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Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Micrus Courier Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.

The provided text is a 510(k) Summary for the Micrus Courier 270 Microcatheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about specific "acceptance criteria" based on device performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving that the device meets such criteria in terms of clinical or diagnostic effectiveness.

Medical devices like microcatheters are typically evaluated for performance in terms of mechanical properties, biocompatibility, and functional aspects (e.g.,
delivery of agents, trackability). The document states that the "Micrus Courier 270 Microcatheter is substantially equivalent to other Micrus Courier Microcatheters in terms of intended use, design, specifications, and materials," and that "The Micrus Courier 270 Microcatheter uses the same methods and materials in construction, packaging, and sterilization as its predicate." This implies that the 'acceptance criteria' for this 510(k) submission are met by demonstrating equivalence to a legally marketed predicate device, rather than through a de novo clinical trial demonstrating specific performance metrics against a predefined threshold.

Therefore, most of the requested information cannot be extracted from the provided text, as it pertains to clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance) typically found in documents for AI/ML-driven devices or devices requiring clinical performance data beyond substantial equivalence.

Information that can be inferred or is directly stated:

• Intended Use/Indications for Use: Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Here's a breakdown of the requested information based on the provided text:

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

Note: The document does not provide specific quantitative performance metrics (e.g., in a clinical setting) against which acceptance criteria would typically be set for AI/ML or novel diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No information available. This type of study data is not typically part of a 510(k) summary for a substantial equivalence claim for a microcatheter.

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)
No information available. Ground truth establishment with experts is not detailed as there isn't a performance study described in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information available. Adjudication methods are not applicable to the type of information presented in this 510(k) summary.

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 information available. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No information available. This is not an AI/ML device, and no standalone algorithm performance study is mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No information available. Ground truth for performance metrics is not discussed, as the document focuses on substantial equivalence of design and function. The 'ground truth' for the regulatory submission is essentially the predicate device's established safety and effectiveness.

8. The sample size for the training set
No information available. This is not an AI/ML device, and no training set is relevant.

9. How the ground truth for the training set was established
No information available. Not applicable.

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Micrus Courier Flex Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Micrus Courier Flex Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.

The provided 510(k) summary for the Micrus Courier Flex Microcatheter does not contain any information regarding acceptance criteria, device performance studies, or data related to AI/algorithm performance.

This document describes a medical device (a microcatheter) and is primarily focused on demonstrating substantial equivalence to a previously approved predicate device. It defines the intended use, describes the device's physical characteristics, and confirms that it uses similar materials and manufacturing processes as its predicate.

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" are typically associated with performance studies for diagnostic or AI-driven devices, which are not detailed in this document.

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The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

The Micrus Microcatheters are tubular devices with a single lumen designed for insertion into the cardiovascular system for diagnostic and therapeutic purposes.

This 510(k) summary (K061963) for the Micrus Microcatheters "Courier Pre-Shaped" describes the device and its intended use, and makes a claim of substantial equivalence to predicate devices based on design, materials, function, and non-clinical testing. However, it does not provide the specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets those criteria in the way you've outlined for medical AI/software performance.

Here's an analysis based on the information provided and how it relates to your requested points:

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

This document does not contain a quantitative table of acceptance criteria and reported device performance. The comparison to predicate devices is qualitative and states that the "Micrus Courier Pre-Shaped microcatheters had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10." This suggests mechanical testing was done, but no specific values or acceptance thresholds are provided.

2. Sample size used for the test set and the data provenance:
No information provided. This document describes a medical device (a microcatheter), not a software or AI device that would typically use "test sets" of data. The "testing" referred to is likely mechanical and bench testing.

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 establishment for a test set is described.

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. This is a physical medical device, not an AI/software product.

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):
Not applicable. For a physical device like a microcatheter, the "ground truth" for performance would be derived from engineering specifications, material properties, and mechanical test results (e.g., tensile strength, flexibility, lubricity measurements).

8. The sample size for the training set:
Not applicable. As a physical device, there's no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
Not applicable.

