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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 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.

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

The Prelude Guide Sheath Introducer is a sterile, disposable device consisting of a (a) a coil reinforced shaft with an atraumatic tip and the distal end: (b) a hemostasis valve with a side port and color-coded stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.

This is a 510(k) summary for a medical device (Prelude Guide Sheath). The document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data and material comparisons, not on evaluating an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or readily extractable from this specific document.

However, I can provide the acceptance criteria and performance as described for the non-clinical tests.

Acceptance Criteria and Reported Device Performance

The document states that "The results of the testing demonstrated that the subject Prelude Guide Sheath met the predetermined acceptance criteria applicable to the performance of the device." The specific numerical acceptance criteria for each test are not provided in this summary, but the general categories of tests performed are listed. The "Reported Device Performance" for each test is simply that the device met those unstated criteria.

Here's a table based on the provided "Performance Tests" section:

The remaining requested information is largely irrelevant to this 510(k) submission, as it pertains to AI/ML algorithm validation for which this device is not. This submission focuses on the physical and material characteristics of a medical device (a guide sheath introducer) and its substantial equivalence to existing predicate devices, rather than the performance of an AI/ML system.

Therefore, the following information is not applicable or extractable from the provided document:

2. Sample sized used for the test set and the data provenance: Not an AI/ML study, so "test sets" in that context don't apply. The non-clinical tests would have their own sample sizes for a variety of physical or chemical tests, but these are not detailed as a single "test set" for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML study; no "ground truth" in the diagnostic/interpretive sense is established by experts here.
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.
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 concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The PreludeSYNC DISTAL™ is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.

The PreludeSYNC DISTAL™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial artery following catheterization procedures. It consists of a soft wristband and thumb saddle strap with secure hook and loop fasteners. The band delivers adjustable compression of the puncture site with an inflatable balloon, and a check valve for easy inflation and deflation with the accompanying 10mL syringe inflator. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement. PreludeSYNC DISTAL is available in a variety of graphic designs and a right or left-hand configuration.

The provided text is a 510(k) Summary for the PreludeSYNC DISTAL™ Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria for clinical performance.

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

• A table of acceptance criteria and reported device performance related to clinical efficacy.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance (this is an AI-specific question, and the device is a physical medical device, not an AI system).
• If a standalone (algorithm only) performance study was done (again, not applicable to this type of device).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
• The sample size for the training set.
• How the ground truth for the training set was established.

What can be extracted and inferred from the text regarding acceptance criteria and performance study:

The document states that "Performance testing of the subject PreludeSYNC DISTAL Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standard". It then lists several international standards for various types of testing, along with a list of "Performance Testing-Bench" tests and "Biocompatibility Testing."

The conclusion states: "The results of the testing demonstrated that the subject PreludeSYNC DISTAL met the predetermined acceptance criteria applicable to testing the safety and efficacy of the device." However, the specific quantitative acceptance criteria for each test and the detailed results are not provided in this summary.

In summary, this document is a regulatory filing for substantial equivalence, not a detailed report of a clinical performance study with explicit acceptance criteria for efficacy in patients. It describes bench testing and biocompatibility studies to demonstrate safety and equivalent performance to a predicate device based on its design and materials.

Here's a breakdown of what the document does provide, modified to fit the request where possible, but acknowledging limitations:

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

Note: The specific quantitative acceptance criteria are not detailed in this summary; only a general statement that they were "met" is provided.

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

• Test Set Sample Size: Not specified for any of the performance or biocompatibility tests.
• Data Provenance: The tests are "Performance Testing-Bench" and "Biocompatibility Testing," implying lab-based, pre-clinical testing presumably conducted by the manufacturer, Merit Medical Systems, Inc. No country of origin for clinical data is mentioned as no clinical studies are referenced. The nature of these tests suggests they are prospective, following established protocols.

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

• Not applicable/Not mentioned. The "ground truth" here refers to engineering specifications and international standards, not expert clinical interpretation.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. This typically relates to clinical studies or assessments requiring human interpretation.

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 device is a physical medical compression device, not an AI system.

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

• Not applicable. This device is a physical medical compression device, not an AI algorithm.

7. The type of ground truth used:

• For Performance Testing-Bench: Engineering specifications, design requirements, and international standards (e.g., ISO 80369-7, ISO 11135, ISO 10993-1, ISO 10993-7, ISO 2233, ASTM D4169).
• For Biocompatibility Testing: The "ground truth" was established based on the materials being identical to those of a legally marketed predicate device with the same intended use and contact, making further testing unnecessary.

8. The sample size for the training set:

• Not applicable/Not mentioned. This refers to algorithm training, not relevant to this physical device.

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

• Not applicable/Not mentioned.

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The Prelude Planning Software for the electron beam IORT treatment can be used for any malignant and benign tumor. For Prelude no limitation is given to the patient population. Local/Regional recommendations or guidelines may indicate patient who will benefit from IORT more than from other treatment modalities.

