Echo™ Distal Access Catheter)
Intended Use	Must be substantially equivalent to predicate devices.	"The Echo Distal Access Catheter is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature." (Identical to predicates or within acceptable variation for substantial equivalence).
Outer Diameter (OD)	6 French	6 French
Inside Diameter (ID)	0.070"	0.070"
Working Length	Must be within the range of predicate devices (90-105cm).	105cm (within the range of 90-105cm of predicates)
Catheter Shaft	Must have a transition in stiffness from hub to tip.	Transition in stiffness from hub to tip.
Materials	Must use materials that are either similar or proven equivalent in vivo performance and biocompatibility to predicate devices.	Predominantly PTFE, Pebax, Stainless Steel, Hydrophilic coating (These are common materials; material equivalence claimed to be demonstrated by in vivo performance and biocompatibility tests)
Performance	Must perform as designed and be suitable for its intended use (verified by in vitro bench testing and in vivo testing).	"In vitro bench testing and in vivo testing have been performed on the device materials and finished devices. Performance, sterilization and biocompatibility testing verified that the Echo Distal Access Catheter performs as designed and is suitable for its intended use."
Biocompatibility	Must meet biocompatibility standards.	Biocompatibility testing verified the device suitability.
Sterilization	Must meet sterilization standards.	Sterilization testing verified the device suitability.

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

This information is not provided in the document. For a 510(k) for a device like a catheter, the "test set" typically refers to the physical devices subjected to bench and in vivo (animal) testing, not a clinical data set of patients. The exact number of devices tested is not detailed, nor is the "provenance" in terms of clinical data. The tests are "in vitro bench testing" and "in vivo testing," implying laboratory and potentially animal studies.

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)

This information is not applicable and not provided. The "ground truth" concept, often used for AI/ML performance evaluation against expert consensus, does not apply to the regulatory submission for this physical device. The testing involved engineering and biological assessments, not expert interpretation of diagnostic images or outcomes.

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

This information is not applicable and not provided. Adjudication methods are relevant for studies where human expert disagreement on interpretation of data is present (e.g., radiology reads). This device submission relies on engineering performance, material science, and in vivo biological response.

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

This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic systems, especially those with AI components, and how they impact human reader performance. The Echo™ Distal Access Catheter is a physical medical device (catheter) for delivery, not a diagnostic imaging or AI system.

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

This information is not applicable and not provided. This question is relevant to AI/ML software. The Echo™ Distal Access Catheter is a physical medical device.

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

This information is not applicable and not provided in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this device's performance would be established by physical measurements matching design specifications, material properties meeting regulatory standards, and biological compatibility (lack of adverse reaction in in vivo tests).

8. The sample size for the training set

This information is not applicable and not provided. This question is relevant to AI/ML software. The Echo™ Distal Access Catheter does not involve a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering principles and iterative testing, not by training an algorithm on a 'training set' of data.

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

This information is not applicable and not provided for the same reasons as #8.

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