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Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.

The provided text describes the 510(k) summary for Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic Catheters. This document is a premarket notification for a medical device and thus does not contain information about studies related to AI or ground truth as it pertains to AI/ML models. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.

Here's the relevant information based on the provided text, adapted for the requested format where applicable, and noting where information is not present:

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 exact sample sizes for each of the listed functional and safety tests. It generally refers to "Bench and laboratory testing." It is a regulatory submission for a reprocessed medical device, not an AI/ML study. Therefore, the concept of "test set" in the context of AI/ML models, data provenance (country of origin), and retrospective/prospective data collection is not applicable here. The testing would have been performed on samples of the reprocessed devices.

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

This information is not applicable. The device is a physical medical device (angiographic catheter), and "ground truth" as it relates to expert-labeled data for an AI/ML model is not relevant to this submission. The "ground truth" in this context would be the established performance specifications for diagnostic angiographic catheters, and the testing validates that the reprocessed device meets those specifications.

4. Adjudication Method for the Test Set

This information is not applicable, as it pertains to expert consensus on AI/ML model outputs, which is not relevant for this device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable as this is a physical medical device (angiographic catheter) and does not involve AI or human readers evaluating images or data.

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

This information is not applicable as the device is a physical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance criteria would be the established performance specifications and safety standards for diagnostic angiographic catheters as defined by relevant industry standards (e.g., ISO, ASTM) and FDA guidance for these types of devices and for reprocessed devices. This includes physical properties, biocompatibility, sterility, and functional performance. It is based on engineering specifications and scientific testing standards, not expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML model; therefore, there is no "training set."

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

This information is not applicable as there is no "training set" for this physical medical device.

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The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire.

The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire.

The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.

The provided text is a 510(k) summary for the reprocessing of medical devices, specifically VersaCross Steerable Sheaths and SureFlex Steerable Guiding Sheaths. It describes the regulatory review process and confirms that the reprocessed devices are substantially equivalent to their predicate devices.

However, the document does not describe a study that proves a device meets acceptance criteria using an AI/algorithm-driven component. The entire document discusses the reprocessing of physical medical devices and their functional and safety testing to establish substantial equivalence, not the performance of an AI or software-based device.

Therefore, I cannot extract the information required to answer your prompt questions about acceptance criteria for an AI device, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or training sets, because this information is not present in the provided text.

The closest relevant information relates to functional and safety testing of the reprocessed physical medical devices, which is presented as:

Functional and Safety Testing (of physical reprocessed catheters):

Bench and laboratory testing evaluated substantial equivalence to the predicate devices. This included the following:

• Biocompatibility
• Cleaning Validation
• Sterilization Validation
• Functional Testing
  • Visual Inspection
  • Dimensional Inspection
  • Tip Deflection
  • Tip Buckling
  • Valve/Joint leak
  • Radiopacity
  • Simulated Use
  • Torque Testing
  • Tensile Testing
  • Corrosion Testing
• Packaging Validation

This list represents the acceptance criteria (or areas of testing) for the reprocessed physical device, not an AI or software device. The document does not provide specific numerical performance metrics for these tests, nor does it detail sample sizes, expert involvement, or adjudication methods for these physical device tests in the way your prompt requests for an AI study.

In summary, the provided text does not contain any information about an AI/algorithm-driven device or a study related to its performance against acceptance criteria.

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The Reprocessed Agilis NxT Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and quidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text is a 510(k) premarket notification for a Reprocessed Agilis NxT Steerable Introducer. This document is for a medical device that facilitates the introduction of catheters into the heart. It is not an AI/ML medical device, and therefore the provided document does not contain information on acceptance criteria for AI models, nor studies that prove an AI device meets acceptance criteria.

The information requested in the prompt (acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is typically found in submissions for AI/ML-driven medical devices, especially those related to diagnostic imaging or analysis.

Since this document pertains to a reprocessed physical medical device (a catheter introducer), the "studies" mentioned are bench and laboratory testing to prove the device's physical and mechanical performance, biocompatibility, cleaning validation, sterilization validation, and packaging validation. These are standard tests for physical medical devices, not for AI model performance.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device assessment.

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The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.

