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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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CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.

The MassTRANSIT is a single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic and therapeutic agents. The shaft tapers from 3.0F proximal to 2.8F distally. The catheter has a hydrophilic coating to provide lubrication for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices.

The provided text describes a 510(k) premarket notification for the CES MassTRANSIT Infusion Catheter, focusing on its substantial equivalence to predicate devices rather than specific performance studies with acceptance criteria for device accuracy or effectiveness.

Therefore, many of the requested elements for describing "the acceptance criteria and the study that proves the device meets the acceptance criteria" are not explicitly available in the provided document. This document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

• Acceptance Criteria: The document mentions "acceptance criteria stipulated in the test protocols" for biocompatibility. For the overall device, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices.
• Reported Device Performance: The document states:
  • "All appropriate biocompatibility tests have been performed according to the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). The catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria stipulated in the test protocols."
  • "The CES MassTRANSIT Infusion Catheter is similar in its basic design, construction, indication for use and performance characteristics to the predicate devices."

Table (based on available information):

Missing Information (not detailed in this 510(k) Summary):

The document does not provide specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, resolution, throughput, etc.) with corresponding acceptance criteria usually associated with studies designed to prove performance for a novel device. As a 510(k) claiming substantial equivalence, such detailed performance studies with quantifiable acceptance criteria are often not required if the device is sufficiently similar to existing legally marketed devices.

Regarding your specific questions (2-9):

Since this is a 510(k) submission focused on substantial equivalence rather than a de novo clinical or performance study for a novel device, the following points are largely not applicable or not extractable from the provided text:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as there are no detailed performance studies on a "test set" described for this device. Biocompatibility tests were performed, but details on sample size or data provenance for these are not provided in this summary.
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" in the context of device performance studies (like for diagnostic AI) is not relevant here.
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. This device is an infusion catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

In summary:

The document serves as a regulatory notification for a medical device (infusion catheter) achieving market clearance through the 510(k) pathway by demonstrating substantial equivalence to already approved predicate devices. It relies on a comparison to existing devices and performance of standard biocompatibility tests, rather than presenting a novel clinical study with detailed performance metrics and acceptance criteria as might be seen for entirely new device types, especially in areas like diagnostics or AI.

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CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or to provide support to facilitate the placement of guidewires.

The CES Infusion Catheters contain a single lumen and a variable stiffness shaft in order to traverse and deliver agents to the coronary, peripheral and neurovasculatures. The outside of the shaft includes a hydrophilic coating and the lumen is lined with PTFE in order to increase lubricity and trackability. The proximal shaft is reinforced with a stainless steel braid to enhance pushability.

The provided text describes a medical device (CES Infusion Catheters) and its clearance through the FDA 510(k) pathway. This pathway establishes substantial equivalence to existing predicate devices, rather than proving device performance against specific, pre-defined acceptance criteria through a dedicated study.

Therefore, the information required to answer your questions regarding acceptance criteria, study details, and ground truth establishment is not available in this document.

Here's a breakdown of why this information is missing based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

   • The document states: "Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."
   • This explicitly indicates that there are no formal performance (acceptance) criteria set by the FDA for this device type at the time of clearance. The clearance is based on substantial equivalence to predicate devices, implying similar safety and effectiveness without needing to meet new, specific performance metrics.
   • The document's "Biocompatibility" section states "All applicable biocompatibility tests were successfully performed on the CES Infusion Catheters." While this indicates successful testing, the specific acceptance criteria for these tests (e.g., cytotoxicity levels, irritation scores) are not detailed, nor are the quantitative results.

2. Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set):

   • The 510(k) pathway typically relies on comparison to existing predicate devices and may involve bench testing, animal studies, or limited human clinical data if necessary to demonstrate equivalence. It does not inherently require a prospective clinical study with a control group, expert adjudication, or formal ground truth establishment in the manner of a novel device approval that needs to prove efficacy against specific endpoints.
   • The document only mentions "Biocompatibility" tests. It does not describe any other studies that would generate the kind of performance data (e.g., sensitivity, specificity, accuracy) typically associated with AI/algorithm performance.
   • There is no mention of a test set, training set, experts, or ground truth in the context of device performance.

In summary, the provided document is a 510(k) clearance letter and associated summary information, which focuses on establishing "substantial equivalence" of a medical device to existing predicate devices. It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies) that would be present for a clinical trial or an AI/software device performance study proving efficacy against defined endpoints.

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