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The CELLO II Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravasular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The CELLO II Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with one radiopaque ring marker on the distal end of the balloon and a bifurcated Luer hub on the proximal end. A compliant urethane balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended balloon volumes are indicated on the product label. Each catheter is supplied with inserters, a Y-Connector, 3-way stopcocks and syringes.

The CELLO II Balloon Guide Catheters are intended for use in hospitals or other health care facilities which are equipped with trained personnel and specialized equipment to perform peripheral and neurovascular procedures.

The CELLO II Balloon Guide Catheter is intended for facilitating the insertion and guidance of intravascular catheters into selected blood vessels in the peripheral and neuro vasculature systems. The tip of the catheter features a balloon of urethane rubber. Radiopaque ring marker identifies the distal end of the balloon. The shaft is a dual lumen type with coaxial structure featuring a built-in braided stainless steel coil.

The materials of construction are similar to those used in many other similar catheters. The shaft is made of polyurethane, polyamide, stainless steel, and fluorine resin; the balloon is made of urethane. Patient contact is of limited duration, less than 24 hours.

Here's a breakdown of the acceptance criteria and study information for the CELLO II Balloon Guide Catheter, based on the provided document:

This document describes a medical device, a catheter, and the tests performed to demonstrate its safety and effectiveness. It is not an AI/ML device, so many of the requested fields regarding AI performance, expert review, training sets, and comparative effectiveness studies are not applicable.

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 a sample size for each individual non-clinical or biocompatibility test. These tests are typically performed on a statistically significant number of manufactured units or material samples to ensure representativeness and reliability of the results. The provenance is likely from the manufacturer's internal testing facilities, as these are in vitro and in vivo (animal studies for biocompatibility) tests, not human data. The document implies these tests were conducted as part of the regulatory submission (premarket notification).

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

Not applicable. This is a medical device (catheter) and not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established scientific methods, standards (e.g., ISO, ASTM), and laboratory measurements.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI/ML evaluations where multiple human readers assess cases and a consensus or tie-breaker is needed. These are laboratory and material 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 a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC studies were performed.

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

Not applicable. No AI algorithm is involved.

7. The type of ground truth used

The ground truth for the nonclinical and biocompatibility tests is based on:

• Established industry standards: Such as ISO 10555-1, ISO 80369-7, ISO 10993 series, and ASTM F756-17, ASTM F2382-18.
• Quantitative measurements: Measuring physical properties (e.g., force, dimensions, burst volume, inflation/deflation time, torque, particle count).
• Qualitative observations: Visual inspection (e.g., surface, damage, tip configuration, radiopacity).
• Biological assays/animal studies: For biocompatibility endpoints (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility experiments using rabbit blood and in vivo thrombogenicity study in dogs).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The CELLO Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with two radiopaque markers on both the distal and proximal ends of the balloon and a bifurcated luer hub on the proximal end. A compliant silicone balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended inflation volumes are indicated on the product label. Each catheter is supplied with an appropriately-size Dilator.

Here's an analysis of the provided 510(k) Summary, focusing on acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance for CELLO Balloon Guide Catheter (K120781)

1. Table of Acceptance Criteria and Reported Device Performance

The device under review is primarily mechanical, and the "acceptance criteria" are embodied in the results of the non-clinical and biocompatibility tests conducted. The reported device performance is indicated by whether each test passed, failed, or was for informational purposes only.

*FIO: For Information Only - These tests were performed, but the results were provided for informational purposes and not necessarily as pass/fail acceptance criteria in the same way as the others. However, the presence of these results implies an expected functional characteristic.

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

• Sample Size: The document does not explicitly state the exact sample sizes used for each nonclinical or biocompatibility test. It mentions "All joints," "All dimensions," and "All balloons" meeting reliability/confidence requirements in "statistical confidence limits test," which implies that a statistically significant number of samples were tested. However, the specific number of units tested for each criterion is not provided.
• Data Provenance: The studies are nonclinical (benchtop and in vitro/in vivo biocompatibility) and were conducted by the manufacturer, Fuji Systems Corporation, or their designated testing laboratories. The country of origin for the data is not explicitly stated, but the manufacturer is based in Japan. These are retrospective data collected as part of the device development and regulatory submission process.

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

This submission pertains to a mechanical medical device (catheter) and focuses on engineering performance and biocompatibility. There is no "ground truth" established by human experts in the context of diagnostic accuracy found in AI/imaging device submissions. The "ground truth" for these tests is defined by the objective measurement criteria and standards outlined in the test protocols (e.g., ISO standards, ASTM standards, internal reliability requirements).

4. Adjudication Method for the Test Set

Not applicable. This is a nonclinical study involving objective measurements and standardized tests, not subjective interpretations requiring adjudication by multiple readers/experts.

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

Not applicable. This is a submission for a mechanical medical device, not a diagnostic imaging or AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

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

• Objective Measurement: Adherence to specified dimensions, force limits, inflation pressures, deployment characteristics, and physical properties.
• Standardized Protocols: Compliance with international standards (e.g., ISO 594-1, ISO 594-2, ISO biocompatibility tests, ASTM methods).
• Pre-defined Pass/Fail Criteria: Each test had distinct criteria that determined a "Pass" or "Fail" outcome (or "For Information Only").

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device; it does not involve machine learning algorithms requiring a training set.

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

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

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The Silbroncho® is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

The Silbroncho® double lumen tube is made of silicone and is available in sizes 33 to 39 French. They are designed as a double lumen tube with 2 cuffs and separate 15 mm connectors for isolating and ventilating one lung during surgical procedures.

The provided text describes a 510(k) premarket notification for the "Silbroncho® tubes," a double lumen tube. The submission focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting performance studies against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from the provided text.

Here is the information that can be extracted, and where the requested details are not available, it is noted:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance results from a study. The submission is based on demonstrating substantial equivalence to pre-existing predicate devices.

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. The document does not describe a performance study with a test set. This is a 510(k) submission focused on substantial equivalence.

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. No performance study using a ground truth is described.

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

Not applicable. No performance study with adjudication is described.

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 medical tube, 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 tube, not an algorithm.

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

Not applicable. No performance study requiring a ground truth is described.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning algorithm or a training set.

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

Not applicable. The document does not describe a machine learning algorithm or a training set.

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