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The PROWLER SELECT LP ES Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER XS Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER SELECT LP ES and PROWLER XS Microcatheters have a 3-zone construction that enables smoother transitions to enhance the stability of the microcatheter. The microcatheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. The maximum outer diameter of a guidewire that is allowed inside the subject microcatheter is 0.014 in.

The proximal shaft is reinforced with a stainless-steel braid to aid in pushability. The distal shafts are reinforced with a Platinum/Tungsten coil to provide flexibility. To provide lubricity, the distal 30 cm of the catheter is coated with a hydrophilic coating.

This document is a 510(k) clearance letter for medical microcatheters (PROWLER SELECT LP ES Microcatheter and PROWLER XS Microcatheter). It focuses on demonstrating substantial equivalence to existing predicate devices, not on proving device performance against specific de novo clinical performance acceptance criteria.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not present in this type of FDA submission.

Here's why and what can be inferred:

• Substantial Equivalence (510(k)) vs. De Novo Clearance/PMA:

  • A 510(k) submission, like this one, aims to show that a new device is as safe and effective as a legally marketed predicate device. This often relies on design comparisons, bench testing (non-clinical performance), and sometimes clinical data if there are new indications or significant technological differences that raise new questions of safety and effectiveness.
  • The prompt's questions are typically relevant for novel devices seeking de novo classification or high-risk devices requiring a Premarket Approval (PMA) application, where the device must prove its safety and effectiveness against defined clinical endpoints and acceptance criteria. This usually involves robust clinical trials, often with AI-based devices needing specific performance metrics like AUC, sensitivity, specificity, and comparison to human performance (MRMC studies).

• What this document does state regarding "performance":

  • Non-Clinical Performance Testing (Section VII): "No new testing was conducted to support the minor changes subject to this submission, because all relevant testing has been previously submitted to and reviewed by the FDA." This means the manufacturer relied on existing data, presumably from the original clearance of the predicate device or prior versions. They emphasize that minor design changes "do not raise different questions of safety and effectiveness."
  • Clinical Performance Data (Section VIII): "No clinical studies were required to support the minor changes." This explicitly states that clinical trials (which would involve human participants, test sets, ground truth establishment, etc.) were not necessary for this specific submission.
  • Ground Truth: The concept of "ground truth" as it pertains to AI/diagnostic performance (expert consensus, pathology, outcomes data) is not applicable here because this is a physical medical device (microcatheter) and the submission doesn't involve an AI component or complex diagnostic performance evaluation. The "ground truth" for a microcatheter's performance is typically established through engineering bench testing (e.g., burst pressure, material integrity, flexibility, guidewire compatibility) and often in vivo animal studies or ex vivo models for more complex functional aspects like navigability, not human clinical consensus on images or diagnoses.

In summary, based on the provided document:

• Acceptance Criteria Table: Not applicable. The "acceptance" is substantial equivalence to a predicate device, demonstrated through non-clinical data already on file. Performance criteria would be engineering specifications (e.g., burst pressure, tensile strength, lubricity), but these specific values are not detailed in this public summary.
• Study that proves the device meets acceptance criteria: The document states "No new testing was conducted" and "No clinical studies were required." The "proof" relies on the existing non-clinical data for the predicate and the manufacturer's assertion that minor changes do not impact safety or effectiveness.
• Sample size for test set / Data provenance: Not applicable for a typical clinical trial. Non-clinical testing would have sample sizes for different mechanical tests, but these are not disclosed.
• Number of experts / Qualifications / Adjudication: Not applicable, as no human expert review for establishing ground truth on a diagnostic test set was performed or required.
• MRMC comparative effectiveness study: No.
• Standalone performance: No.
• Type of ground truth used: Not applicable in the context of diagnostic performance. For physical device performance, ground truth would be established through engineering metrology and standardized test methods.
• Training set sample size / Ground truth for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring training data.

This 510(k) clearance is for a conventional medical device, not an AI/ML device or one requiring de novo clinical validation against complex diagnostic endpoints.

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The PROWLER SELECT PLUS Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER EX Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER SELECT PLUS Microcatheter and PROWLER EX Microcatheter are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal sections of the catheter bodies are radiopaque to aid visualization under fluoroscopy, and the distal tips are clearly distinguished by a radiopaque marker.

The provided FDA 510(k) summary (K210838) is for a medical device, specifically a microcatheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The document does not describe studies proving an AI/ML powered device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria, performance tables, sample sizes, expert involvement, or MRMC studies from the provided text, as those concepts are not applicable to the device described (a physical microcatheter).

The document details performance testing for this physical device as follows:

Acceptance Criteria and Device Performance (Not applicable to AI/ML):

The document describes non-clinical performance testing for the PROWLER SELECT PLUS Microcatheter and PROWLER EX Microcatheter. The acceptance criteria are implicit in the "Test Method Summary" and the "Results" sections.

