Search Results

The Resilience Fully Covered Esophageal Stent System is intended for maintaining esophageal luminal patency in patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.

The MERIT ENDOTEK® Resilience™ Fully Covered Esophageal Stent System is a through-the-scope system comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible silicone membrane. Stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with unique geometrical features at the distal and proximal ends to anchor the stent and resist migration. The proximal and distal ends of the stent are threaded with suture intended for use in repositioning and removal of the stent.

The stents come in nine (9) sizes, comprising all combinations of three lengths (5cm, 6cm, and 7cm) and three midbody diameters (14mm, 17mm, and 20mm). The midbody lengths are 1cm, 2cm, and 3cm with the flared ends comprising the remaining length. The ends of the stents are larger in diameter than the midbody.

There is one 10.5Fr delivery system used to deploy all 9 stents.

The provided FDA 510(k) clearance letter and summary for the Resilience Fully Covered Esophageal Stent System describes non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not include information about clinical studies involving human readers or AI algorithms. The clearance is based on the device itself (the stent system), not an AI algorithm performing diagnosis or analysis.

Therefore, many of the requested points, especially those pertaining to AI performance, human reader studies, and ground truth establishment for AI, cannot be answered from the provided text.

Here's an analysis based on the information provided, focusing on the device's non-clinical testing:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The study described is a series of non-clinical, in-vitro tests on the mechanical and material properties of the Resilience Fully Covered Esophageal Stent System and its delivery system.

Information Not Found in the Provided Text:

Since this is a clearance for a medical device (esophageal stent) and not an AI/software device, the following points related to AI studies are not applicable or not present in the provided document.

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

   • This device clearance is based on non-clinical, in-vitro testing. It does not utilize "test sets" in the context of clinical data for AI analysis. The "test sets" here refer to batches of manufactured stents and delivery systems for mechanical and material property evaluation. Specific sample sizes for each non-clinical test are not detailed in this summary, but the summary states "all of the above testing passed the predetermined specifications" and "All design validation requirements were met."

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

   • Not applicable as this is not an AI/software clearance based on expert-labeled clinical data. Ground truth for non-clinical device testing is typically based on engineering specifications and direct physical measurements/observations.

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:

   • Not applicable. This is not an AI-assisted device.

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 (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical testing, the "ground truth" or "reference standard" would be the pre-defined engineering specifications and performance criteria derived from established medical device standards and the predicate device's performance benchmarks. For biocompatibility, the ground truth is compliance with ISO 10993-1.

8. The sample size for the training set:

   • Not applicable, as this is not an AI/software 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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Ventrax™ Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart.

The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The sheath may be used for percutaneous entry. The system consists of four components: a sheath, a pigtail dilator, a straight dilator and a J-tipped Amplatz guidewire.

VENTRAX™ DELIVERY SYSTEM COMPONENTS
A. 8.5F Guiding Sheath Introducer: provides a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. The sheath has an integrated valve to restrict blood loss, and a sideport for flushing and withdrawing blood.
B. Mating Pigtail Dilator: designed to conform to the sheath introducer inner diameter, has a tapered tip, has a pigtail at the distal end to assist aortic valve crossing, has an integrated valve to restrict blood loss, and has a sideport for flushing.
C. Mating Straight Dilator: designed to conform to the sheath introducer inner diameter and has a tapered tip. Usage of this straight dilator is optional. This straight dilator is intended to be used only when access is unsuccessful after using the mating pigtail dilator.
D. 0.035" X 220cm J-tipped Amplatz guidewire: provide path for sheath and dilator advancement.

This looks like a 510(k) summary for a medical device called the Ventrax™ Delivery System. However, this submission does not contain information about software with AI/ML components. The document focuses on the substantial equivalence of the Ventrax Delivery System to a previously cleared predicate device with respect to its physical design, materials, and mechanical performance. There is no mention of accepting criteria related to AI/ML device performance, or any studies designed to prove AI/ML performance.

Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and study details related to AI/ML. The provided text does not contain any of that information.

Ask a specific question about this device

The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire.

