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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 Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years.

The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021.

The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm.

The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990).

The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.

This document is a 510(k) premarket notification for a medical device called the "Super Sheath Introducer Sheath". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance data like an AI/ML diagnostic device would.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria for an AI/ML-based device. The original request is formulated for a performance study of a diagnostic device (likely AI-powered), which requires metrics like sensitivity, specificity, or AUC, and details on clinical validation with ground truth.

The document describes a physical medical device (an introducer sheath), and its substantial equivalence is proven through:

• Bench Testing: Mechanical and physical properties (tensile strength, kink resistance, connection strength, pressure tests, lubricity, radiopacity, corrosion resistance).
• Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, hemocompatibility, pyrogen test, LAL test.
• Comparison of Technological Characteristics: To a predicate device (K121504) across features like French sizes, indications for use, regulation numbers, components, sterilizations, and dimensional comparisons.

In summary, the provided document does not allow for a response to the specific questions regarding acceptance criteria and performance study details for an AI/ML device.

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The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The Thinline Introducer Sheath is a single-lumen, coil-reinforced catheter. The Thinline Introducer Sheath is available in 11cm and 23cm lengths (French size 9F) and is designed to accept 0.038 inch diameter quide wires. A radiopaque outer laver is included for angiographic visualization. A valved hub with integrated suture ring is attached to the proximal end with extension tubing and a three way stop cock which allows attachments for flushing and aspiration. This catheter is designed for use in providing access and facilitating the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The dimensions for the Thinline Introducer Sheath are indicated on the product label. A dilator and guidewire accessory are included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.

The provided document is a 510(k) Premarket Notification for a medical device called the "Thinline Sheath Introducer." This document details the device's characteristics, indications for use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.

Crucially, this document is for a physical medical device (a catheter introducer) and contains no information about an AI/ML-driven device or its acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria for an AI/ML device, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone performance. The performance data presented in the document (Table 6.2) relates to physical and functional tests of the sheath introducer, such as tensile strength, burst pressure, and sterility, not AI algorithm performance.

If you can provide a document that discusses an AI/ML-driven medical device and its validation study, I would be able to answer your questions.

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ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation.
ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter.
ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal.
ARMADA Renal Dilator: Used for dilatation of Renal Tract.
Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract.
Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire.
Introducer Sheath: Used for introducing safety wire during nephrostomy.
Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Allwin Dilator & Sets", which specifies the device's indications for use and regulatory information. However, it does not describe any acceptance criteria or a study that proves the device meets specific performance criteria through a rigorous testing process involving AI or human reader performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval letter for a medical device (dilators and sets), not a technical report or study detailing the validation or performance of an AI/ML diagnostic tool.

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The 9F Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The 9F Prelude IDeal 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. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The 9F Prelude Ideal Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French size 9F) and is designed to accept 0.038" diameter guide wires. The 9F Prelude Ideal Hydrophilic Sheath Introducer is marketed with the following components: quide wire, metal access needle, quide wire insertion device.

This document describes the 510(k) summary for the 9F Prelude IDeal Hydrophilic Sheath Introducer, a medical device. It does not contain information about an AI/ML powered device, therefore, the requested information elements (1-9) which are related to AI/ML device studies and ground truth establishment are not applicable.

The document focuses on demonstrating the substantial equivalence of the 9F Prelude IDeal Hydrophilic Sheath Introducer to its predicate device (K173750 and K142829) through performance testing.

Here's the relevant information about the non-clinical performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, referencing applicable international and internal standards. It generally states that the device "met the predetermined acceptance criteria applicable to the performance of the device." However, specific numerical acceptance criteria and the exact reported device performance values are not provided in this summary. The table below outlines the tests performed:

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

• Sample Size: Not explicitly stated in the provided document for each specific test.
• Data Provenance: The tests are "Nonclinical performance data" and internal validation tests. The provenance is internal to the manufacturer, Merit Medical Systems, Inc.

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

• This is a non-clinical device filing, and expert adjudication for ground truth (as in a clinical study or AI/ML model evaluation) is not applicable or described. The tests are based on engineering and material science standards.

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

• Not applicable for non-clinical performance testing.

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 not an AI/ML powered device.

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

• Not applicable. This is not an AI/ML powered device.

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

• The "ground truth" for this device's performance is established by meeting the requirements of recognized international and internal engineering, material, and sterility standards (e.g., ISO, ASTM). These standards define objective, measurable criteria for device functionality and safety.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML powered device.

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

• Not applicable. This is not an AI/ML powered device.

