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The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter of a compatible aspiration pump and to allow the user to control the fluid flow.

Both the CEREGLIDE ™ 42 Intermediate Catheter and CEREGLIDE ™ 57 Intermediate Catheter are variable stiffness, single lumen catheters designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless-steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless-steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories.

The RHV with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.

The CEREGLIDE ™ 42 Intermediate Catheter and the CEREGLIDE ™ 57 Intermediate Catheter are designed for use in the removal of thrombus from the neurovasculature using continuous aspiration from an external vacuum source. The CEREGLIDE ™ 42 Intermediate Catheter and CEREGLIDE ™ 57 Intermediate Catheter are intended to be used with a compatible aspiration pump as a vacuum source that provides a minimum vacuum pressure of -68 kPa [-20 inHg] and a maximum vacuum pressure of -95 kPa [-28 inHg], and minimum 17 L/min flow rate, with a collection canister of at least 1000 mL volume.

The CEREGLIDE ™ 42 Intermediate Catheter and the CEREGLIDE ™ 57 Intermediate Catheter are intended to be connected to the vacuum source using the Cerenovus Aspiration Tubing Set which is an externally manufactured tubing set with an internal diameter (ID) of 0.110" and overall length of 112", containing an integrated flow control switch.

This document is a 510(k) premarket notification for CEREGLIDE™ 42 Intermediate Catheter, CEREGLIDE™ 57 Intermediate Catheter, and Cerenovus Aspiration Tubing Set. It aims to demonstrate substantial equivalence to a legally marketed predicate device.

The entire submission focuses on non-clinical performance data (bench testing), sterilization, shelf-life, and biocompatibility testing. Crucially, there is no mention of a study involving human readers, AI assistance, ground truth establishment by experts, or any clinical performance data derived from patient studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of AI/human reader performance or clinical outcomes, because this information is not present in the provided text. The document explicitly states:

• "No animal studies were required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing."
• "Clinical studies were not required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing."

The "acceptance criteria" and "device performance" described in the document are limited to bench testing results for physical and mechanical properties, sterilization, shelf life, and biocompatibility.

Here's the information that can be extracted or inferred from the provided text regarding the closest equivalent to "acceptance criteria and device performance" for this specific device, which is based on bench testing:

Acceptance Criteria and Reported Device Performance (Bench Testing)

The "acceptance criteria" for this device, based on the provided document, are that the samples for each test "met the established acceptance criteria." The document does not provide the specific quantitative thresholds for these criteria. The "device performance" is simply reported as "PASS" for all tests.

Since the device is a catheter and tubing set for mechanical thrombectomy, and the submission is a 510(k) for substantial equivalence based primarily on bench testing, the requested information that typically applies to diagnostic AI algorithms or clinical trials with human outcomes is not applicable here.

Here's a breakdown of why the specific points of your request cannot be answered from the provided document:

1. A table of acceptance criteria and the reported device performance: Provided above for bench testing. No clinical or human-reader performance criteria are given.
2. Sample sized used for the test set and the data provenance: For bench testing, it states "All testing was conducted using sampling methods as required by internal procedure," but does not provide specific sample sizes. Data provenance is "bench testing," not from patient data or clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for image interpretation or clinical outcomes was established by experts in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation or adjudication 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 is not an AI-enabled device and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the typical sense for image analysis. The "ground truth" for this device's performance is engineering specifications and compliance with ISO standards confirmed by bench testing.
8. The sample size for the training set: Not applicable. No training set for an algorithm is described.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for an algorithm is described.

In summary, the provided FDA 510(k) clearance letter and summary for the CEREGLIDE™ catheters and tubing set demonstrate substantial equivalence through non-clinical bench performance testing, focusing on the physical and mechanical characteristics of the device. It does not involve AI, human readers, clinical trials, or the establishment of ground truth by medical experts in the context of diagnostic or interventional efficacy.

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The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter are indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Both the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter (hereafter referred to as the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters) are variable stiffness, single lumen catheters designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainlesssteel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless-steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the catheter hub which can be used to attach accessories for flushing. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing and insertion of catheters. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.

This document describes the premarket notification (510(k)) for the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters, asserting their substantial equivalence to a predicate device based on non-clinical performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states: "All testing was conducted using sampling methods as required by internal procedure." However, specific sample sizes for each test are not provided. The data provenance is from bench testing and in-vitro usability studies conducted by the manufacturer, Cerenovus, Inc. The document does not specify a country of origin for the data beyond the manufacturer's location (Miami, FL, United States). These studies are considered prospective as they were conducted specifically for the purpose of this submission.

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

This information is not applicable as the document describes performance testing for medical devices based on engineering specifications and benchmark comparisons, not diagnostic or interpretive tasks requiring expert ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set:

This information is not applicable for the type of device performance testing described. Adjudication methods are typically used in clinical studies where multiple human readers or systems interpret data, and discrepancies need to be resolved. The tests here involve objective measurements against predefined acceptance criteria.

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:

This information is not applicable. The device is an intermediate catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.

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

This information is not applicable. The device is a physical medical instrument, not a software algorithm. Standalone performance refers to the assessment of AI algorithms without human intervention, which is not relevant here.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests outlined is based on pre-defined engineering specifications, industry standards (e.g., ISO 10555-1), and comparative performance against a legally marketed predicate device. For example, "Catheter ID" uses internal diameter requirements as its ground truth, and "Peak Tensile Strength" uses ISO 10555-1 Section 4.5.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is a physical product and not an AI/machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as above.

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