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The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set (herein referred to as Optima set), model 14000ES16, consists of a sheath, vessel dilator, introducer, and in-sheath dilator. The Optima set is available with inner sheath diameter of 16 French and is used to facilitate introduction and removal of compatible devices used with the Edwards transcatheter heart valve (THV) systems into/from the vasculature.

The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer jacket expands by stretching radially, temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing.

The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.

The 29mm loader (included with the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

The provided text is a 510(k) clearance letter for a medical device called the Edwards eSheath Optima Introducer Set. It outlines the regulatory process and asserts the device's substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that an AI/software device meets those criteria, as typically seen in AI/ML medical device submissions.

The document pertains to a physical medical device (catheter introducer) and its non-clinical performance testing. The "summary of non-clinical testing" section lists various engineering and biocompatibility tests performed on the device itself, not on an AI algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/software device.
2. Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or how training ground truth was established, because this information is not present in the provided document regarding an AI/software device.

The document is about a physical medical device and its non-clinical (engineering and biocompatibility) testing, not an AI/ML-based device.

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The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The modified AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements.

The modified AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bi-directional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.

The provided FDA 510(k) Clearance Letter for the AuST Steerable Sheath (K251051) does not describe an AI/Software as a Medical Device (SaMD). Instead, it describes a physical medical device – a catheter introducer sheath.

Therefore, many of the requested criteria related to AI/SaMD performance studies, such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission.

The clearance letter focuses on demonstrating substantial equivalence to a predicate physical device through engineering and performance testing rather than clinical effectiveness studies for an AI algorithm.

Here's an analysis based on the information provided for a physical medical device:

Acceptance Criteria and Device Performance for AuST Steerable Sheath (K251051)

Since this is a submission for a physical medical device (catheter introducer) and not an AI/SaMD, the "acceptance criteria" discussed are primarily related to general device safety and performance standards for such devices, demonstrating substantial equivalence to a predicate device. The study design described is engineering and bench testing, not a clinical trial involving patient data or expert interpretation of AI output.

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on ensuring the modified device meets established safety and performance benchmarks for catheter introducers and is substantially equivalent to its predicate. The "acceptance criteria" are implied by the successful completion of the listed tests.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "test units representative of finished devices" for engineering tests. For physical device performance testing, sample sizes are typically determined by statistical methods for engineering verification, but specific numbers are not provided in this summary.
• Data Provenance: The data is generated from in-vitro (bench) testing of the manufactured medical device components and finished product, adhering to recognized standards (e.g., ISO, ANSI/AAMI). Since it's a physical device, there's no "country of origin of data" in the sense of patient data, nor is it retrospective or prospective clinical data.

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

This criterion is not applicable for this physical device. Ground truth, in the context of an AI/SaMD, refers to accurate diagnostic labels or measurements. For a physical device, "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards. No human experts are described as establishing "ground truth" in this context.

4. Adjudication Method for the Test Set

This criterion is not applicable for this physical device. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or AI performance evaluations where expert disagreement on ground truth or interpretation needs resolution. For engineering testing, adherence to a test protocol and meeting predefined specifications are the primary "adjudication."

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

No, an MRMC study was not done. MRMC studies are specific to evaluating the diagnostic performance of imaging systems or AI algorithms, often comparing human readers with and without AI assistance to measure reader improvement (effect size). This is a physical device, and such a study is not relevant.

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

No, this is not applicable. This is a physical medical device. "Standalone performance" refers to the performance of an AI algorithm without human input, which is not relevant to a catheter introducer sheath.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is defined by:

• Engineering Specifications: The design parameters and performance characteristics that the device is designed to meet.
• Standard Test Methods: Validated methodologies (e.g., per ISO or AAMI standards) used to assess physical properties and performance (e.g., strength, leak resistance, dimensions, biocompatibility).
• Predicate Device Performance: The modified device is compared to a legally marketed predicate device (AuST Steerable Sheath, K242106), implying that the predicate's established performance serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This criterion is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical device, not an AI or software product.

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

This criterion is not applicable. As there is no AI component, there is no "training set" or ground truth establishment relevant to machine learning.

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The Merit Prelude Wave Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guidewires.

