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The MAGiC Sweep™ EP Mapping Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the heart.

The MAGiC Sweep™ EP Mapping Catheters are biocompatible, flexible, radiopaque fixed catheters that are 130cm in length and available in multiple electrode spacing configurations and multiple magnet spacings. They have magnets encapsulated in the device shaft to allow manipulation through the vasculature and placement by a physician controlled robotic magnetic navigation system. Each device consists of 19 electrodes plus one tip electrode and come in three (3) different electrode spacings. In addition there are twenty (20) different magnet spacings for each electrode spacing configuration. The catheters are 8F diameter tapering to 5F at the distal end of the device shaft. The variety of configurations facilitate the navigation of the device to specific areas of the heart and facilitate recording of intracardiac signals and/or stimulation in the atrial and ventricular regions of the heart during electrophysiology studies.

The MAGiC Sweep™ EP Mapping Catheter is designed to be positioned in various endocardial and intravascular sites utilizing the Stereotaxis magnetic navigation system (MNS) along with the Stereotaxis catheter advancement system (CAS). The MAGiC Sweep™ EP Mapping Catheter is designed for recording intracardiac signals when connected to a recording system and for cardiac stimulation when connected to a stimulation system.

The MAGiC Sweep™ EP Mapping Catheter is comprised of a Pebax catheter shaft, platinum-iridium ring electrodes, platinum-iridium electrode tip, Neodymium Boron Magnets attached to a safety cable, and Redel electrical connectors. The Neodymium Boron Magnets are encapsulated within the catheter shaft.

The provided 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the Stereotaxis MAGiC Sweep™ EP Mapping Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

The Viking Fixed Curve Diagnostic Catheters (also referred to as Viking Catheters) are intended for use in electrophysiology procedures to record, stimulate and pace in the diagnosis of cardiac arrhythmias.

The Viking Catheters receive electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter into the vasculature percutaneously. To reach the right side of the heart, either the internal jugular vein, the subclavian veins, or the femoral veins can be accessed. To reach the left ventricle, the retrograde approach via the femoral artery can be used. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism, as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

Viking Catheters are radiopaque, flexible, insulated catheters. The catheters have a polymer shaft that houses the electrical wiring that connects the electrodes to a connector at the proximal end of the catheter; each electrode wire is soldered into this connector. When the catheter is used, the connector is attached to a sterile cable that connects to the hospital recording and pacing equipment.

The Viking Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

The provided FDA 510(k) clearance letter and summary for the VIKING™ Fixed Curve Diagnostic Catheter do not contain any information regarding acceptance criteria and studies demonstrating device performance in the context of an AI/algorithm-based diagnostic device.

The document describes a medical device, specifically a diagnostic catheter, and the FDA's determination of substantial equivalence to a predicate device. The performance data discussed relates to:

• Bioburden Testing: To confirm bioburden levels were not adversely affected.
• Design Verification Testing: To demonstrate adherence to product specifications at baseline and after accelerated aging (25 months/761 days).
• Packaging Verification Testing: To ensure packaging meets design input and maintains sterility.

These tests are standard for physical medical devices to ensure safety, sterility, functionality, and shelf-life, not for evaluating the diagnostic accuracy or effectiveness of an AI algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to an AI diagnostic device because the provided text is for a physical diagnostic catheter and does not involve AI or algorithmic performance evaluation.

To directly answer your numbered points based only on the provided text, without making assumptions:

1. A table of acceptance criteria and the reported device performance: Not applicable for AI performance from this document. The document presents performance data for physical device characteristics (bioburden, design verification, packaging verification) to support substantial equivalence, but no specific acceptance criteria or reported values are detailed in the summary itself.
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 for AI performance from this document. The document refers to "Design Verification Testing" and "Packaging Design Verification testing" but does not specify sample sizes or data provenance in the context of diagnostic accuracy.
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 for AI performance from this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for AI performance from this document.
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, as this is a physical diagnostic catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for AI performance from this document. The "ground truth" for the catheter's physical performance would be its adherence to engineering specifications and international standards.
8. The sample size for the training set: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.

In summary, the provided FDA document pertains to the clearance of a physical medical device (a catheter) and does not involve the evaluation of an AI algorithm or its diagnostic performance.

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EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

This document describes the FDA's decision to clear Boston Scientific's EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters for marketing based on a determination of substantial equivalence to predicate devices. This clearance is not based on a study proving the device meets specific performance criteria for diagnostic accuracy in the same way an AI/ML diagnostic would be; rather, it relates to the device's physical and functional characteristics and its ability to acquire electrical signals.

Therefore, the requested information (acceptance criteria and study details related to diagnostic performance, human reader improvement with AI, ground truth, expert adjudication, etc.) is not applicable to this 510(k) submission. This is a clearance for a physical medical device (catheter) used to acquire data, not a software-based diagnostic algorithm.

