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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 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 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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Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/ Stent Sets (GEPD, GPDS, GPSO, GPSOS); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF); Endoscopic pancreatic stent placement is used for pancreatic drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, disrupted duct, fistula/pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.

Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS): Endoscopic pancreatic stent placement for pancreatic drainage of obstructed ducts that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, and disrupted duct.

Pushing Catheter and Guiding Catheter (GC, PC): These devices are indicated for use with biliary and pancreatic stents for the following indications. For endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction and benign or malignant strictures. For endoscopic pancreatic stent placement for pancreatic duct drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreatic fluid collection, pancreatic stones, disrupted duct, fistula / pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.

The intended use of all Cook pancreatic stents and sets is to drain pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems.

The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.

These Cook pancreatic stents and sets are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

The provided document (K233079) describes the Cook Ireland Ltd. Zimmon and Geenen Pancreatic Stents/Stent sets, Johlin Pancreatic Wedge Stent and Introducer Set, and Pushing and Guiding Catheters. This submission is for medical devices, not an AI/ML powered device, therefore, the information requested in the prompt related to acceptance criteria and studies that prove the device meets these criteria is not applicable in the context of AI/ML performance.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Pancreatic Stents & Sets cleared under K172057) through comparisons of technological characteristics and non-clinical performance data. There is no mention of acceptance criteria related to AI/ML device performance metrics like sensitivity, specificity, or AUC, nor any studies involving test sets, ground truth established by experts, or human reader performance with or without AI assistance.

The performance data mentioned in the document are:

• Biocompatibility evaluation: Conducted in accordance with ISO 10993-1: 2018 and FDA's biocompatibility guidance.
• Performance testing: Included simulated use, dimensional and visual testing, tensile strength testing, MRI conditional testing, radiopacity, flow rate, and shelf-life testing.

These tests aim to ensure the physical and material integrity, safety, and functionality of the pancreatic stents and catheters.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided text.

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The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038-inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

The Micropuncture® Pedal Access Set is intended to introduce up to an 0.038" wire guide into the peripheral vasculature. It is also used to introduce diagnostic and/or interventional devices able to pass through the ID of the introducer.

The Micropuncture® Introducer Sets and Micropuncture® Pedal Access Sets are utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are composed of either a 4.0 French or a 5.0 French outer sheath and a 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, a 0.018 inch mandrel with a distal coil tip, and (optionally) a Check-Flo® Hemostasis valve, a Tuohy-Borst Sidearm Adapter, and a wire guide inserter. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.

The provided document is a 510(k) summary for the Micropuncture® Introducer Sets and Micropuncture® Pedal Access Sets. It details the device description, indications for use, and a comparison to predicate devices, focusing on materials, methods of construction, principles of operation, and basic technological characteristics.

However, the questions you've asked pertain to acceptance criteria and study data for a software or AI-powered medical device. The document describes a physical medical device (catheter introducer) and its performance testing (tensile strength, liquid leakage, Luer performance, etc.), but it does not include any information about a study proving the device meets acceptance criteria related to a software or AI-driven diagnostic or assistive function, nor does it mention anything related to human readers, experts establishing ground truth, or adjudication methods for diagnostic output.

Therefore, I cannot answer most of your specific questions based on the provided text. The document refers to the acceptance criteria being met for various physical and mechanical tests, but these are not related to AI or diagnostic accuracy studies.

Here's a breakdown of what I can glean from the document in relation to your questions, and what I cannot:

What I Can Answer (Limited to the scope of this hardware device):

• 1. A table of acceptance criteria and the reported device performance:
  • The document states that for all listed tests ("Tensile," "Liquid Leakage," "Luer Performance Testing," "Non-Rotating Hub Cap Summative Evaluation"), the "predetermined acceptance criteria for all studies were met."
  • It does not provide the specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) or the exact reported performance values. It only states that the products passed.