The Prelude Wave™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. The sheath tubing is coated with a hydrophilic coating. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The Prelude Wave™ Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guidewires. The Prelude Wave™ Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guidewire, metal access needle, access needle with inner metal needle and outer plastic cannula and SnapFix™ securement device.

The provided FDA 510(k) clearance letter and summary for the Prelude Wave Hydrophilic Sheath Introducer (K250909) do not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes for training and testing, expert qualifications, or detailed descriptions of ground truth establishment for an AI/ML medical device.

This document describes a traditional medical device (a catheter introducer), not an AI/ML-based device. Therefore, the types of studies and acceptance criteria typically associated with AI/ML device clearance (as outlined in your prompt questions) are not applicable here.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device (Prelude IDEAL Hydrophilic Sheath Introducer, K173750). This is a common pathway for traditional medical devices.
• Performance Testing: Verification and validation studies to ensure the device meets its specifications and performs as intended, based on established international standards (ISO 10555-1, EN ISO 11070, ISO 10993-1, ISO 14971). These tests are standard for physical medical devices and include mechanical, functional, and biocompatibility assessments.
• Design Changes: Highlighting minor design modifications from the predicate, such as sheath material, sheath/dilator tip fit, and inclusion of an adhesive fixation device.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device study parameters (like MRMC, standalone AI performance, expert labeling, training data) based on the provided text. The provided text simply does not contain this information because it's a submission for a physical medical device, not an AI software.

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The PeriCross™ Epicardial Access Kit is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies in adult patients.

The PeriCross™ Epicardial Access Kit is designed to provide safe and reliable access to the epicardium. The kit is supplied sterile and is designed to deliver a .018" guidewire to the pericardial space.

The PeriCross™ Epicardial Access Kit consists of the following components:

• One (1) PeriCross™ Tunneler Assembly
• One (1) PeriCross™ Access Device
• One (1) Guidewire – 0.018" OD × 80cm Long
• One (1) Coaxial Introducer – 5F × 18cm

The PeriCross™ Tunneler assembly consists of a cannula and a removable blunt obturator that, together, create an atraumatic assembly, which is utilized to gain access to the pericardium via the subxiphoid approach. When the tip of the PeriCross™ Tunneler Assembly reaches the pericardial surface, the obturator is removed, leaving a path to the pericardial surface through the open cannula. The PeriCross™ Access Device is inserted into the cannula and secured via a snap connection. The PeriCross™ Access Device incorporates a thumb slide that deploys tines to engage and retract the pericardium away from the surface of the epicardium. The space created allows for the deployment of an integrated 21ga needle to puncture the pericardium in a location away from the heart. The PeriCross™ Access Device prevents inadvertent deployment of the needle and retraction of the tines via an interlock mechanism. A .018" guidewire can then be deployed through the PeriCross™ Access Device. A 5F x 18cm coaxial introducer is provided to allow for subsequent dilation and guidewire exchange to a .032" guidewire.

The provided FCC 510(k) clearance letter and summary for the PeriCross™ Epicardial Access Kit discuss its design, comparison to predicate devices, and general non-clinical and clinical testing performed to demonstrate substantial equivalence. However, it does not contain the specific details required to fully address all aspects of acceptance criteria and the study that proves the device meets them as requested in the prompt.

Specifically, the document states:

• "The primary efficacy endpoint of achieving guidewire access to the pericardial space using the PeriCross Epicardial Access Kit, confirmed by standard X-ray technique, was achieved in all subjects."
• "There were two non-serious cardiac perforations (≤ 80 mL of bleeding) and one serious cardiac perforation (≥ 80 mL of bleeding), with no surgery required for closure."

This information is related to the outcome of the study, but it does not provide a table of acceptance criteria (e.g., minimum success rate, maximum complication rate) or explicitly state how these specific results meet predefined acceptance criteria. It also lacks details about the test set, ground truth experts, adjudication, MRMC studies, or training set specifics.

Therefore, I will provide a response based on the inference of typical medical device study reporting and what might be implied by the passing results, acknowledging the limitations of the provided text.

Acceptance Criteria and Study Proving Device Performance: PeriCross™ Epicardial Access Kit

Based on the provided 510(k) summary, the primary efficacy endpoint for the PeriCross™ Epicardial Access Kit was the successful achievement of guidewire access to the pericardial space. Safety endpoints related to cardiac perforations were also assessed. While explicit numerical acceptance criteria are not detailed in the provided document, the successful clearance implies that the study results met the FDA's requirements for demonstrating substantial equivalence and safety/efficacy.