In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.

The Prelude software supports the IORT treatment workflow. Prelude Dosimetric measurement data of the radiation device can be displayed by selecting the machine parameters. Upon that information the user can easily plan the treatment and the software calculate the required parameters for the IORT devices.

For quality assurance the machines parameters can be recorded and visualized.

For the calculation of the output factors or the monitor units either the IAEA or AAPM protocol is followed.

The software is intended to be used by medical professionals in the area of radiation therapy.

The main purpose is to plan the technical parameters required to perform an electron beam IORT to treat both malignant and benign tumors

This document describes the MedCom GmbH Prelude planning software, K180308, for electron beam Intraoperative Radiation Therapy (IORT) treatment planning.

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

The provided text does not contain a specific table of acceptance criteria with corresponding device performance metrics in the format typically used for AI/ML device submissions (e.g., sensitivity, specificity, AUC, FROC analysis). Instead, the document focuses on general software safety, effectiveness, and usability assessments, emphasizing that the software meets its intended use and is safe and effective.

The performance details are described qualitatively rather than quantitatively against specific acceptance criteria. Key performance aspects reported include:

2. Sample size 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 states that "Clinical patient data was simulated." It does not specify a numerical sample size for this simulated data.
• Data Provenance: The data used for testing was "dosimetric measurement data from a Mobetron® device" and "simulated" clinical patient data. The country of origin for the simulated data or the Mobetron® device's data is not explicitly mentioned, but MedCom GmbH is located in Germany. The study appears to be a retrospective analysis of simulated data and device performance.

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)

The concept of "ground truth" as typically defined for AI/ML diagnostic devices (e.g., truth established by pathology or expert consensus on a test set) is not directly applicable here in the same way. The device is a planning software, not a diagnostic one.

Instead, the "truth" or correctness of the outputs was assessed through:

• Comparison to "expected parameters" for the simulated input data.
• Usability testing with "users" and "Mobetron users and other experts in that field" who provided feedback.
• Risk assessment team included "application specialists and a medical expert besides the development team and quality managers with risk management experience." Specific numbers and detailed qualifications of these individuals are not provided, beyond stating they were "medical expert" and "experts in that field."

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

No formal adjudication method (like 2+1 or 3+1 for resolving disagreements among multiple readers) is described for a test set in the context of diagnostic decision-making. The testing involved verification that the software produced "expected parameters" for simulated data and that users could successfully create plans and approve them, and that the software assisted in optimizing the treatment delivery.

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 multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is mentioned. The software is a planning tool, not an AI diagnostic assistant. Its purpose is to support medical professionals in radiation therapy by assisting in treatment planning and QA, not to be a diagnostic aid that would typically involve an MRMC study.

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

The evaluation described is intrinsically "human-in-the-loop" as Prelude is a planning software intended to be used by medical professionals. The software assists in calculations and visualizations, but the user defines parameters, approves plans, and interprets outputs. The testing included assessing user interaction and ability to create and approve plans.

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

The "ground truth" for evaluating this planning software was based on:

• Expected parameters: For the simulated clinical patient data, the software's calculated output parameters were compared against "expected parameters" for a treatment.
• Usability Feedback/Expert Opinion: Evaluation of whether users could successfully create treatment plans, define parameters, and whether the workflow was understandable. This suggests expert review of the software's functionality and output.
• Established Radiation Therapy Protocols: The software follows IAEA or AAPM protocols for calculation methods, implying adherence to recognized standards.

8. The sample size for the training set

The document does not describe the use of machine learning models requiring a distinct "training set." Prelude is a treatment planning software that performs calculations based on measured dosimetric data and established physical principles (IAEA/AAPM protocols), rather than a system trained on a large dataset of patient images or outcomes. Therefore, the concept of a "training set" in the context of AI/ML is not applicable here.

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

As there is no mention of a training set for machine learning, the question of how its ground truth was established is not applicable. The software's calculations leverage "dosimetric measurement data of the radiation device," which serves as input to its algorithms based on physics principles, not as training data for a learning model.

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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 PreludeSYNC is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.

The PreludeSYNC™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It consists of a soft wristband with a secure hook and loop fastener and a clear curved backer plate that provides optimal visualization of the puncture site and ease of placement. The inflatable bulb delivers adjustable compression of the puncture site. A check valve and tubing allow for easy inflation and deflation with the accompanying 20ml syringe inflator. PreludeSYNC is available in a variety of graphic designs and in two band sizes: regular (24cm) and long (29cm).

This document is a 510(k) Summary for the PreludeSYNC™ Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission and device. This document primarily outlines bench testing and biocompatibility testing conducted to ensure safety and function in comparison to a predicate, not to establish diagnostic accuracy or human performance improvement.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test and then report the exact performance. Instead, it lists the types of performance and biocompatibility tests conducted, implying that the device "meets the requirements" as part of the substantial equivalence determination.

