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The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.

The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS 8F Balloon Guide Catheter is an 85 and 95 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads 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, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS 8F Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 8F Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.

This document describes the non-clinical performance testing for the BOSS 8F Balloon Guide Catheter, a medical device. There is no information regarding a study of an AI device. As such, I cannot provide details on factors like sample size, ground truth, expert qualifications, or comparative effectiveness studies related to AI.

However, I can provide the acceptance criteria and reported device performance based on the non-clinical bench testing for the BOSS 8F Balloon Guide Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is uniformly reported as "Pass" for all tests, indicating that "All samples met the pre-determined acceptance criteria" or similar outcomes for biocompatibility (e.g., "Noncytotoxic," "Non-hemolytic"). The reference standards listed for each test effectively serve as the basis for the acceptance criteria.

The following information is Not Applicable (N/A) as the provided document describes non-clinical performance testing for a physical medical device (catheter), not an AI/Software as a Medical Device (SaMD).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is bench testing of a physical device.
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. "Ground truth" in this context would refer to objective material properties or performance under specified conditions, measured by instrumentation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's testing is implicitly defined by the quantifiable limits and observable characteristics specified in the referenced ISO and FDA standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The BOSS Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

The BOSS Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS Balloon Guide Catheter is a 90 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads 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, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.

This document is a 510(k) Summary for the BOSS™ Balloon Guide Catheter, a medical device. It describes the non-clinical performance testing conducted to demonstrate substantial equivalence to legally marketed predicate devices, which means no clinical studies were required. Therefore, the information typically associated with AI/ML device studies (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance) is not applicable here as this is a medical device, not an AI/ML diagnostic tool.

The "acceptance criteria" for this device are the pre-determined thresholds for various physical, functional, and biocompatibility tests, as detailed in the "NONCLINICAL PERFORMANCE TESTING SUMMARY" and "Biocompatibility Testing Summary" sections. The "study that proves the device meets the acceptance criteria" refers to the successful completion of all these non-clinical (bench and animal) tests.

Here's a breakdown of the requested information based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document repeatedly states "All samples met the pre-determined acceptance criteria" or similar for the non-clinical bench tests. While the exact numerical sample size for each test is not explicitly listed, it implies that a sufficient number of devices were tested to meet the requirements of the referenced standards (e.g., ISO 10555-1, FDA guidances). For the animal study, the sample size is not specified but it states "an acute porcine model."
• Data Provenance:
  • Country of Origin: Not specified for the bench tests. The animal study used an "acute porcine model."
  • Retrospective or Prospective: All testing was prospective, designed specifically to evaluate the device against established standards and criteria for regulatory 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. The "ground truth" for this medical device 510(k) submission is established by the performance standards (e.g., ISO, ASTM, FDA guidances) and the physical properties of the device itself (e.g., dimensions, strength, material characteristics). Experts were involved in setting these standards and conducting the tests, but not in the "ground truth" establishment in the sense of labeling data for an AI/ML model for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of results in the context of an AI/ML model. The "adjudication" is inherent in whether the device "passes" or "fails" the pre-defined engineering and performance 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 is a medical device (catheter) and the submission is based on non-clinical performance and substantial equivalence to predicate devices, not an AI/ML diagnostic tool requiring MRMC studies.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Established international and national standards for medical devices (e.g., ISO 10555 series, ISO 10993 series, AAMI, ASTM).
• FDA guidance documents for specific device types (e.g., PTCA Catheters).
• Pre-determined engineering specifications and performance criteria for the device.
• Results from a non-GLP (Good Laboratory Practice) animal study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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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