Here's a breakdown based on the provided document, addressing what is relevant and noting what is not:

1. Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are based on the device's physical and functional performance, sterilization, and packaging, demonstrating it is substantially equivalent to a predicate device. There are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) reported because this is not a diagnostic algorithm.

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

N/A. This 510(k) summary does not describe a clinical study for diagnostic performance with a test set of patient data. The "test set" for this device would refer to units of the manufactured catheters themselves undergoing engineering and bench testing. The document states "Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters," implying a sample of the manufactured devices were tested, but specific numbers are not provided in this summary.

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

N/A. This is not a diagnostic algorithm requiring expert-established ground truth on patient data. The ground truth for this device's performance relates to engineering specifications and international standards (e.g., ISO 11607-1 for packaging, ISO 11737-1 for bioburden).

4. Adjudication Method for the Test Set

N/A. Not applicable to a physical device's engineering and performance testing.

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

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a diagnostic tool that acquires electrical signals, not an AI-powered diagnostic system.

6. If a Standalone Performance Study Was Done

No, not in the context of an algorithm's diagnostic performance. The "performance data" described (Bioburden, Design Verification, Packaging Verification) are standalone tests of the device's physical and functional attributes against engineering specifications and regulatory standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's clearance is based on:

• Engineering Specifications: The design inputs and performance requirements set by Boston Scientific for the catheters.
• International Standards: E.g., ISO 11737-1 for bioburden, ISO 11607-1 for packaging, and likely other ISO standards for biocompatibility and electrical safety (though not explicitly listed in the summary).
• Predicate Device Performance: The primary "ground truth" for 510(k) clearance is that the new device performs "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and the same intended use.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a training set of data.

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

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

In summary: The provided document is a 510(k) clearance letter for a medical device (catheter) based on substantial equivalence. It does not contain information about acceptance criteria or studies related to the diagnostic accuracy of an AI/ML algorithm, nor does it describe human-in-the-loop performance studies. The "performance data" refers to the physical and functional characteristics of the catheter itself, not its diagnostic accuracy in interpreting patient data.

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The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.

The provided text describes the submission for a 510(k) premarket notification for the "Nordica PV Cryo Mapping Catheter" and focuses on demonstrating substantial equivalence to a predicate device.

Crucially, this document focuses on the safety and performance of a medical device (a catheter) through various engineering, sterilization, biocompatibility, and animal studies. It explicitly states: "This section is not applicable as the subject and predicate devices do not contain any software components or utilize software for their intended use." and "Human Clinical Performance Testing: Clinical testing was not required to demonstrate substantial equivalence to the predicate device."

Therefore, the request for acceptance criteria and a study proving a device meets the acceptance criteria in the context of AI/software performance, human readers, ground truth, and training/test sets is not applicable to this document.

The document details the following types of testing for the physical medical device:

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

The document provides a "Table 1: Comparison of Technological Characteristics with the Predicate Device" which implicitly serves as a comparison of the subject device's features against the predicate's known characteristics, thereby establishing the "acceptance criteria" through equivalence. The "reported device performance" is then demonstrated through various specific tests.

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 for Biocompatibility: "All tested subject devices met the acceptance criteria for each biological endpoint test". The exact number of devices tested for each biological endpoint (e.g., ISO MEM Elution, Hemolysis, etc.) is not specified, but it implies a sufficient sample size was used for each test to provide robust results.
• Test set for Benchtop Studies: "The results of benchtop testing demonstrated the design outputs of the subject device met the design input acceptance criteria required to demonstrate substantial equivalence with the predicate device." Similarly, exact sample sizes for each benchtop test (e.g., buckle force, catheter deflection, etc.) are not provided.
• Pre-Clinical GLP Animal Study: A "chronic GLP animal study" was performed on a "canine animal model". The exact sample size (number of animals) is not specified.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, beyond stating it was a "chronic GLP animal study" which implies a prospective, controlled study in a laboratory setting. All testing appears to be internal (Synaptic Medical Corporation) or contracted to ISO/ASTM compliant labs.

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

This is not applicable as the studies are engineering, biological, and animal model evaluations, not human-read AI evaluations.

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.

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

Not applicable. The device has no software components or AI.

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

For the various tests, the "ground truth" is defined by the established scientific and engineering standards and methods:

• Biocompatibility: Defined by the acceptance criteria of ISO 10993 series standards (e.g., no cytotoxicity, no hemolysis, no sensitization, no pyrogenicity, etc.).
• Sterilization: Defined by ISO 11135:2014+A1:2019 (achieving SAL of 10^-6 or better) and EN ISO 10993-7:2008 + A1:2022 (residual limits).
• Shelf-Life: Defined by ASTM F1980-21 for accelerated aging and specific packaging integrity tests (ASTM F2096-11(2019), ASTM F88/F88M-21).
• Benchtop Performance: Defined by ISO 10555-1:2013/AMD 1:2017 and internal "design input acceptance criteria" for various physical properties (e.g., buckle force, tensile strength, electrical continuity).
• Pre-Clinical GLP Animal Study: Evaluation of "chronic safety, performance, and usability" in a canine model, presumably against pre-defined physiological endpoints and observational criteria.