Inferring from the "Pass" results and the successful clearance, the implied acceptance criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance

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The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set consists of a sheath, vessel dilator, introducer, and insheath dilator. The Edwards Optima introducer set is available with inner sheath diameter of 14 French (model 14000ES14). The Edwards eSheath Optima introducer set is used to facilitate introduction of the Edwards transcatheter heart valve systems into the vasculature.

The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer iacket expands by stretching radially. temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing.

The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.

The loader (included in the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

The provided document is an FDA 510(k) clearance letter and summary for the Edwards eSheath Optima introducer set. It demonstrates substantial equivalence to a predicate device based on non-clinical testing. However, it does not contain a detailed study meeting the specific criteria you've outlined, particularly for AI/algorithm performance. The information provided relates to the physical and functional performance of a medical device, not an AI or software component.

Therefore, I cannot extract the following information from the provided text:

• 1. A table of acceptance criteria and the reported device performance: While the document mentions various bench tests were "successfully completed" and "all design requirements were met," it does not provide specific quantitative acceptance criteria or detailed numerical results for each test.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as this is non-clinical bench testing of a physical device, not an AI or software study 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: Not applicable.
• 4. Adjudication method 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 device does not involve AI or human readers.
• 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: Not applicable in the context of AI/software performance. For a physical device, the "ground truth" would be the engineering specifications and established test methods.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

The document describes the Edwards eSheath Optima introducer set, a physical medical device.

Device Description:
The introducer set comprises a sheath, vessel dilator, introducer, and in-sheath dilator. It's designed to facilitate the introduction and removal of compatible devices used with Edwards transcatheter heart valves. Key features include an expandable inner member and outer jacket, a radiopaque marker, a hydrophilic coating, hemostatic seals, and an optional in-sheath dilator.

Non-Clinical Testing:
A list of bench tests was performed to demonstrate substantial equivalence to the predicate device and that all design requirements were met. These tests cover various physical and functional aspects of the device, including:

• Recovered Outer Diameter (OD)
• In-Sheath Dilator (ISD) Max Distal OD
• Tip OD
• ISD Insertion & Retrieval
• Tip Inner Diameter (ID)
• Sheath Insertion & Retrieval
• Sheath Working Length
• ISD Working Length
• Hemostasis
• Kink Radius
• Fishmouth
• Lubricity and Durability
• Bond Tensile Strengths (Sheath Housing to Shaft, Sheath Shaft to Tip, Flush Tube to Housing, Stopcock to Flush Tub, ISD Hub to Shaft)
• Transcatheter Heart Valve (THV)/Sheath Interaction
• Device Interaction
• Guidewire Compatibility
• Delivery System Insertion & Retrieval
• Crimped THV Retrieval
• Radiopacity
• Particulate Testing
• Sterilization Validation
• Biocompatibility (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity)

The document states that these tests were "successfully completed" and that "all design requirements were met," leading to the conclusion that the device is substantially equivalent to the predicate. However, it does not provide specific acceptance criteria values or the quantitative results from these tests.

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The ViaOne Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to deliver diagnostic and therapeutic interventions for ventricular tachycardia.

ViaOne Epicardial Access System is a sterile, single-use access tool consisting of a concealed needle within a leading channel to facilitate guidewire access into the pericardium through a subxiphoid incision. The device consists of a radiopaque distal tip designed to retract a portion of the pericardial tissue into the device, and away from the heart muscle, where it is punctured by the concealed needle and a guidewire is introduced into the pericardial space.

The provided text describes the 510(k) premarket notification for the ViaOne Epicardial Access System. However, it does not contain the detailed acceptance criteria and the specific study results in a format that would allow for a complete table of acceptance criteria and reported device performance.

The text generally states that the device "met the predetermined acceptance criteria" and "All tests were successfully completed and passed, and the device met the defined acceptance criteria." but does not quantify these criteria or results.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document lists performance tests but does not state the specific acceptance criteria (e.g., "tensile strength > X N") nor the quantitative results from those tests (e.g., "tensile strength Y N").