The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with IEC 60601-2-2. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and optionally to an external pressure monitoring system via a luer connection. The dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Reprocessed NRG Transseptal Needle.

Important Note: The provided document is an FDA 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel efficacy or performing clinical trials with the same rigor as for a new drug or a high-risk de novo device. Therefore, the "study" described is primarily a series of bench and functional tests to ensure the reprocessed device performs comparably to the original and remains safe. It does not involve human subjects, AI performance, or typical clinical effectiveness measures that would require ground truth established by medical experts for a diagnostic algorithm.

Acceptance Criteria and Reported Device Performance

Given the nature of this submission (reprocessed device seeking 510(k) clearance), the "acceptance criteria" are primarily related to the device's functional integrity, safety, and equivalence to the original predicate device after reprocessing.

Study Information

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

   • The document does not specify numerical sample sizes for each test mentioned (e.g., how many devices were subjected to cleaning validation, electrical safety, etc.).
   • The "data provenance" is derived from internal testing conducted by Innovative Health, LLC, the reprocessor and applicant. It's a retrospective evaluation of reprocessed devices. The country of origin for the data is implicitly the United States, where the company operates.

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

   • This question is not directly applicable to this type of device clearance. The "ground truth" for a reprocessed medical device is its ability to meet engineering specifications and safety standards, not a diagnostic accuracy against expert consensus. These "bench and laboratory tests" are typically performed against pre-defined engineering requirements and international standards by qualified engineers and technicians, not medical experts.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human evaluation of diagnostic images or clinical scenarios where expert disagreement is possible. For functional and safety testing of a physical device, the outcome is typically an objective pass/fail against a standard, not subject to expert adjudication of subjective interpretations.

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, an MRMC comparative effectiveness study was not done. This is a reprocessed medical device (a transseptal needle), not an AI diagnostic algorithm or a device requiring human interpretation of data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.

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

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

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

   • The "ground truth" for this device's performance is established by engineering specifications, international performance standards, and safety requirements for medical devices (e.g., ISO, ASTM, IEC standards for biocompatibility, sterility, electrical safety, mechanical strength, etc.). It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical trial. The premise is that if the reprocessed device consistently meets these defined physical and chemical parameters, it is substantially equivalent and safe for its intended use as the original device.

7. The sample size for the training set:

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

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

   • Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

The reprocessed umbilical cable is an insulated, multi-conductor cable that us 200 cm (6.6 ft) in length with multi-pin connectors at each end.

The provided document is a 510(k) summary for a Reprocessed Umbilical Cable, not an AI/medical imaging device. As such, it does not contain the information required to answer the prompt, which is specifically looking for details about the acceptance criteria and study proving performance for an AI device.

The document describes the reprocessing of a physical medical cable and includes information on:

• The device description and its intended use (providing an electrical connection between a mapping catheter and a signal station).
• Bench and laboratory testing performed for safety and effectiveness, such as cleaning validation, sterilization validation, visual inspection, dimensional verification, electrical continuity testing, HiPOT testing, and packaging validation.
• The reprocessed cable's substantial equivalence to a predicate device.

It does not contain any information about:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets or training sets for an algorithm.
• Data provenance for AI training/testing data.
• Expert involvement in establishing ground truth for AI.
• Adjudication methods for AI ground truth.
• MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Ground truth types like pathology or outcomes data for AI.

Therefore, I cannot fulfill the request as the source document does not pertain to an AI device.

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The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digitial IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cut down into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge. starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.

The Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

This is a medical device submission, specifically a 510(k) premarket notification for a reprocessed intravascular ultrasound (IVUS) catheter. The document details the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain detailed information about acceptance criteria for a study or the results of such a study proving the device meets those criteria in a way that allows for the extraction of the requested information regarding AI device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

The document focuses on demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices, a requirement for 510(k) clearance. The testing mentioned in this document (biocompatibility, cleaning validation, sterilization validation, functional testing, etc.) are standard tests for reprocessed medical devices to ensure they are safe and effective after reprocessing, not necessarily a clinical study to evaluate diagnostic performance against a specific set of acceptance criteria for an AI algorithm.