Regarding the specific questions asked for an AI/ML device:

1. A table of acceptance criteria and the reported device performance: Provided above for the physical device.
2. Sample sized used for the test set and the data provenance: Not explicitly stated (e.g., number of microcatheters tested in "test sample microcatheters" or "all tested baseline and aged samples"). The data is from non-clinical bench testing, not patient data (so no country of origin, retrospective/prospective information).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical microcatheter's performance is based on direct measurement and observation of physical properties and simulated use, not expert interpretation of AI output.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is a physical medical device, not an AI-powered diagnostic/analytic tool.
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.): Ground truth for this device is based on established engineering specifications, physical testing standards, and direct observation of mechanical performance (e.g., successful delivery, particle generation counts, burst pressure measurements).
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

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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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The PROWLER® SELECT™ Infusion Catheters 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 and 14 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 .014" and smaller 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PROWLER® SELECT™ Infusion Catheters.

It's important to note that this document is a 510(k) Premarket Notification, which primarily demonstrates substantial equivalence to a legally marketed predicate device. This type of submission relies heavily on non-clinical performance data and often does not involve the extensive clinical trials or human reader studies typically associated with novel AI-powered diagnostic devices.

The information provided describes a medical device (infusion catheters), not an AI/ML-powered diagnostic device. Therefore, many of the requested categories related to AI/ML device studies (like MRMC efficacy, expert-established ground truth for AI, standalone algorithm performance, training set details) are not applicable to this document.

Acceptance Criteria and Study for PROWLER® SELECT™ Infusion Catheters

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantified, pass/fail manner for each test. Instead, it states that "Design verification testing showed that the PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips performed as intended" and "No new questions of safety and effectiveness were raised." This implies that the tests were performed and the results met the design specifications and internal performance requirements, which constitute the implicit acceptance criteria for such a device. These are primarily engineering and mechanical performance tests.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of units) used for each design verification test. It refers generally to "Design verification testing."
• Data Provenance: The tests are described as "Design verification testing," which refers to in-house laboratory testing conducted by the manufacturer (Cordis Neurovascular, Inc.). This is retrospective data collected during the device's design and development phase for regulatory submission. There is no indication of country of origin for the data other than the manufacturer's location in Miami Lakes, Florida, USA.

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

• Not Applicable. This is a physical medical device (catheter), and the "ground truth" for its performance is established through engineering specifications, validated test methods, and industry standards, not by expert consensus on clinical data or images. The "experts" involved would be the design engineers, quality control personnel, and potentially materials scientists from Cordis Neurovascular, Inc.

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are non-clinical engineering and materials performance tests, there is no adjudication process involving multiple human evaluators or a consensus process in the sense of clinical decision-making. The results are based on objective measurements against pre-defined specifications.

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

• No. An MRMC study is not relevant to the evaluation of a physical medical device like an infusion catheter, as it is designed to assess the performance of diagnostic devices or algorithms with human readers.

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

• No. This is not an algorithm or AI-powered device, so standalone algorithm performance testing is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., for biocompatibility, material properties, and mechanical performance). It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense. The ultimate "ground truth" for a 510(k) submission is substantial equivalence to a predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set." Device design and manufacturing processes are refined through iterative development and testing, rather than machine learning training.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Prowler Plus Infusion Catheters 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 Plus is 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. The catheter body is radiopaque with a distinguishable marker 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 text describes the Prowler Plus Infusion Catheter and its summary of safety and effectiveness, including a statement of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria with numerical targets, nor does it detail a study with reported device performance against such criteria in the format typically used for medical device efficacy or AI performance evaluation. The information provided is for a traditional medical device (catheter), not an AI/ML-enabled device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from the given document, as these pertain to studies typically conducted for AI/ML device validation.

Based on the provided text, here's what can be extracted:

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

The document does not explicitly state numerical acceptance criteria. Instead, it states that "Design verification testing showed that the Prowler Plus Infusion Catheter performs as well or better than the predicate devices tested." This implies an equivalence or non-inferiority standard, but specific numerical targets are not provided. The performance is described qualitatively as meeting this standard.

The design verification tests included:

• Pull Strength Test
• Trackability Test
• Dimensional Testing (Tip OD, ID, Body OD, Joint OD, Length Assembly, Hub Taper)
• Static Burst Pressure Test
• Alternative Flow Rate Calculation
• Air Aspiration
• Linear Stiffness Test (Boink)
• Shapeability Test

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. The "Summary of Studies" only lists the types of tests performed.

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 applicable and not provided. The device is a physical catheter, and its performance is evaluated through engineering design verification tests, not clinical studies requiring expert ground truth or AI/ML model evaluation.

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

This information is not applicable and not provided. It relates to studies typically conducted for AI/ML device validation.

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

An MRMC study was not done, as this is a physical medical device (catheter), not an AI/ML system.

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

A standalone performance study a it is a physical medical device (catheter), not an AI/ML system.

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

Not applicable. The "ground truth" for a physical device like a catheter is the engineering specification and performance standards derived from predicate devices, verified through physical and mechanical testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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To offer to the consuming public, an electric 3-wheel scooter, that is reliable, safe and affordable.

ADI 3-wheel scooter

I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a 3-wheel scooter. It does not contain any information about acceptance criteria, device performance, study details, expert qualifications, or ground truth related to a medical device or AI system.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

The indication for use is: "To offer to the consuming public, an electric 3-wheel scooter, that is reliable, safe and affordable."

Therefore, this document does not contain the type of information needed to answer your questions about acceptance criteria and a study proving device performance as it pertains to a diagnostic or AI-driven medical device.

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