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The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for a device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

The document states that the TRUFILL DCS ORBIT™ Detachable Coil and associated syringes have been found substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. However, it does not provide the specific performance data or the study design used to demonstrate this equivalence.

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The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:

Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.

This document describes the 510(k) premarket notification for the TRUPUSH® Coil Pusher, a component of the TRUFILL® Vascular Occlusion System. The submission aims to demonstrate substantial equivalence to a predicate device, focusing on process changes, packaging changes, and manufacturing site transfer.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed with quantitative targets in the provided document. Instead, the "Design Verification Testing" and "Design Validation Testing" sections list the types of tests performed. The implication is that the device met the inherent acceptance criteria for each test to support substantial equivalence. Without specific numerical thresholds, we can only infer that the performance was deemed acceptable for regulatory clearance.

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

The document does not explicitly state the sample sizes used for each of the "Design Verification Testing" or "Design Validation Testing" items. It also does not specify the provenance of the data (e.g., country of origin).

The document mentions "in-vitro and in-vivo testing." In-vitro testing typically refers to tests conducted in a controlled environment, such as a lab bench, using bench models or simulators. In-vivo testing often involves animal models or human subjects. Given the context of a 510(k) for a device like a coil pusher, in-vivo testing likely refers to animal studies to simulate real-world use conditions, as human clinical trials are typically not required for 510(k) unless there are significant performance or safety questions not addressed by bench testing or animal studies. The text does not specify sample sizes or details of these studies.

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

This information is not applicable and not provided in the document. The studies conducted are engineering and performance tests (e.g., dimensional measurements, mechanical strength, pushability, retractability, package integrity), not diagnostic or interpretative tasks requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective engineering and performance measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret medical images, and the AI's impact on their performance is assessed. The TRUPUSH® Coil Pusher is a physical medical device, not an AI or diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study (in the context of an algorithm's performance) was not done. The device is a physical medical instrument, not an algorithm. The "standalone" performance here refers to the physical device's function as designed, which is what the design verification and validation tests aim to assess.

7. Type of Ground Truth Used

The "ground truth" for the tests described are engineering specifications, measurement standards, and functional performance requirements for mechanical and material properties, as well as operational characteristics like pushability and retractability. For example, the ground truth for "Total Product Length" would be the engineering drawing's specified length with its permissible tolerance range. The ground truth for "Seal Integrity Test (Dye Penetration)" would be the absence of dye penetration under specified conditions.

8. Sample Size for the Training Set

This information is not applicable. The TRUPUSH® Coil Pusher is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for a machine learning model.

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The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.

The Cordis Neurovascular, Inc. HYPERTRANSIT™ Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.

The information provided describes the HYPERTRANSIT™ Infusion Catheter and its testing for substantial equivalence to a predicate device. This submission focuses on in-vitro testing to address design changes for improved kink resistance. It does not describe a study involving human readers, AI, or expert ground truth in the way a diagnostic AI device would.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document, as it pertains to a physical medical device and its mechanical performance testing.

Here's the breakdown of the available information:

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

The document lists the types of in-vitro tests conducted but does not provide specific acceptance criteria or quantitative performance results for each test. Instead, it states that these tests were conducted "to support substantial equivalence to the predicate device, addressing the design changes made to improve kink resistance at the distal end of the strain relief." The conclusion is that the proposed device is "similar in its basic design, construction, indication for use, and performance characteristics to the predicate HYPERTRANSIT™ Infusion Catheter."

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

Not applicable. The study involved in-vitro testing of a physical medical device, not a diagnostic algorithm with a test set of 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)

Not applicable. Ground truth as typically understood for diagnostic AI devices (e.g., expert consensus on medical images) is not relevant to this in-vitro mechanical device testing.

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

Not applicable. No expert adjudication process is described for this in-vitro mechanical device testing.

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 a study involving human readers or AI assistance.

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

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

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

For the in-vitro tests, the "ground truth" would be established by objective physical measurements and adherence to engineering specifications and performance characteristics demonstrating equivalency to the predicate device. The document implies compliance with these standards through the conducted tests.

