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The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

The Beacon® Tip Torcon NB® Advantage Catheters are visually identified by a distal radiopaque tip bonded onto a nylon catheter shaft with braided stainless steel. Beacon® Tip Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, and 6.0 French with lengths measuring 40 to 170 centimeters. The catheter inner lumen is manufactured to accept a 0.035 or 0.038 inch diameter wire guide. These devices are manufactured without sideports and in a variety of distal tip configurations.

The Torcon NB® Advantage Catheters are selective angiographic catheters manufactured with a thinwall radiopaque nylon material and constructed with stainless steel braiding. The Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, 6.0, 7.0 and 8.0 French with lengths measuring 35 to 150 centimeters. The catheter inner lumen is manufactured to accept a 0.025, 0.035, or 0.038 inch diameter wire guide. These devices are manufactured with zero to twelve sideports, depending on the distal curve radius, and are available in a variety of distal tip configurations. These tips may be tapered at the distal endhole, depending upon device specifications. The catheters are also available in a variety of distal tip configurations.

Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are for use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Because medical device approval documents do not typically include detailed clinical study reports found in drug approvals, many of the requested data points (e.g., test set sample size and provenance, number and qualifications of experts, adjudication methods, MRMC study details, training set specifics) are not available in the provided text. The document focuses on demonstrating substantial equivalence through engineering and bench testing, rather than human-in-the-loop performance or clinical outcomes.

Here's the partial information based on the provided text:

Acceptance Criteria and Reported Device Performance for Beacon® Tip Torcon NB® Advantage Catheter and Torcon NB® Advantage Catheter

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The tests described are bench tests, so the "sample size" refers to the number of physical devices tested in each category.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by Cook Incorporated.

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

• Not applicable. The "ground truth" for these tests is based on objective physical measurements and adherence to international standards (e.g., ISO, FDA regulations) as performed by laboratory technicians/engineers. No expert radiologists/physicians were involved in establishing "ground truth" for the performance of these physical tests.

4. Adjudication method for the test set:

• Not applicable. Performance against acceptance criteria for these bench tests is determined by direct measurement and comparison, not by expert adjudication.

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

• No MRMC or human-in-the-loop study was done. This device is a physical medical catheter, not an AI or imaging 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 a software algorithm. The "standalone performance" is the device's performance in bench tests as outlined above.

7. The type of ground truth used:

• The "ground truth" for these technical performance tests is based on objective physical measurements and adherence to international standards (e.g., ISO 10555-1, ISO 10555-2, ISO 10993-1).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

• Not applicable. There is no "training set" for this type of device.

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The Advance® Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.

The Advance® Salivary Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5. 2.0, 2.5 and 3.0 millimeters in a balloon length of 2 centimeters. The catheter is available in an outer diameter of 2.5 French and in a length of 30 centimeters. Hydrophilic coating is applied to the distal 15 centimeters of the catheter shaft, which provides a lubricious surface when wetted. The balloon catheter is supplied with a 0.014 inch (0.36 millimeter) diameter stainless steel mandrel wire guide in a length of 50 centimeters. It is sterile and intended for one-time use.

Acceptance Criteria and Device Performance Study

The provided text describes the Advance® Salivary Balloon Catheter with Wire Guide and the studies conducted to demonstrate its reliable design and performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes for each of the performance tests. It refers to "testing shows" and implies that sufficient samples were tested to meet the predetermined acceptance criteria for each test. The data provenance is not specified beyond the tests being conducted for regulatory submission for a device to be marketed in the USA. Given the nature of these engineering and performance tests, they are typically conducted in a controlled laboratory environment. The "Simulated Clinical Use" test specifically mentions a "human cadaver model," implying prospective testing in a controlled lab setting, likely in the country of manufacture (USA, given the applicant is Cook Incorporated in Bloomington, IN).

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable for most of the tests. The tests are engineering and performance-based, not reliant on expert interpretation for ground truth. For the "Simulated Clinical Use" test using a human cadaver model, while clinical utility is being assessed, the document does not specify the number or qualifications of experts who established the "ground truth" or evaluated the performance of the device in this context. It simply states that the "predetermined acceptance criteria were met," which would likely align with successful navigation and deployment as observed by the testing personnel.

