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The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.

The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:

• . 087 Balloon Guide Catheter
• 1cc Inflation Syringe ●
• 8Fr Peel Away Introducer ●
• Hub Extension
• Three Way Stopcock ●
  The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.

The provided document is a 510(k) Premarket Notification from the FDA for the 087 Balloon Guide Catheter System. This document outlines the regulatory review of a medical device, focusing on demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on your request:

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

The document presents a "Nonclinical Performance Testing Summary" which serves as the primary evidence for meeting acceptance criteria. Each "Study Name" implicitly defines an acceptance criterion (e.g., "Conditioning, Distribution, and Shelf Life Aging Verification" implies a criterion for packaging strength and integrity). The reported device performance for all tests is simply "Pass" with the statement "All samples met the pre-determined acceptance criteria."

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

The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence." The entire submission relies on non-clinical performance bench test data.

• Sample Size: The document does not specify the numerical sample size for any of the individual bench tests. It consistently reports "All samples met the pre-determined acceptance criteria," implying that a specific sample size was tested for each criterion, but the exact number is not provided.
• Data Provenance: The data is from non-clinical bench testing. There is no information about the country of origin of the data as these are laboratory tests. It is inherently retrospective in the sense that the testing was performed and then reported for this submission.

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

This information is not applicable to this submission. The "ground truth" for the non-clinical performance bench tests is established by technical standards and pre-determined acceptance criteria (e.g., ASTM, ISO standards, or internal specifications). There's no indication that human experts were used to establish ground truth for these device performance metrics.

4. Adjudication method for the test set

This is not applicable. Since the ground truth for the bench tests is based on objective measurements against pre-defined numerical or qualitative criteria (e.g., "Pass/Fail" based on whether a specification is met), there is no need for expert 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

There was no MRMC comparative effectiveness study done. This device is a physical medical instrument (catheter), not an AI/software device that assists human readers with interpretation. Therefore, questions regarding AI assistance and effect size are not relevant here.

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

This is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI.

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

The ground truth for the non-clinical performance bench tests is based on established engineering and material science standards (e.g., ISO and ASTM standards) and pre-determined internal acceptance criteria. For example:

• ASTM F88 for Seal Strength
• ASTM F2096 for Detecting Gross Leaks
• ISO 10555-1 for General requirements of intravascular catheters
• ISO 10555-4 for Balloon Dilatation Catheters
• ISO 80369-7 for Small-bore connectors
• AAMI TIR42 and **USP ** for particulates
• DIN EN 13868 for kink resistance
• FDA CTQ: Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices, August 2015 (for particulates)

These standards define the methodologies and acceptable limits for various physical and functional characteristics of catheters.

8. The sample size for the training set

This is not applicable. The device is a physical catheter, not a machine learning model. Therefore, there is no "training set."

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

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

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The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.

The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:

• 087 Balloon Guide Catheter
• 1cc Inflation Syringe
• 8Fr Peel Away Introducer
• Hub Extension
• Three Way Stopcock

The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Neurovascular Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.

The provided document is a 510(k) Premarket Notification summary for the Q'Apel Medical LLC 087 Balloon Guide Catheter System. It describes the device, its indications for use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.

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

Key Takeaway: The entire submission focuses on demonstrating the substantial equivalence of a new medical device (a catheter system) to an already legally marketed predicate device, rather than proving the efficacy of a new AI/software-based medical device. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth adjudication, and training set details are not applicable to this document. The "studies" here are primarily benchtop and biocompatibility tests on a physical medical device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Pass" indicating that "All samples met the pre-determined acceptance criteria" for each listed test. The reported performance is a statement of compliance with these criteria.

Biocompatibility Testing Summary:

Study Details (Applicability to a Physical Medical Device, Not AI/Software)

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

   • The document states "All samples met the pre-determined acceptance criteria" for each test. However, the specific number of samples tested for each benchtop performance or biocompatibility test is not explicitly provided in the summary.
   • Data provenance: These are laboratory/benchtop tests and in vitro biocompatibility tests, not data derived from patients or clinical sources. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable. The tests are conducted in a controlled lab environment.

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

   • Not applicable. For a physical device like a catheter, "ground truth" is established by adherence to engineering specifications and international standards (e.g., ISO, ASTM) through objective physical testing, not by expert consensus on interpretations of data.
   • Experts, if involved, would be internal engineers, quality control personnel, or third-party testing labs specializing in medical device testing, not typically medical experts like radiologists establishing diagnostic "ground truth."

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading, clinical diagnoses) where multiple experts might disagree. These are objective engineering and biological tests with defined pass/fail criteria.

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, an MRMC study was not done. This type of study is specifically for evaluating the impact of AI algorithms on human performance in diagnostic tasks (e.g., radiology). This submission is for a physical catheter, not an AI software. The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."

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

   • Not applicable. This relates to the performance of an AI algorithm alone. The device is a physical catheter system, not a software algorithm.

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

   • Ground truth for this device is based on engineering specifications, physical measurements, and adherence to established international standards (e.g., ISO 10555-1, ASTM F88, ISO 10993 series). It's objective, quantitative data from benchtop and in vitro (laboratory) tests.

7. The sample size for the training set:

   • Not applicable. This concept pertains to machine learning models (AI). There is no "training set" for a physical medical device. The device itself is manufactured to specifications.

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

   • Not applicable. As above, there is no training set for this type of device.

In summary, the provided document details the testing and acceptance criteria for a physical medical device (a catheter system) to demonstrate its substantial equivalence to a predicate device for FDA 510(k) clearance. It does not involve AI or software, and therefore, many of the questions related to AI validation methodologies (e.g., MRMC studies, expert adjudication, training/test sets) are not relevant to this specific submission.

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