What I Cannot Answer / Is Not Applicable (as it pertains to AI/Software studies):

• 2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device testing. The "test set" here refers to physical units of the device being tested, not a dataset for an AI model.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device is based on physical/mechanical engineering standards and validation. The "Expert Review" mentioned under "Validation" for the "Non-Rotating Hub Cap Summative Evaluation" is likely an engineering or usability review, not a diagnostic image review by radiologists.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, this was not done as it's a physical device, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, ground truth is based on engineering specifications, material properties, and performance standards (e.g., ISO 11070, ISO 80369-7).
• 8. The sample size for the training set: Not applicable, as this is not an AI model.
• 9. How the ground truth for the training set was established: Not applicable, as this is not an AI model.

In summary, the provided document details the regulatory clearance for a physical medical device. It successfully demonstrates that the device meets its design input requirements through various engineering and performance tests, but it does not contain the kind of information about AI model validation or human-in-the-loop studies that your questions are looking for.

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The 14F 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 14F 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 14F 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 coatinq 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.

This is a submission for a medical device (14F iSLEEVE™ Introducer Set) and therefore doesn't involve AI/ML. The provided text describes a 510(k) submission for a non-AI medical device, focusing on its substantial equivalence to a predicate device based on physical and mechanical properties. Therefore, most of your requested information (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types) is not applicable to this document.

However, I can extract information related to the device's performance testing given the provided text:

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

The rest of the requested information is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML algorithm.

Here's why the other points are not applicable:

• 2. Sample size used for the test set and the data provenance: This relates to data for AI/ML validation, not physical device testing. The "test set" here refers to physical devices, not data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device. Ground truth is usually established through engineering specifications and physical measurements.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are for AI-assisted image interpretation, not physical devices.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Standalone" in this context refers to the device itself, which performs its function physically, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical devices, ground truth often comes from engineering specifications, material properties, and in vitro/in vivo measurements that are compared against predefined performance limits. For this specific submission, the "ground truth" for the tensile strength test would be the engineering specification for how much force the sheath-to-hub connection must withstand.
• 8. The sample size for the training set: Not applicable as there is no AI/ML algorithm to train.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA clearance document pertains to a physical introducer set, and the "study that proves the device meets the acceptance criteria" refers to non-clinical performance data, specifically mechanical testing, rather than studies involving AI/ML performance metrics.

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The 14F 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 14F 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 14F 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 describes a 510(k) premarket notification for a medical device, the 14F iSLEEVE Introducer Set. It focuses on demonstrating substantial equivalence to a predicate device, specifically after a modification involving an alternative hydrophilic coating.

However, the document does not contain the level of detail typically found in a clinical study report or a robust performance study for an AI/ML medical device, which would include the specific acceptance criteria tables, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, and MRMC study details.

The provided information pertains to the acceptance criteria and study that proves the device meets the acceptance criteria for a medical device with a coating change, not an AI/ML algorithm.

Based on the provided text, here is an attempt to address your questions, while highlighting the limitations due to the nature of the document:

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

The document mentions that "Testing demonstrated that the modified 14F iSLEEVE Introducer Set met all previously established acceptance criteria." However, it does not provide a specific table of acceptance criteria with corresponding performance numbers. It lists the types of non-clinical tests performed:

Note: The "Reported Performance (Implied)" column is based on the statement "Testing demonstrated that the modified 14F iSLEEVE Introducer Set met all previously established acceptance criteria" and "Results confirm that the modified device remains biocompatible for its intended use." Specific quantitative results are not provided in this summary.

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

• Test Set Sample Size: Not explicitly stated for each non-clinical test. The document refers to "the modified device" meeting criteria. For the animal study, it mentions a "double-blinded animal study" in the "porcine model," implying a sample size of animals, but the exact number of animals or devices tested is not provided.
• Data Provenance:
  • Non-clinical testing: Performed internally by the manufacturer (Boston Scientific Corporation). The location of the testing is not specified, but it's presumed to be in a controlled laboratory environment.
  • Animal Study: Conducted in a "porcine model." No information on the country of origin or whether it was retrospective or prospective is given, though animal studies for device testing are typically prospective.

