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The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.

The Acta "Vessel Occlusion System (VOS) is provided sterile and is intended for one-time use. The implant is a self-expandable, ovoid shaped implant with delivery device. The implant is made from a double layer of Nitinol wire mesh which is secured at proximal and distal ends with platinum marker bands. The delivery device allows the implant to be delivered through commercially available catheters. Detachment of the implant from the delivery device is achieved by operator activation of the delivery handle.

The provided text describes a Premarket Notification [510(k)] Summary for the Nfocus Neuromedical Acta™ Vessel Occlusion System (VOS). This device is an arterial embolization device. The document primarily focuses on establishing substantial equivalence to a predicate device (Amplatzer Vascular Plug) rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way one might typically find for an AI/ML medical device.

Therefore, many of the requested categories (especially those related to AI/ML device performance, human reader studies, and ground truth establishment for training/test sets) are not directly applicable or explicitly mentioned in this type of regulatory submission for a physical medical device.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or reported device performance in a table format that mimics an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various tests that have been or will be performed prior to commercialization to ensure the product meets requirements and conforms to needs and intended uses. These are related to the physical integrity, material properties, and functionality of the device.

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

• Sample Size: Not specified. The document refers to "testing" (e.g., tensile strength, corrosion, simulated use) which typically involves a number of physical units, but the specific sample sizes for each test are not provided.
• Data Provenance: Not applicable in the context of this device type. These are engineering and biocompatibility tests performed on the physical device, not clinical data from patients.

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

• This is not applicable for a physical device like the Acta VOS. "Ground truth" in this context would be engineering specifications and standards, verified by qualified engineers and lab personnel, not medical experts establishing a diagnosis from patient data.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth from expert reads of medical images/data. For device performance testing, results are measured against established engineering standards and specifications.

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, not an AI/ML algorithm intended to assist human readers. Therefore, an MRMC study is 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

• The "ground truth" for this device's performance testing would be established technical specifications, engineering standards, biocompatibility requirements, and regulatory guidelines (e.g., for MRI compatibility, material properties). The device's performance is measured against these established quantitative and qualitative criteria to demonstrate safety and effectiveness and substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable.

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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.

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.

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.

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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