The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

The provided text is a 510(k) summary for the Merit Micro Ace™ Gold Advanced Micro Access System. It describes the device, its intended use, comparison to a predicate device, and the safety and performance testing conducted.

However, this document does not describe a study proving a device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) product. Instead, it pertains to a physical medical device (vessel dilator for percutaneous catheterization) and describes the verification and validation tests for its physical characteristics and biocompatibility.

Therefore, many of the requested items, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and review.

The document focuses on demonstrating substantial equivalence to a predicate device through physical and material property testing, rather than performance of an AI algorithm based on data analysis.

Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.

Acceptance Criteria and Device Performance (for a physical medical device):

The document lists "Design Verification Studies" and "Design Validation Studies" as evidence that the device meets "pre-established performance criteria" and addresses "unacceptable risks." The acceptance criteria are implicitly the successful completion of these tests as per relevant international standards.

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

The document broadly states: "All tested samples met pre-established performance criteria and were deemed acceptable." It does not provide a quantitative table of specific acceptance criteria values and the measured performance results 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: The document states that "The tests were performed on both 4F and 5F Micro Ace™ Gold products." It also mentions "All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize." It does not specify the exact number of samples per test for the test set.
• Data Provenance: The data provenance is from internal testing conducted by Merit Medical Systems, Inc. The document does not specify country of origin for the data (beyond the company's location in South Jordan, Utah, USA), nor does it classify the study as retrospective or prospective in the context of clinical data, as this is a device verification/validation study.

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

• Not Applicable in the context of AI/SaMD ground truth establishment.
• For the "Clinician feedback following assessment of design changes" in the Design Validation Studies, the specific number and qualifications of clinicians are not provided. This feedback typically informs the practical usability and design, rather than establishing a 'ground truth' for an AI algorithm.

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

• Not Applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI ground truth, which is not what this document describes.

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 type of study is for evaluating the impact of AI on human reader performance, and is not applicable to a physical vessel dilator device.

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

• No. This applies to AI/SaMD performance, which is not the subject of this submission.

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

• Not Applicable in the sense of 'ground truth' for AI performance. The "ground truth" for this device's performance is defined by its compliance with engineering specifications, industry standards (ISO 10555-1, EN ISO 11070 2014/A1:2018, ISO 10993-1, ISO 14971), and successful completion of pre-established physical, mechanical, and biocompatibility criteria.

8. The sample size for the training set:

• Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Not Applicable. As above, this document does not describe an AI algorithm or its training set.

Ask a specific question about this device

The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.
The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.

The Prelude® Small O.D. Introducer Guide Wire is composed of a stainless-steel core wire inside a stainless-steel coil. The guide wire is welded at the distal and proximal tips and has a polished weld finish. The stainless-steel construction provides radiopacity and visibility to the user under X-ray. The wires are available in outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to 80 cm, straight and double-ended J 3mm / straight tip shapes, Standard and Firm body wire stiffness profiles, with a flexible atraumatic tip.

The provided text is a 510(k) summary for a medical device called the "Prelude Small O.D. Introducer Guide Wire." It details the device's characteristics, intended use, and a comparison to a predicate device, along with a list of non-clinical performance and biocompatibility tests conducted.

However, the request asks for specific information regarding acceptance criteria and a study that proves the device meets the acceptance criteria, particularly in the context of an AI-powered device or a study involving human readers and AI assistance.

The provided document does not describe an AI-powered device, a study involving human readers, a test set with expert ground truth, or an MRMC comparative effectiveness study. The tests listed are for a physical medical guide wire, focusing on its mechanical properties, material integrity, and biocompatibility.

