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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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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 Microcatheter-027 is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.

The Reverse Medical Microcatheter-027 is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter-027 dimensions are included on the individual device labels. The Reverse Medical Microcatheter-027 inner lumen can accommodate guidewires up to 0.025 inches inner diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization.

Each Reverse Medical Microcatheter-027 is provided with accessories, which include a shaping mandrel and peel away introducer within a Tyvek™ pouch.

The shaping mandrel allows the catheter tip to be steam shaped by the physician for proper adjustment to the anatomy prior to use. Test data is presented in this submission for both the 027 and 021 Reverse Medical Microcatheters to support the inclusion of the shaping mandrel and the peel away introducer.

The Reverse Medical Microcatheter-027 incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reverse Medical Microcatheter-027:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence through non-clinical (bench-top) testing. There isn't a comprehensive "device performance" section in the way one might expect for a clinical study with sensitive/specific metrics. Instead, the performance is reported against established engineering or safety criteria.

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify exact sample sizes for each bench-top test. For some tests (e.g., Tip Buckling, Coating Lubricity, Guidewire Compatibility, Guide Catheter Compatibility, Static Pressure, Kink Resistance, Tensile Strength), the acceptance criteria mention "95/90," which typically refers to a 95% confidence level with 90% reliability, implying a statistically significant sample size was used for those specific tests. However, the absolute number of devices tested is not provided.
• Data Provenance: All data presented is from pre-clinical (bench-top) testing. The document does not indicate any human data or provide country of origin, as it's not a clinical study. It's internal testing conducted by Reverse Medical Corporation.

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

This information is not applicable to the provided document. The "ground truth" for this submission is based on established engineering standards (ISO, USP, internal protocols) and comparison to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. This document describes bench-top engineering tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of a medical device (microcatheter) through non-clinical testing, not on the performance of an AI algorithm or human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of an AI algorithm was not done. The device is a physical microcatheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests is derived from:

• Established international and national standards (e.g., ISO, USP).
• Internal test protocols and specifications.
• Performance of legally marketed predicate devices, against which the new device's performance is compared for substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

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

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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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The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.

The Reverse Medical Microcatheter is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter dimensions are included on the individual device labels. The Reverse Medical Microcatheter inner lumen can accommodate guidewires up to 0.018 inches in diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization. The Reverse Medical Microcatheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

The provided text describes the 510(k) submission for the Reverse Medical Microcatheter. Here's a breakdown of the requested information, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally not explicitly stated with specific numerical thresholds (e.g., "flexibility must be X N/m"). Instead, the report indicates that the device "Met established criteria" for each test. This implies qualitative or pre-defined quantitative criteria that were assessed for conformance.

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

The document does not specify the exact sample sizes for each bench-top or in-vivo test. It states, "All testing was performed on units that were sterilized and met all inspection criteria." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). This is a 510(k) submission, which typically relies on pre-clinical data (bench-top and potentially animal studies for in vivo testing).

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

Not applicable. This document describes a medical device's physical, mechanical, and biological performance testing, not an AI or diagnostic device that requires expert-established ground truth.

4. Adjudication method for the test set

Not applicable, as this is not an AI/diagnostic device and does not involve human readers for ground truth establishment.

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 a medical device for physical intervention (microcatheter), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device; there is no "algorithm only" performance concept in this context.

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

The "ground truth" for the performance criteria in this context is defined by industry standards, engineering specifications, and established scientific methods for evaluating medical device properties (e.g., ISO standards, USP tests, internal design control procedures). For example, biocompatibility uses established biological assay methods, and mechanical tests rely on engineering principles.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable. There is no training set for this type of medical device submission.

