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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 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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