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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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The Cerenovus Large Bore Catheter, 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

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

The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheter 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 for navigation of vessels. 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 hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.
The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.

The provided text does not describe an acceptance criteria study for an AI/ML-enabled device but rather a 510(k) submission for a physical medical device (Cerenovus Large Bore Catheter and Aspiration Tubing Set). Therefore, much of the requested information regarding AI/ML device performance (like expert consensus, adjudication methods, MRMC studies, training/test set details) is not applicable or present in the document.

However, I can extract the relevant acceptance criteria and performance data for the mechanical device as found in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" for this context:
For physical medical devices, "acceptance criteria" for performance testing typically refer to specific measurable thresholds or ranges that the device must demonstrate to confirm its functionality and safety. While the exact numerical values for these criteria are not explicitly stated in this summary, the document indicates that pre-established criteria exist and were met ("Samples met the established acceptance criteria").

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

• Sample size: Not explicitly stated in the summary. The document mentions "samples" in the plural form were tested for each performance test.
• Data provenance: Not explicitly stated. The testing ("Performance Testing - Bench") was conducted by Cerenovus, Inc. as part of their 510(k) submission.

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

• Not applicable. This pertains to AI/ML device evaluations. For a mechanical device, performance is typically measured against engineering specifications and industry standards, not expert-established ground truth in the same manner as image interpretation or diagnosis.

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

• Not applicable. This pertains to AI/ML device evaluations.

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:

• No. This pertains to AI/ML device evaluations. The device mentioned is a physical catheter and aspiration set, 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 pertains to AI/ML device evaluations.

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

• Bench Testing / Engineering Specifications: For this mechanical device, the "ground truth" or reference for performance is established by engineering specifications, validated test methods, and potentially industry standards (e.g., ISO, ASTM for material properties, fluid dynamics). The specific parameters measured (flow rate) are compared against pre-defined acceptable ranges.

8. The sample size for the training set:

• Not applicable. This pertains to AI/ML device evaluations. This device is not an AI/ML model that requires training data.

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

• Not applicable. This pertains to AI/ML device evaluations.

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The CEREGLIDE 92 Intermediate Catheter 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 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 Intermediate Catheter is packaged with a Tuohy Borst hemostasis valve (RHV) with a side port and two slit introducer accessories. 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 document is a 510(k) Premarket Notification from the FDA regarding the "CEREGLIDE 92 Intermediate Catheter." It details various performance tests conducted on the device to demonstrate its substantial equivalence to a legally marketed predicate device.

However, it's crucial to understand that this document does NOT describe the acceptance criteria and study proving device performance for an AI/ML-driven medical device.

Instead, this document pertains to a traditional, physical medical device (a catheter). The "performance testing" described are typical bench testing (physical and mechanical properties) and biocompatibility testing for hardware, not algorithmic performance.

Therefore, many of the specific questions asked in the prompt, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," and "ground truth for the training set," are not applicable to the content of this document. These questions are relevant to the validation of AI/ML models in medical devices.

I will address the questions to the extent possible with the information provided, explicitly stating when information is not present or not applicable.

Acceptance Criteria and Device Performance for the CEREGLIDE 92 Intermediate Catheter

The CEREGLIDE 92 Intermediate Catheter is a physical medical device, not an AI/ML-driven one. Therefore, the "acceptance criteria" and "device performance" in this context refer to its physical, mechanical, and biological properties rather than algorithmic performance.

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

The document provides a summary of "Performance Testing - Bench" and "Biocompatibility Testing." For each test, the "Result" uniformly states "PASS: Samples met the established acceptance criteria" or simply "PASS." The specific numerical or quantitative acceptance criteria are generally not explicitly stated in the summary tables but are implied by the "PASS" result.

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

The document states: "All testing was conducted using sampling methods as required by internal design control procedures." However, the specific sample sizes for each test are not provided.