8. The sample size for the training set

Not applicable. This is not a machine learning model; therefore, there is no training set.

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

Not applicable. There is no training set mentioned.

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The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils.

The provided document describes the TRUFILL® DCS Syringe II, an artificial embolization device, and its substantial equivalence to a predicate device. The information details the performance and safety testing, as well as design validation, conducted to demonstrate its safety and effectiveness.

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 are implied by the "Performance and Safety Testing" and "Design Validation Testing" conducted. The reported device performance is that these tests were conducted and the device performed as intended and met specifications.

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

The document does not specify the sample sizes used for each specific test or the data provenance (e.g., country of origin of the data, retrospective or prospective). It generally states that "in-vitro laboratory performance testing" and "in-vitro testing" were conducted.

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

This information is not provided in the document. The studies described are in-vitro laboratory tests, which typically rely on measurement instruments and adherence to technical specifications rather than human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided. Given the nature of in-vitro engineering and performance testing, there's no mention of human adjudication methods like 2+1 or 3+1.

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

No, an MRMC comparative effectiveness study was not done. The studies described are in-vitro performance and design validation tests of the device itself, not studies comparing human reader performance with or without AI assistance.

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

The device is a physical medical instrument (a syringe) used to manipulate medical coils. It does not involve an "algorithm" or "AI" in the context of image analysis or diagnostic support. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The tests performed are standalone in the sense that they assess the device's technical specifications and functionality independent of a human operator, but it's not an AI or algorithm.

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

The ground truth for the in-vitro tests would have been established by engineering specifications, validated measurement techniques, and established industry standards for device performance, material compatibility, and sterile processing. For example, gauge accuracy would be compared against a known standard, and dimensional verification against engineering drawings.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical medical device like the TRUFILL® DCS Syringe II.

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The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing certain intracranial ancurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:

very high-risk for management by traditional operative techniques l )

inoperable 2)

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulac of the neurovasculature.

The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details for the Trufil! DCS Orbit Detachable Coil System Line Extension. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use. It does not include data from performance studies or clinical trials that would provide the specific information requested about acceptance criteria and how they were met.

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The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.

The Cordis Neurovascular, Inc. HYPERTRANSIT Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.

The provided 510(k) summary describes a medical device, the HYPERTRANSIT™ Infusion Catheter, and its substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a standalone study with specific performance metrics.

Instead, the document details comparative and performance testing to demonstrate safety and effectiveness and substantial equivalence to existing devices already on the market. It does not present acceptance criteria with target performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or available in this document.

However, I can extract information related to the types of testing conducted and the basis for substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This section is adapted as the document focuses on equivalence and performance testing rather than acceptance criteria for an AI/driven device's diagnostic performance. The "Acceptance Criteria" here are implicitly meeting performance benchmarks comparable to predicate devices and acceptable safety profiles. "Reported Device Performance" refers to the successful completion of these tests as implied by the FDA's clearance.

Not Applicable / Not Provided Information for AI/ML Device Study:

The following information is not present in the given document because the device (HYPERTRANSIT™ Infusion Catheter) is a physical medical device, not an AI/ML software or algorithm requiring diagnostic performance metrics.

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

• Not Applicable. This document describes testing for a physical catheter, not an AI/ML algorithm that uses a test set of data. The "test set" would refer to the catheters themselves undergoing various physical and functional tests.

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

• Not Applicable. Ground truth, in the context of AI/ML, refers to a label or diagnosis established by experts for a dataset. For a physical device, testing involves measuring physical properties or observing performance in simulated/animal environments, not expert labeling of data.

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

• Not Applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI/ML ground truth. This is not relevant for testing a physical instrument.

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 specific to AI/ML devices that aim to assist human readers in tasks like image interpretation. This device is a catheter.

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

• Not Applicable. This refers to the performance of an AI algorithm in isolation. The HYPERTRANSIT™ Infusion Catheter is a physical device used by clinicians.

