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The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary, peripheral, and neufosvasculature.

The Cordis Vista Brite Tip Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless steel braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different stiffness to provide gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter.

This document is a 510(k) summary for the Cordis Vista Brite Tip Guiding Catheter. It establishes substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the manner of a clinical trial for a new therapeutic device.

Therefore, many of the requested sections regarding acceptance criteria and a study proving their fulfillment, especially those involving expert reviews, ground truth, and statistical analyses (like MRMC studies) are not applicable or extractable from this type of regulatory submission. The document focuses on performance characteristics and biocompatibility to demonstrate equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific, quantifiable acceptance criteria (e.g., specific thresholds for success, safety endpoints) with corresponding device performance results from a dedicated study. Instead, it relies on demonstrating substantial equivalence to a previously approved predicate device.

The performance characteristics mentioned are general design features and biocompatibility.

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

Not applicable. This is a 510(k) submission demonstrating substantial equivalence, not a clinical study involving a test set of data or patient samples. The review is based on device design, materials, and comparison to a predicate.

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

Not applicable. No "ground truth" for a test set was established by external experts in the context of this submission. The FDA reviews the provided information to determine substantial equivalence.

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

Not applicable. There was no test set requiring 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

Not applicable. This device is a guiding catheter, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.

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

Not applicable. This is a physical medical device (guiding catheter), not an algorithm or software requiring standalone performance evaluation.

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

Not applicable. There was no "ground truth" in the context of a clinical study or diagnostic performance evaluation. The "truth" in this submission is that the device is demonstrably equivalent in design, materials, indications, and performance to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a training set would be used.

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

Not applicable. There was no training set.

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The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature.

The Vista Brite Tip Guiding Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Cordis Vista Brite Tip® Guiding Catheter":

It's important to note that this document is a Premarket Notification (510(k)) Summary of Safety and Effectiveness from 1997. At that time, the scope and requirements for demonstrating "acceptance criteria" and "study results" for medical devices, particularly regarding algorithmic performance (AI), were fundamentally different from today's standards. AI, as we understand it in medical devices now, did not exist in this context. The focus of this 510(k) is on demonstrating substantial equivalence to predicate devices through design, materials, and biocompatibility, rather than statistical performance against specific clinical endpoints derived from a study.

Therefore, many of the requested categories for AI/algorithm-based devices will not be directly applicable or present in this document. I will fill in the table and information based on what is provided and explain where information pertinent to AI/algorithm studies is missing due to the nature of the submission.

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are interpreted as the successful completion of standard evaluations for medical devices of this type, primarily focusing on safety and equivalence. There are no quantifiable performance metrics in the way one would define for an AI algorithm (e.g., sensitivity, specificity, AUC).

Study Information (as applicable to a 1997 510(k) for a physical device, NOT an AI algorithm)

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

• Test Set Sample Size: Not applicable. This document is a 510(k) submission for a physical medical device (guiding catheter) and does not describe a "test set" in the context of an algorithm or clinical study with patient data. The 'testing' would have primarily been bench testing for mechanical properties and biocompatibility. No specific sample sizes for such tests are detailed in this summary.
• Data Provenance: Not applicable. No clinical data or patient data is referenced that would have a provenance like 'country of origin'.

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

• Number of Experts/Qualifications: Not applicable. "Ground truth" in the context of expert consensus for imaging or clinical diagnosis is not relevant to this device submission. The primary "ground truth" for a device like this would be engineering specifications and predicate device characteristics, not expert interpretation of cases.

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

• Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission.

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

• MRMC Study / AI Effect Size: Not applicable. This device is a physical guiding catheter, not an AI-powered diagnostic or assistive tool. No MRMC studies were performed, and AI was not a component of this submission.

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

• Standalone Performance: Not applicable. This is a physical device, not an algorithm.

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

• Type of Ground Truth: For a 510(k) of this nature, the "ground truth" is primarily based on engineering specifications, material science standards, biocompatibility testing results, and the established characteristics and performance of the identified predicate devices. There is no clinical or diagnostic "ground truth" from patient data involved in this summary.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI algorithm, so there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. As there's no training set, there's no ground truth for it.

In summary: This 1997 510(k) submission demonstrates the substantial equivalence of a physical medical device (a guiding catheter) to existing, legally marketed predicate devices. The "acceptance criteria" are based on meeting design, material, and biocompatibility standards comparable to those predicates, and successfully satisfying the FDA's regulatory requirements for a Class II device. The modern concepts of "acceptance criteria" and "study results" as they pertain to AI algorithms are not present or applicable in this historical document.

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The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral and neurovasculature.

The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.

This document is a Premarket Notification 510(k) for a Cordis Guiding Catheter (K6346a). It is focused on demonstrating substantial equivalence to predicate devices.

Based on the provided text, the device is a physical medical device (a catheter), not an AI/software-based medical device. Therefore, the questions related to AI performance, ground truth, expert adjudication, training sets, test sets, and multi-reader multi-case studies are not applicable.

The acceptance criteria for such a device would typically involve physical and mechanical performance testing, biocompatibility, and sterilization validation, rather than metrics like sensitivity, specificity, or AUC which are relevant for diagnostic algorithms.

