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The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

The provided 510(k) clearance letter pertains to a Micro Catheter and describes its performance and testing to demonstrate substantial equivalence to a predicate device. This document does not discuss an AI/ML powered device, nor does it present data from a study involving human readers or the establishment of ground truth for AI model training or testing. Therefore, I cannot address most of your specific questions related to AI device evaluation.

However, I can extract the acceptance criteria and performance data for the Micro Catheter based on the provided text.

Acceptance Criteria and Device Performance for Micro Catheter

The document describes the testing performed on the Micro Catheter to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are implied by the "Results" column in the tables, indicating whether the device met the required performance standards for each test.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for a medical device like a micro catheter focuses on engineering and biocompatibility performance rather than AI-specific metrics. The "acceptance criteria" are implicitly met if the "Results" indicate compliance, comparability to a predicate, or "met the acceptance criteria."

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The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.

The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.

The provided text describes a 510(k) premarket notification for the XO Cath Microcatheter, demonstrating its substantial equivalence to a predicate device. It is a medical device, specifically a microcatheter, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing conducted to demonstrate its functional equivalence to the legally marketed predicate device, rather than a clinical study or AI model validation study.

Here's a breakdown of the requested information based on the provided text, focusing on the device performance testing rather than a software algorithm or AI model:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met pre-determined acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test or the specific numerical results for the XO Cath Microcatheter. Instead, it relies on a comparative analysis to the predicate device.

Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)

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The Peregrine System™ Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.

The Peregrine System Infusion Catheter is a continuous flush catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 3-7 mm in diameter and is compatible with guide catheters of at least 7F.

This document is a 510(k) summary from the FDA for the Peregrine System™ Infusion Catheter. It does not describe a study involving AI or a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it detail acceptance criteria related to algorithmic performance.

Instead, this document details the substantial equivalence of a medical device (a catheter) to a previously cleared predicate device. The acceptance criteria and performance data discussed are related to the physical and functional properties of the catheter, not the performance of an AI algorithm in diagnosing or detecting conditions.

Therefore, I cannot extract the information required by your prompt, as the provided text pertains to a traditional medical device clearance, not an AI-based system. The prompt's questions (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are relevant to the evaluation of AI/ML-driven medical devices, which is not the subject of this FDA clearance letter.

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ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

The subject device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (or ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe) is intended for the delivery of FDA-approved sclerosant Asclera® in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

The ScleroSafe device includes a 5 Fr dual lumen catheter ("DLC"), mountable on a 0.018 inch straight-tipped guidewire in an over-the-wire configuration. The DLC is connected to a hub that splits the catheter into two separate tubes. One of the tubes ends with a blue luer lock for the aspiration extension and the other with a transparent luer lock for the injection. Following needle insertion into the guidewire is removed and a Dual Procedure Syringe ("DPS") is connected to the DLC hub via dedicated luers. The larger syringe (10 ml) is connected to blue luer lock connector (Aspiration Extension) of the smaller syringe (5 ml) is connected to a transparent luer lock connector of the catheter (Injection Extension) so fluids are simultaneously injected through one lumen and aspirated through another lumen. ScleroSafe is provided in two sizes: 150mm and 350mm.

The provided text describes a medical device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm, and its premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons, rather than providing specific acceptance criteria and a detailed study report for a novel AI/ML device.

Therefore, many of the requested elements for AI/ML device evaluation (like MRMC studies, expert adjudication for ground truth of an AI model, training set size, etc.) are not present in this document as it pertains to a different type of medical device (a physical catheter/syringe system).

However, I can extract information related to the device's performance based on the clinical study part mentioned, even though it's not strictly "acceptance criteria" in the AI/ML sense, but rather a performance outcome from a human-in-the-loop clinical use evaluation.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent.

Device: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe)

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" in a table format for the clinical performance. Instead, it describes subjective outcomes for safety and efficacy in a clinical study.

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

• Sample Size: 20 patients
• Data Provenance:
  • Country of Origin: Germany
  • Retrospective or Prospective: Retrospective (The company retrospectively evaluated the subject device in 20 ScleroSafe procedures that were performed in 20 patients in Germany between January and June 2019).

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

• This information is not provided in the text. The clinical study describes outcomes (vein obliteration, recurrence, adverse events) which would have been assessed by treating physicians and follow-up clinicians, but the specific number and qualifications of independent experts establishing a "ground truth" for a test set are not mentioned, as this is not an AI/ML study involving image interpretation.

