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PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

Each PerQseal Introducer ('S', 'L', Elite 14F, and Elite 18F) includes an Introducer Sheath with a Dilator positioned within the lumen. The Introducer Sheath comprises a simple sheath that provides access to the site, while the Dilator is a component which guides the Introducer Sheath to the access site and provides a blood signal that is used to ensure proper positioning of the Introducer Sheath.

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The Introducer Sheath set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

The Introducer Sheath Set consists of a sheath and a dilator. The sheath is comprised of a sheath tube, a sheath hub, and a hemostatic valve. While the dilator comprises a dilator hub, a dilator tube and a rod cap. The sheath features a hydrophilic coating. Each set of products is equipped with a sheath and a dilator. The product is sterilized with ethylene oxide and is disposable.

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The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Introducer Kit is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion.

The Abiomed 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end and a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

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The Primero Safe Access System is intended to facilitate placing a catheter through the skin into a vein or artery. The introducer needle is used in facilitating entry through the skin into a vein or artery to provide a conduit for the guidewire. The guidewire is an accessory device which is used for placement of a catheter or sheath in the vein or artery.

The Primero Safe Access System (SAS) is a catheter introducer that facilitates a quick approach for placement of a guidewire during the introduction of a catheter for vascular access. The Primero SAS combines an introducer needle, guidewire, advancer, and storage tube into a single integrated device to promote ease of use and quick access by the healthcare provider. The introducer needle consists of an 18Ga stainless steel needle with an echogenic tip and terminates on the proximal end with a colored translucent standard female luer lock hub. The introducer needle has an enhanced echogenic tip, that has been slightly modified to incorporate a small bulb-like feature at the proximal end of the tip bevel to enhance ultrasonic visualization during vascular access. The introducer needle is secured to the advancer through a luer lock connector at the distal end of the advancer. The advancer is a light-weight polymer handpiece that allows the user to grip the entire setup while introducing the needle into the vessel and then advancing the guidewire through the needle by either 'thumb" or 'two-finger" advancing based on the preference of the user. A cutout in the advancer handpiece wire path exposes the guidewire and conveniently allows the user to advance the guidewire with their fingers without having to let go of the handpiece. An internal path within the handpiece feeds the guidewire from a storage tube into the introducer needle. The looped storage tube is connected to the proximal end of the advancer and holds a spooled pre-loaded guidewire ready for deployment. A back stop has been inserted into the tube at the proximal end to prevent a guidewire from being over-retracted from the advancer. The Primero SAS is pre-loaded with a commercially available guidewire (previously cleared under K142393) ready for deployment through the introducer needle once placed in the target vessel. The guidewire is comprised of an uncoated nitinol core wire that is tapered at the distal tip where a stainless-steel coil is secured over the full-length of the core. The South53 Primero Safe Access System (SAS) integrates all the necessary elements into a single device to complete the Seldinger technique as part of a vascular access procedure.

The Primero SAS is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used.

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The Pounce™ Sheath is intended to introduce therapeutic or diagnostic devices into the vasculature.

The Pounce™ Sheath 16Fr is a single-use, sterile introducer sheath intended for the introduction of therapeutic or diagnostic devices within the vasculature. The Pounce™ Sheath 16Fr includes the following features:

• Braided nitinol, self-expanding funnel at the sheath's distal end
• Handle assembly with slider button to actuate the funnel's deployment
• Hub and hemostasis valve assembly to allow for device introduction and removal
• Aspiration assembly including tubing, a stopcock, and connection for a 60 cc syringe

Additional components provided within the packaging include:

• 0.035" guidewire compatible pre-dilator for access site preparation
• 0.035" guidewire compatible dilator designed for atraumatic introduction of the sheath
• 60 cc locking syringe, compatible with the sheath's aspiration assembly

A radiopaque marker band is located at the distal tip of the sheath during introduction and removal, when the funnel is sheathed. When the funnel is unsheathed, the radiopaque marker band is located proximally to the funnel. The funnel is sheathed and unsheathed with the actuation of a slider button located on the handle assembly. The hemostasis valve can be actively defeated (opened), during device introduction or removal, by pressing down on the base of the surrounding hub. This action is designed to minimize device contact across the hemostatic valve during the introduction or removal of devices. The aspiration assembly also aids in the delivery of contrast or saline.

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The Vertex™ Catheter is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Jupiter Endovascular's Vertex™ Catheter is a single-use catheter consisting of a multilayer shaft, a hemostatic valve, and an included locking obturator ("dilator"). The effective length of the catheter is coated to improve lubricity. The handle of the catheter includes a flush line, a fixation line for fixation control, and a hemostatic valve. The catheter shaft and obturator bodies are radiopaque. The distal tip of the catheter has a non-radiopaque region that is no more than 5 mm in length. The device is packaged as sterile and is for single use only.

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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

Note: The specific numerical thresholds for "acceptable" rates of complications are not provided in the document. The "Pass" implies these rates were deemed acceptable by the FDA for clearance.

2. Sample Size and Data Provenance

• Test Set Sample Size: 39 adult patients.
• Data Provenance: The study was a "prospective, non-randomized, single-arm clinical study." The country of origin of the data is not specified in the provided summary. No information is given about a separate test set in the context of an AI/algorithm-driven device, as this is a physical medical device. The "test set" here refers to the clinical study cohort.

3. Number of Experts and Qualifications for Ground Truth

• This device is a physical medical device (catheter introducer), not an AI algorithm. Therefore, the concept of establishing ground truth by "experts" for a test set in the way it applies to diagnostic algorithms (e.g., radiologists labeling images) is not directly applicable.
• The "ground truth" for the device's performance was established by direct observation and confirmation during the clinical procedures (e.g., guidewire access confirmed by X-ray technique, measurement of bleeding for perforations). Clinical outcomes were assessed by the physicians and medical staff conducting the study. The qualifications of these physicians are not detailed but would be assumed to be interventional electrophysiologists or cardiologists performing these complex procedures.

4. Adjudication Method for the Test Set

• As this is a physical device efficacy and safety study, not an AI diagnostic study relying on subjective interpretations, formal "adjudication" in the sense of multiple expert readers is not described.
• The study followed ISO 14155, which specifies requirements for clinical investigations of medical devices for human subjects. This standard would include methods for objective assessment and reporting of outcomes, rather than subjective adjudication.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is specifically relevant for diagnostic AI tools that assist human readers in interpreting medical images or data. The PeriCross™ Epicardial Access Kit is a physical surgical access device.
• The study was a "comparative effectiveness" study in the sense that it compared the device's performance to a "historical control of a Touhy needle," but this comparison was clinical outcome-based, not an MRMC study comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This concept is applicable to diagnostic algorithms performing without human intervention. The PeriCross™ Epicardial Access Kit is a physical device used by a human operator.

7. Type of Ground Truth Used

• The ground truth used was clinical outcomes and objective measurements observed during the procedures.
  • Efficacy: Guidewire access confirmed by standard X-ray technique.
  • Safety: Presence and severity of cardiac perforations (quantified by bleeding volume, and whether surgery was required). This is essentially outcomes data directly observed during the procedure.

8. Sample Size for the Training Set

• This question is not applicable as the PeriCross™ Epicardial Access Kit is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established

• This question is not applicable for the same reason as above.

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