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The Reverse Medical ReFlex™ Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The ReFlex™ Balloon Guide Catheter is a flexible, variable stiffness composite catheter shaft has a hydrophilic coating to reduce friction during use. A compliant balloon is mounted on the distal end of the catheter. The ReFlex™ Balloon Guide Catheter dimensions are included on the individual device labels. The ReFlex™ Balloon Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The proximal end of the ReFlex™ Balloon Guide Catheter has a bifurcated luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Balloon Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: ReFlex™ Balloon Guide Catheter
K Number: K112262

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various in vitro and in vivo tests conducted to demonstrate the substantial equivalence of the ReFlex™ Balloon Guide Catheter. The "acceptance criteria" are implied by the statement "Met established criteria" for each test. The reported device performance is that it successfully met these criteria.

Note on Biocompatibility: The document also lists specific biocompatibility tests and states that the blood-contacting materials "successfully passed all of the following biocompatibility tests:"

• Cytotoxicity (L929 MEM Elution Test)
• Sensitization (Kligman Maximization)
• Intracutaneous Reactivity (Irritation) (Intracutaneous Injection Test)
• Systemic Toxicity (Acute) (ISO Acute Systemic Injection Test)
• Hemocompatibility (Complement Activation, Hemolysis, Inactivated Partial Thromboplastin Time Test, In vivo thrombogenicity)
• Pyrogenicity (USP Material Mediated Rabbit Pyrogen Test)
• EtO Residuals (Ethylene oxide and Ethylene chlorohydrins residuals)

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

The document does not explicitly state the specific sample sizes used for each individual test within the "Design Verification (Bench-Top Testing)" or "In vivo Tests" sections. It only states that "All testing was performed on units that were sterilized and met all inspection criteria."

The data provenance is not specified regarding country of origin, but the tests are described generally as "non-clinical data" and "bench-top testing" and "in vivo tests," implying laboratory and potentially animal studies, not human clinical trials. The data is thus prospective, as it was generated specifically for this device's 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 studies described are primarily product performance and safety tests (mechanical, physical, biocompatibility, in vivo performance) rather than studies requiring expert consensus on a 'ground truth' in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically relevant for studies where human interpretation or judgment is involved, such as in clinical image reading or diagnosis. These are not applicable to the bench-top and animal (in vivo) performance studies described for this medical device. The "ground truth" for these tests would be objective measurements against established engineering, biological, or regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical instrument (a balloon guide catheter), not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument and does not involve an algorithm.

7. The Type of Ground Truth Used

For the various tests:

• Physical and Mechanical Tests (Bench-Top): The ground truth is based on established engineering specifications, industry standards, and internal design criteria. The results were compared against these predefined criteria (e.g., "Met established criteria").
• Biocompatibility Tests: The ground truth is based on recognized international standards and guidelines, specifically FDA General Program Memorandum #G95-1 and ISO 10993-1 guidelines, which specify acceptable biological responses to materials.
• Sterilization: Ground truth is based on ANSI / AAMI / ISO 11135 standards for achieving a Sterility Assurance Level (SAL) of 10^-6^ (stated as 10^-8^ in the document, which is stricter than common).
• In vivo Tests: The ground truth would be based on observed physiological responses, device functionality in a relevant biological model, and histopathological assessment against predefined safety and performance parameters in the animal model.

8. The Sample Size for the Training Set

Not applicable. This submission describes the testing of a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

The RePort™ Guide Catheter System is a two-catheter system comprised of the RePort™ Sheath and the RePort™ Dilator. The RePort™ Sheath has a distal region which expands when the RePort™ Dilator is advanced. The RePort™ Guide Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy. The proximal ends of the RePort™ Sheath and the RePort™ Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the RePort™ Sheath's distal expandable region into the catheter introducer sheath. The System is provided sterile, non-pyrogenic, and is intended for single use only.

The provided document describes the RePort™ Guide Catheter System and its substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, the questions related to AI/ML specific aspects like AI assistance effect size, standalone algorithm performance, training set, and AI specific ground truth are not applicable.

However, the document does contain information about the acceptance criteria and the studies performed to demonstrate the device meets these criteria in the context of a medical device submission.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device "Met established criteria" for all tests, indicating that the acceptance criteria for each test were successfully achieved. The specific numerical values or ranges for these criteria are not provided, only the outcome.

