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The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

The Cardima Ablation System consists of the disposable Cardima Ablation Probe with Stabilization Sheath, the reusable INTELLITEMP® energy management device, and associated cables.

This document describes the Cardima Ablation System, a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. Based on the provided information, the following details about its acceptance criteria and study are available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "Results of in-vitro testing," indicating that the testing was conducted in a laboratory setting. However, it does not specify the sample size (e.g., number of tests, number of devices) used for this in-vitro testing. It also doesn't provide information about the data provenance; specifically, it doesn't mention the country of origin of the data or whether it was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for the in-vitro testing. Therefore, there is no information about the number or qualifications of such experts.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned in relation to the reported in-vitro testing.

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

No MRMC comparative effectiveness study is mentioned. The document only refers to in-vitro testing.

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

This device is an electrosurgical system, not an AI algorithm. Therefore, the concept of a "standalone algorithm-only performance" study does not apply. The device's performance is inherently tied to its physical operation and interaction.

7. The Type of Ground Truth Used:

For the in-vitro testing, the ground truth would inherently be based on measurable physical and electrical parameters related to the ablation process (e.g., lesion depth, tissue temperature, energy delivery). However, the document does not explicitly specify the "type of ground truth" using terms like "expert consensus," "pathology," or "outcomes data."

8. The Sample Size for the Training Set:

This device is not an AI algorithm that would require a "training set."

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

This device is not an AI algorithm; therefore, there is no "training set" or ground truth establishment relevant in this context.

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The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

Cardima® Ablation System

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Cardima Ablation System, which primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and detailed device performance metrics are NOT available. The document only states:

Missing Information:

The summary does not provide quantitative acceptance criteria (e.g., specific thresholds for ablation depth, temperature, lesion size, or success rates) or detailed performance data (e.g., actual measured ablation parameters, complication rates, success rates in a clinical context). The statement "safe and effective" is a high-level conclusion, not a detailed performance metric.

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

• Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" but does not provide details on the number of samples, devices, or tests performed.
• Data Provenance: The testing appears to be in-vitro, meaning conducted in a controlled laboratory environment rather than on live subjects. The country of origin of the data is not specified, but the applicant (Cardima, Inc.) is based in Fremont, CA, USA, suggesting the testing was likely conducted in the US.

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

• Not Applicable / Not Specified. For in-vitro testing of an ablation system, "ground truth" would typically be established by physical measurements (e.g., using calipers, thermometers, oscilloscopes, or histological analysis of tissue models) rather than expert interpretation of images or clinical data. There is no mention of human experts establishing ground truth for the in-vitro performance tests described.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified. Since the ground truth for in-vitro tests is typically objective measurement, an adjudication method for human expert disagreements would not be relevant or mentioned.

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

• No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an ablation system, and the reported testing is primarily in-vitro performance, not related to image interpretation by humans. No mention of such a study is made.

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

• Not Applicable / Not Specified. This device is a manual-use surgical tool, not an AI algorithm. "Standalone performance" in this context refers to the device operating as intended without human intervention for automated tasks. While the device itself operates "standalone" in delivering energy, the concept of "algorithm only" or "human-in-the-loop" performance doesn't apply as it's not an AI-driven diagnostic or automated system. The reported in-vitro testing can be considered an evaluation of the device's standalone physical performance parameters.

7. The Type of Ground Truth Used

• Physical/Objective Measurements: For "in-vitro testing," the ground truth would have been established through objective measurements of physical parameters such as temperature, energy delivery, lesion size, depth, or electrical characteristics in tissue models or non-biological materials. The specific type of measurements or the gold standard used for these measurements is not detailed in the summary.

8. The Sample Size for the Training Set

• Not Applicable / Not Specified. This device is an electrosurgical ablation system, not an AI/machine learning device that requires a "training set." Therefore, there is no training set in the context of AI.

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

• Not Applicable / Not Specified. As there's no training set for an AI algorithm, this question is not relevant to the provided document.