4. Adjudication method for the test set:

• This information is not provided. As it's a clinical follow-up rather than multi-reader image interpretation, formal adjudication methods like 2+1 or 3+1 are typically not described in this context for human clinical assessment.

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 performed. This device is not an AI/ML diagnostic or assistive tool, but a physical medical device.

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

• No. This is not an AI/ML algorithm. The performance described is of the physical device used by clinicians.

7. The type of ground truth used:

• The "ground truth" in this context refers to the clinical outcomes and assessments by healthcare professionals.
  • Obliteration/Recurrence: Assessed by "duplex check at follow up session." This implies sonographic assessment.
  • Safety: Clinical observation and assessment of adverse events by treating staff.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a training set. The clinical study described served as a performance evaluation.

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

• Not applicable. (See point 8).

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The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The TriSalus® TriNav® LV Infusion System is a 0.025" lumen microcatheter, a self-expanding tip at the distal end. The TriNav® LV serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires with outer diameter up to 0.018" (0.46 mm), guiding catheters with inner diameter at least 0.048" (1.22 mm), embolic hydrogel particles 500 um or less in size and glass microspheres 110 um or less in size. The TriNav® LV has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels 3.0 mm to 5.0 mm in diameter. An optional, commercially available hemostasis valve (HV) is included. There are two radiopaque markers located at the distal end of the TriNav® LV device to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The TriSalus® TriNav® LV Infusion System is provided sterile (EtO) for single patient use.

The TriSalus® TriNav® LV Infusion System is explicitly stated as not having undergone clinical testing to demonstrate substantial equivalence. Instead, the submission relies on animal and bench performance test data. Therefore, the request for details on acceptance criteria and study proving the device meets them in the context of human clinical performance cannot be fully answered from the provided text.

However, based on the provided text, we can describe the performance testing conducted and the general acceptance criteria used:

The document states that the TriSalus® TriNav® LV Infusion System meets the same performance specifications and acceptance criteria as the predicate device. This implies that the acceptance criteria are tied to demonstrating equivalence or non-inferiority to the predicate device across various performance aspects.

Here's an attempt to extract relevant information based on the provided text, focusing on the type of studies conducted and what constitutes "performance" in this context for the device's clearance:

Device Performance Study (Bench and Animal Testing for Substantial Equivalence)

The performance of the TriSalus® TriNav® LV Infusion System was demonstrated through a series of bench testing and an animal study to show substantial equivalence to a predicate device (Surefire Spark Infusion System (rebranded as TriNav) K180677).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "meets the same performance specifications" and "acceptable/comparable" to the predicate device.
Since this document is a 510(k) summary, specific numerical acceptance thresholds and detailed performance results are not typically disclosed. However, the categories of performance evaluated are provided.

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

• Test Set (Bench Testing): Not specified.
• Test Set (Animal Study): Not specified. The text only states "An animal study was performed."
• Data Provenance: Not specified, but generally, bench testing would be conducted in a lab and animal studies in a vivarium. The studies are prospective in nature for device validation.

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

• Bench Testing: Not applicable in the context of human expert ground truth.
• Animal Study: The study assessed performance "as defined by physicians in a simulated clinical environment." The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

• Not specified. This is less relevant for bench and animal studies compared to human reader studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was NOT done. The document explicitly states: "No clinical testing was required to demonstrate the substantial equivalence of the subject device to its predicates. Therefore, no pre-market clinical testing was performed nor is any included within this 510(k) submission."

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

• Not applicable as this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications, material standards, and comparisons against predicate device performance data (presumably internal data or published specifications for the predicate).
• Animal Study: Direct observation by "physicians" in a "simulated clinical environment" and relevant biological/physiological measurements. The "ground truth" for success was defined by "defined user needs" and "comparability to the predicate device."

8. The Sample Size for the Training Set

• Not applicable as this is a physical medical device, not a machine learning model.

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

• Not applicable.

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The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils.

The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro Catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each microcatheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous vasculature.

The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.

Here's a summary of the acceptance criteria and the study details for the Wallaby 017 Micro Catheter, based on the provided document.