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

• Test Set Sample Size: The document does not explicitly state the specific number of units or samples used for each test. It generally states that "All testing was performed on units which were twice sterilized."
• Data Provenance: The tests are described as "bench-top testing" and "in vivo tests," implying some animal or cadaveric testing for the in vivo portion. There is no mention of human clinical trial data for this 510(k) submission for the RePort™ Guide Catheter System. The document focuses on demonstrating substantial equivalence through non-clinical data. The country of origin for the data is not specified, but the applicant is Reverse Medical Corporation, Irvine, CA, suggesting the testing was likely conducted in the US or by US-based contractors/labs. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

• This question is not applicable as the document describes physical, mechanical, and biological testing of a medical device, not an AI/ML system requiring expert-established ground truth from images or other data. The "ground truth" for these tests would be the measured physical properties or biological responses against established engineering and biological standards.

4. Adjudication Method for the Test Set

• Not applicable for this type of medical device testing. Adjudication methods like 2+1 or 3+1 are used for reviewing ambiguous cases or discrepancies in image interpretation or diagnosis, which is not relevant here. The results of the tests were compared against "established criteria."

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 describes a non-AI/ML medical device. No human reader studies with or without AI assistance are mentioned.

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

• Not applicable. This pertains to an AI/ML algorithm, which is not the subject of this document.

7. The Type of Ground Truth Used

• For the bench tests, the "ground truth" was defined by established engineering standards and specifications (e.g., dimensional tolerances, strength requirements, leak rates).
• For the biocompatibility tests, the "ground truth" was established by international biological evaluation standards (ISO 10993-1), with the results compared against acceptable biological responses.
• For the in vivo tests, the "ground truth" would be direct observation of performance (e.g., deliverability, compatibility, visibility, aspiration performance) and histopathological examination of treated vessels, assessed against pre-defined safety and performance parameters.

8. The Sample Size for the Training Set

• Not applicable. This refers to an AI/ML device. The RePort™ Guide Catheter System is a physical medical device and does not involve a training set.

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

• Not applicable. This refers to an AI/ML device.

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The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.

The ReFlex™ Guide Catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The ReFlex™ Guide Catheter shaft is visible under fluoroscopy. The ReFlex™ Guide Catheter dimensions are included on the individual device label. The ReFlex™ Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The proximal end of the ReFlex™ Guide Catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

The ReFlex™ Guide Catheter's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size for each individual test. However, it mentions that "All testing was performed on units which were sterilized and met all inspection criteria."

The data provenance is from bench-top (in vitro) and in vivo testing conducted by Reverse Medical Corporation, the device sponsor. The document does not specify the country of origin for the in vivo testing, but considering the sponsor is based in Irvine, CA, USA, it's likely conducted in the US. The studies are prospective in nature, as they involve testing of newly manufactured devices under controlled conditions to evaluate their performance.

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

This information is not provided in the document. The tests performed are primarily engineering and biological performance tests, not diagnostic tests requiring human expert interpretation in the context of ground truth establishment for a test set. The "ground truth" for these tests is based on established engineering standards, biological compatibility requirements, and functional specifications, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

This information is not applicable as the tests are objective measurements and evaluations against established criteria, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that rely on human interpretation of images or data, often with AI assistance, to measure the impact of the AI on human performance. The ReFlex™ Guide Catheter is an interventional device, and its evaluation focuses on its physical, mechanical, and biological performance.

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

Yes, the testing described is primarily focused on the standalone performance of the device itself. The "Design Verification (Bench-Top Testing)" and "In vivo Tests" assess the intrinsic characteristics and functionality of the ReFlex™ Guide Catheter without human interaction being a variable in the performance evaluation.

7. The type of ground truth used:

The "ground truth" for the tests is based on:

• Established engineering standards and specifications: For dimensional, mechanical (torque, kink resistance, tensile strength, leak, burst, aspiration), and material (corrosion, particulate) tests.
• Biological compatibility standards: For biocompatibility tests (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemocompatibility, pyrogenicity) in accordance with ISO 10993-1 guidelines.
• Functional performance criteria: For guidewire compatibility, navigation and accessibility capabilities, and system deliverability/compatibility/visibility/aspiration.
• Histopathological evaluation: For acute histopathology of treated vessels, likely performed by a qualified pathologist, to assess tissue reaction.