Data provenance: Given that these are bench tests for a physical device, the "data provenance" would refer to the testing conditions and lab environment, rather than patient data. The tests were conducted internally by the manufacturer. No country of origin for specific "data" (in the sense of patient data) is applicable. This was a non-clinical study involving bench testing and in-vitro/in-vivo animal tests for biocompatibility, not a clinical trial involving human patients or patient data.

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

Not applicable. This device is a physical catheter, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests refers to established engineering specifications, ISO standards, and biological safety limits.

4. Adjudication method for the test set

Not applicable. There is no "adjudication" in the sense of reconciling expert opinions on data. Adjudication methods like 2+1 or 3+1 are used for human-labeled datasets, typically for AI/ML models.

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. MRMC studies are performed to evaluate the diagnostic performance of AI-assisted human readers compared to human readers alone, typically in medical imaging or diagnostics. This document is about a physical interventional device, not a diagnostic AI tool.

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

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

7. The type of ground truth used

For the bench testing and biocompatibility assessments, the "ground truth" is based on:

• Established engineering specifications and design requirements for the catheter's physical dimensions, mechanical properties (tensile strength, burst pressure, kink resistance, trackability, etc.).
• International standards (e.g., ISO 10555-1) for catheter performance.
• Regulatory guidance and standards for biocompatibility (e.g., ISO 10993-1, ISO 11135 for sterilization, EN ISO 10993-7 for EO residuals).
• Comparison to predicate device characteristics to demonstrate substantial equivalence.

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. As above, no training set for an AI/ML model.

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The CEREGLIDE™ 71 Intermediate Catheter 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 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

The CEREGLIDE™ 71 Intermediate Catheter is a variable stiffness, single lumen catheter 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. 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.

The CEREGLIDE™ 71 Intermediate Catheter is a medical device for facilitating neurovascular interventions. The document provided outlines the non-clinical performance data to demonstrate its substantial equivalence to a legally marketed predicate device, the CERENOVUS Large Bore Catheter (K191237).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CEREGLIDE™ 71 Intermediate Catheter are implicitly defined by a series of bench tests and biocompatibility tests, with the reported performance consistently being "PASS" or "Samples met the established acceptance criteria," sometimes exceeding comparator devices.

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

The document states: "All testing was conducted using sampling methods as required by internal procedure." Specific sample sizes for each test are not explicitly provided.

The data provenance is non-clinical bench testing and in-vitro testing. There is no mention of human clinical data or patient data. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.

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

Not applicable. This device's evaluation relies on objective engineering and material science tests (bench and in-vitro, and biocompatibility tests), not expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. As the studies described are bench and biocompatibility tests, human adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device clearance based on substantial equivalence using non-clinical performance data, not an AI or diagnostic imaging device requiring human reader interaction.

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

Not applicable. This pertains to an intermediate catheter, which is a physical medical device, not a software algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical tests is established by pre-defined engineering specifications, material properties, and regulatory standards (e.g., ISO standards, ASTM methods, USP guidance). The device's performance is compared against these objective criteria. For the biocompatibility tests, the "ground truth" is typically the absence of adverse biological reactions as defined by the specific test (e.g., no cytotoxicity, no sensitization, no irritation).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The CEREGLIDE™ 71 Intermediate Catheter, 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

The CEREGLIDE™ 71 Intermediate Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the euro 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™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.

The provided text describes the regulatory clearance of a medical device (CEREGLIDE™ 71 Intermediate Catheter and Cerenovus Aspiration Tubing Set) and outlines the non-clinical performance data used to demonstrate its substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML performance evaluation. Therefore, I cannot extract the requested information based on the input.

However, I can provide a summary of the non-clinical performance data presented in the document, which are described as meeting acceptance criteria, albeit not for an AI/ML device.

Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)

Since the provided document is a 510(k) clearance letter for a physical medical device (catheter and aspiration tubing set) and does not describe any AI/ML components or studies, I cannot answer the questions related to AI/ML specific evaluations:

2. Sample size used for the test set and the data provenance: Not applicable, as there's no machine learning test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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.): The "ground truth" for the non-clinical tests would be the established engineering and biocompatibility standards and specific design requirements.
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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