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

• Not Applicable. For the physical device, "ground truth" is established by engineering specifications, validated test methods (e.g., for flow rate, burst pressure), and clinical/biological observations in animal studies.

8. The sample size for the training set

• Not Applicable. Training sets are used for machine learning. This document describes the development and testing of a physical medical device.

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

• Not Applicable. As there is no AI/ML training set, the concept of establishing ground truth for it is irrelevant in this context.

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The TRUFILL® DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:

1. very high-risk for management by traditional operative techniques
2. inoperable

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

Not Found

Here's a breakdown of the requested information, assuming the provided text relates to a medical device approval and not an AI-driven diagnostic or treatment tool. The document is an FDA 510(k) clearance letter for a TRUFILL DCS ORBIT™ Detachable Coil System. Therefore, the acceptance criteria and study described will pertain to the safety and effectiveness of this physical device, not an AI's performance.

Based on the provided text, there is no information related to an AI/Machine Learning device or its performance criteria, studies, or ground truth establishment. The document is a standard FDA 510(k) clearance letter for a physical medical device (detachable coil system) and its indications for use.

Therefore, many of the specific questions regarding AI performance criteria, test sets, ground truth, experts, and MRMC studies are not applicable to this document. The information that can be extracted relates to the device itself and the regulatory process.

Re-interpretation of "Acceptance Criteria" for a Physical Medical Device 510(k):

For a 510(k) clearance, the "acceptance criteria" are not reported as specific performance metrics in the same way an AI algorithm's accuracy would be. Instead, acceptance criteria are generally met by demonstrating substantial equivalence to a previously legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. This demonstration typically relies on bench testing, biocompatibility testing, sterilization validation, and potentially limited clinical data, all compared against established standards and the predicate's performance.

Based on the provided document, here's what can be inferred and what aspects are not present:

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

• Acceptance Criteria (Implicit for 510(k) Submission):
  • Demonstrate substantial equivalence in intended use, technological characteristics, and performance to a predicate device.
  • Safety and effectiveness comparable to the predicate.
  • Compliance with relevant performance standards and regulations (e.g., biocompatibility, sterility, mechanical integrity).
• Reported Device Performance:
  • The document states that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "reported performance" from a regulatory standpoint—it meets the criteria for market clearance.
  • Specific quantitative performance metrics (e.g., rates of successful embolization, complication rates) are NOT detailed in this letter. These would typically be found in the actual 510(k) submission, including summaries of non-clinical and, if applicable, clinical testing.

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

• Not explicitly stated in this document. For a 510(k), test sets would likely include:
  • Bench Testing: Often involves hundreds or thousands of cycles for mechanical durability, often dozens of samples for burst pressure, tensile strength, etc. The sample size depends on the specific test and statistical justification.
  • Biocompatibility Testing: Typically uses a small number of samples, following ISO 10993 guidelines.
  • Limited Clinical Data (if any): While not always required for 510(k), if clinical data were submitted, the sample size would vary.
• Data Provenance: Not stated. For a 510(k), data provenance would typically be from the manufacturer's internal testing labs, contract research organizations (CROs), or possibly clinical sites (if clinical data was part of the submission).

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

• N/A (Not Applicable to this type of device and document). Ground truth, in the context of an AI device, implies an independent, verified determination that the AI is trying to predict. For a medical device like an embolization coil, the "ground truth" for its safety and effectiveness is established through validated scientific and engineering tests, and potentially clinical outcomes, rather than expert consensus on an interpretation task like with AI.
• Experts involved would be those conducting the bench tests (engineers, materials scientists) and potentially clinicians for any clinical studies (neurointerventionalists, neurosurgeons). Their qualifications would be expertise in their respective fields, but they wouldn't be "establishing ground truth" for an AI.

4. Adjudication method for the test set

• N/A (Not Applicable). Adjudication methods (like 2+1, 3+1) are common in clinical trials or for establishing ground truth from expert readings (e.g., for AI training/testing data). This document does not describe such a process for the coil system's testing. Testing for a physical device typically follows pre-defined protocols and acceptance limits without "adjudication" in this sense.