4. Adjudication Method for Test Set

Not applicable. The tests described are objective, quantitative, or pass/fail engineering and performance tests, not requiring an adjudication method akin to clinical studies where multiple readers interpret results.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The studies described are focused on the device's inherent design and performance characteristics, not on a comparison of human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was performed. The entire section "Technological Characteristics" details various tests conducted on the device itself (e.g., bond strength, burst strength, fatigue, inflation/deflation time, corrosion resistance, visual/dimensional analysis, simulated use, balloon working length/catheter integrity, simulated clinical use). These tests assess the algorithm/device's performance in isolation from a human-in-the-loop scenario.

7. Type of Ground Truth Used

The ground truth used for these tests is based on engineering specifications, predetermined quantitative thresholds, and observable physical properties. For example:

• Bond Strength: Conformance to ISO 10555-1 standards.
• Balloon Minimum Burst Strength: Bursting at or above a specified pressure.
• Inflation and Deflation Time: Within 60 seconds.
• Resistance to Corrosion: Withstanding a tensile force greater than or equal to 5 N.
• Simulated Use: Catheter passing through a simulated stricture, removal force less than 0.95 lbf.
• Balloon Working Length: 2.0 cm ± 0.1 cm.
• Simulated Clinical Use: Observable successful introduction, tracking, compatibility, removal, and verifiable location in a cadaver model.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (catheter, balloon, wire guide), not an AI algorithm or a device that uses a "training set" in the machine learning sense. The "training set" concept is not relevant here.

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

Not applicable, as there is no "training set" for this type of medical device.

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The Flexor® Radial Hydrophilic Introducer Access Set is introduce diagnostic and interventional devices in radial arterv access procedures.

The Flexor Radial Hydrophilic Introducer Access Set is comprised of an introducer sheath, a dilator, a wire guide, and an access needle.

This document describes the Cook, Inc. Flexor® Radial Hydrophilic Introducer Access Set (K132592). It details the testing conducted to demonstrate substantial equivalence to predicate devices, focusing on the quality and performance of the device components.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document details various performance and laboratory tests. However, it does not specify sample sizes for each test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective data). These tests appear to be bench and laboratory-based assessments of the device's physical and biological properties.

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

This information is not provided in the document. The tests described are primarily engineering and laboratory evaluations, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., for image interpretation).

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

This information is not applicable or not provided. The listed tests are objective, quantifiable physical and biological tests, not subjective interpretations requiring adjudication.

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 document describes a medical device (introducer access set), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant and was not conducted.

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

No. This document describes a physical medical device. The concept of "standalone algorithm only" performance is not applicable.

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

The "ground truth" for the tests performed is based on established engineering standards (e.g., BS EN ISO 11070:1999, EN ISO 9626:1995), biocompatibility standards (e.g., ISO 10993-1:2009), and internal predetermined acceptance criteria derived from the device's intended use and design specifications. These are objective measures rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This refers to a training set for machine learning or AI models. Since this is a physical medical device and not an AI/ML product, there is no "training set" in this context.

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

As there is no training set for an AI/ML model, this question is not applicable.

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The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

The Cook Ciaglia percutaneous tracheostomy devices are designed for percutaneous dilational tracheostomy for management of the airway. More specifically, the devices allow for two approaches to the dilation of the stoma: serial dilation (Ciaglia Percutaneous Tracheostomy Introducer Set) or single-stage dilation (Blue Rhino® and Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set). Serial dilation is achieved using numerous progressively larger dilators. Single-stage dilation is achieved with a single rhino-horn-shaped dilator using an in-and-out motion. The Cook Ciaglia percutaneous tracheostomy devices are sold sterile for single use. There are multiple configurations that include various set and tray components (Table 1) associated with the procedure and/or in gaining percutaneous access.

The provided document describes the Cook Ciaglia percutaneous tracheostomy devices and their substantial equivalence to a predicate device, K041348: Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit. The submission focuses on non-clinical testing and a summary of existing clinical literature rather than a new standalone clinical study for this 510(k) submission.

Here's the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests with associated acceptance criteria, but it primarily states that the test article met the predetermined acceptance criteria or was greater than/less than or equal to the acceptance criterion/predicate. Specific numerical acceptance criteria or performance metrics are not explicitly detailed in the tables or text.