8. The sample size for the training set:

There is no mention of a training set as this product is a physical medical device, not an AI/machine learning algorithm that requires training data.

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

Not applicable, as there is no training set for this device.

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The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

The Reverse Medical ReCruit™ Microcatheter consists of a flexible, tapered reinforced composite catheter with a braided mesh retrieval element attached to the distal region of the catheter. The inner lumen can accommodate a guidewire to aid in placement of the catheter. The catheter contains radiopaque markers to facilitate fluoroscopic visualization- a distal tip marker, markers at the proximal and distal end of the retrieval element, and circumferentially placed markers within the retrieval element. The retrieval element is deployed through the advancement of a guidewire or the ReAct™ stylet through the lumen to radially expand the retrieval element. The selection of guidewire sizes in accordance with device compatibility allows for guidewires to be used either for navigation and placement or for deployment of the element. The proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is coated with a hydrophilic coating. The catheter is designed to be used with a guide catheter. The catheter is offered in various retrieval element sizes to accommodate physician preferences and patient anatomy. Each ReCruit™ Microcatheter is packaged with a ReAct™ stylet and torque device. The ReAct™ stylet is a stainless steel wire with a platinum tip that may be used to activate the ReCruit™ Microcatheter's retrieval element. The ReCruit™ Microcatheter can be used in vessel diameters ranging from 2mm to 4mm. Materials used in the Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.

The provided text does not contain specific acceptance criteria or an analytical study proving the device meets those criteria. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

However, based on the information provided, we can infer some aspects related to how performance was demonstrated:

Acceptance Criteria and Reported Device Performance (Inferred):

Since this is a 510(k) submission for substantial equivalence, the "study" demonstrating the device meets criteria is primarily focused on demonstrating that its performance characteristics are comparable to a legally marketed predicate device, rather than establishing entirely new performance benchmarks. The preclinical studies mentioned would support this claim of comparable performance.

Here's a breakdown of the other requested information based on the provided text:

1. Sample size used for the test set and the data provenance:

   • Sample size for test set: Not explicitly stated. The text mentions "in vitro and in vivo laboratory studies" but does not quantify the number of tests, simulated retrievals, or animals/models used.
   • Data provenance: "in vitro and in vivo laboratory studies." This suggests the studies were conducted in a controlled lab setting, likely by the manufacturer or a contract research organization. The country of origin is not specified but is implied to be related to the submitting company (Reverse Medical Corporation, likely US-based, given FDA submission). The studies would be considered prospective as they were conducted to test the device's performance.

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

   • Not applicable/Not provided. For a device like a microcatheter, "ground truth" would likely be established by direct observation of successful retrieval, measurement of forces, or biological responses in established models, rather than expert consensus on diagnostic images. The performance would be assessed against engineering specifications or successful outcomes as defined by the study protocol.

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

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., image reading). For direct device performance studies, success or failure is usually determined by objective criteria defined in the study protocol.

4. 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 MRMC study was done. This type of study relates to diagnostic AI devices involving human readers, which is not applicable to a foreign body retrieval microcatheter.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm. Its performance inherently involves human manipulation (human-in-the-loop).

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

   • For the "in vitro" studies, the ground truth would be based on objective physical measurements and observations (e.g., successful capture and removal of foreign objects, force measurements, catheter trackability, deployment efficacy) against predefined engineering specifications.
   • For the "in vivo" studies, the ground truth would be based on direct observation of physiological response and device function in a living system (e.g., successful retrieval, absence of vessel damage, adherence to anatomical constraints) against specified animal model outcomes.
   • For biocompatibility, the ground truth is established by conformance to ISO 10993-1 and FDA requirements through specific biological tests.

7. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI algorithm that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As noted above, there is no "training set" for this physical device.

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