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

• Sample Size: Not specified for individual tests. The testing methodology is outlined by referencing various ISO and ASTM standards (e.g., ISO 594-1, ISO 594-2, ISO 2233:2001, ISO 11607-1:2006, ASTM D4169-09, ASTM F1980-11, ISO 11135:2014, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006). These standards would dictate the sample sizes for the specific tests, but the document itself does not report these numbers directly.
• Data Provenance: Not applicable in the context of clinical data. This is bench and biocompatibility testing of a physical device.

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

• Not applicable. Ground truth, in the sense of expert review for diagnostic accuracy, is not relevant for this type of device and testing. The "ground truth" for the performance tests would be the measurement against established engineering or material specifications, and for biocompatibility, the results of standardized biological assays.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication process is described for these types of engineering and biocompatibility tests.

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

• No. This is a physical medical device (radial compression device), not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

6. Standalone (Algorithm Only) Performance Study

• No. This is a physical medical device, not an algorithm or software. "Standalone performance" in this context refers to the device's physical function and safety, without human-in-the-loop, which is addressed by the bench and biocompatibility testing.

7. Type of Ground Truth Used

• The "ground truth" for these tests are:
  • Engineering Specifications: For dimensions, tensile strength, leak tests, burst tests, etc.
  • Material Science Standards: For absorbency, transparency, ink adherence.
  • Biological Assay Results: For cytotoxicity, sensitization, irritation, and systemic toxicity, as defined by the ISO 10993 series of standards.
  • Functional Objectives: For simulated use, ensuring the device performs its intended mechanical function.

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. There is no training set.

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For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Prelude SNAP™™ Splittable Hydrophilic Sheath Introducer is a splittable hemostatic introducer system that is intended for the introduction of various types of pacing leads and catheters. The Prelude SNAP™™ Splittable Hydrophilic Sheath Introducer system consists of a splittable sheath introducer lubricated with hydrophilic coating, dilator, 18g introducer needle, guide wire, and a syringe. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities. The splittable sheath introducer contains a hemostasis valve to minimize blood loss and air ingress during use. The introducer is available with a side-port and three-way stopcock that provides means for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The splittable sheath introducer is available in two lengths: 13cm and 25cm. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip. The materials of construction are primarily polymers with the exception of the guide wire and needle cannula which are stainless steel.

The provided text describes a 510(k) premarket notification for a medical device called the "Prelude SNAP™ Splittable Hydrophilic Sheath Introducer." This document is from the FDA and details the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness, and substantial equivalence to a predicate device.

It's important to note that this is a medical device and not an AI/ML-based device. Hence, the acceptance criteria and study described are for a physical medical product, not an AI algorithm. Many of the requested points related to AI/ML (e.g., training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the information provided.

However, I can extract the relevant information regarding the acceptance criteria and studies for this physical medical device.

Acceptance Criteria and Device Performance for the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer

The document states that the device was "thoroughly tested through verification of product specifications and user requirements" and that "the results of the testing demonstrated that the subject Prelude SNAP™ Splittable Hydrophilic Sheath Introducer met the predetermined acceptance criteria of the device."

The study design is based on bench testing, sterilization validation, and biocompatibility testing, referencing several international and industry standards. The acceptance criteria themselves are explicitly stated for some tests, while others are implied as meeting the requirements of the referenced standards.

Here's a summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For many tests, the document simply states "met the predetermined acceptance criteria of the device" or implies compliance with the referenced standards, rather than providing specific numerical results or thresholds. This is typical for a 510(k) summary where detailed test reports are submitted separately.

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

The document does not specify the exact sample sizes used for each test. The studies were bench tests and laboratory validations (sterilization, biocompatibility). Data provenance would be internal laboratory testing data from Merit Medical Systems, Inc. This device is a physical product, not data-driven software, so terms like "country of origin of the data" or "retrospective/prospective" studies as they apply to clinical data are not directly applicable.

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 a physical medical device is established through engineering specifications, standard test methods, and compliance with recognized industry standards (e.g., ISO, ASTM, USP). It does not involve human expert consensus in the way an AI algorithm for image interpretation would.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of human interpretations or clinical outcomes.

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-assisted diagnostic tool. No MRMC study was performed or needed.

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

Not applicable. This is not an algorithm. Device performance is inherent to its physical design and manufacturing process, independent of human interaction beyond its intended use.

7. The type of ground truth used

The ground truth is based on engineering specifications, established performance standards (e.g., ISO, ASTM, USP), and risk analysis. For example:

• Mechanical properties: Defined by engineering design and tested against specifications (e.g., sheath diameter, peel force).
• Sterility: Verified through sterilization validation processes adhering to standards like ISO 11135-1.
• Biocompatibility: Established by testing materials in accordance with ISO 10993 series for material safety with biological systems.
• Functionality: Tested against "user requirements" and "product specifications" (e.g., insertion, kink resistance).

8. The sample size for the training set

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

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

Not applicable. No training set for an AI model.

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