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The NAVIPORT deflectable guiding catheter is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

The NAVIPORT is a sterile, single use only, dual lumen, deflectable tip, guiding catheter with various curve reach configurations. NAVIPORT device is torquable and has a steering mechanism (control knob) in the handle. The control knob allows the catheter tip to be curved or to be straightened while the NAVIPORT is being routed to the desired location. The control knob is connected to an anchor ring located at the distal tip of the guiding catheter by a stainless steel pull wire. The pull wire runs from the control knob through a small closed lumen which terminates at the anchor ring. The anchor ring function is to allow the tip of the catheter to be deflected from the handle. A large central continuous lumen with a female luer at the proximal end and the deflectable tip at the distal end serves as a conduit for medical devices to the cardiovascular system.

This document describes a 510(k) premarket notification for the Cardima NAVIPORT™ Deflectable Tip Guiding Catheter, which primarily relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints. Therefore, many of the requested elements for a study proving device meets acceptance criteria are not directly applicable or explicitly stated in this type of submission.

However, I can extract and infer information about the evaluation process.

Acceptance Criteria and Reported Device Performance

The submission focuses on establishing equivalence and safety through various types of testing, rather than reporting quantifiable performance metrics against specific "acceptance criteria" in the way a clinical trial would for performance claims. The "acceptance criteria" here are largely implied by compliance with existing guidance documents and successful completion of the described tests.

Study Details

Given this is a 510(k) submission and not a traditional clinical trial comparing performance against specific numerical endpoints for a device with novel performance claims, the requested study details are largely absent or not applicable in the way they would be for a direct performance study.

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

• Test Set: Not explicitly stated as a separate "test set" for performance evaluation in a clinical sense. The "testing" involved biocompatibility, reliability, mechanical, and animal studies.
  • Animal Studies: The number of animals or specific procedures is not detailed.
  • Bench Testing: The number of units tested for mechanical properties, reliability, etc., is not provided.
• Data Provenance: Not specified, but generally, 510(k) bench and animal studies are conducted internally by the manufacturer or by contract research organizations (CROs) in the country of origin (implied to be the USA for Cardima, Inc., based on the address). These are prospective tests performed specifically for the submission.

2. 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 in this context would be defined by the inherent properties of the materials and device design (for bench testing) or by veterinary assessment of animal health and trauma (for animal studies). No human expert "ground truth" was established for a clinical test set in this submission.

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

• Not applicable. This is not a study involving human interpretation or multi-reader assessment requiring adjudication.

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 guiding catheter, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This is a physical medical device.

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

• For Bench Testing: Physical measurements, engineering specifications, material properties, and comparison against established industry standards.
• For Animal Studies: Direct observation of access, device delivery, and assessment of trauma by trained veterinary personnel or researchers.

7. The sample size for the training set

• Not applicable. There is no machine learning or AI component requiring a training set described in this 510(k) submission.

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

• Not applicable. As there is no training set mentioned, no ground truth establishment method for it is relevant.

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The Tracer diagnostic mapping device is intended for use in cardiac multations For Ose. This catheter can be used to temporarily record epicardial electrical signals from the coronary sinus. The Tracer catheter can be used to temporarily pace during the mapping procedure.

The Cardima Tracer Over-the-Wire Mapping Microcatheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The Tracer catheter can also be utilized for temporary epicardial pacing during the mapping procedure. The catheter is designed to accommodate a 0.010" guide wire and is available in five configurations with either 4, 8, or 16 electrodes. Both the 4 and 8 electrode catheters come with either regular spaced electrodes of 5mm or electrode pair spacing of 2-5-2 mm. The 16 electrode catheter is available only with 2-5-2mm pair spacing. The outer diameter of the catheter is 3.2F - 3.3F and will be available with working lengths of 145cm. The outer surface is treated with a hydrophilic coating to enhance lubriciousness. The Tracer is not indicated for ablation.

The provided text describes the regulatory clearance of the Cardima Tracer Over-the-Wire Mapping Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device and outlines safety and effectiveness testing, but it does not include a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in a way that aligns with a typical AI/software device evaluation.

The information provided is for a physical medical device, not an AI/software product, which typically has quantitative performance metrics for acceptance criteria. As such, I will interpret "acceptance criteria" based on the described safety and effectiveness evaluations for this type of device.

