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The Cordis Webster Fixed Curve Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e. stimulation and recording only.

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Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each performance measure.
  • For "adequate pull strength," it states "All samples," but the number of samples is not specified.
  • For "absence of adverse events in pediatric patients," it refers to "three letters from physicians," which implies a limited sample, but the specific number of pediatric patients observed by these physicians is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective studies. The physician letters suggest clinical experience, which could be retrospective observation. The complaints data would be real-world post-market data. The pull strength testing would be in a controlled lab environment.
• Country of Origin: Not specified in the provided text.

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

• Number of Experts: Three (physicians).
• Qualifications: "Physicians" are mentioned. Their specific qualifications (e.g., pediatric cardiologists, electrophysiologists, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• No formal adjudication method is described for the "absence of adverse events" data from the physicians. It appears to be based on individual clinical experience as reported in letters. For pull strength, it's a pass/fail mechanical test, so no expert adjudication is required. For complaint data, it is simply a record of complaints.

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

• No MRMC study was done. This device is a physical catheter, not an AI or imaging device where MRMC studies are typically conducted to assess reader performance with or without AI assistance.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

• Not applicable. This is a physical medical device (catheter), not a software algorithm.

7. Type of Ground Truth Used

• Pull Strength: Mechanical testing against predefined acceptance criteria for physical properties.
• Absence of Adverse Events: Clinical observation and experience as reported by physicians. This is a form of real-world evidence or expert opinion.
• Complaints: Real-world post-market surveillance data.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set. The "capability testing" for pull strength would be considered part of the verification and validation process, not "training."

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

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

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The intended use of the Diagnostic Deflectable Tip Catheter is to map cardiac structures using stimulation and recording techniques. The Cordis Webster Diagnostic Deflectable Tip Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e. stimulation and recording only.

The Diagnostic Deflectable Tip Catheter (5 French size) modification is applicable only to the Instructions for Use. The function, component materials, and intended use of the Diagnostic Deflectable Tip Catheter as compared to the Predicate Device (of the same name - K892265) are identical. An additional indication for use and warning are added that allows the use of the catheter to not only be used in adults but in children 4 years of age and older. The additional warning is to alert the physician regarding the possibility of brachial plexus injury. These additions to the IFU were requested by FDA on behalf of P950005/S3, the pediatric indication approval for Cordis Webster's Diagnostic/Ablation Deflectable Tip Catheters, 6 and 7 French. They also apply to the 5 French diagnostic catheter. The safety or effectiveness of the subject device was not affected as the device itself has not been altered. The Diagnostic Deflectable Tip Catheter (5 French size) is essentially a smaller diameter version of the Premarket Notified 6. 7 French design. These catheters were designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing platinum electrodes that can be used for stimulation and recording. The 5 French Deflectable Catheter utilized the same design features that are in the present deflectable catheter with the exception of the tip electrode connection/termination method. The electrical connection is made in the same way as is done with the Predicate Device, however, the puller-wire which is normally anchored proximal to the tip is terminated (soldered) directly to the tip electrode. Since the puller-wire is attached to the tip electrode, the puller-wire replaces the safety wires that were in the 6 and 7 French Deflectable Catheters. This tip electrode connection/termination method is also utilized for the Crista Cath™ diagnostic catheter approved under K953768.

The provided text describes a 510(k) submission for a Diagnostic Deflectable Tip Catheter (5 French size) modification. The submission aims to demonstrate substantial equivalence to a predicate device (K892265). The core of the modification is an additional indication for use, allowing the catheter to be used in children 4 years of age and older, and a warning about brachial plexus injury. The device itself has not been altered in its fundamental design or function compared to the predicate device, other than being a smaller diameter version of 6 and 7 French designs. The key change is a modification in the tip electrode connection/termination method, where the puller-wire is soldered directly to the tip electrode, replacing safety wires.

Here's the information broken down as requested:

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

Based on the provided text, the acceptance criteria are not explicitly stated as numerical targets. Instead, the performance evaluation relies on demonstrating substantial equivalence to a predicate device and showing the safety and effectiveness of the modifications.