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

The document does not specify the sample sizes (n) used for each individual non-clinical test mentioned (e.g., tensile, compression, fracture). The data provenance for these non-clinical tests is "in-house" by Cook Incorporated.

For the summary of clinical performance, which involved an evaluation of published clinical evidence:

• Test Set (Clinical Evidence Review):
  • Cook devices: 24 articles incorporating 8,726 patients.
  • Predicate device (Portex Ultraperc): 4 articles incorporating 1,036 patients.
• Data Provenance: Retrospective literature review of published clinical evidence. The specific countries of origin for the studies included in this review are not mentioned.

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

N/A for the non-clinical tests, as ground truth is based on engineering specifications and direct measurement.

For the clinical evidence review, there is no mention of external experts establishing ground truth for the summarized papers. The review itself constitutes an assessment by the applicant, Cook Incorporated.

4. Adjudication Method for the Test Set

N/A for non-clinical testing. For the clinical evidence review, no specific adjudication method for the included articles is described; it appears to be a summary of findings rather than a formal adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical tests were not required to demonstrate substantial equivalence of the Cook Ciaglia percutaneous tracheostomy devices as compared to the predicate devices." Instead, a summation of existing clinical literature was performed. Therefore, an MRMC comparative effectiveness study was not conducted as part of this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a medical device (tracheostomy introducer set), not an AI algorithm. The performance evaluation is based on the physical properties and function of the device itself and its components.

7. The Type of Ground Truth Used

• Non-Clinical Testing: Engineering specifications, design requirements, and direct physical measurements (e.g., load, force, kinking absence, fit). For some tests (e.g., 3 Point Bend, Insertion Force), the predicate device's performance also served as a comparative "ground truth" or benchmark.
• Summary of Clinical Performance: Published clinical evidence (peer-reviewed articles) on the safety and effectiveness of the subject and predicate devices, which would have their own established ground truths (e.g., clinical outcomes, complication rates from patient data).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device. There is no "training set" in the context of this device submission.

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

N/A. Not applicable as there is no training set for an AI/ML device.

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The Cantata® 2.9 Microcatheters are intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

The Cantata 2.9 Microcatheters are braided microcatheters with hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. The devices include one radiopaque marker band to assist in fluoroscopic visualization of the catheter during use. The catheters are available in 2.9 French shafts and are available in 100, 110, 135, and 150 centimeter lengths. The devices are compatible with a 0.038 inch (0.97 millimeters) diameter angiographic catheter and can accept 0.018 inch (0.46 millimeters) and 0.021 inch (0.53 millimeters) diameter wire guides.

The provided text describes performance testing for the Cantata® 2.9 Microcatheter. This is a medical device, not an AI/ML algorithm, therefore most of the requested information about AI model specifics (training set, experts, MRMC studies, etc.) is not applicable.

Here's the information that can be extracted relevant to the performance of the Cantata® 2.9 Microcatheter:

Acceptance Criteria and Device Performance

Study Information (Non-AI Device)

1. Sample size used for the test set and the data provenance: Not explicitly stated for each test in terms of a "test set" for an algorithm. These are physical device tests. Sample sizes would refer to the number of physical devices or animal subjects used, which is not detailed beyond "test article(s)" or "animal model." The provenance is internal testing by Cook Incorporated, a U.S. company. The studies are prospective in nature, as they involve testing newly manufactured devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and biocompatibility tests is established through standardized methodologies and objective measurements, not expert consensus on interpretations.
3. Adjudication method for the test set: Not applicable. Test results are objective measurements against predetermined physical or biological criteria.
4. 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 device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used:
   • Physical Properties: Objective measurements against engineering specifications (e.g., force in Newtons, pressure in kPa/psi, diameter in mm, radius in mm).
   • Biocompatibility: Established ISO standards and direct biological response (e.g., lysis score, sensitization response, observation of toxicity, hemolytic index, clotting time).
   • Functional Performance: Qualitative and quantitative assessment of device behavior in simulated environments (e.g., tracking through a tortuosity fixture, ability to deliver particles) or animal models (e.g., preparation, introduction, pushability, trackability, radiopacity).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The Advance CS Coronary Sinus Infusion Catheter is intended for temporary occlusion of the coronary sinus for infusion of contrast media, drugs, or therapeutic agents; or possible introduction of devices into the coronary venous system.