Therefore, I cannot fulfill the request for information on acceptance criteria and study proving device meets the criteria for an AI device or a study involving human readers and AI assistance, as the provided text pertains to a traditional, non-AI medical device.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: While the document states "The subject Prelude Small O.D. Introducer Guide Wire met the predetermined acceptance criteria," it does not list the specific numerical or qualitative acceptance criteria for each test (e.g., "Tensile strength must be >X Newtons"). It also does not report the exact performance results (e.g., "Tensile strength was Y Newtons"). It only confirms that the criteria were met.
• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical guide wires tested, not a dataset of images or clinical cases. Sample sizes for each mechanical and biocompatibility test are not provided. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of device testing.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for AI/imaging studies (e.g., expert radiological reads) is not relevant for the physical testing of a guide wire.
• 4. Adjudication method for the test set: Not applicable. There's no "adjudication" for mechanical and biocompatibility tests in the way there would be for expert interpretations of medical images.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable. This type of study involves human readers interpreting medical images, usually with and without AI assistance. The device in question is a physical guide wire, not an AI algorithm for imaging.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is not an algorithm.
• 7. The type of ground truth used: Not applicable. Ground truth in the context of AI/imaging studies (expert consensus, pathology, outcomes data) is not relevant here. The "ground truth" for this device's performance is derived from standardized physical and chemical tests (e.g., measuring tensile strength against a specification).
• 8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI model.
• 9. How the ground truth for the training set was established: Not applicable, as there's no training set.

In summary, the provided document is for a conventional medical device (a guide wire) and does not contain the information requested regarding AI device performance studies.

Ask a specific question about this device

The Impress Angiographic Catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

The Merit Impress Angiographic Catheters with/without hydrophilic coating are intravascular diagnostic catheters that are intended for the administration of contrast for conducting fluoroscopic studies. The catheters are available in a variety of 4F and 5F wire-braided and non-braided configurations ranging in length from 40cm to 125cm. The device may include a marker band to assist anatomical measurements. The devices are available in a variety of tip shapes to cater to variations in physician preference and patient anatomy.

The catheters consist of a shaft with a molded hub assembly. It is the shaft that may be offered with or without a wire-braided reinforcement. The distal tip of the device is tapered for efficient volume flow and dispersion of the contrast media. The distal tip is flexible so as to minimize the potential for vessel trauma.

The provided text is a 510(k) premarket notification summary for the Impress Angiographic Catheter. It outlines the device's characteristics, indications for use, comparison to predicate devices, and the testing conducted to demonstrate its safety and performance. However, this document does not contain information about an AI/algorithm-based medical device study.

The device in question, the "Impress Angiographic Catheter," is a physical medical device used for delivering radiopaque media in the vascular system. The testing described (design verification, design validation, and biocompatibility studies) are standard for physical medical devices and do not involve AI or software performance evaluation against an acceptance criterion that would be typical for an AI/ML product.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI device meets those criteria based on the provided text. The document focuses on the substantial equivalence of a physical catheter, primarily due to changes in its material composition.

Ask a specific question about this device

The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.

The Siege Vascular Plug is intended for therapeutic embolization to reduce or obstruct blood flow.

The subject Siege Vascular Plug ("Device") is a self-expanding braided Nitinol vascular embolization implant that is supplied with components used for implantation. The Device has radiopaque marker bands attached to each end and a screw attachment for connection to the Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 225 cm Delivery Wire that is provided within a hoop dispenser. The Delivery Wire has a lubricious, hydrophilic coating at its distal end (approximately 26.5cm long). A Tuohy Borst Valve is provided for flushing and maintaining hemostasis: a Torque Device is provided for releasing the Device; a Non-Vented Luer Cap is provided for device preparation.

The subject Siege Vascular Plug has been designed with a material, size, configuration, and shape that allows introduction through recommended 0.021" or 0.027" inner diameter commercial microcatheters for the embolization of arterial blood vessels in the peripheral vasculature. The Siege Vascular Plug Devices are provided in three different outer diameters (4.5 mm, 6.5 mm, 8.5 mm) to treat different artery diameter ranges (1.5 - 2.5 mm, 2.5 - 4 mm, 4 - 6 mm) in the peripheral vasculature.