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

• Non-clinical tests: Ground truth is established by standard engineering and biocompatibility testing methodologies and validated equipment, not typically by human experts in the same way as medical image analysis.
• Animal Study: "Physicians were asked to separately evaluate the performance of the insertion and removal of the predicate and alternative hydrophilic coated device."
  • Number of experts: Not specified (e.g., "physicians" could be one or multiple).
  • Qualifications of experts: Only identified as "Physicians." No details on their specialty, experience level, or specific training are provided.

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

• Non-clinical tests: Not applicable in the context of human expert adjudication.
• Animal Study: The phrase "Physicians were asked to separately evaluate" suggests individual assessments, but it does not specify an adjudication method (e.g., consensus, majority vote) if multiple physicians were involved. It implies a comparative evaluation between the modified and predicate device's performance characteristics during insertion and removal.

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 MRMC study was performed. This document describes the testing for a physical medical device (introducer sheath) with a coating change, not an AI/ML algorithm. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

• Not applicable. This relates to a physical medical device, not an AI/ML algorithm.

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

• Non-clinical tests: Ground truth is established through physical measurements, chemical analyses, and standardized biological assays, adhering to relevant standards (e.g., ISO 10993-1 for biocompatibility).
• Animal Study: Ground truth was based on the "functional performance" assessed by "physicians" during the insertion and removal of the devices in the porcine model. This would involve qualitative and potentially some quantitative assessment of ease of use, resistance, and other performance characteristics directly observed during the procedure. It's a form of expert observation/assessment in a simulated use environment.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm. It is a manufactured physical good, and as such, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal development and verification.

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

• Not applicable. See point 8.

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

The 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end 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 14 Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14 Fr 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.

This document describes the FDA's 510(k) clearance for the Abiomed 14Fr Low Profile Introducer Set. The information provided heavily focuses on the comparison to predicate devices and performance testing. However, it does not explicitly state acceptance criteria in a quantitative format, nor does it detail a clinical study with human patients, as the clearance was based on bench testing and substantial equivalence to predicate devices.

Let's break down the available information based on your request:

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

The document broadly states that the device "met the acceptance criteria," but it does not specify what those criteria are in a numerical or categorical table format for each test. Instead, it lists the types of tests performed.

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

• Sample Size for Test Set: Not specified for each individual bench test. The document mentions "Performance testing (bench) was completed," but doesn't detail the number of units tested for each specific test.
• Data Provenance: The document does not specify the country of origin of the data. The study was a retrospective evaluation based on bench testing, as it states "No clinical data were required to demonstrate substantial equivalence."

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 as there was no test set involving human data or expert review to establish ground truth in the traditional sense for medical imaging or diagnostic devices. The acceptance was based on engineering and biocompatibility bench testing.

4. Adjudication method for the test set:

• Not applicable. There was no human-reviewed test set requiring adjudication in the context of this 510(k) submission.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data were required to demonstrate substantial equivalence." This type of study would involve human readers and clinical cases, which was not part of this clearance process.

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

• Not applicable. This device is a physical medical introducer set, not an AI algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The performance evaluated was the device's physical and functional attributes through bench testing.

7. The type of ground truth used:

• The "ground truth" for this device's performance was established via engineering specifications, material science standards, and biocompatibility standards (e.g., ISO 10993-1). For example, "leak testing" would have a pre-defined maximum allowable leak rate as its ground truth, based on engineering requirements for a safe and effective introducer.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As stated above, there is no "training set" for this type of device.

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Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the femoral artery while minimizing blood loss during interventional procedures.

Radial Artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wres, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.

The Introducer Set is supplied with an introducer sheath, a dilator, a guidewire and an access needle. These devices will be manufactured in 5.0, 6.0, 7.0, and 8.0 French and in lengths of 5, 7 and 11 centimeters. The sets are compatible with the supplied 0.018", 0.021" guidewire and 21G needle in length of 7cm. The sets are supplied sterile and intended for single use.

The sheath shaft and hub are manufactured of Fluorinated ethylene propylene and copolyester; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.

The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.

Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.

The provided text describes a 510(k) submission for the INT Introducer Set. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving performance against specific acceptance criteria for AI or diagnostic accuracy, which is what your request implies.