The Advance® CS Coronary Sinus Infusion Catheter is an over-the-wire catheter. The 5.0 Fr balloon catheter is compatible with a 0.035 inch diameter wire guide. The device will be supplied sterile and intended for one-time use.

The Cook Advance® CS Coronary Sinus Infusion Catheter underwent a series of non-clinical bench and animal tests to establish its safety and performance. The primary goal of these tests was to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

• 2. Sample Size and Data Provenance:

  • The document does not explicitly state the specific number of devices or samples used for each individual test. However, the phrasing "all test articles" and "similar test articles" suggests that multiple units were tested for each criterion.
  • The testing was performed by Cook Medical, a U.S.-based company. The animal evaluation was conducted in vivo, likely in a controlled laboratory setting (indicated by "acute inflation of the balloon in the porcine coronary sinus"). This suggests prospective testing for device validation.

• 3. Number of Experts and Qualifications for Ground Truth:

  • This section is not applicable as the study involves non-clinical bench testing and animal evaluations, not studies requiring human expert assessment of images or data for ground truth establishment.

• 4. Adjudication Method:

  • This section is not applicable for non-clinical bench and animal testing. The results are typically objectively measured and evaluated against predefined engineering specifications.

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

  • No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices interpreting medical images, not for the performance testing of a catheter.

• 6. Standalone Performance (Algorithm Only):

  • This section is not applicable as the device is a physical medical catheter, not a software algorithm.

• 7. Type of Ground Truth Used:

  • The ground truth for these tests was established through:
    • Engineering Specifications/Standards: Predetermined acceptance criteria based on product design specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility), and regulatory requirements for medical devices.
    • Physical Measurements: Direct measurements of device attributes (e.g., burst pressure, dimensions, inflation/deflation times, force resistance).
    • Qualitative Observations: Visual inspection for leaks, damage, and compatibility.
    • Biological Response Assessment: In the animal study, the safety and biological response were characterized, implying observation and evaluation by veterinarians or researchers.

• 8. Sample Size for the Training Set:

  • This section is not applicable. There is no "training set" in the context of physical medical device performance testing, as these are not machine learning or AI models. The testing described focuses on verifying the device's adherence to specifications.

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

  • This section is not applicable for the reasons stated above.

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Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject® PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The proposed Spectrum Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr and 5.0 Fr single and double lumen catheters. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

The provided text describes a 510(k) summary for the Cook Medical Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set. It outlines the device's intended use, comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For "Static Failure Pressure Testing" and "Antimicrobial Testing", the specific numerical acceptance criteria (other than >15mm for antimicrobial, which is also stated as "predetermined") are not explicitly defined in the document, but the document states the device met them.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., number of catheters tested for tensile strength or leakage).
The data provenance is retrospective, as the submission is for modifications to previously cleared devices (K081690, K072625, K132334, K132885). The testing was conducted to demonstrate substantial equivalence to these predicate devices. The country of origin of the data is not specified, but the applicant address is in Bloomington, IN, USA.

3. Number of Experts and Qualifications

The document does not mention the involvement of experts to establish ground truth for a test set. The tests describe physical and performance characteristics of the device, which are typically evaluated through laboratory testing against predefined engineering specifications.

4. Adjudication Method

Not applicable. This type of submission (510k for a medical device) typically relies on laboratory testing and engineering specifications rather than expert adjudication of a test set, which is more common in diagnostic device or AI algorithm evaluations.

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

No MRMC comparative effectiveness study was mentioned. The device is a "Peripherally Inserted Central Venous Catheter Set," a physical medical device, not a diagnostic imaging or AI-assisted system that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established criteria for medical device safety and effectiveness. For example:

• Tensile strength: Measured against a force (10 N).
• Leakage: Absence of liquid/air leakage.
• Pressure: Ability to withstand specified pressure (325 psi).
• Antimicrobial activity: Measured zone of inhibition (15 mm).
  These are objective, quantitative measurements against predefined standards.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal validation and verification activities, but these are not referred to as training sets.

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

Not applicable, as there is no training set for this type of device. The specifications and acceptable performance limits are derived from industry standards (e.g., ISO 10555-1:1995), regulatory requirements, and the performance characteristics of predicate devices.

