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Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.

The Chaperon Guiding Catheter system is designed to advance interventional and diagnostic devices through the vasculature. The device is intended for general intravascular use, including the neuro and peripheral vasculature. The Chaperon Guiding Catheter is a two-catheter system comprised of the outer catheter and the inner catheter. The Chaperon Guiding Catheter system can be used individually with 0.035 in or a 0.038 in guidewire or together with the Inner Catheter to access the desired anatomy.

This document describes the regulatory submission for the Chaperon Guiding Catheter System. Based on the provided text, the device is a medical catheter and the "study" referred to is a series of bench tests conducted to demonstrate both the safety and performance characteristics of the device, as well as its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document lists various "Bench Testing" categories and their "Result," which consistently states "Met established criteria." This implies that specific acceptance criteria were defined for each test and the device successfully fulfilled them. However, the specific quantitative or qualitative acceptance criteria for each test are not detailed in this document.

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

The document does not specify the sample sizes used for each of the bench tests. It also does not provide information on data provenance in terms of country of origin or whether it was retrospective/prospective, as these types of clinical study details are not relevant for bench testing of a medical device of this nature in a 510(k) submission. Bench tests are typically conducted in a laboratory setting by the manufacturer.

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

This question is not applicable to the type of "study" described, which is a series of engineering/bench tests. "Ground truth" established by experts is typically relevant for studies involving qualitative assessments or diagnostic interpretation (e.g., image analysis, clinical diagnosis), not for objective physical and mechanical performance testing of a catheter.

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

This question is not applicable. Adjudication methods are typically used in clinical studies where there's a need to resolve discrepancies in expert interpretations or outcomes. For bench testing, the results are typically quantitative measurements or objective assessments against predefined pass/fail criteria, not subject to adjudication in the same sense.

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

This question is not applicable. MRMC studies and concepts of AI assistance for human readers are relevant for diagnostic devices, particularly those involving image interpretation. The Chaperon Guiding Catheter System is an interventional device, and the submission details only bench testing.

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

This question is not applicable. This device is not an algorithm or AI system, but a physical medical device (catheter). Standalone performance refers to the performance of an algorithm without human intervention, which is not relevant here.

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

For these bench tests, the "ground truth" would be the engineering specifications and predefined performance thresholds for each test, based on industry standards, regulatory requirements, and the predicate device's characteristics. For example, for "Tensile Strength," the ground truth would be a specific minimum force the catheter must withstand without breaking. For "Flow Rate," it would be a minimum flow volume under specific pressure conditions.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device and involves bench testing, not machine learning.

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

This question is not applicable, as there is no training set for a machine learning model in this submission.

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The Neuron™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Neuron Intracranial Access System has a Neuron Select Catheter 053 (predicate device), which is 3.5F and has multiple tip configurations, and a Neuron Select Catheter 070 (modified device) which is 5F and has multiple tip configurations. The Neuron Intracranial Access System also has a Neuron Delivery Catheter size 053, which tapers from 6F to 5F, and a Neuron Delivery Catheter 070, which is 6F. Materials used in the Neuron Intracranial Access System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.

This 510(k) summary describes a medical device, the Neuron™ Select Catheter, and its substantial equivalence to a predicate device, rather than providing data from a study directly comparing the device against acceptance criteria in the style you've requested for AI/software-based devices.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable or not provided by this type of regulatory submission for a physical medical device.

However, I can extract information related to the general "acceptance criteria" and "study" mentioned for this device:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, acceptance criteria are generally established through testing against design specifications, manufacturing standards, and regulatory requirements rather than performance metrics like sensitivity/specificity.

• Intended use
• Method of operation
• Methods of construction
• Materials used | "The intended use, method of operation, methods of construction, and materials used are either identical or substantially equivalent to the existing, legally marketed, predicate devices." |

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

• Sample Size for Test Set: Not specified. This document refers to "Bench testing, in vitro testing, and in vivo testing" which would involve testing a certain number of devices or components, but the exact sample sizes are not detailed in this summary.
• Data Provenance: Not specified, but generally, such testing is conducted within controlled laboratory environments (bench, in vitro) and/or animal models (in vivo) as part of the device development and validation process.

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

• Not Applicable. For physical devices, "ground truth" often refers to engineering specifications, material properties, and functional performance benchmarks rather than expert consensus on diagnostic images. Experts involved would typically be engineers, material scientists, and medical professionals contributing to design validation, but not in the context of establishing "ground truth" for a test set as you would for an AI algorithm.

4. Adjudication method

• Not Applicable. Adjudication methods are typically relevant for human interpretation of data, especially in the context of AI performance evaluation where there might be disagreements among human experts. This is not mentioned or relevant for the testing of this physical catheter.

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

• No. This type of study is typically performed for diagnostic imaging devices or AI algorithms that assist human readers. This document describes a physical catheter, not a diagnostic or AI-assisted device.

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

• Engineering specifications, material testing results, and functional performance benchmarks. For example, tests would confirm catheter dimensions, tensile strength, pushability, trackability, torque response, lubricity, burst pressure, and biocompatibility against predefined acceptable ranges.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. Training sets are relevant for AI/machine learning algorithms.

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

• Not Applicable. As above, this is a physical medical device.

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