It's important to note that the document describes a medical device rather than an AI/ML powered device. Therefore, many of the typical questions for AI studies (like sample size for test/training sets, ground truth methodology with experts, adjudication, or MRMC studies) are not applicable here. The "performance" being evaluated is the physical and functional performance of the catheter itself, not the performance of an algorithm.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on passing various bench tests and biocompatibility evaluations. The full "acceptance criteria" are implied by "met all pre-defined acceptance criteria" for each test. Specific numerical thresholds for each criterion are not provided in this summary but would have been defined in detailed test protocols.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Applicable for a medical device cleared via 510(k))

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

   • The document does not specify exact sample sizes (N-values) for each bench test. For example, "The device was evaluated..." doesn't indicate if this was one unit or multiple units.
   • The data provenance is from non-clinical bench testing performed by Wallaby Medical for regulatory submission in the United States (as indicated by the FDA 510(k) process). It is prospective in the sense that the testing was conducted specifically to support this regulatory submission.
   • No human-collected test sets (like medical images) are involved, so country of origin of data in that sense is not applicable.

2. 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 as this is a physical medical device, not an AI/ML algorithm. "Ground truth" for physical device performance is established through standardized engineering and biological tests against predefined specifications and industry standards (e.g., ISO standards).
   • For the "Physician Validation (Usability)" test, it states "The device was evaluated in a simulated anatomy model by physicians." The number and qualifications of these physicians are not detailed in this summary.

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

   • Not applicable. This concept pertains to expert review for AI/ML algorithm performance. For physical device testing, results are typically objective measurements or observations against predefined pass/fail criteria.

4. 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 non-AI medical device without human "readers" in the context of an AI study.

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

   • Not applicable. The device itself is standalone in the sense that it is a physical product, but the concept of "standalone algorithm performance" does not apply.

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

   • "Ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ISO 10555-1, ISO 594-1, ISO 11135:2014, ISO 10993 series, USP ), and comparison to legally marketed predicate devices. The results of the bench tests and biocompatibility evaluations, when conforming to these standards and specifications, are the "ground truth" for proving the device's safety and effectiveness.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML model for which to define a training set.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI/ML model or training set.

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The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the wire device placement. The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Mechanical thrombectomy is achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

The provided text describes a 510(k) submission for a device modification to the Cleaner Plus™ Thrombectomy System. This is a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm-only) performance," and "ground truth for the test and training set," are not applicable.

The submission focuses on demonstrating the substantial equivalence of a modified device to a predicate device through non-clinical performance testing.

Here's the relevant information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Test results demonstrate that all acceptance criteria were met." However, the specific acceptance criteria values are not detailed in the provided text. The types of tests performed indicate the areas for which acceptance criteria would have been established.

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

The document does not specify the sample sizes for the individual tests. The tests were non-clinical (laboratory/bench testing), so data provenance from countries or whether it was retrospective/prospective is not applicable in the typical sense.

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

Not applicable, as this is a medical device performance study, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. Adjudication methods are typically for clinical studies or studies involving expert interpretation, not for bench testing of device components.

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 medical device, not an AI/ML system.

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

Not applicable. This is a medical device, not an AI/ML system.

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

The documentation did not specify a "ground truth" in the context of clinical or diagnostic outcomes. For performance testing of a physical device, the "ground truth" would be established physical measurements and material properties relevant to the device's function and safety (e.g., tensile strength, torque, aspiration volume, biocompatibility assays).

8. The sample size for the training set

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

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

Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set with established ground truth.

Summary of Study Type:

The study described is a non-clinical verification testing of a medical device modification to support substantial equivalence to a predicate device. The tests included various engineering performance tests (e.g., corrosion, tensile, torque, fatigue, simulated use) and biocompatibility assessments. Clinical and animal testing were not required for this determination of substantial equivalence.

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The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

The Maestro Microcatheter is available in working length sizes 110cm, 130cm, 150cm, 165cm and 175cm lengths. The distal tip of the microcatheter is offered in straight or pre-shaped 45 degree and swan neck configurations. The proximal end of the catheter consists of a molded winged hub with a tapered strain relief. The outer surface of the distal 80cm of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the catheter into the vasculature. The microcatheter incorporates a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The Maestro Microcatheter is offered with two 3ml syringes.

This document is a 510(k) premarket notification for the Maestro Microcatheter and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing conducted to support this claim, but it does not detail a study involving AI or human readers, or provide specific acceptance criteria and reported device performance in the manner typically seen for AI/CADe devices.

Therefore, many of the requested sections about AI/CADe study design cannot be answered from the provided text.

Here is the information that can be extracted or inferred from the document regarding acceptance criteria and performance, as appropriate for a medical device cleared via 510(k) demonstrating equivalence:

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

The document does not explicitly present a table of acceptance criteria alongside reported performance for each specific test in numerical detail as would be expected for an AI system's metrics (e.g., sensitivity, specificity, AUC). Instead, it broadly states that the conducted tests met "predetermined acceptance criteria."