Summary of Conclusions from the Document:

The 9F Prelude IDeal Hydrophilic Sheath Introducer demonstrated substantial equivalence to its predicate devices by meeting predetermined acceptance criteria in nonclinical performance tests. These tests included manual testing against international standards, coating adhesion and particulate testing, transportation integrity, biocompatibility, sterilization validation, and accelerated aging. The differences from the predicate (larger diameter, different hemostasis valve, colorants, tubing material, removal of compression sleeve, and dilator material change) and minor changes in indications for use (exclusion for radial artery use and specific access needle) were deemed not to raise new questions of safety or effectiveness.

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The Merit Prelude IDeal 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 guide wires.

The Prelude IDeal 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. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The Prelude Ideal Hydrophilic Sheath Introducer is available in 7cm. 11cm, 16cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guide wires. The Prelude Ideal Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guide wire, metal access needle, access needle with inner metal needle and outer plastic cannula and BowTie guide wire insertion device.

The provided text describes a 510(k) premarket notification for a medical device, the Prelude IDeal Hydrophilic Sheath Introducer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML algorithm's performance.

Therefore, many of the requested criteria, such as those related to AI/ML specific studies (sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training data), are not applicable to this document. The document describes traditional medical device performance testing.

Here's an analysis of what can be extracted from the document regarding acceptance criteria and performance, as well as the parts that are not applicable:

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

The document lists numerous performance tests performed, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it makes a general statement about the results.

• Bench Performance Tests: Suture Ring Rotation, 90º Tip Bend Test/Conditioning, Tensile Tip to Shaft, Sheath Assembly Leak (300kPa), Tensile Hub to Sidearm (4F only), Tensile - Valve Cap to Hub, Tensile Suture Ring to Strain Relief, Dilatory Drag through Sheath Tip and Valve, Sheath Effective Length, Kink Dual Pivot, Stiffness (Force of Deflection), Sidewall Compression, Tip Insertion Force (with coating activation), Coating Lubricity and Durability, Sheath Bend Radius, Radiopacity of Shaft and Tip, Hydrophilic Coating Uniformity and Coverage Length, Tensile - Hub to Shaft, Sheath Tip Ball Gauge Drag, Sheath Shaft Inner Diameter, Sheath Shaft Outer Diameter, Tensile Shaft, Torque Shaft to Hub, Corrosion Resistance, Particulate Evaluation (Outer Surface), Stiffness with Dilator, Catheter Insertion and Exchange, Sheath Stiffness without Dilator.
• Biocompatibility Tests (based on ISO standards): Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation, Chemical Characterization. |
  | The device must demonstrate substantial equivalence to the predicate device regarding safety and effectiveness. | "Based on the indications for use, design, and performance testing, the subject Prelude IDeal Hydrophilic Sheath Introducer raises no new questions of safety or effectiveness compared to the predicate device and is substantially equivalent to the predicate device, the PreludeEASE Hydrophilic Sheath Introducer, K140543 and K150257, manufactured by Merit Medical Systems, Inc." (Page 7) |

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of devices tested) for each of the performance or biocompatibility tests. It only lists the types of tests performed.
• Data Provenance: Not specified, but generally, medical device testing for FDA clearance is conducted by the manufacturer (Merit Medical Systems, Inc. in Utah, USA) or its designated testing facilities. This is a pre-market submission, so the data is prospective in the sense that it's generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a traditional medical device, not an AI/ML device that requires human expert review for establishing ground truth from medical images or data. Performance is evaluated through physical and chemical testing.

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

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

Not applicable. See point 5.

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

For this device, "ground truth" is established by:

• Engineering specifications and design requirements: The device's performance is measured against these pre-defined standards (e.g., specific tensile strength, leak rate, flexibility limits).
• International Standards (e.g., ISO): Many tests are conducted according to well-established international standards (e.g., ISO 11070 for catheter introducers, ISO 10993 series for biocompatibility) which set the benchmarks for acceptable performance.
• Predicate Device Performance: Comparative testing against the predicate device to show similar performance characteristics is implicit in demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that involves a "training set."

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

Not applicable. See point 8.

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The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.

The Prelude Pursuit™ Splittable Sheath Introducer is a splittable introducer system indicated for the introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature. The "splittable” function allows the introducer to be withdrawn over a diagnostic/therapeutic catheter (e.g. peripherally inserted central catheter, totally implantable venous access device/port, dialysis, drainage, hemodynamic line, etc.) or pacing/defibrillator lead and from the vessel while maintaining said device in place. The product is available in 16 French sizes, from 5 F through 16 F, and in two different lengths, 13 cm and 25 cm. It is packaged either as a kit with optional accessory components (introducer needle, syringe, guide wire), or as a stand-alone (sheath-dilator) set. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities. The splittable sheath introducer is lubricated with a silicone dispersion and its hub has a threaded locking mechanism for dilator engagement. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip for ease of insertion.

