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The Reverse Medical Micro Vascular Plug (MVP-7, MVP-9) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Reverse Medical® MVP® Micro Vascular Plug System consists of a micro vascular occlusion plug that is attached to a composite delivery wire and is intended to be delivered to the treatment site through a catheter. The MVP occlusion plug is a selfexpandable, ovoid-shaped frame made from nitinol and incorporates a PTFE cover over the proximal portion of the ovoid. The plug device is secured at both ends with platinum marker bands. The proximal marker band is attached to a delivery wire that is used to push the plug device through a commercially available catheter to the intended treatment site. After satisfactory deployment of the plug device at the treatment site, the implant is detached from the delivery wire by rotating the wire counter clockwise.

The provided text describes a 510(k) premarket notification for the Reverse Medical Micro Vascular Plug (MVP-7 & MVP-9) and outlines the basis for determining substantial equivalence to predicate devices. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document primarily focuses on demonstrating that the modified MVP-7 and MVP-9 devices are substantially equivalent to their predicate devices (MVP-3Q, MVP-5Q, MVP-3, and MVP-5) based on their intended use, design, materials, principle of operation, and overall technological characteristics.

Instead of a specific clinical study with detailed acceptance criteria and performance metrics, it lists a series of non-clinical performance tests conducted to verify the design changes. These tests primarily address the physical and mechanical aspects of the device and its compatibility with delivery systems.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding "reported device performance" values for clinical outcomes. The performance tests listed are primarily non-clinical assessments.

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

The document does not specify human clinical "test set" sample sizes, as the performance tests described are non-clinical tests performed on "units that were sterilized and met all inspection criteria." Data provenance is from in-house non-clinical testing by Reverse Medical Corporation.

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

Not applicable. The tests described are engineering/material performance tests, not clinical evaluations requiring expert interpretation of ground truth in the context of diagnostic or interventional efficacy.

4. Adjudication method for the test set

Not applicable for non-clinical engineering tests.

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. This is not an AI-assisted diagnostic or interventional device, but a physical vascular embolization device.

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

Not applicable. This is not an algorithm, but a physical medical device.

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

For the non-clinical tests, the "ground truth" is defined by the specifications and standards of the tests themselves (e.g., dimensional requirements, force measurements, compliance with ASTM standards for corrosion and MRI compatibility).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The "units" for testing refer to manufactured devices.

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

Not applicable. There is no training set for this device.

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The Reverse Medical® Corporation MVP® Micro Vascular Plug System is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Reverse Medical® MVP® Micro Vascular Plug System consists of a micro vascular occlusion plug that is attached to a composite delivery wire and is intended to be delivered to the treatment site through a catheter. The MVP occlusion plug is a selfexpandable, ovoid-shaped frame made from nitinol and incorporates a PTFE cover over the proximal portion of the ovoid. The plug device is secured at both ends with platinum marker bands. The proximal marker band is attached to a delivery wire that is used to push the plug device through a commercially available catheter to the intended treatment site. After satisfactory deployment of the plug device at the treatment site, the implant is detached from the delivery wire by rotating the wire counter clockwise.

The provided document describes the acceptance criteria and a study demonstrating that the Reverse Medical® MVP® Micro Vascular Plug System, with modifications, meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices or tests) used for each individual performance test. It broadly states that "All testing was performed on units that were sterilized and met all inspection criteria."

The data provenance is prospective, as the tests were conducted specifically to evaluate the modified devices. The tests were conducted by Reverse Medical Corporation, presumably in the United States, given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The performance tests described are primarily engineering and technical evaluations of the device's physical properties and functionality, not clinical studies requiring expert ground truth for interpretation like image analysis or diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The performance tests are objective measurements against defined product specifications and industry standards, not subjective assessments requiring adjudication by experts.

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, an MRMC comparative effectiveness study was not done. This submission is for modifications to a mechanical vascular embolization device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.

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

No, a standalone algorithm performance study was not done. This device is a mechanical medical implant and does not involve any algorithms.

7. The Type of Ground Truth Used

The ground truth used for the performance tests consists of pre-defined product specifications, engineering standards (e.g., ASTM G71, ASTM F-2503), and acceptance criteria established by Reverse Medical Corporation. These are objective benchmarks against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the same reason as point 8.

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