Here's an attempt to answer the request based on the provided text, highlighting where information is not available due to the nature of the device and the provided document:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The Cardima Tracer Over-the-Wire Mapping Microcatheter received clearance based on demonstrating substantial equivalence to a predicate device (Cardima 2.5F Pathfinder electrode recording catheter, K955802) and through safety and effectiveness evaluations. The "acceptance criteria" for this type of device primarily revolve around material compatibility, mechanical/electrical integrity, and biological safety and performance in a relevant physiological environment.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Animal Studies: The animal study for maneuverability, signal quality, and pacing involved an unspecified number of animals/instances, but pacing was conducted on "twelve occasions". The provenance is not explicitly stated but implies a controlled laboratory setting (likely within the USA). The study appears to be prospective in nature, as it describes the conduct and results of specific tests.
• Bench Testing: Sample sizes for reliability and mechanical/electrical property testing are not specified, nor is the provenance, but it would have been conducted in a laboratory setting.
• Biocompatibility: The biocompatibility testing was conducted on the Pathfinder predicate device and deemed applicable to the Tracer. The sample size for this original testing is not provided.

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

Not applicable in the context of this physical device evaluation. The "ground truth" was established through objective measurements (e.g., signal recording, pacing threshold measurements, post-mortem examination) and established regulatory standards (e.g., ISO 10993-1, Electrode Recording Catheter Preliminary Guidance).

4. Adjudication method for the test set

Not applicable. The evaluation methods described (bench testing, animal studies, biocompatibility) rely on objective measurements and established protocols rather than expert adjudication of subjective assessments.

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

Not applicable. This is a physical medical device, not an AI/software algorithm. No human reader studies or AI assistance were part of this evaluation.

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

Not applicable. This refers to a physical medical device, not an algorithm.

7. The type of ground truth used

• Bench Testing: Physical and electrical measurements.
• Biocompatibility: Results against ISO 10993-1 standards for biological response.
• Animal Studies: Direct observations during catheter placement, recorded electrical signals, measured pacing thresholds, and macroscopic/microscopic examination of tissues post-mortem. This could be considered outcomes data or pathology in the animal model.

8. The sample size for the training set

Not applicable. This is a physical medical device clearance, not an AI/ML model that requires a training set. The "development" of the device involves engineering and design, validated through the described testing.

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

Not applicable (as above).

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The Cardima EP SELECT Switchbox is an accessory intended to provide selective connection of multi-electrode catheters for electrogram recording and pacing during diagnostic electrophysiology studies.

The Cardima EP SELECT Switchbox is a passive switching unit used in conventional electrophysiology (EP) diagnostic procedures. It is designed to provide a convenient means by which the user can record or pace from multiple unipolar or bipolar intracardiac electrodes. The device is designed to be placed on a horizontal surface or at the patient's side. It is designed to accept up to eight electrodes using standard pin connectors typically found in the EP lab. Switching between record or pace modes is accomplished by a simple switch for each electrode.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" in the context of clinical or performance data using a sample of devices. The safety and effectiveness study was based on conformance to an engineering standard. Therefore, traditional sample size and data provenance for a test set (e.g., country of origin, retrospective/prospective) are not applicable in the way they would be for a clinical study involving patient data. The study primarily involved testing the device itself against engineering specifications.

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

This information is not applicable. The ground truth was established by conformance to an industrial safety standard (IEC-60601-1), which involves engineering testing and evaluation, not expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable as the "test set" refers to the device being evaluated against an engineering standard, not a clinical dataset requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a passive switching unit, not an AI or diagnostic tool that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone (algorithm only) performance study was not conducted for an AI component. The device is a hardware component with a specific electrical function, not an algorithm. The study was focused on the device's electrical safety and functionality.

7. Type of Ground Truth Used:

The ground truth used was conformance to established engineering and safety standards, specifically International Electrotechnical Commission (IEC) electromechanical standard IEC-60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.

8. Sample Size for the Training Set:

This information is not applicable. The device is a hardware product, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This information is not applicable as there is no training set for a machine learning model. The safety and effectiveness were established through
"Declaration of Conformity" with a recognized consensus standard.

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The Cardima Pathfinder 1.5F Microcatheter is intended for electrogram recording from within the coronary venous system during diagnostic electrophysiology studies.

The Cardima Pathfinder® 1.5F Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The catheter is available with 4, 1mm long electrodes spaced either 2mm or 2-6-2mm apart providing for a total electrode recording length of 10-14 mm. The working outer diameter is 1.5F and will be available with working lengths of 135cm and 170cm. The Pathfinder is not indicated for pacing or ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.