The document provided describes a 510(k) premarket notification for a medical device called the "Prelude Pursuit Splittable Sheath Introducer". It does not describe an AI/ML powered device, therefore, many of the requested categories (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.

Here's an analysis based on the information provided, focusing on the device's performance given its classification as a medical device (not an AI/ML product):

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (catheter introducer) and not an AI/ML product, the "acceptance criteria" are related to its physical and functional properties, as well as safety standards. The "reported device performance" refers to the successful completion of these tests, demonstrating compliance with the predicate device and established standards.

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

This information is not provided in the document. For physical device testing, sample sizes are typically determined by statistical rationale for verification and validation (V&V) testing based on product specifications and standards, but the specific numbers are not disclosed here. The "data provenance" for such a device would refer to the testing being performed in a laboratory setting under controlled conditions, not from patient data.

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

This is not applicable as the device is a physical medical instrument, not an algorithm requiring expert-established ground truth from medical images or data. Ground truth for physical properties is established through validated measurement techniques and adherence to engineering specifications and international standards.

4. Adjudication method for the test set

Not applicable for a physical device. Performance is judged against objective physical and safety 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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device. "Standalone" performance for this device would refer to its physical function as tested against its specifications.

7. The type of ground truth used

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

• Engineering Specifications: Designed dimensions, material properties, and functional performance targets derived from the device's intended use.
• International Standards (e.g., ISO, ASTM, USP): These standards (listed in the document) provide objective, established benchmarks for safety, biocompatibility, sterilization, and functional performance of medical devices. Failure to meet these standards would indicate the device does not meet "ground truth" for safe and effective use.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. There is no "training set" in the context of physical medical device development in this manner.

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

Not applicable, as this is not an AI/ML device.

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The HeartSpan® Steerable Sheath Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The HeartSpan® Steerable Sheath Introducer consists of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The device is provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities. The HeartSpan® Steerable Sheath Introducer has three configurations; Small, Medium, and Large Curl (differing curve radii). The steerable sheath introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheath introducer handle includes a rotating knob to enable clockwise and counterclockwise tip deflection ≥180° with a radius of 16.4 - 50 mm nominal (measured at 180° deflection). The steerable sheath introducer also includes distal holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the outer surface. The dilator is designed to mate to the inner diameter of the sheath, and has a tapered tip. The guide wire is super-stiff with PTFE coating and J-tip. The guide wire maintains a percutaneous path through the skin and tissue over which the sheath/dilator assembly is tracked. The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement and deflection wires in the sheath introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.

The provided text describes a 510(k) premarket notification for a medical device, the HeartSpan® Steerable Sheath Introducer. It details the device's characteristics, indications for use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.

However, the document does not contain the specific information required to address the request fully, particularly regarding a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop system. The provided text is for a physical medical device (a steerable sheath introducer), not an AI algorithm or an imaging device whose performance is measured in terms of reader improvements or AI standalone performance. Therefore, many of the requested fields are not applicable to the submitted content.

Based on the provided text, I can extract information related to the acceptance criteria and performance of the physical device.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists various performance tests conducted on the HeartSpan® Steerable Sheath Introducer, which serve as the acceptance criteria for its physical and functional attributes. The general statement about performance is that "The results of the testing demonstrated that the subject HeartSpan® Steerable Sheath Introducer met the predetermined acceptance criteria applicable to the safety and efficacy of the device." Specific quantitative results are not provided in this summary.

Biocompatibility Testing:

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

• Not Applicable / Not Provided: The document discusses testing for a physical medical device, not an AI model that uses a "test set" in the context of image analysis. The tests mentioned are bench tests and biocompatibility tests on the device itself. Sample sizes for these types of engineering and biological tests are not specified in this summary document.
• Data Provenance: Not applicable in the context of clinical data for AI, but for the physical device, the tests are performed in a lab setting by the manufacturer (Merit Medical Systems, Inc.).

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

• Not Applicable: This pertains to clinical data labeling for AI models. This document describes a physical device.

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

• Not Applicable: This pertains to clinical data labeling for AI models.

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 is a physical medical device, not an AI-assisted diagnostic tool.