Summary of what is provided vs. what is requested:

The provided document is a 510(k) summary for a physical medical device (microcatheter). The questions you've asked are predominantly tailored for the evaluation of medical AI or software as a medical device (SaMD), which requires different types of studies and performance metrics (e.g., sensitivity, specificity, AUC, human reader studies).

For this 510(k) submission, the "study" proving the device meets acceptance criteria is implied to be a series of non-clinical bench and mechanical tests. These tests would likely compare properties such as:

• Mechanical properties: Tensile strength, pushability, trackability, torqueability, flexibility, kink resistance.
• Dimensional accuracy: Inner/outer diameters, length, tip shape.
• Material compatibility: Biocompatibility (though typically covered by material predicate).
• Coating integrity/lubricity.
• Radiopacity.

The document states that the new device "had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10," indicating that specific mechanical tests were performed to demonstrate mechanical performance metrics (like force required to traverse a tortuous path). However, the specific acceptance criteria (e.g., "force must be less than X N" or "within Y% of predicate device") and the detailed quantitative results of these non-clinical studies are not included in this high-level 510(k) summary. These details would typically be found in the full 510(k) submission and the internal test reports of the manufacturer.

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The MicroCatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

The Micrus Microcatheter consists of 4 major components:

• A flexible shaft with a lubricious liner extruded from Teflon. The liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax,
• An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
• A standard luer hub insert, which is molded onto the flexible shaft.
• A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.

This 510(k) submission (K032624) is for a medical device called the "Micrus Microcatheter," which is a diagnostic and therapeutic intravascular catheter. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K960806, Tracker Excel 14 Microcatheter) rather than presenting a study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested sections related to acceptance criteria, device performance, ground truth, and specific study designs (MRMC, standalone algorithm) do not apply directly to this type of regulatory submission as described in the provided text. This submission focuses on non-clinical testing and comparison to an already cleared device to establish safety and effectiveness.

Here's a breakdown of the information that can be extracted or deduced from the provided text, and where the requested details are not applicable:

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

   This information is not provided in the document. This 510(k) submission doesn't detail specific performance criteria or a study with numerical performance results for the Micrus Microcatheter itself. Instead, it states that based on non-clinical testing and comparison to a predicate device, it is considered substantially equivalent in safety and effectiveness. The "non-clinical testing" is not further elaborated upon for specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   This information is not provided in the document. As no clinical study results are presented, there is no mention of a test set, sample size, or data provenance. The submission refers to "non-clinical testing," which typically includes bench testing (e.g., mechanical, material properties) rather than human subject data.

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)

   This information is not provided in the document. There is no mention of ground truth establishment or expert involvement for evaluating device performance in a clinical setting.

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

   This information is not provided in the document. No adjudication method is described, as there is no clinical test set or human evaluation of diagnostic results.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.

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

   No, a standalone algorithm performance study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.

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

   This information is not provided in the document. As there is no clinical study assessing diagnostic or intervention outcomes, no ground truth type is defined.

8. The sample size for the training set

   This information is not provided in the document. There is no training set mentioned, as this is not an AI or machine learning device.

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

   This information is not provided in the document. There is no training set or ground truth establishment relevant to the type of device.

Summary based on the provided text:

The submission for the Micrus Microcatheter primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Tracker Excel 14 Microcatheter, K960806). The basis for this equivalence is stated as:

• Design, materials, function, and intended use of the new device being comparable to the predicate.
• Non-clinical testing performed by Micrus Corporation. While the specifics of this testing are not detailed in the provided excerpts, it would typically involve bench testing for material biocompatibility, mechanical properties (e.g., tensile strength, kink resistance, pushability, trackability), and fluid dynamics, ensuring these properties are equivalent or superior to the predicate device.

Crucially, this 510(k) does not contain information about clinical studies with human subjects, diagnostic performance metrics, or AI algorithm evaluation. The FDA's letter (K032624) confirms the finding of substantial equivalence based on the information provided in the premarket notification.

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