Here's an analysis of the Cardima Pathfinder 1.5F Mapping Microcatheter's acceptance criteria and the study used to demonstrate its safety and effectiveness, based on the provided text:

Acceptance Criteria and Device Performance for Cardima Pathfinder 1.5F Mapping Microcatheter

The provided document describes the predicate device equivalence rather than a detailed list of acceptance criteria from a specific clinical trial with performance metrics. The safety and effectiveness evaluation for this device was primarily based on biocompatibility testing and animal studies, as it is a modified version (smaller outer diameter) of an already approved device. The "acceptance criteria" can therefore be inferred from the successful completion of these tests and the demonstration of substantial equivalence.

Study Details:

Given the nature of the submission (510(k) for a modified device), the "study" demonstrating performance is primarily preclinical (animal study) and bench testing, rather than a full-scale human clinical trial with extensive statistical and expert-driven ground truth establishment.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document mentions "animal studies" and "2 dogs" for specific findings, but doesn't provide a precise total sample size for the animal study. It's safe to assume a small number of animals, typical for preclinical studies of this nature.
   • Data Provenance: The study was (presumably) conducted by the manufacturer, Cardima, Inc., and is a preclinical, prospective animal study. The country of origin for the data is not specified, but would likely be the United States, given the manufacturer's location and FDA submission.

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

   • The document does not specify the number of experts or their qualifications for evaluating the animal study results. This type of preclinical study would typically involve veterinary professionals, potentially electrophysiologists or cardiologists for interpreting signal quality, and pathologists for gross and microscopic examination of tissues.

3. Adjudication method for the test set:

   • The document does not mention any specific adjudication method (e.g., 2+1, 3+1). Decisions on clinical significance of findings and signal quality would have been made by the researchers conducting the animal study, likely through consensus or standard veterinary/medical practice.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was NOT done. This type of study typically involves multiple human readers evaluating medical images or data, often with and without AI assistance, and comparing their performance. The provided document concerns a physical medical device (catheter) and preclinical testing, not an AI or imaging diagnostic tool. Therefore, effects of human readers improving with AI assistance are not applicable.

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

   • Not applicable. The device is a physical mapping microcatheter, not an algorithm or AI system. Its performance is inherent in its physical and electrical characteristics and its ability to acquire signals in vivo.

6. The type of ground truth used:

   • Animal study observations, physiological measurements, and gross/histopathological findings.
     • Maneuverability: Direct observation during the procedure.
     • Signal Quality: Electrogram recordings and interpretation.
     • Adverse Events: Direct observation of tissue, dye, and pericardial effusions during necropsy/examination.
     • Biocompatibility: Laboratory analysis of biological response to materials.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no "training set" in the computational sense. The design and modifications were likely based on engineering principles and experience with the predicate device.

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

   • Not applicable. See point 7.

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The Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter is intended for temporary occlusion of the coronary sinus ostium during a venogram and to serve as a conduit for access to the coronary venous system.

The VUEPORT is intended for use to access the coronary sinus and perform occlusive venograms. The catheter may serve as a conduit for the delivery and support of other devices.

The Cardima Vueport™ is a sterile, single use only, dual lumen, balloon tipped guiding catheter with various tip configurations. The Cardima Vueport™ is a "Y" connector and each branch of the "Y" houses a lumen. The smaller lumen extends from a one-way stopcock (vented and included with the Vueport), to inflate the balloon and is used for air delivery and withdrawal. The connector on a female luer is attached to the occluded lumen to perform a coronary venogram. The larger lumen is a guide to the coronary sinus vasculature for the delivery of other devices and has an open atraumatic catheter tip.

The provided text describes a medical device, the Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter, and its approval through the 510(k) pathway, which establishes substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance metrics typically seen in AI/ML device evaluations.

Therefore, the information required to populate a table of acceptance criteria and performance, as well as details about test sets, ground truth establishment, and MRMC studies, is not present in the provided document. The submission focuses on substantial equivalence based on intended use, design, and physical characteristics.

However, I can extract the information that is available:

Here's an analysis based on the provided text:

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

This information is not provided in the document. The 510(k) submission for this device relies on demonstrating substantial equivalence to a predicate device (Electro-Catheter Corp., Elecath Occlusion Catheter (K945963) and Zeppelin Balloon Guiding Catheter (K945963)), rather than establishing specific performance acceptance criteria for a novel functionality or algorithm.