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 the "process capability study" on puller wires: Not specified. The text only states that "pull tests were conducted."
  • For the "published literature" cited for pediatric use: Not specified. It's external literature, not a study performed by the applicant on this specific device.
  • For "complaint data": Not specified. "Number of complaints versus the number of units sold" is mentioned, but no actual numbers are provided.
• Data Provenance: Not explicitly stated for any of the data points.
  • The "process capability study" would likely be an internal study conducted by the manufacturer, but the location is not mentioned.
  • "Published literature" could be from various global sources.
  • "Complaint data" would be post-market surveillance data, likely collected globally wherever the predicate device was sold.
  • General information points to the applicant's address in Baldwin Park, CA, and Diamond Bar, CA, which are in the USA.

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. The submission does not describe a study involving expert review or ground truth establishment in the traditional sense for a diagnostic algorithm. The assessment relies on mechanical testing (pull tests), existing literature, and market surveillance.

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

• Not Applicable. There is no mention of expert adjudication for a test set.

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

• No. This is a medical device (catheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

• No. This is a medical device (catheter), not an algorithm. Standalone performance for an algorithm is not applicable.

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

• For the pediatric indication, the "ground truth" for safety and effectiveness appears to be derived from published literature on similar smaller French-size catheters, rather than a specific ground truth established for this device's study.
• For the mechanical integrity of the puller-wire, the ground truth is established through physical pull tests where the wire's breaking strength or securement is objectively measured against engineering specifications. No expert consensus, pathology, or outcomes data is relevant here.
• For overall safety, complaint data (post-market outcomes) indirectly serves as a measure.

8. The sample size for the training set

• Not Applicable. As this is a medical device (catheter) and not an AI/algorithmic device, there is no concept of a "training set" in the context of machine learning.

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

• Not Applicable. Same as above, no training set is relevant.

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The intended use of the Modified Device is to provide stability and directional control during transcatheter ablation of endocardial tissue.

PREFACE Braided Guiding Sheath - The intended use of the percutaneous Braided Guiding Sheath is for the introduction of intravascular electrophysiology catheters into any cardiac chamber.

PERRY Exchange Dilator - The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.

The components of the Predicate Device (K970264) consists of 1) a Guiding Sheath with posterior, anterior or multipurpose shaped distal tip section, 2) a conventional sheath vessel dilator (vessel dilator), 3) a dual-tapered long vessel dilator (exchange dilator), 4) a .032", 260cm guidewire, and 5) a guidewire funnel. The components of the Predicate Device are packaged in four configurations: 1) Guiding Sheath w/ posterior curve and vessel dilator, 2) Guiding Sheath w/ anterior curve and vessel dilator, 3) Guiding Sheath w/ multipurpose curve, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel, and 4) Posterior, Anterior and Multipurpose Guiding Sheaths, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel.

The packaging configuration of the Predicate Device has been modified to offer the Guiding Sheath and Exchange System in two separate packages. The Guiding Sheath (PREFACE Braided Guiding Sheath) with posterior, anterior or multipurpose shaped distal tip sections is packaged with a vessel dilator and a short .032", 150cm guidewire. The Exchange System includes the exchange dilator (PERRY Exchange Dilator), .032", 260cm guidewire, and guidewire funnel. The distal end of the vessel dilator and both ends of the PERRY Exchange Dilator were modified by adding radiopaque tips with tungsten to improve visibility under fluoroscopy. The function and intended use of the Modified Device as compared to the Predicate Device are identical, as are all component materials with the exception of the tungsten dilator material. The addition of the tungsten material does not affect safety or effectiveness as demonstrated in the Verification Test Data provided in Appendix I.

The PREFACE Braided Guiding Sheaths are intended to provide stability and directional control during catheter ablation. The PREFACE Braided Guiding Sheath is packaged with a vessel dilator with a radiopaque distal tip, and a .032", 150cm guidewire. The PERRY Exchange Dilator will be utilized by the physician to exchange the existing PREFACE Braided Guiding Sheath for an alternate PREFACE Braided Guiding Sheath without losing the established intracardiac position. The PERRY Exchange Dilator with radiopaque ends is packaged with a .032", 260cm guidewire and guidewire funnel.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

The document (K982740) describes a Special 510(k) for a "Device Modification Cordis Webster Braided Guiding Sheath Exchange System." This is a modification of an existing device (Predicate Device K970264). The core of this submission is to demonstrate that the modified device is substantially equivalent to the predicate device, particularly because of changes made to the dilators (adding radiopaque tips with tungsten for improved visibility).