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

• Biocompatibility: Not specified.
• Sterilization, Packaging and Shelf Life Testing: Not specified.
• Performance Testing: Not specified for individual tests.
• Animal Study: Not specified (e.g., number and type of animals).
• Clinical Information: "multi-central clinical trial which included VT subjects." The exact number of subjects is not specified. Data provenance (country of origin, retrospective/prospective) explicitly is not specified, though "multi-central" implies a prospective clinical trial.

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 for any of the studies mentioned.

4. Adjudication method for the test set

This information is not provided for any of the studies mentioned.

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 is not applicable to this device. The ViaOne Epicardial Access System is an access tool, not an AI-powered diagnostic device.

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

A standalone performance study of an algorithm is not applicable to this device as it is a physical medical device, not an AI algorithm.

7. The type of ground truth used

• Biocompatibility: Established by ISO 10993-1 standards.
• Sterilization, Packaging and Shelf Life Testing: Established by ISO 11135-1 standards and internal performance criteria.
• Performance Testing: Established by internal design specifications and ISO 11070:2014 standards.
• Animal Study: Ground truth was based on observation of device performance, malfunction, and Histopathology evaluation and pathological examination.
• Clinical Information: Ground truth for adverse events would be clinical observation and diagnosis by medical professionals. Ground truth for pericardial space access success would be confirmed during the procedure.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this is a physical medical device.

Summary of available and missing information:

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The iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE™ Introducer Set is suitable for use in vessels > 5.5 mm diameter.

The iSLEEVE Expandable Introducer Set (iSLEEVE Introducer Set) is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of cardiovascular devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a three-way stopcock.

The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the working end of the iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.

A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

The provided text is related to a 510(k) premarket notification for a medical device called the "iSLEEVE Introducer Set." It describes the device, its intended use, and the regulatory process. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document focuses on regulatory approval based on substantial equivalence to a predicate device and mentions general categories of non-clinical performance data.

Therefore, I cannot provide the specific information requested in the format of a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided text.

The text does state:
"Testing demonstrated that the modified iSLEEVE Introducer Set met the previously established acceptance criteria."
And lists the types of non-clinical testing performed:

• Luer Connections
• Simulated Use Testing
• Dimensional Requirements
• Tensile Testing
• Packaging Testing
• Radiopacity
• Sterilization
• Usability

However, it does not provide the specific acceptance criteria values or the reported performance data against those criteria. It also doesn't contain the detailed study design elements you asked for, such as the number of experts, adjudication methods, or specific study types.

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The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wres, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.

The Introducer Sheath System devices consist of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface in length of 20cm on the distal portion.

The System consists of the following components:

• A One Introducer Sheath with hemostasis valve
• A One or two dilator(s)

The provided text describes a 510(k) premarket notification for a medical device called the Catapult Guide Sheath / Introducer Sheath System. It details the device, its intended use, comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the questions you've asked are typical for the evaluation of AI/ML-driven medical devices, especially related to diagnostic or classification tasks (e.g., image analysis for disease detection). The device described in the document (Catapult Guide Sheath) is a physical medical device (an introducer sheath system) used for physical introduction of interventional and diagnostic devices into the vasculature, not an AI/ML software device.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML device. Many of the questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are irrelevant to the type of device being reviewed in this FDA submission.

Here's why and what information is available:

• Type of Device: The Catapult Guide Sheath is a Class II physical medical device (introducer catheter). It's a tool, not a diagnostic or AI algorithm.
• Purpose of Submission (510(k)): This submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (Catapult Guide Sheath Introducer Sheath System, K240957). This is a common pathway for physical devices with modifications or new physical devices that are very similar to existing ones. The core of the substantial equivalence argument relies on demonstrating that the new device performs similarly to the predicate device, especially after a material change (insourced HVA).
• "Acceptance Criteria" for this device: For this type of device, "acceptance criteria" are related to mechanical performance, biocompatibility, sterilization, and shelf-life, ensuring the device functions as intended and is safe. These are detailed in Table 2, listing the tests performed and the applicable standards.
• "Study that proves the device meets the acceptance criteria": The document lists a series of non-clinical (laboratory) tests that were performed. These tests are the "study" demonstrating the device meets the performance requirements for substantial equivalence.