Therefore, many of the requested categories related to AI performance, expert ground truth, multi-reader studies, and training sets are not applicable to this type of device and document.

Below is a breakdown of the available information based on your request, with an explanation of why certain categories are not applicable.

Acceptance Criteria and Study Details for INT Introducer Set

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like an introducer set, "acceptance criteria" are typically defined by engineering specifications and relevant ISO/ASTM standards, rather than diagnostic performance metrics. The "reported device performance" is the result of testing against these engineering criteria.

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of devices) used for each individual bench or biocompatibility test. It lists the tests performed, implying that appropriate sample sizes were used according to the referenced standards.
Data provenance is for the device being submitted (INT Introducer Set), manufactured by Shanghai Kindly Medical Instruments Co., Ltd. The studies are non-clinical (bench and lab-based biocompatibility studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical medical instrument (introducer set), not an AI/diagnostic software. "Ground truth" in this context refers to objective measurements and adherence to engineering and biocompatibility standards, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or AI output review. This document describes bench and biocompatibility testing of a physical device.

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
This question is not applicable. This is a physical medical device, not an AI or imaging diagnostic software that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's performance is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) for physical and material properties, sterility, and biocompatibility. The tests performed are designed to objectively measure these properties against predefined specifications from these standards.

8. The sample size for the training set
This question is not applicable. There is no AI component or algorithms that require a training set for this device.

9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.

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The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.

The iSLEEVE Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of compatible transcatheter heart valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a threeway 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 entire iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.

The provided text is a 510(k) summary for the Boston Scientific iSLEEVE Introducer Set. It focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. Since this is a medical device, the acceptance criteria and study that proves the device meets the acceptance criteria are based on non-clinical performance (bench testing), as explicitly stated in the document.

The document does not describe:

• A table of acceptance criteria and reported device performance with specific numerical values beyond meeting general criteria for physical integrity, functionality, and performance.
• Sample sizes used for a "test set" in the context of an AI/human reader study.
• Data provenance, number of experts, adjudication methods, or MRMC studies, as these relate to AI/image-based diagnostic devices, not a catheter introducer.
• Standalone algorithm performance or details about training sets for an AI.
• Types of ground truth in a clinical sense (e.g., pathology), as the device's performance is assessed through bench tests.

Based on the provided text, here is the information that can be extracted, and where applicable, why certain information (relevant to an AI or diagnostic device) is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a quantitative table of acceptance criteria with specific numerical performance values. Instead, it broadly states the categories of performance assessed through bench testing.

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

• Sample Size: Not specified in terms of a "test set" as would be relevant for an AI or diagnostic study. Performance was evaluated via bench testing, which typically involves a specified number of physical units, but this specific number is not provided in this 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data for a "test set" as this is bench testing of a physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. Ground truth for a physical catheter introducer is established by engineering specifications, material properties, and physical testing protocols, not by expert clinical review of images or data.

4. Adjudication Method for the Test Set

• Not applicable, as this refers to a process for resolving discrepancies in expert labeling or diagnoses for clinical data, which is not relevant for bench testing of this device.

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

• No, an MRMC study was not done. The document explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the iSLEEVE Introducer Set." MRMC studies are typically performed for diagnostic devices (e.g., AI in radiology) to assess changes in human reader performance with and without AI assistance.

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

• Not applicable. This device is a physical catheter introducer, not an algorithm. Standalone performance refers to the performance of an AI algorithm on its own, which is irrelevant here.

7. The Type of Ground Truth Used

• Engineering Specifications and Benchmarking: The ground truth for this device's performance is established by pre-defined engineering specifications, functional requirements, and comparison to the performance of the predicate device (K191871) under controlled bench test conditions. For example, "dimensional requirements" means the device must meet specific size tolerances, which is a quantitative ground truth. "Visibility under fluoroscopy" would be assessed against a defined standard or observation.

8. The Sample Size for the Training Set

• Not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence to a predicate, primarily through non-clinical bench testing.

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

• Not applicable. As there is no training set for an algorithm, there is no "ground truth" to establish for it in this context. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for medical devices.

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