Key Finding: This submission does not detail a study with specific acceptance criteria related to a diagnostic or AI-based performance. Instead, it focuses on verification testing to demonstrate that the modification (the addition of tungsten to the dilators) does not adversely affect the device's safety or effectiveness compared to the predicate device.

Therefore, many of the requested categories (like performance metrics, sample size for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and AI-specific ground truth) are not applicable to this type of device modification submission.

Acceptance Criteria and Study Details (Based on Provided Text)

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

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: Not specified in the provided summary. The submission refers to "Verification Test Data provided in Appendix I," which is not included. These types of tests typically involve a limited number of physical samples (e.g., a few units of each size/component for mechanical testing).
• Data Provenance: Not specified, but generally, such verification testing is conducted in a controlled lab environment by the device manufacturer.

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 not a diagnostic device or an AI-algorithm requiring expert ground truth in that sense. The "ground truth" for mechanical properties would be derived from standard engineering measurement techniques and comparison to established benchmarks (e.g., the predicate device or a standard sheath).

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

• No. This is not a diagnostic device, and no AI component is described.

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

• No. This is not an AI-enabled device.

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

• The ground truth for the mechanical properties (stiffness, insertion force) would likely be quantitative physical measurements obtained through standard engineering testing methods. The "ground truth" for safety and effectiveness relative to the modification is the comparison against the predicate device's established performance and relevant material standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning device.

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

• Not Applicable. See point 8.

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The intended use of the New Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment.

The Cordis Webster REF-STAR External Reference Patch is indicated for the use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.

The REF-STAR External Reference Patch (ERP) is an integral part of a nonfluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the intracardiac location of the NAVI-STAR or NOGA-STAR mapping catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to an handle that houses the printed circuit board.

The ERP, like the Predicate Device the Ex Surface Reference Device, is an external device placed on the patient's back by an adhesive patch. The adhesive patch is located on the distal end of the reference device and sandwiches a Biosensor in-between two hypoallergenic adhesive foam pads. The patch is permanently fixed to the shaft and acts as protection for the Biosensor in addition to providing a way to attach the sensor to the patient. The shaft is an Estane material which is radiolucent and houses the electrical cables for the Biosensor. The Biosensor is connected to a PC board which amplifies the electrical signal before it is transferred to the CARTO or NOGA system. The PC board also contains calibration data for the X, Y and Z axis of the sensor. The strain relief for the shaft as it enters the Barrel Cone is made up of two layers of Polyolefin heat shrink tubing. The Barrel Cone is made of Delrin and is attached to the Barrel Extension which is also made of Delrin. The Barrel Extension houses the PC board and connector. The PC board is surrounded by a Mu Metal Shield to protect it from electromagnetic interference.

The provided document describes a 510(k) summary for the REF-STAR External Reference Patch. It is a submission for substantial equivalence to a predicate device, not a study proving a novel device meets specific acceptance criteria in a clinical setting with human subjects. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes "Verification testing" to confirm the device's characteristics against a predicate. It does not list specific numerical acceptance criteria or performance metrics directly from the testing. The statement is broad, indicating the new device's technological characteristics are the same as the predicate.

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

The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It refers to "Verification testing" but doesn't elaborate on the methodology or data collection.

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

Not applicable. This is a regulatory filing for a device, not a study involving expert-established ground truth. The device's function is purely technical in providing a reference location.

4. Adjudication method for the test set

Not applicable. This does not involve adjudication by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This device is a passive external reference patch, not an AI or diagnostic tool that would typically undergo such a study.

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

This is not applicable as the device is a hardware component. Its performance is inherent to its physical and electrical properties when integrated into the CARTO and NOGA systems. It does not have an "algorithm only" mode.

7. The type of ground truth used

"Verification testing" was conducted against the "Predicate Device." The ground truth for proving the new device's performance is essentially the established performance and characteristics of the existing, legally marketed predicate device.

8. The sample size for the training set

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

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

Not applicable. This device is not an AI algorithm.

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The Cordis Webster REF-STAR Ex Surface Reference Device is indicated for use with the NAVI-STAR®, NOGA-STAR™, or REF-STAR catheters and the CARTO™ and NOGA ™ systems to provide catheter tip location.