This document describes the 510(k) premarket notification for the Siege Vascular Plug, a medical device intended for arterial embolization in the peripheral vasculature. The device's manufacturer, Merit Medical Systems, Inc., demonstrated substantial equivalence to a legally marketed predicate device (Siege Vascular Plug [K212817]) through a series of non-clinical performance tests and a GLP animal study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All test results were comparable to the predicate Siege Vascular Plug and the subject Siege Vascular Plug met the predetermined acceptance criteria." However, specific numerical acceptance criteria and detailed performance results for each test are not explicitly provided in the furnished text. Instead, it lists the types of tests conducted:

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

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of plugs tested for tensile strength or fatigue).

For the GLP Animal Study:

• Sample Size: Not specified (only mentions "a porcine model").
• Data Provenance: Prospective (as it's a study explicitly conducted to evaluate the subject device). The "country of origin" is not specified.

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

This information is not applicable and therefore not provided in the document. The acceptance criteria were based on "requirements outlined in guidance's and industry standards," and the performance was evaluated through physical and biological testing, not through expert-established ground truth in the context of diagnostic performance.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used for evaluating human-in-the-loop diagnostic performance, not for the technical and biological performance tests described here.

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

No, an MRMC comparative effectiveness study was not done. The evaluation focused on the physical, mechanical, and biological performance of the device itself, not on human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical vascular plug, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests was adherence to established industry standards, guidance documents, and pre-defined specifications. For the animal study, the ground truth was the observable acute and chronic safety, performance, and handling within the porcine model, compared to a reference device. This is equivalent to performance against established benchmarks/standards and direct observation of biological safety/effectiveness.

8. The Sample Size for the Training Set:

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

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

This information is not applicable, as there is no training set for a physical medical device.

Ask a specific question about this device

Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Bearing nsPVA particles are irregularly-shaped, hydrophilic, non-resorbable particles made of 100% crosslinked poly(vinyl alcohol). These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon placement through a catheter.

The particles of the subject device, the Bearing nsPVA Express, are provided sterile and for single use in a 20 mL polycarbonate syringe with a luer-lock connector, individually packaged in a sterile foil peel pouch.

Bearing nsPVA particles are calibrated and available in 7 size ranges (see table below) to enable the physician to choose depending on the diameter of the vessel to be embolized. Each syringe contains 100 mg of Bearing nsPVA particles.

The provided text describes testing conducted for the Bearing nsPVA Express™ device, which is an embolization particle packaged in a syringe. The majority of the testing relates to hardware and packaging, and does not describe a clinical study for establishing performance against specific acceptance criteria in a human population, nor does it involve AI or human readers.

Therefore, many of the requested categories are not applicable to the information provided in this document.

Here's a breakdown of the available information:

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

The document details various engineering and biological testing with associated acceptance criteria. Instead of "device performance" in a clinical sense, these refer to the manufacturing quality, sterility, packaging integrity, and biocompatibility of the physical product.

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

The document does not specify general "test set" sample sizes or data provenance in terms of patient data. The tests are primarily laboratory-based and follow established standards for medical device testing. For example:

• Sterilization Validation: Involves testing a certain number of units to establish a sterility assurance level. The exact number of units is not specified but would follow ISO 11137-2.
• Pyrogenicity: "routine pyrogen testing for each lot"
• Biocompatibility: Involves animal models for certain tests (e.g., acute systemic toxicity, intracutaneous irritation, sensitization) and in vitro tests (e.g., cytotoxicity, hemocompatibility). The specific number of animals or repetitions is not provided but would be dictated by the ISO 10993 standards cited.

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

Not applicable. This document describes physical and biological testing of a medical device, not a diagnostic or AI-assisted clinical study requiring expert human interpretation or ground truth establishment.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication is mentioned.

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

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was mentioned.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the biological and physical performance testing described:

• Sterility: Achieved through rigorous validation adhering to ISO standards and verified by microbiological methods.
• Pyrogenicity: Verified by the Limulus Amebocyte Lysate (LAL) test against a quantitative limit.
• Biocompatibility: Established through standardized in vitro and in vivo biological tests according to ISO 10993 guidelines, measuring specific biological endpoints (e.g., cell viability, immune response, blood compatibility).
• Design Verification (Product/Packaging): Established through visual inspections and mechanical integrity tests against internal specifications and relevant ASTM/ISO packaging standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or a training set.