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

This document describes bench and design validation testing, not a clinical study involving a "test set" of patient data. Therefore, the concepts of sample size for a test set, data provenance, and retrospective/prospective do not apply in the context of this 510(k) submission.

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, as this is bench and design validation testing for a physical medical device, not a diagnostic AI system requiring expert-established ground truth.

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

Not applicable for the reason stated above.

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 submission is for a microcatheter, not an AI or CADe device. No MRMC study was conducted.

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)

For the bench and design validation tests, the "ground truth" implicitly refers to physical measurements, engineering specifications, and established limits defined by relevant standards (e.g., ISO 10555-1) and internal product requirements. The tests assessed characteristics like effective length, tensile force, leakage, pushability, trackability, etc., against predefined pass/fail criteria.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device submission.

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

Not applicable. No training set is involved.

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The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.

This document, a 510(k) Summary, describes the Vericor Support Catheter and its substantial equivalence to a predicate device. This is a medical device, not an AI/ML product, so the questions regarding AI/ML clinical studies are not applicable.

Here's the breakdown of the acceptance criteria and the study (non-clinical) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) Summary details numerous non-clinical tests. The column "Test Method Summary" indirectly describes the acceptance criteria by outlining what the test aims to demonstrate (e.g., "To demonstrate that the device meets the corrosion resistance"). The "Results and Conclusion" column reports that the device met these criteria.

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

The document does not explicitly state the sample sizes for each non-clinical test. It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not applicable in terms of country of origin or retrospective/prospective for these non-clinical, laboratory-based tests. The tests were performed on the Vericor Support Catheter itself.

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

This is not applicable as the studies are non-clinical, laboratory-based performance tests, not studies involving human interpretation or clinical data. Ground truth in this context is established by adherence to specified standards and measurement techniques.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and adherence to established standards, not expert adjudication of subjective interpretations.

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 conventional medical device (support catheter), not an AI/ML diagnostic or assistive device.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For these non-clinical tests, the "ground truth" is defined by the objective criteria within the referenced international and national standards (e.g., ISO 10993, ISO 10555-1, ASTM standards, USP). Performance is measured against these established technical specifications and benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

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

Not applicable. This device does not involve a training set.

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The MAGIC Flow-Dependent Microcatheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified embolization materials and diagnostic materials such as contrast media.

The MAGIC Flow-Dependent Microcatheter is designed with progressive suppleness and a rigid proximal shaft to allow control and navigability in the vascular system. By their diameter and progressive suppleness features, these catheters are specifically designed for catheterization of small diameter, sinuous distal vessels.

The catheter body and its distal tip (ring) are radiopaque to provide visibility under fluoroscopy. The MAGIC Flow-Dependent Microcatheter has an external hydrophilic coating which provides a lubricious surface during use.

A coated mandrel is included inside the MAGIC Flow-Dependent Microcatheter to provide support during product preparation and insertion through the guide catheter.

The MAGIC Flow-Dependent Microcatheter and accompanying support mandrel are provided sterile, nonpyrogenic, and intended for single use only.

The provided document is a 510(k) Pre-market Notification for the MAGIC Flow-Dependent Microcatheter (K213435). This document does NOT contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. Instead, it details a comparison between the subject device and predicate/reference devices to establish substantial equivalence.

The "acceptance criteria" and "device performance" mentioned in the document relate to bench testing done to demonstrate the subject device's ability to deliver embolic materials. This is not for software performance but for the physical device's function. No AI/ML component is mentioned in the device description or testing.

Therefore, I cannot provide the requested information for an AI/ML device study.

However, based on the provided document, here is the information related to the physical device's performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

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

• Sample Size: Not specified in the document. The description only states "The subject device was evaluated..."
• Data Provenance: The test was non-clinical bench testing, meaning it was conducted in a laboratory setting, not with patient data.

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. For physical device bench testing, "ground truth" is typically established by engineering specifications and direct physical measurement/observation against those specifications, not by expert consensus in diagnostic interpretation.

4. Adjudication method for the test set:

Not applicable. The testing was a direct performance evaluation against predefined criteria, not an interpretive task requiring adjudication.

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 (microcatheter), not an AI/ML algorithm that assists human readers.

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

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

7. The type of ground truth used:

For the bench testing, the "ground truth" would be the successful delivery of embolic materials as defined by engineering and performance specifications in the tortuous anatomical model.

8. The sample size for the training set:

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

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

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

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