Therefore, for most of your specific questions, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Not Available in the Provided Text:

• A table of acceptance criteria and the reported device performance (in the context of an AI device or a diagnostic performance study): The document lists functional and safety testing for a reprocessed physical device, not an AI or diagnostic performance study with specific criteria like sensitivity, specificity, or AUC.
• Sample size used for the test set and the data provenance: Not applicable as no diagnostic performance study of an AI device is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable for a diagnostic performance study.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that can be partially inferred or is directly stated (though not in the context of an AI study):

• Device Name: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
• Device Type: Intravascular Ultrasound (IVUS) Catheter (a physical medical device, not an AI algorithm)
• Purpose: Evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image.
• Testing Conducted (Functional and Safety, not diagnostic performance):
  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional testing (Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility)
  • Drying Validation
  • Packaging Validation
• Conclusion from the document: Innovative Health concludes that the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein, based on the functional and safety testing for a reprocessed device.

In summary, this document is a 510(k) submission for a reprocessed medical device (an IVUS catheter) and does not describe the evaluation of an AI-powered diagnostic device or a study with "acceptance criteria" in the sense of diagnostic performance metrics for an algorithm.

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The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with compatible Carto 3 EP Navigation Systems.

The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise ≤ 180° and counterclockwise ≤ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to allow fluoroscopic visualization.

This document describes the FDA's 510(k) clearance for the Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath (K212165). This is a reprocessed medical device, and the submission focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device.

The provided text does not contain information related to a study involving AI, machine learning, or complex algorithms. The device is a physical medical instrument (a guiding sheath used in cardiac procedures). Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth for the test set," "Adjudication method," "Multi-reader multi-case (MRMC) comparative effectiveness study," "Stand-alone (algorithm only) performance," "Type of ground truth," "Sample size for the training set," and "How ground truth for the training set was established" are not applicable to this type of device and submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a reprocessed device like this primarily revolve around demonstrating that the reprocessed device is as safe and effective as the original, single-use device. This is typically shown through functional, material, and safety testing (e.g., sterilization, biocompatibility, mechanical integrity).

Here's an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table with numerical acceptance criteria and direct performance metrics in the way one might expect for an AI algorithm (e.g., sensitivity, specificity). Instead, substantial equivalence for a reprocessed device is shown by demonstrating that the reprocessed device meets the same performance characteristics as the predicate device.

Overall Conclusion: Innovative Health concludes that the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is substantially equivalent to the predicate devices described herein, implying all functional and safety tests were met.

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

Not Applicable for this type of device. The testing performed is physical/bench testing on representative reprocessed devices, not a test set of data like in AI/ML studies. The "provenance" would be the manufactured/reprocessed devices themselves, subject to the testing protocols.

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

Not Applicable. Ground truth in this context is established through validated physical, chemical, and electrical testing methods and standards, performed by qualified laboratory personnel, not by medical experts making diagnoses.

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

Not Applicable. This is a physical device re-processing submission, not an AI/ML diagnostic system requiring expert adjudication of results.

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

Not Applicable. This is not an AI-assisted device.

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

Not Applicable. This is not an algorithmic device.

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

For this device, "ground truth" is fundamentally defined by meeting established engineering specifications, safety standards (e.g., ISO, ASTM), and clinical performance criteria for physical devices. This is verified through:

• Biocompatibility testing: Conformance to standards like ISO 10993.
• Cleaning validation: Demonstrated removal of biological soil to predefined levels.
• Sterilization validation: Demonstrated sterility assurance level (SAL).
• Functional and Mechanical testing: Meeting pre-defined specifications for dimensions, leak integrity, steerability, electrical safety, etc., often benchmarked against the original predicate device's performance.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set. The "training" in manufacturing comes from established and validated reprocessing procedures.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant. For a reprocessed device, established procedures and performance specifications for the predicate device guide the reprocessing "training" and validation.

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The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.

This document is a 510(k) Premarket Notification from the FDA for a reprocessed medical device, specifically a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It details the device, its indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the functional and safety testing was conducted "to demonstrate performance (safety and effectiveness)" and the conclusion is that the device is "substantially equivalent," implying that all these tests met their respective acceptance criteria. Specific quantitative acceptance criteria (e.g., "electrical continuity must be X ohms") are not detailed in this summary.