Here's a breakdown of what is provided and why the AI-related questions are not answerable from this document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail values in this summary document. For a physical device like a catheter, general acceptance criteria would revolve around:
  • Biocompatibility: Passed (stated: "All appropriate biocompatibility tests for the guiding catheters were successfully completed.")
  • Mechanical Integrity/Performance: Implied to be acceptable through demonstration of substantial equivalence to predicate devices which are already cleared. This would typically include tests for tensile strength, torque transmission, kink resistance, pushability, trackability, lubricity, etc., but specific values are not in this summary.
  • Dimensional Specifications: Implied to be acceptable to fit the intended use with other devices.
  • Material Properties: Implied to be acceptable and consistent with predicate devices.
  • Radiopacity: The "Brite Tip segment...is pellethane with a radiopaque filler," indicating it meets a functional requirement for visibility under fluoroscopy.
• Reported Device Performance:
  • Biocompatibility: "Successfully completed."
  • General Performance: "similar in design, construction, indication for use and performance characteristics to other commercially available guiding catheters." This is the core claim of substantial equivalence.

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

• Not Applicable. This is a physical device. Performance testing would involve physical samples of the catheter, not a "test set" of data in the AI sense. This document does not detail the number of catheters subjected to physical testing.

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. No "ground truth" establishment in the context of diagnostic accuracy is relevant for this device.

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

• Not Applicable.

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

• Not Applicable. This device is a tool for a physician, not a diagnostic algorithm that assists human readers.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Not Applicable. The "ground truth" for a physical device is its adherence to design specifications, material properties, and functional performance under various conditions, which are evaluated through engineering tests, not clinical "ground truth" as for diagnostics.

8. The sample size for the training set

• Not Applicable. This device uses physical engineering and manufacturing processes, not machine learning training.

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

• Not Applicable.

In summary: The provided document is a 510(k) for a conventional medical device (a catheter). The questions posed are primarily relevant to AI/software as a medical device (SaMD) and therefore cannot be answered from this document. The "study that proves the device meets the acceptance criteria" in this context is the demonstration of substantial equivalence to legally marketed predicate devices, supported by biocompatibility testing and presumably other engineering verification and validation (V&V) activities which are not detailed in this high-level summary.

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The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless steel braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometer (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is Pellethane® with a radiopaque filler, this is the softest material in the catheter.

This 510(k) premarket notification for the Cordis Guiding Catheter (K965211) does not contain the information requested in your prompt. The document is from 1997 and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert involvement, or specific ground truth methodologies.

Here's why the information cannot be extracted:

• Type of Device: The Cordis Guiding Catheter is a physical medical device (catheter) used for vascular access, not a software algorithm or AI-powered diagnostic tool. The concepts of "acceptance criteria" and "study" in your prompt primarily relate to the performance of such algorithms, often involving metrics like sensitivity, specificity, AUC, etc., derived from analyzing a dataset.
• Regulatory Context (1997 510(k)): In 1997, 510(k) submissions for physical devices like catheters focused heavily on demonstrating substantial equivalence to already legally marketed predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The core of such a submission usually involves:
  • Comparison of design, materials, and manufacturing processes.
  • Bench testing (mechanical strength, material properties, biocompatibility).
  • Sometimes limited animal or human use data if there are significant technological differences or new intended uses, but it's not the primary focus for demonstrating equivalence.
• Missing Information:
  • Acceptance Criteria & Device Performance Table: Not applicable/provided in this context. Performance is typically demonstrated through bench testing (e.g., tensile strength, burst pressure) and comparison to predicates, not metrics like sensitivity found in diagnostic AI.
  • Sample Size (Test Set) & Data Provenance: Not applicable for this type of device and submission.
  • Number/Qualifications of Experts for Ground Truth: Not relevant for a physical catheter's equivalence claim.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: Not applicable.
  • Standalone Performance Study: The document doesn't detail a specific performance study in the way you're asking. It mentions "All appropriate biocompatibility tests for the guiding catheters were successfully completed" but doesn't provide the raw data, acceptance criteria, or methodology for these tests.
  • Type of Ground Truth: Not applicable in the context of diagnostic accuracy.
  • Training Set Sample Size/Ground Truth: Not applicable, as this is not an algorithm based on machine learning.

In summary, the provided 510(k) document is for a physical medical device and therefore does not contain the information typically associated with the performance evaluation of diagnostic algorithms or AI-powered devices as outlined in your prompt.

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The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.

The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.

This document is a 510(k) premarket notification for a medical device cleared in 1996. It does not contain the information requested about acceptance criteria or a study proving device performance against such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which was the standard for regulatory clearance at that time. It lists:

• Device Name: Cordis Guiding Catheter (Proprietary Name: Cordis Vista Brite Tip®)
• Predicate Device: Cordis Vista Brite Tip (implying it's substantially equivalent to itself or a prior version of itself, which is unusual for a modern 510(k) but was sometimes seen, or it refers to an earlier cleared version).
• Indications for Use: Intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.
• Device Description: Single lumen catheter with a nylon body, stainless braid wire reinforcement, varying durometer nylons, and a radiopaque pellethane tip.
• Biocompatibility: States that "All appropriate biocompatibility tests for the guiding catheters were successfully completed."

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth provenance, expert qualifications, or AI performance, as this information is not present in the provided text.

The provided text belongs to an era of medical device regulation where the emphasis for devices like coronary catheters was more on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive performance studies against pre-defined acceptance criteria, especially not in the way current AI/ML devices require. Clinical performance data, especially for standalone algorithm performance or human-in-the-loop improvements, would not typically be part of such a submission.

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