Therefore, I cannot fill out the detailed table and answer the specific questions about AI/ML device evaluation based on the provided text. The text focuses on the mechanical, material, and safety performance of a physical device, not the diagnostic or predictive performance of an AI algorithm.

If your intention was to ask about the evaluation of a physical medical device, I can re-frame the answer based on the provided document.

Assuming you are asking for information relevant to the physical medical device described, here's an attempt to interpret your questions in that context, recognizing that most are geared towards AI/ML:

Device: Catapult Guide Sheath / Introducer Sheath System

1. Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to meeting specifications derived from regulatory standards and predicate device performance. The "reported device performance" are the results of the listed tests that demonstrated compliance.

2. Sample Size for the Test Set and Data Provenance

For a physical device, "test set" refers to the number of units tested. The specific sample sizes for each mechanical test are not detailed in this summary (they would be in the full submission). The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer and external laboratories. It is not patient data, so "country of origin of the data," "retrospective or prospective" do not apply.

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

This question is not applicable. "Ground truth" in the context of AI/ML diagnostic devices refers to a definitive diagnosis or finding. For a physical device, the "ground truth" is established by the specifications and performance requirements derived from engineering principles and relevant ISO standards. No human experts are used to "establish ground truth" in this context; instead, engineers and technicians conduct specified physical and chemical tests.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" (e.g., consensus among readers) needed for a physical device's performance testing. Test results are quantitative measurements against defined criteria.

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

Not applicable. MRMC studies are for evaluating human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is not an AI diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm. Its "standalone performance" refers to its mechanical and material properties as tested in the lab.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for performance is defined by:

• International standards (ISO, AAMI, ASTM, EN): These standards define acceptable limits and testing methodologies for medical device properties (e.g., leakage, tensile strength, biocompatibility, sterility).
• Predicate device performance: The previously cleared predicate device provides a benchmark for expected performance characteristics of the new device.
• Manufacturer's internal design specifications and risk analysis: Derived from the intended use and safety considerations.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.

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

Not applicable. There is no "training set" or "ground truth" for training in the AI/ML sense for this device.

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The Agilis NxT Steerable Introducer Dual-Reach is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™™ is a sterile, single-use device that consists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. It has a sideport with a three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

This document is a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving the device meets specific acceptance criteria in the way a clinical trial would for an AI/algorithm-based product.

The information provided describes design verification activities for a hardware medical device (steerable introducer), not an AI algorithm. Therefore, many of the requested categories (e.g., sample size for test/training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable.

Here's an analysis based on the provided text, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective." However, specific numerical acceptance criteria and their corresponding reported device performance values are not detailed in this summary. The document lists the types of testing performed and the standards met.

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

This is not applicable as the document describes physical device testing, not an AI/algorithm-based test set with data provenance. "Test set" here refers to the physical devices subjected to various engineering and biological tests. The sample sizes for each specific test (e.g., number of devices for durability, sterility, or biocompatibility) are not provided in this summary, but would be part of the full design verification report.

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

Not applicable. "Ground truth" in the context of expert consensus is relevant for AI algorithms interpreting medical images or data. For a physical medical device like an introducer, "ground truth" is typically established by engineering specifications, validated test methods, and biological safety standards. Experts involved would be engineers, microbiologists, and other technical specialists relevant to the specific tests performed (e.g., biocompatibility specialist, sterilization expert).

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for reconciling differing expert opinions on ground truth for AI algorithms. For device performance testing, adjudication involves comparing test results against predefined acceptance criteria from engineering specifications and regulatory standards.

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 hardware device (catheter introducer), not an AI system 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 hardware device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering specifications, international and national standards (e.g., ISO, ANSI AAMI listed), and regulatory requirements for mechanical performance, material compatibility, biocompatibility, and sterility. For example, for biocompatibility, the ground truth is that the materials do not elicit an adverse biological response as defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This refers to AI/machine learning models.

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

Not applicable. This refers to AI/machine learning models.

Summary of Study Type:

The study referenced is a series of non-clinical design verification activities and laboratory tests. These tests were conducted to demonstrate that the modifications made to the Agilis NxT Steerable Introducer Dual-Reach™ (the subject device) did not adversely affect its safety and effectiveness and that it continues to meet established performance, biological safety, and sterility standards, making it substantially equivalent to its predicate device. This is typical for a 510(k) submission for a modified hardware device.

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