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

• N/A (Not Applicable). This document refers to a physical embolization device, not an AI system that assists human readers. Therefore, an MRMC study and effects of AI assistance are irrelevant to this FDA clearance.

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

• N/A (Not Applicable). This is a physical medical device, not an algorithm.

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

• N/A (Not Applicable in the AI sense). For a physical device, "ground truth" for safety and effectiveness is established by:
  • Bench Testing Standards: e.g., device integrity under stress, embolization effectiveness in a simulated vessel model.
  • Biocompatibility Data: Demonstrating non-toxicity, non-immunogenicity.
  • Sterilization Validation: Proving the device is sterile.
  • Clinical Outcomes Data (if applicable for 510(k), or more extensively for PMA): Patient outcomes (e.g., aneurysm occlusion rates, complication rates, long-term stability) would be the ultimate "ground truth" for effectiveness and safety. However, the 510(k) pathway often relies heavily on non-clinical data and comparison to a predicate, not always requiring extensive new clinical trials.

8. The sample size for the training set

• N/A (Not Applicable). This device is not an AI algorithm, so there is no "training set."

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

• N/A (Not Applicable). As there's no AI, there's no training set or ground truth in this context.

In summary: The provided document is an FDA 510(k) clearance letter for a physical medical device, the TRUFILL DCS ORBIT™ Detachable Coil System. It confirms the device's substantial equivalence to a predicate, allowing it to be marketed. The concepts of AI acceptance criteria, training/test sets, ground truth, experts for AI evaluation, and MRMC studies are not relevant to this document.

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The TRUFILL DCS ORBIT™ Detachable Coil is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: very high risk for management by traditional operative techniques, or, 1. inoperable, 2. and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

The TRUFILL DCS ORBIT™ Detachable Coil System is comprised of the TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe.

• The TRUFILL DCS ORBIT™ Detachable Coil consists of a delivery system . (delivery tube and coil introducer) and an embolic coil. The delivery tube segment comprises the body of the device and has the combined functionality of a guidewire and a mini infusion catheter. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the infusion catheter. The embolic coil is the implantable segment of the device.
• The TRUFILL® DCS Syringe is used to generate a controlled pressure for . preparation and detachment of the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube. The gauge faceplate is calibrated for three settings for use with the TRUFILL® family of Detachable Coils.

The provided text is a 510(k) summary for the TRUFILL DCS ORBIT™ Detachable Coil System. It details the device's intended use, comparison to a predicate device, and summaries of non-clinical performance data.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in a format applicable to AI/ML device evaluations. The document describes a traditional medical device submission for substantial equivalence based on in-vitro and animal testing and comparison to a predicate device, not an AI/ML algorithm.

Therefore, I cannot populate the requested table and information points. The information about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this type of submission.

The document discusses "Performance Standards" but states "There are no performance standards applicable under Section 514 of the Food, Drug and Cosmetic Act for Artificial Embolization Devices." This further indicates that the requested type of acceptance criteria and performance study (as would be typical for AI/ML) is not a component of this submission.

In summary, this document is not a study proving an AI/ML device meets acceptance criteria, but rather a 510(k) summary for a physical medical device.

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The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .018" and smaller for PROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10 and 14, depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.

The provided document describes a medical device, the PROWLER® SELECT™ Infusion Catheter, and its safety and effectiveness summary for a 510(k) submission. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based device.

The document discusses "Design verification testing" for the PROWLER® SELECT™ PLUS Infusion Catheters. This type of testing is standard for medical devices like catheters to ensure physical characteristics and performance align with design specifications. The tests listed are entirely related to the physical properties and functionality of the catheter itself, not to an algorithm's performance.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them based on the provided text. The document is for a physical medical device, not an AI or algorithmic device.

However, I can extract the information about the device verification testing that was performed for this specific catheter system:

Summary of Device Verification Testing (Not AI-related Acceptance Criteria)

Regarding the other requested points (for an AI/algorithmic device):

The provided text does not contain any of the following information because it pertains to a physical medical device (catheter) and not an AI or algorithmic system:

• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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