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Product code NRY:
The CEREGLIDE 71 Catheter System, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is 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 to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

Product code QJP:
The CEREGLIDE 71 Catheter System is 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 71 Catheter System is also indicated for use as a conduit for retrieval devices.

The CEREGLIDE™ 71 Catheter System consists of the CEREGLIDE™ 71 Intermediate Catheter and associated accessories including the INNERGLIDE™ 7 Delivery Aid, Rotating Hemostasis Valve, and Slit Introducers.

The CEREGLIDE™ 71 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE inner lumen liner to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets.

These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.

The CEREGLIDE™ 71 Catheter System is packaged with an INNERGLIDE™ 7 Delivery Aid, a Rotating Hemostasis Valve (RHV) with a side port and two Slit Introducer accessories. The INNERGLIDE™ 7 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 71 Catheter System to facilitate delivery of the CEREGLIDE™ 71 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and insertion of catheters. The Slit Introducers are designed to introduce the CEREGLIDE™ 71 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 71 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.

Product code NRY: The CEREGLIDE™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.

This document is a 510(k) clearance letter for a medical device (CEREGLIDE 71 Catheter System), and does not contain the information requested about acceptance criteria and a study proving a device meets these criteria for an AI/software medical device.

The 510(k) summary explicitly states:

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

The document details the device's technical specifications, indications for use, and a comparison to predicate devices, along with non-clinical (bench) performance testing. These bench tests are primarily focused on the physical characteristics and performance of the catheter system, such as dimensions, material properties, durability, and a simple in vitro usability study.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not present in the provided document. The device in question is a physical medical catheter system, not an AI/software medical device that would typically involve such studies for regulatory submission.

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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 92 Catheter System is 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™ 92 Catheter System consists of the CEREGLIDE™ 92 Intermediate Catheter and associated accessories, including the INNERGLIDE™ 9 Delivery Aid, Rotating Hemostasis Valve (RHV), and Slit Introducers.

Intermediate Catheter: The CEREGLIDE™ 92 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE lined inner lumen to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets. These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.

The CEREGLIDE™ 92 Catheter System is packaged with an INNERGLIDE™ 9 Delivery Aid, an RHV with a side port, and two Slit Introducer accessories. The INNERGLIDE™ 9 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 92 Catheter System to facilitate delivery of the CEREGLIDE™ 92 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and insertion of catheters. The Slit Introducers are designed to introduce the CEREGLIDE™ 92 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 92 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.

The provided text describes information about the CEREGLIDE 92 Catheter System (K233982). However, it does not include details about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device (CEREGLIDE™ 92 Intermediate Catheter K230726) through non-clinical performance testing (bench, animal, and clinical were not required).

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi Reader Multi Case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only without human-in-the-loop performance) study results.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The "acceptance criteria" mentioned in the document refer to the success metrics for the bench testing conducted on the CEREGLIDE 92 Catheter System, primarily for individual physical and functional properties, not for an AI/ML-based diagnostic or prognostic task. The reported performance for these tests is simply "PASS: Samples met the established acceptance criteria."

Summary of what the document does provide regarding performance testing:

The device underwent non-clinical performance testing, primarily bench testing, to demonstrate substantial equivalence to the predicate device.

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

Biocompatibility Testing:

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