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The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.

The VasCon Roamer Microcatheters are single lumen catheters, incorporating a Pebax body reinforced with stainless steel and platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in French sizes of 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105 cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019, 0.021, and 0.027 inches. They have a hydrophilic coating to provide lubricity during use.

The provided text describes a 510(k) summary for the VasCon Roamer Microcatheter, a medical device. This document is a premarket notification for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML powered device.

The text focuses on establishing substantial equivalence to a predicate device based on technological characteristics and laboratory testing to assure compliance to specifications and biocompatibility. There is no mention of an AI or ML component, therefore, the specific questions related to AI/ML device performance (sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not applicable to this document.

However, I can extract information regarding the device's summary and the testing performed to demonstrate its safety and effectiveness based on the provided text.

Here's a breakdown of what can be extracted:

• Device Name: VasCon Roamer Microcatheter
• Intended Use: The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
• Predicate Device: Cordis Catheters (MassTransit®, Prowler® Plus, and the Prowler® 14)
• Summary of Technological Characteristics: Single lumen catheters, incorporating a Pebax body reinforced with stainless steel and platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. Available in various French sizes and lengths. Hydrophilic coating for lubricity.
• Testing Summary: "Laboratory testing has been performed on the VasCon Roamer Microcatheter to assure compliance to the specifications. In addition, laboratory testing has been performed on the materials to assure biocompatibility."
• Conclusions: "The testing as discussed above demonstrates that, like the predicate devices, the VasCon Roamer Microcatheters are safe and effective for its intended use."

Since the request is specifically for elements related to acceptance criteria and a study proving device meets acceptance criteria in the context of AI/ML, and this document does not refer to an AI/ML device, I cannot directly answer most of the questions.

However, if we interpret "acceptance criteria" and "study" in a general medical device context (not AI/ML specific), this is what the document implies:

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

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

• Information Not Provided: The document states "laboratory testing has been performed" but does not specify sample sizes for these tests, the type of data, or its provenance.

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)

• Not Applicable (No AI/ML): This question is relevant for AI/ML device validation involving expert review. This medical device documentation does not mention such a process.

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

• Not Applicable (No AI/ML): This is for AI/ML ground truth establishment by experts.

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 (No AI/ML): This is for AI/ML device performance evaluation in collaboration with humans.

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

• Not Applicable (No AI/ML): This question relates to AI/ML algorithm-only performance.

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

• Not Applicable (No AI/ML): Ground truth for this type of device would likely be derived from physical measurements against design specifications and material safety standards through laboratory bench testing, rather than clinical "ground truth" as described (e.g., pathology).

8. The sample size for the training set

• Not Applicable (No AI/ML): No training set as there is no AI/ML component.

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

• Not Applicable (No AI/ML): No training set as there is no AI/ML component.

In summary, the provided 510(k) summary describes a traditional medical device (a microcatheter) and its path to market based on substantial equivalence and non-AI/ML related laboratory testing. It does not provide the detailed information requested for an AI/ML powered device.

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VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.

The VasCon NeuroPath™ Guiding Catheter is a single lumen catheter, incorporating a PEBAX® body reinforced with a stainless steel wire braid. The intermediate segment is also PEBAX® with a stainless steel coil to reduce kinking and to promote improved torque response. The tip is composed of radiopaque 35D PEBAX® to reduce potential vessel injury. They are available in 5Fr and 6Fr, 90 and 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate devices.

The provided text describes a 510(k) submission for a medical device, the VasCon NeuroPath™ Guiding Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proof of independent safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of a standalone performance evaluation with a test set, expert ground truth, or MRMC comparative effectiveness study.