The Cordis Webster REF-STAR Ex Surface Reference Device has been designed to be placed externally on the patient's back in order to compensate for movement during electrophysiological and electromechanical mapping of the heart. The Cordis Webster REF-STAR Ex Surface Reference is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology known as CARTO™ and NOGA ™. When used with the CARTO and NOGA system, the location of the mapping catheter tip, the NAVI-STAR, NOGA-STAR or REF-STAR is compared to the location of the reference device. This reference device consists of a sensor embedded in a polyurethane shaft, which is connected to a handle that houses the printed circuit board.

This 510(k) summary describes a substantial equivalence determination for the Cordis Webster REF-STAR Ex Surface Reference Device, comparing it to a predicate device. The information provided focuses on the nonclinical testing performed to demonstrate this equivalence, rather than a clinical study with detailed acceptance criteria and performance metrics in the way a new, innovative device might be evaluated for efficacy.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria in the typical format of a new product performance study (e.g., sensitivity > X%, accuracy > Y%). Instead, the acceptance criterion for this 510(k) submission is "no significant differences in the outcome of the tests...that would affect the safety and effectiveness of the device" compared to the predicate device.

2. 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 nonclinical testing. Therefore, there are no human subject sample sizes or data provenance in terms of country of origin or retrospective/prospective clinical data mentioned. The "tests" refer to laboratory or bench tests.

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)

This information is not applicable as the evaluation was based on nonclinical performance testing, not human expert interpretation or ground truth establishment in a clinical context.

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

This information is not applicable as the evaluation was based on nonclinical performance testing, not human 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

This information is not applicable. The device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

This information is not applicable. The device is a physical surface reference device, not an algorithm. The testing described is nonclinical performance testing comparing the device to a predicate.

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

For the nonclinical performance testing, the "ground truth" would be the expected performance specifications and measurements defined for the device and its predicate. The performance of the REF-STAR Ex Surface Reference Device was compared directly against the performance of the predicate device (Cordis Webster REF-STAR catheter) in a controlled test environment. The implicit ground truth is that the predicate device is considered safe and effective, and thus the new device must perform comparably.

8. The sample size for the training set

This information is not applicable. The device is not an AI algorithm requiring a training set. The testing was nonclinical comparative performance testing of a physical device.

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

This information is not applicable for the same reason as above; there is no training set for a physical device undergoing nonclinical performance testing.

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The intended use of the percutaneous Braided Guiding Sheath Exchange System is for the introduction of intravascular electrophysiology catheters into any cardiac chamber.

The Cordis Webster Braided Guiding Sheath Exchange System consists of guiding sheaths with a sideport and valve, pre-shaped distal tip section with radiopaque brite tip, a guidewire, a conventional vessel dilator, and a long tapered exchange vessel dilator with a multipurpose curve at the distal end. The guiding sheaths have large non-tapered lumens that allow for intravascular passage of catheters and infusion of heparinized normal saline and/or contrast medium. The guiding sheaths feature a nylon body reinforced with a tightly wound stainless steel braid wire. The braid wire extends from the proximal hub through several flexible transition segments to the "brite tip" which is a low durometer Polyurethane with radiopaque filler at the distal end. The transition segments are comprised of several durometers of material designed to vary the stiffness along the entire length of the guiding sheath shaft. The higher durometer is used on the proximal segment of the shaft to yield a stiffer segment. This stiffer segment provides the added support required to manipulate the guiding sheath during cannulation. The distal transition segments utilize an increasingly softer durometer which provides the flexible atraumatic distal tip segment.

This submission describes a medical device, the Cordis Webster Braided Guiding Sheath Exchange System, seeking 510(k) clearance, which relies on demonstrating substantial equivalence to predicate devices rather than proving novel performance against specific acceptance criteria in a clinical study. Therefore, a direct table of acceptance criteria and reported device performance, as well as several other requested study details, are not applicable in the context of this 510(k) summary.

Here's a breakdown of the information provided in the 510(k) summary as it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A) for a 510(k) Predicate Device Submission.

For 510(k) submissions demonstrating substantial equivalence, the "acceptance criteria" are generally that the new device performs as well as or does not raise different questions of safety and effectiveness compared to a legally marketed predicate device. The performance data presented focuses on showing this equivalence.

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

• Sample Size for Test Set: Not specified in terms of patient data. The "tests" refer to nonclinical (bench) performance testing. The number of samples for each specific bench test (e.g., tensile strength, flexibility) is not provided.
• Data Provenance (e.g., country of origin, retrospective or prospective): The data is from nonclinical testing (bench testing), not human or animal studies. Therefore, concepts like country of origin, retrospective, or prospective do not apply.