The document states:

• "Safety and effectiveness were evaluated through biocompatibility testing, reliability and mechanical testing and animal studies."
• "Mechanical properties of the catheter and found to be acceptable."
• "The Vueport™ performance was satisfactory when placed into the Coronary sinus ostium, the balloon inflated and deflated and performed acceptable venographs."
• "Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter when compared to the control catheter (i.e., Elecath) the performance was equivalent."

These statements indicate that the device met its intended function and was comparable to the predicate, but specific performance metrics (e.g., sensitivity, specificity, accuracy, or precise quantitative measures) with defined acceptance thresholds are not detailed.

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

This information is not provided in the document. The "test set" and "data provenance" concepts are typically associated with AI/ML or clinical trials. The document mentions "animal studies" without specifying the sample size or further details.

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 provided as there is no mention of "experts" establishing a "ground truth" for a test set in the context of an AI/ML or similar evaluation. The evaluation was primarily based on mechanical functionality, biocompatibility, and animal studies, which likely involved veterinary professionals or skilled device operators.

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

This information is not provided. Adjudication methods are relevant for human expert review processes, which are not described here.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is specific to evaluating AI-assisted workflows, and the Vueport™ device is a physical catheter, not an AI/ML algorithm.

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

No, a standalone algorithm performance study was not done. The device is a physical catheter, not an algorithm.

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

The concept of "ground truth" as typically applied to performance studies aiming for objective accuracy (like for AI/ML) is not explicitly stated in the provided text. The "ground truth" for the device's acceptable performance was assessed through:

• Biocompatibility testing: Likely adherence to standards for biological safety.
• Reliability and mechanical testing: Adherence to engineering specifications.
• Animal studies: Successful occlusion of the coronary sinus ostium and performance of "acceptable venographs" (presumably evaluated by veterinarians or imaging specialists looking for clear visualization of the venous system). The "equivalence" to the control catheter in animal studies serves as the benchmark.

8. The sample size for the training set

This information is not provided. The concept of a "training set" applies to machine learning, which is not relevant for this device.

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

This information is not provided as there is no "training set."

In summary, the provided document is a 510(k) summary for a physical medical device (catheter) demonstrating substantial equivalence. It does not contain the type of detailed performance data, acceptance criteria tables, or study designs (e.g., test set, ground truth experts, MRMC studies) typically associated with AI/ML device evaluations or detailed clinical trial reports.

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The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The Pathfinder is also indicated for pacing. It is contraindicated for ablation.
The Cardima Pathfinder 3mm catheter is intended for electrogram recording and pacing during diagnostic electrophysiology studies.

The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The catheter is available with 4 or 8, 3mm long electrodes spaced 2mm apart providing for a total electrode recording length of 4cm. The working outer diameter of the catheter is 3.3F and will be available with useable lengths of 100cm and 135cm. The Pathfinder is also indicated for pacing. It is contraindicated for ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.

The provided text describes a submission for a medical device (Cardima Pathfinder 3mm Mapping Microcatheter) for 510(k) clearance, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This is not a study proving the device meets acceptance criteria as typically found in an AI/ML context with performance metrics like sensitivity/specificity.

Instead, this document focuses on demonstrating substantial equivalence to an existing device and assessing safety and effectiveness through different types of testing common for physical medical devices. Therefore, many of the requested categories (e.g., AI performance metrics, readers, training sets, ground truth types) are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Animal Studies: The text mentions "animal studies" and "one animal" where thrombosis occurred, implying a small number of animals were part of the study. The exact number of animals in the study is not specified.
• Data Provenance: The studies were conducted by the manufacturer, Cardima, Inc. They are prospective animal studies and laboratory bench testing. The country of origin is implicitly the USA (manufacturer is in Fremont, CA, and submission is to FDA).

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

• Not Applicable (N/A) in the context of this device. The evaluations were primarily objective measurements (biocompatibility, electrical/mechanical tests) and direct observation by researchers/veterinarians during animal studies. There's no mention of expert consensus for interpreting complex data like images, which would require multiple human experts to establish "ground truth."

4. Adjudication Method for the Test Set

• N/A. As above, expert adjudication for a "test set" in the AI/ML sense is not relevant for this type of device submission. Direct measurements and observations were the basis of evaluation.