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The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapoplal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Advance® 35LP PTA Balloon Dilatation Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 3, 4. 5, 6, 7, 8, 9, 10, and 12 millimeters and balloon lengths of 1.5. 2. 2.5. 3. 4. 6. 8. 10. 12. 14. 17. and 20 centimeters. The catheters are 5.2 French or 5.7 French, dependent upon device specification, and will be available in lengths of 80 and 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.

The provided text describes the acceptance criteria and a study demonstrating that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter meets these criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a specific numerical sample size for each test. Instead, it uses phrases like "each balloon," "diameters for each catheter," and "the balloons," implying that multiple devices were tested to ensure consistency across their product line.
• Data Provenance: The data appears to be retrospective and internal to Cook Medical, generated from laboratory testing conducted on manufactured devices ("under simulated body temperature conditions"). There is no mention of data from external sources or clinical trials. The country of origin for the company is the U.S. (Bloomington, IN).

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

This information is not provided in the document. The tests performed are engineering and performance-based (e.g., measuring diameter, resistance, burst pressure, fatigue cycles), which typically do not involve human expert consensus for 'ground truth' in the same way clinical diagnoses would. The "ground truth" for these tests is defined by pre-established engineering specifications and international standards (e.g., ISO 10555-4, ISO 10555-1).

4. Adjudication method for the test set:

This information is not applicable as the tests are objective, performance-based measurements against predefined engineering criteria, rather than subjective assessments requiring adjudication by multiple experts.

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

This is not applicable. The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The device is a physical medical device, not an algorithm. The "standalone performance" is demonstrated by the physical and mechanical tests outlined (e.g., compliance, burst, fatigue).

7. The type of ground truth used:

The ground truth used for these tests is based on engineering specifications, predetermined acceptance criteria, and compliance with international standards (ISO 10555-1, ISO 10555-4). For example, the "labeled diameter at the nominal pressure" and "minimum rated burst pressure" serve as the ground truth against which device performance is measured.

8. The sample size for the training set:

This is not applicable. The device undergoes physical and mechanical testing, not machine learning or AI model training. Therefore, there is no "training set."

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

This is not applicable for the same reason as above; there is no training set mentioned or implied as this is not an AI/ML device.

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The Entuit™ Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

The Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set consist of 2 or 3 introducer needles with pre-loaded suture anchors and a wire guide. A notch is located on the distal tip of the introducer needle. The coil anchor is placed in the notch prior to placement. The proximal end of the suture anchor contains the suture retention mechanism.

The retention mechanism of the Entuit Secure Gastrointestinal Suture Anchor consists of an extension spring which is glued on the proximal end within a suture retention housing. The suture is threaded through the coils of the extension spring. When the suture retention mechanism is pushed towards the anchor, tension is applied to the spring, which causes the coils of the spring to open. This allows the suture to slide through the spring and allows the retention mechanism to slide along the suture. When the retention mechanism is pulled away from the anchor, the coils of the spring compress and clamp down on the suture. This does not allow the suture to slide through the spring and maintains tension on the suture anchor.

The adjustable suture retention mechanism of the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set consists of a suture retention housing, a compression spring, a compression jaw, and a removable adjustable tab. The suture is threaded through the suture retention housing and held in place by the compression jaws and the compression spring. The adjustable tab must be compressed for the suture to be adjusted. When the adjustable tab is compressed, the spring and compression jaws do not contact the suture. This allows the suture retention mechanism to slide along the suture. Once the suture retention mechanism is in place, the compression jaws will maintain tension on the suture anchor, and the adjustable tab can be removed.

Both of the proposed devices are supplied sterile and are intended for one-time use.

The provided text describes a 510(k) summary for the Entuit™ Secure Gastrointestinal Suture Anchor Set and its adjustable counterpart. This summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

Based on the document, here's what can be extracted and inferred regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria":

The "device" in this context refers to the Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set.

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the devices met predetermined acceptance criteria for various tests. However, the specific numerical acceptance criteria themselves are not provided, nor are precise quantitative performance results. Instead, it offers qualitative statements about meeting these criteria.

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

The document does not specify the sample sizes used for the tensile, fatigue, biocompatibility, or torque testing. It also does not mention country of origin of data or whether the studies were retrospective or prospective, as these are typically bench tests or in-vitro tests for a device of this nature, not clinical studies involving patient data.