Here's why, and what information is available:

• No Acceptance Criteria or Reported Device Performance (as requested): The document states that "Mechanical laboratory testing has been performed on the VasCon NeuroPath™ Guiding Catheter to assure compliance to the specifications." However, it does not specify what those "specifications" are, nor does it report the results of these tests against any defined acceptance criteria (e.g., minimum tensile strength, maximum kinking angle, etc.). The conclusion simply states the device is "safe and effective for its intended use" based on these tests and biocompatibility, as compared to predicate devices.
• No Sample Size for Test Set or Data Provenance: As there is no standalone performance study described, this information is not present.
• No Number of Experts or Qualifications for Ground Truth: No expert-derived ground truth is mentioned.
• No Adjudication Method: Not applicable as there's no expert review or ground truth establishment described.
• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study would involve human readers and their performance with and without AI assistance. The submission is for a physical medical device, not an AI or software device, so such a study would not be relevant or expected.
• No Standalone Performance Study (as requested): The submission relies on demonstrating substantial equivalence to predicate devices based on "non-clinical tests" (mechanical and biocompatibility testing) and "technological characteristics are equivalent to the predicate devices." A standalone performance study with a test set and defined performance metrics is not described.
• No Type of Ground Truth Used: Not applicable, as there's no clinical or expert-defined "ground truth" established for device performance. The "truth" here is compliance with engineering specifications and biocompatibility, which are confirmed through laboratory tests.
• No Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are relevant to AI/machine learning models. This submission is for a physical medical device (guiding catheter), not a software or AI device, so there is no training set mentioned or implied.

Summary based on the provided text:

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The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.

The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.

Here's an analysis of the provided information regarding acceptance criteria and device performance:

Unfortunately, the provided document does not contain the specific information required to complete the detailed table and answer most of the questions about acceptance criteria and the study that proves the device meets them.

The document is a 510(k) Summary for a medical device (VasCon Polaris™ Guiding Catheter) and the FDA's clearance letter. While it mentions "Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications," it does not elaborate on what those specifications (acceptance criteria) were, nor does it provide any specific performance data from the testing.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (VasCon Polaris™ Guiding Catheters, 510(k) K033633) based on similar technological characteristics and intended use, rather than a detailed performance study with explicit acceptance criteria and results.

Therefore, I cannot fill in the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.

Here's what I can provide based on the given text:

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

Summary of Device Performance (as stated in the document):

• Conclusion: "The testing as discussed above demonstrate that, like the predicate device, the VasCon Polaris™ Guiding Catheters are safe and effective for its intended use."
• Technological Characteristics: "The technological characteristics are equivalent to the predicate device."

Missing Information:

The document lacks the specific numerical acceptance criteria and the actual performance results from the laboratory testing. It states that testing was performed to assure compliance but does not detail the compliance itself.

Regarding the specific questions:

• 2. Sample sized used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external expert review or ground truth establishment is described for performance testing of this type of device in the provided text. Device performance is typically assessed by engineers/technicians in a lab setting against technical specifications.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this refers to clinical interpretation by experts, not laboratory testing of a guiding catheter.
• 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 device is a guiding catheter, 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 device is a guiding catheter, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For guiding catheters, "ground truth" would typically be derived from engineering specifications and physical measurements, rather than clinical consensus or pathology. The document only states "compliance to the specifications."
• 8. The sample size for the training set: Not applicable, as this refers to a machine learning context.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, while the document confirms that laboratory testing was performed and concluded the device is safe and effective and substantially equivalent to a predicate, it does not provide the detailed acceptance criteria or performance data of those tests.

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The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.

The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.

The provided 510(k) summary for the VasCon Polaris™ Guiding Catheter does not include information about specific acceptance criteria or an associated study conducted to prove the device meets these criteria in the context of AI/ML performance.

Instead, this submission is for a traditional medical device (a guiding catheter) and focuses on demonstrating substantial equivalence to a predicate device. The acceptance criteria and testing summary refer to engineering and biocompatibility tests, not studies related to AI/ML performance.

Therefore, I cannot populate the table or answer the subsequent questions related to AI/ML acceptance criteria and studies based on the provided text. The document clearly states:

• "Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications."
• "In addition, laboratory testing has been performed on the materials to assure biocompatibility."
• "The technological characteristics are equivalent to the predicate device."

This indicates a focus on physical, mechanical, and biological properties, and substantial equivalence to a pre-existing non-AI device.

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