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 an AI/ML device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

• No. This is not an AI/ML device.

7. The Type of Ground Truth Used

• For Biocompatibility: Laboratory test results against ISO 10993-1 standards (e.g., cytotoxicity tests, irritation tests).
• For Reliability: Laboratory measurements and physical inspections against specified performance criteria (e.g., electrical impedance, mechanical strength, flexibility).
• For Animal Study (Maneuverability, Signal Quality, Pacing, Safety): Direct observation of catheter performance, physiological signal analysis, and post-procedure examination of animal welfare/injury by the researchers/veterinarians conducting the study. This aligns more with outcomes data (direct observation of device function and biological response) rather than expert consensus on a subjective measure or pathology (though pathology might be part of post-mortem analysis, it's not explicitly detailed here as the primary ground truth).

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device, so there is no "training set."

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

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

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Both devices are made to aid physicians specializing in cardiac electrophysiology, cardiac surgery and interventional cardiology in the management of abnormal rhythms of the heart. The main function of both devices is diagnostic sensing of electrical impulses in the heart muscles to provide precise, localized data.

The 2.5 Fr. Pathfinder Electrode Recording Catheter is a diagnostic medical device designed to sense electrical signals by use of multiple electrodes placed on the distal end of the catheter, each of which is connected to a connector at the proximal end of the catheter by means of a conductor wire. The connector is matched with a connector cable which functions to link the catheter to a standard ECG recording/monitoring system. The device is a composite construction of biocompatible materials commonly used in other (FDA) approved catheters. The catheter is available in 4. 8 and 16 electrode configurations and provides for a distal electrode recording length of up to 7 cm. The working outer diameter of the catheter is 2.3F or 2.5F depending upon the number of electrodes. The useable lengths are 100, 135. 150 and 200cm.

This document describes a 510(k) submission for the Cardima Pathfinder electrode recording device, comparing it to the Cordis Webster Orthogonal device. The focus is on demonstrating equivalence in safety and effectiveness.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance

Study Details

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

   • Clinical Test Set Sample Size: 20 patients.
   • Data Provenance: Clinical investigation conducted at two clinical sites. The text does not specify the country of origin, but it is a "controlled clinical investigation." Given the FDA context, it's likely U.S.-based or compliant with U.S. regulatory standards. It is a prospective study design, as patients "undergoing an electrophysiology study for arrhythmia" were enrolled for the purpose of the investigation.

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

   • The document mentions "a conclusive statement from the independent reviewers supporting the equivalence claim" in the general summary. However, for the clinical study itself, it does not specify the number of experts or their qualifications for establishing ground truth (e.g., assessing signal quality, maneuverability, complications, or drawing equivalence conclusions). The study design used patients as their own controls, where "signal recordings, device maneuverability/placement, and complications were compared." This suggests direct clinical observation and comparison by the treating/investigating physicians, whose expert judgment would implicitly form the "ground truth" for the observed parameters.

3. Adjudication method for the test set:

   • The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "patients as their own control" design implies direct comparison of data collected from the same patient using both devices. The assessment of "signal recordings, device maneuverability/placement, and complications" would likely have been performed by the clinical investigators at the two sites.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is comparing two medical devices (catheters) for signal recording capabilities and safety, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

   • No, this is not an algorithm-only device. It is a physical medical device (catheter) used by physicians to record electrical signals. Its performance is inherently tied to human use and interpretation.

6. The type of ground truth used:

   • For the animal study: The "ground truth" for signal quality and safety was established by direct comparison to the predicate device in a GLP animal study.
   • For the clinical study: The "ground truth" was established by direct within-patient comparison of signal quality, device maneuverability/placement, and observed complications between the new device and the predicate device. This is a form of expert clinical observation and comparison. The ultimate "ground truth" for equivalence in safety and effectiveness was based on the interpretation of these clinical observations by the independent reviewers/investigators.

7. The sample size for the training set:

   • This submission describes a medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "training" of the device itself would refer to its design and engineering, not data-driven model training.

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

   • As there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the device's design and manufacturing would be based on engineering specifications, regulatory guidelines (e.g., "Electrode Recording Catheter Preliminary Guidance. June 1994"), and biocompatibility standards.

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