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

Not Applicable.

No expert consensus for ground truth was established because the testing was nonclinical (bench testing) comparing physical and mechanical properties to predicate devices, not clinical outcomes requiring expert interpretation.

4. Adjudication Method for the Test Set

Not Applicable.

No adjudication method was used as the testing was nonclinical (bench testing).

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

No, an MRMC comparative effectiveness study was not done.

This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure the impact of the AI. As this submission describes a physical medical device (guiding sheath system) and relies on nonclinical testing for 510(k) clearance, an MRMC study is not relevant or required.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done.

This type of study applies to AI/ML algorithms. The device in question is a physical medical device.

7. Type of Ground Truth Used

Not Applicable.

For nonclinical testing of a physical device, the "ground truth" is typically established by engineering specifications, material properties, and established test methods for device performance (e.g., burst pressure, stiffness, lubricity). It's not a clinical "truth" derived from pathology or outcomes data. The "truth" here is the performance of the predicate devices.

8. Sample Size for the Training Set

Not Applicable.

There is no "training set" as this is a physical medical device and not an AI/ML algorithm.

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

Not Applicable.

As there is no training set, there's no ground truth established for it.

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The Cordis Webster deflectable 720 electrode catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The preformed shape of the tip section is designed specifically for the tricuspid annulus.

The Cordis Webster deflectable 720 electrode catheter has been designed for electrophysiological mapping of the tricuspid annulus. The catheter has a high-torque shaft with a halo-shaped tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The tip section also contains a radiopaque marker in the center of the electrode array. The tip section of the catheter has a halo-shaped preformed loop which can be positioned around the atrial aspect of the tricuspid annulus.

A piston in the handpiece is attached to an internal puller which changes the radius of curvature. When the piston is pushed forward, the radius of curvature of the preformed loop is reduced; when the thumbknob is pulled back, the radius of curvature is increased until the tip section returns to the preformed shape. The high-torque shaft allows the plane of the loop to be maneuvered in order to facilitate accurate positioning.

The Cordis Webster deflectable T20 electrode catheter facilitates simultaneously local electrograms spanning the tricuspid annulus, from midseptal to anterior to lateral to posterolateral. Recordings of the entire annulus can be obtained without repositioning the catheter tip.

This product is a medical device (catheter), not an AI/ML device, and therefore the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies, standalone AI performance, training/test set details, and ground truth establishment for AI) is not applicable.

The provided text describes a 510(k) summary for a Cordis Webster T20 Diagnostic Deflectable Tip Catheter. This summary focuses on demonstrating substantial equivalence to a predicate device, which is a common regulatory pathway for medical devices that are not novel.

Here's an breakdown of the relevant information provided, explaining why AI-specific questions are not applicable:

1. Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: For non-AI medical devices, acceptance criteria are generally established based on safety and effectiveness compared to a legally marketed predicate device. The goal is to show the new device is "as safe and effective" as the predicate.
   • Reported Device Performance: The document states that "The nonclinical performance testing performed on the 720 electrode catheter compared to the predicate device indicated that there were no statistically significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device."
   • Basis for Performance: The performance was evaluated through nonclinical tests (likely bench testing, mechanical tests, electrical integrity, biocompatibility, etc.) according to FDA's "Electrode Recording Catheter Preliminary Guidance."

   Table (Not Directly Available for AI Metrics, but for Device Equivalence):

   Acceptance Criterion (Implicit)	Reported Device Performance
   Safety and Effectiveness comparable to predicate device	"no statistically significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device."
   Performance according to FDA's "Electrode Recording Catheter Preliminary Guidance"	Tests "were performed according to FDA's 'Electrode Recording Catheter Preliminary Guidance'." (Success implied by "no statistically significant differences" conclusion)

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

   • Not applicable: This pertains to clinical data for AI/ML or efficacy trials. The provided document describes nonclinical (bench) testing, not patient data trials. Therefore, sample sizes for "test sets" in the AI sense, data provenance, retrospective/prospective distinctions, and country of origin are not mentioned or relevant to this type of device 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: Ground truth and expert adjudication are concepts relevant to AI model validation, particularly in image interpretation or diagnostic aid devices. This catheter is a diagnostic tool for electrophysiological mapping, not an AI interpreting data or images. Its performance is assessed through engineering and physical tests.

