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The Reverse Medical Micro Vascular Plug (MVP-5) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.027" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 3.0 -5.0mm. The proximal marker band attaches to a delivery wire that pushes the device through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set - 275 cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).

The provided document is a 510(k) summary for the Reverse Medical MVP™ Micro Vascular Plug System (MVP-5). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) might.

Therefore, the information requested in the prompt, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9, which relate to studies proving a device meets acceptance criteria (as typically defined for diagnostic or effectiveness claims), is not directly applicable to this 510(k) submission.

This 510(k) demonstrates the MVP-5's safety and effectiveness by comparing it to an existing predicate device (Reverse Medical MVP-3 System, K123803) based on:

1. Non-Clinical Data: Biocompatibility testing and Design Verification (bench-top testing).
2. Performance and Design Equivalence: Showing that the new device's materials, specifications, performance, and intended use are substantially equivalent to the predicate, and that any differences do not raise new questions of safety or effectiveness.

Here's how the provided information relates to the prompt's categories:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implicitly the successful passing of each test and demonstrated equivalence to the predicate device, as per 510(k) requirements.

2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical trial data with human subjects. The tests performed are non-clinical (bench-top and biocompatibility). The sample sizes for these tests are not provided in this summary.

• Data Provenance: Non-clinical (laboratory testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was a non-clinical submission. No "ground truth" was established by experts for a test set of patient data, as would be the case for diagnostic or AI algorithm evaluations.

4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is mentioned.

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 device is a vascular plug, not a diagnostic imaging device or an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used
Not applicable in the context of clinical "ground truth" for diagnostic evaluation. For non-clinical tests, the "ground truth" is established by standard laboratory methods and validated test protocols (e.g., ISO standards for biocompatibility, engineering specifications for mechanical properties).

8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not an algorithm or AI system that requires a training set.

9. How the Ground Truth for the Training Set was Established
Not applicable.

Summary of Study Type

The study described is a non-clinical design verification and biocompatibility study, supplemented by a comparison to a legally marketed predicate device. The primary goal was to establish substantial equivalence for the purpose of 510(k) clearance, not to demonstrate clinical efficacy against specific acceptance criteria in a human population. The "acceptance criteria" are the successful passing of established laboratory and bench-top tests, and the demonstration that the device's characteristics and performance are comparable to the predicate.

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

The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.021" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 1.5 – 3.0mm. The proximal marker band attaches to a delivery wire that pushes through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set – 275 cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).

This document is a 510(k) Summary for the Reverse Medical MVP™ Micro Vascular Plug System, which focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain a study that establishes acceptance criteria for specific device performance metrics in the way a clinical trial or a detailed performance study with defined endpoints would. Instead, it relies on non-clinical data (biocompatibility, sterilization, and bench-top testing) to show that the device performs as intended and is comparable to predicate devices.

Therefore, many of the requested sections (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission, as it's not a clinical effectiveness study of an AI/ML device.

Here's a breakdown of the available information:

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

The document provides a table for biocompatibility tests, which acts as acceptance criteria for the biological safety of the materials. It also lists various design verification tests (bench-top testing) that were performed, indicating that "All tests performed passed successfully." However, specific numerical acceptance criteria and reported performance values for each of these mechanical/performance tests are not provided in this summary.

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

• Sample Size for Test Set: Not specified for individual bench tests; generally involves representative samples of manufactured devices.
• Data Provenance: Not explicitly stated, but all testing described is non-clinical (bench-top, in vitro/ex vivo lab testing, and animal testing for biocompatibility). Given the company location (Irvine, CA), it's highly likely this testing was conducted in the US or by US-based contractors, but this is not explicitly stated as "country of origin for data." All data is prospective insofar as it was generated specifically for this 510(k) submission, not gathered from past clinical procedures.

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. This is a medical device 510(k) for a physical implant, not an AI/ML diagnostic device requiring expert interpretation for ground truth. Ground truth for these tests is based on objective measurements, chemical analysis, and standardized biological observations.

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

• Not applicable. Ground truth is established through laboratory test protocols, not physician adjudication.

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 device is a physical implant, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This device is a physical implant, not an AI/ML algorithm.

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

• For biocompatibility: Ground truth is established by standardized biological assays and observation of biological responses, compared against control samples where relevant.
• For design verification: Ground truth is established by engineering specifications, objective physical measurements (e.g., tensile strength, dimensions, detachment time), and functional tests (e.g., flow occlusion in a mock vessel).

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. As above, no machine learning training set is involved.

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