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

This information is not applicable and therefore not provided in the document. The tests performed are engineering and biological tests (tensile, fatigue, biocompatibility, torque) on the device components or the entire device, not clinical evaluations that require expert interpretation of results or ground truth established by medical professionals.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are relevant for studies where multiple expert opinions are reconciled, typically in clinical evaluations or image interpretation. The tests described are objective, physical measurements.

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

An MRMC comparative effectiveness study was not done, as this device is a medical instrument (suture anchor set) and not an AI-powered diagnostic or interpretive tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

A standalone performance evaluation was not done, as this device is a medical instrument and does not involve any algorithms or AI.

7. The Type of Ground Truth Used

For the engineering tests (tensile, fatigue, torque), the "ground truth" would be defined by engineering specifications and standards (e.g., minimum tensile strength required for anchoring the stomach wall, acceptable levels of fatigue over a certain number of cycles, biocompatibility standards per ISO 10993-1). These are objective, measurable criteria. For biocompatibility, it's about meeting established biological safety levels.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI/algorithm and therefore does not have a "training set."

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

This section is not applicable as the device is not an AI/algorithm.

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The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

The Cook® Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction at term when the cervix is unfavorable for induction. The tip of the Cook® Cervical Ripening Balloon is placed through the vagina and the cervical canal into the uterus. The distal balloon is positioned against the internal cervical os and inflated with up to 80 mL of saline; the proximal balloon is positioned against the external cervical os and also inflated with up to 80 mL of saline. The Cook Cervical Ripening Balloon provides gradual mechanical cervical dilation by simultaneously providing pressure on the internal and external cervical os.

In addition to the standard version, the Cook® Cervical Ripening Balloon is also available with a removable stylet to add rigidity to the catheter and aid in placement of the balloon through the cervix. The stylet runs the length of the catheter shaft of the Cook® Cervical Ripening Balloon in a separate lumen that is closed at the distal tip. The user removes the stylet from the device once the distal uterine balloon is above the level of the internal cervical os.

The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. This device is regulated under 21 CFR § 884.4260 as a Class II device (Hygroscopic Laminaria cervical dilator).

Acceptance Criteria and Device Performance:

The provided document describes a series of verification tests to demonstrate the reliable design and performance of the Cook® Cervical Ripening Balloon. The acceptance criteria are implicitly defined by the successful completion of these tests.

Study Details:

The provided text describes a premarket notification for a medical device (510(k)) and outlines the verification testing performed. It does not describe a clinical study in the traditional sense with patient data, statistical analyses, or comparative effectiveness. Instead, it focuses on engineering and biocompatibility testing. Therefore, many of the requested details are not applicable to the information provided.

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

   • The document describes verification testing rather than testing on a clinical "test set" of patient data. The "samples" would refer to the number of devices tested for each engineering and biocompatibility test (e.g., how many balloons were burst tested, how many catheters were tensile tested). This information (specific sample sizes per test) is not provided in the summary.
   • Data provenance for these engineering tests would typically be the manufacturing facility or a contract testing lab. This information is not explicitly stated, nor is it typically included in a high-level 510(k) summary for engineering tests. The tests are "simulated use conditions," implying laboratory or bench testing rather than human subject data.

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

   • Not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For engineering and biocompatibility tests, "ground truth" is typically defined by scientific principles, standards (like ISO 10993-1), and pre-defined pass/fail criteria. These tests are conducted by engineers and scientists, not typically by medical experts establishing a "ground truth" for patient cases.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation) where there might be disagreement among reviewers. For physical product verification tests, the results are typically objective measurements against pre-defined specifications.

4. 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 device (balloon catheter), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance, especially of AI/CAD systems.

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

   • Not applicable, for the same reason as above. This is a physical device, not an algorithm.

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

   • For the engineering tests, the "ground truth" is defined by the technical specifications, standards (e.g., ISO 10993-1 for biocompatibility), and physical laws that govern the device's performance. The successful demonstration against these criteria means the device performs as intended and meets safety requirements.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of physical medical device verification testing as described. This term applies to machine learning or AI models.

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

   • Not applicable, as there is no training set for this type of device submission.

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