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

   • Not applicable: Adjudication methods are used in studies where human reviewers provide judgments (e.g., classifying images), and discrepancies need to be resolved. This is not relevant for a physical medical device undergoing nonclinical 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: MRMC studies evaluate the impact of an AI diagnostic aid on human reader performance. This device is a catheter used for recording, not an AI software.

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

   • Not applicable: This question refers to AI algorithm performance without human intervention. The device is a physical catheter that requires a human operator for its intended use.

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

   • Not applicable: As explained above, "ground truth" as a reference for AI model accuracy is not relevant here. The "truth" in this context is whether the catheter meets its engineering specifications and performs comparably to the predicate device in nonclinical tests.

8. The sample size for the training set:

   • Not applicable: Training sets are used for machine learning models. This is a physical medical device.

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

   • Not applicable: See point 8.

In summary, the provided document describes a traditional 510(k) submission for a non-AI medical device (a catheter). The evaluation is based on nonclinical performance testing to demonstrate substantial equivalence to a predicate device, not on AI/ML performance metrics like accuracy, ground truth, or reader studies.

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The Cordis Webster deflectable braided-tip electrode catheter is indicated for electrophysiological mapping of cardiac structures; i.e., endocardial stimulation and recording within the right side of the heart.

The Cordis Webster deflectable braided-tip electrode catheter has been designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque shaft with an internal stainless steel braid and a tip section containing platinum electrodes that can easily be seen under fluoroscopy. The tip section also employs an internal braid to provide additional lateral stability during mapping procedures.

A piston in the handpiece is attached to an internal puller which changes the radius of curvature of the tip section. When the piston is pushed forward, the radius of curvature of the tip section is reduced; when the thumbknob is pulled back, the radius of curvature is increased until the tip section returns to its original state. The high-torque shaft allows the tip section to be maneuvered in order to facilitate accurate positioning within the heart.

This 510(k) summary describes a medical device, a deflectable braided-tip electrode catheter, and its substantial equivalence to predicate devices. It focuses on the physical and technological characteristics and non-clinical performance, rather than a study involving acceptance criteria and device performance as typically understood for AI/software devices. Therefore, a direct response to your specific questions about acceptance criteria, sample sizes, ground truth, and human reader studies is not fully applicable.

However, I can extract the relevant information from the provided text that describes the performance assessment conducted for this non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI physical device, the "acceptance criteria" are not explicitly quantitative thresholds like sensitivity or specificity. Instead, they are implied by the comparison to predicate devices and adherence to guidance documents.

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

The document describes "non-clinical performance testing." This typically involves laboratory testing on physical samples of the device.

• Sample Size: Not explicitly stated. The phrase "the braided-tip electrode catheter" and "predicate devices" implies testing of multiple units, but a specific number is not provided.
• Data Provenance: Not applicable in the context of human data. The "data" comes from engineering and laboratory performance tests of the physical catheter.

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

• Experts: Not applicable. For a physical medical device, "ground truth" is established through standardized engineering tests, measurements, and comparisons to established device specifications or performance of predicate devices. There wouldn't be human experts establishing "ground truth" in the way it's done for diagnostic image analysis.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This concept is for resolving disagreements in human expert labeling or interpretation, which is not relevant here.

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

• MRMC Study: No. This type of study assesses human reader performance with and without AI assistance, which is not relevant for a physical electrophysiology catheter.

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

• Standalone Performance: No. This question pertains to AI algorithms. The described device is a physical catheter.

7. The Type of Ground Truth Used:

• Type of Ground Truth: For this physical device, the "ground truth" is established by:
  • Engineering Specifications: Performance against pre-defined engineering standards for electrical and mechanical properties.
  • Comparative Performance Data: Direct comparison of the device's measured electrical, mechanical, and physical properties (e.g., tip stiffness, side load capability) against those of the identified predicate devices.
  • Regulatory Guidance: Adherence to "Electrode Recording Catheter Preliminary Guidance."

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device does not involve machine learning or an AI algorithm that requires a "training set."

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

• Training Set Ground Truth: Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary: The provided text describes a non-clinical performance study of a physical medical device (catheter) to demonstrate substantial equivalence to predicate devices based on engineering characteristics and adherence to regulatory guidance, rather than a clinical study or an AI/software performance study. Therefore, many of your questions, which are framed for AI/software evaluations, are not directly applicable.

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