Ask a specific question about this device

The Merit Mighty Wire is intended to be used to facilitate the placement of devices during diagnostic and interventional procedures in the central circulatory system, excluding the coronary arteries and neurovasculature.

The wire is composed of a PTFE (polytetrafluoroethylene) coated stainless-steel core wire with a grind profile ending in a flexible distal tip. A PTFE coated stainless steel distal coil is laser-welded to the proximal end of the core wire grind profile and plasma arc-welded to the distal end of the core wire profile. The PTFE coating covers 100% of the guide wire surface. For wire lengths 230, 260, and 300cm, an additional radiopaque Platinum-Tungsten marker coil is welded to the core wire flexible distal tip. The distal tip is radiopaque.

The provided text is a compilation of FDA documents related to the 510(k) clearance of the "Mighty Wire Guide Wire". It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The document is for a physical medical device (guide wire) and outlines the regulatory process for its clearance based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML enabled device from the provided text. The questions pertaining to sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment are not applicable to the content of this document.

Ask a specific question about this device

The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Advanced Micro Access System (hereafter referred to as Micro Ace™) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018" (0.46mm) guide wire.

The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires:
• Some catalog codes will include a nitinol wire with platinum guide wire tips;
• Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Micro Ace™ Advanced Micro Access System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on human-in-the-loop or standalone AI performance.

Therefore, the following information cannot be extracted from the provided text:

• No AI/Machine Learning Component: The prompt's questions (e.g., about AI assistance, standalone algorithm performance, training/test set ground truth, expert adjudication) are relevant to a medical device that incorporates AI or machine learning. The Micro Ace™ Advanced Micro Access System is a physical medical device (a vessel dilator for percutaneous catheterization) and does not appear to have any software or AI component described in this document. The term "algorithm" is not mentioned in the context of device performance.
• No "Acceptance Criteria" for AI/Software Performance: The document outlines the performance testing conducted to ensure the device functions as intended and is safe, but these are typical engineering and biocompatibility tests for a physical device, not performance metrics for an AI algorithm.
• No Human Reader Study: Since there's no AI component, there's no multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting with AI.
• No Training or Test Sets for AI: The concepts of training and test sets and ground truth establishment (expert consensus, pathology, outcome data) are specific to AI/ML model development and evaluation. These do not apply to the physical device described.

Instead, the document details the following for a physical medical device:

1. Acceptance Criteria and Reported Device Performance (Summary):

The document states that "All tested samples met pre-established performance criteria and were deemed acceptable." Specific numeric acceptance criteria are not provided in the text, nor are the detailed reported performance metrics for each test. The document lists the types of tests performed:

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

The document mentions that both 4F and 5F Micro Ace™ products were tested, and testing included sterile devices (following ethylene oxide processing) and aged devices. The exact numerical sample size for each test is not specified.
The data provenance is from Merit Medical Systems, Inc., the manufacturer. It is internal device testing, not patient data from a specific country or retrospective/prospective study in a clinical setting.

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

This question is not applicable as the studies relate to physical device performance testing (e.g., mechanical properties, biocompatibility), not the establishment of ground truth for diagnostic imaging or similar applications requiring expert consensus. "Clinician feedback" was part of design validation, but the number and qualifications of these clinicians are not detailed.

4. Adjudication Method for the Test Set:

Not applicable. This refers to consensus building among experts for tasks like image labeling, which isn't relevant to the described device testing.

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

No. This type of study is for evaluating diagnostic performance (often with AI assistance). The Micro Ace™ is a physical medical access system, not a diagnostic device.

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

No. This refers to AI algorithm performance.

7. The Type of Ground Truth Used:

Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance is determined by meeting pre-specified engineering and biocompatibility test standards (e.g., a specific tensile strength value, absence of cytotoxic effects).

8. The Sample Size for the Training Set:

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable.

Ask a specific question about this device