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

• Not Applicable: This is a physical medical device, not an AI algorithm. Its performance is inherent to its design and material properties, not an algorithm's output.

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

• For the physical device, the "ground truth" for acceptance criteria is based on engineered specifications, validated test methods, and compliance with recognized international standards (e.g., ISO, ASTM, USP, AAMI). For biocompatibility, it's established by the outcomes of standard biological tests.

8. The sample size for the training set:

• Not Applicable: This pertains to AI model training, not a physical device.

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

• Not Applicable: This pertains to AI model training.

In summary, the provided document is a 510(k) summary for a physical medical device (HeartSpan® Steerable Sheath Introducer) and outlines the engineering and biological testing performed to demonstrate its safety and effectiveness for substantial equivalence. It does not provide the type of information typically associated with the development and validation of an AI-powered diagnostic or assistive tool.

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The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Bioteq Sheath Introducer consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 4-way stopcock is affixed to the proximal end of the side port extension. The Bioteq Sheath Introducer assembly includes a vessel dilator that rotates securely with the sheath introducer hub and guidewire which is cleared by the Food and Drug Administration (K920884).

The sheath introducer is available in 5 French (F) to 7F sizes in length of 11cm or 23cm. The vessel dilator is tipped specifically to accept either a 0.038 inch or a 0.035 inch diameter guidewire with the length of 45cm or 80cm.

The provided document describes the 510(k) premarket notification for a Sheath Introducer device, demonstrating its substantial equivalence to a legally marketed predicate device. This is not a study proving the device meets acceptance criteria for an AI/ML-based medical device.

The document discusses:

• The device: Sheath Introducer, used for percutaneous introduction of devices into veins/arteries.
• The testing conducted: Sterilization validation, biocompatibility, and various performance tests (e.g., force at break, leakage, radiopacity, insertion force, guidewire compatibility, kink resistance).
• The comparison: The proposed device is compared to the Merit Prelude™ Sheath Introducer (K050962).
• The determination: The FDA found the device substantially equivalent based on intended use, design, technology/principles of operation, and performance.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device testing (e.g., sample size for test/training sets, expert ground truth, MRMC studies, effect size, standalone performance) cannot be answered from this document.

This document specifically states: "No clinical test data was used to support the decision of the substantial equivalence." and focuses on bench testing and material comparisons.

However, if we interpret "acceptance criteria" and "study" in the context of this specific medical device (a physical sheath introducer) as a substantial equivalence determination, then the information would be as follows:

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

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

• Sample size: Not explicitly stated for each test, but standard test methods for medical devices typically involve specific sample sizes per ISO/ASTM standards.
• Data provenance: Not specified beyond "A series of tests were performed." The tests are non-clinical, meaning they were conducted in a laboratory setting. No indication of country of origin for the data itself, but the manufacturer is in Taipei, Taiwan. The tests are "retrospective" in the sense that they are conducted on manufactured samples, not "prospective" clinical trials.

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

• Not applicable as this is a physical medical device undergoing bench testing, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established engineering and material science standards and measurement techniques.

4. Adjudication method for the test set:

• Not applicable. Performance is measured against pre-defined engineering and material standards, not subjective expert judgment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a physical, non-AI medical device. No human-in-the-loop performance or AI assistance involved.

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

• Not applicable. This is a physical, non-AI medical device.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is derived from established engineering and material science standards (e.g., ISO, ASTM standards for medical devices), physical measurements, and chemical analyses. For instance, a "force at break" test's ground truth is the measured force value compared to an acceptable range.

8. The sample size for the training set:

• Not applicable. This is a physical, non-AI medical device. There is no "training set" in the context of machine learning.

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

• Not applicable. There is no training set or machine learning "ground truth" for this device.

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The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

The PTFE Super Sheath Introducer 2.1 is a catheter introducer. The sole difference between the predicate device (K130855; Super Sheath 2.0) and the proposed device is the material change to dilatory. The dilator material that was approved in the predicate 510K submission was nylon, the proposed has a dilator composed of a nylon/Pebax blend.

The provided text is a 510(k) premarket notification for a medical device (PTFE Super Sheath Introducer 2.1) and does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

The document discusses substantial equivalence to a predicate device (PTFE Super Sheath Introducer 2.0, K130855) for a physically manufactured medical instrument, not a software-based AI/ML device. The "Bench / Performance Data" section lists in-vitro tests performed, but these are for the physical properties of the introducer, such as liquid leakage, air leakage, force at break, simulated use, and equipment interaction. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details) because the provided text is not about an AI/ML medical device study.

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