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

The document does not provide specific sample sizes for the functional and safety testing mentioned.
Therefore, the sample size for the test set is not specified.
The data provenance is from bench and laboratory testing conducted by Innovative Health, LLC. The country of origin of the data is implicitly the United States, as Innovative Health, LLC. is based in Scottsdale, Arizona, and is interacting with the U.S. FDA. The testing conducted is likely prospective in nature, as it was performed to support the 510(k) submission for the reprocessed device.

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

This document does not describe the establishment of a "ground truth" in the sense of expert consensus on diagnostic imaging or clinical findings, as it pertains to a physical medical device (a catheter) and its reprocessing. The "testing" involved demonstrating physical, electrical, and sterilization performance. Therefore, this section is not applicable in the context of this device and submission.

4. Adjudication Method for the Test Set

This section is not applicable as the tests performed are objective measurements (e.g., electrical continuity, dimensional verification) or validations (e.g., sterilization, cleaning), not subjective assessments 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

This section is not applicable. The device is a physical medical instrument (a mapping catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

This section is not applicable. The device is a physical medical instrument (a mapping catheter), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics of this device is established by:

• Engineering specifications and standards: These define acceptable dimensional tolerances, electrical properties, and mechanical characteristics for a functional catheter.
• Biocompatibility standards: Defines acceptable levels of biological response to materials.
• Sterilization and cleaning validation protocols: These define validated processes to ensure sterility and cleanliness, often with established microbial reduction or residue limits.
• Predicate device performance: The reprocessed device is compared to the performance characteristics of the original cleared device and other predicate reprocessed devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device. The device is a physical product, not an algorithm that requires training data.

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

This section is not applicable for the same reasons as point 8.

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The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.

The provided text describes the regulatory clearance of a reprocessed medical device, the Reprocessed IntellaMap Orion High Resolution Mapping Catheter, and lists the types of functional and safety testing conducted to demonstrate its performance. However, it does not provide specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I detail a study that proves the device meets specific acceptance criteria based on the information given. The document focuses on regulatory equivalence to a predicate device rather than presenting a performance study with detailed metrics against defined acceptance criteria.

Based on the provided text, here's what can be inferred regarding the request:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly indicates that the reprocessed device's performance (safety and effectiveness) needs to be demonstrated and that its purpose, design, materials, function, and intended use are "identical to the predicate device."
   • Reported Device Performance: No specific numerical performance metrics are reported in this document. The document lists the types of tests performed (e.g., Biocompatibility, Cleaning Validation, Functional testing, Electrical Safety Testing, Packaging Validation), but not their outcomes or criteria for success.

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. The document mentions "Bench and laboratory testing" but does not specify sample sizes or data provenance for these 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 provided. The testing described is primarily laboratory and bench testing, not clinical studies requiring expert ground truth establishment in the context of diagnostic interpretation.

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

   • This information is not applicable and not provided, as the testing described does not involve expert adjudication of a diagnostic output.

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

   • No MRMC comparative effectiveness study is mentioned. This device is a physical medical instrument (catheter), not an AI diagnostic tool, so this type of study is not relevant to its clearance.

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 physical medical instrument, not an algorithm.

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

   • For the functional and safety testing, "ground truth" would be established through engineering specifications, material standards, and validated testing methodologies (e.g., sterilization validation based on established microbial inactivation levels, biocompatibility based on ISO standards, electrical safety based on IEC standards). No expert consensus, pathology, or outcomes data is mentioned as a "ground truth" for these tests in this document.

8. The sample size for the training set:

   • This is not applicable. The device is a reprocessed physical instrument, not an AI model, so there is no "training set."

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

   • This is not applicable for the reasons stated above.

In summary, the provided document is a regulatory clearance letter focused on substantial equivalence based on a comparison to a predicate device and a list of performed functional and safety tests. It does not contain the detailed performance data, acceptance criteria, or study specifics that would be expected for an AI/diagnostic software clearance, or a clinical study on a novel device.

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The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) premarket notification clearance letter from the FDA for reprocessed electrophysiology catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a study with acceptance criteria.

The "Functional and Safety Testing" section (page 5-6) lists the types of tests conducted (e.g., Biocompatibility, Cleaning Validation, Functional Testing, Electrical Safety Testing, Shelf-life Validation), but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement for any specific performance study.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

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