8. The sample size for the training set

Not applicable, as this device does not involve AI/machine learning.

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

Not applicable, as this device does not involve AI/machine learning.

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The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.

The Cosine-10 Diagnostic Catheter is a sterile, single-use, steerable decapolar mapping catheter with a bidirectional deflecting tip intended for electrophysiological mapping of cardiac structures (i.e., stimulation and recording). The catheter contains 10 electrodes spaced in 5 pairs, including a distal dome electrode. Two electrode spacing configurations are available: 2-8-2 (AFR-00017) or 2-5-2 (AFR-00018). All catheter electrodes may be used for recording or stimulation. The catheter can be used with a compatible introducer sheath (7.5Fr minimum).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the Cosine-10TM Diagnostic Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed acceptance criteria or the specific study results related to AI/algorithm performance that your request asks for.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or detailed performance metrics from a study related to an algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). It only states that "all acceptance criteria were met" for various engineering and biological tests (sterilization, biocompatibility, design verification, etc.).
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, as this device is a physical catheter, not an AI/software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical diagnostic catheter.
7. The type of ground truth used: Not applicable in the context of an AI study. The document mentions "electrophysiological mapping" and "stimulation and recording" as the device's function.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

The document describes the device, its intended use, and its similarities and differences to a predicate device (DECANAV Mapping Catheter K231312). It states that "Safety and performance testing applicable to the subject device was completed to ensure it performs as intended per product specifications and requirements/user needs." The list of completed testing includes:

• Sterilization validation and adoption
• Biocompatibility
• Design verification
• Packaging validation
• Design validation
• Pre-clinical animal testing

These are standard engineering and biological tests for a physical medical device, not studies of an AI's diagnostic performance. The document concludes that "No questions of safety or effectiveness are raised as a result of the testing. The subject device is as safe and effective as the predicate device and the subject device is considered substantially equivalent to the predicate device."

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The Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.

The Polaris X Unidirectional Steerable Diagnostic Catheter is a sterile, single use, unidirectional, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter consists of a distal electrode segment, a shaft and a handle. The distal electrode segment consists of 10 electrodes (decapolar); 1 tip electrode that is 2 mm in length and 9 ring electrodes in a variety of electrode spacings, as detailed in Table 1. The distal electrode segment is capable of forming a 270° standard curve configuration. The shaft of the Polaris X catheter has a 6 French (F) outer diameter and a useable length of 105 cm. The proximal end of the shaft is connected to a handle, which contains a patented thumbslide steering control that actuates the curve. This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.

The provided text is a 510(k) Summary for a medical device called the Polaris X™ Unidirectional Steerable Diagnostic Catheter. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, this document does not contain information about the device's acceptance criteria, performance against those criteria, or details of a study (such as a clinical trial or performance investigation) that proves the device meets specific acceptance criteria.

The section titled "8. Performance Data" explicitly states "Not applicable for Special 510(k)." This indicates that for this type of submission (a Special 510(k)), the FDA did not require new performance data to demonstrate safety and effectiveness, as it relies on the substantial equivalence to a previously cleared predicate device.

Therefore, I cannot provide the requested information based on the given text. The text does not describe an AI/Software as a Medical Device (SaMD), but rather a physical diagnostic catheter. As such, concepts like "ground truth," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "training set," or "adjudication methods" are not applicable in this context.

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The Blazer Dx-20 Catheter is indicated for use to diagnose cardiac arrhythmia.

The Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is a sterile, single use, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter is provided in two different bidirectional curve configurations, Medium (25 mm diameter) and Super Large (56 mm diameter), to assist the physician in reaching the desired anatomical location.

The distal electrode segment of the catheter contains an electrode tip and 19 electrode rings which are designed to carry electrical signals for endocardial stimulation (pacing) and/or recording. The electrode rings are placed on the distal segment of the catheter in various electrode spacing configurations, as described in Table 1. A 7F torqueable shaft connects the distal electrode segment to an ergonomically designed cylindrical handle.

The catheter handle contains both a steering knob and tension control knob. The degree of tip deflection of the catheter is controlled by the steering knob. The adjustable tension control knob can be tightened to hold the tip in the desired position

This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.

The provided document describes a 510(k) premarket notification for the BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter. This type of submission, particularly a "Special 510(k)," is often used when modifications to a previously cleared device do not affect its fundamental safety or effectiveness.

Based on the information given, the document does not contain the detailed performance study information requested in the prompt. The text explicitly states:

• "8. Performance Data: Not applicable for this Special 510(k)."

This indicates that clinical performance data and acceptance criteria for a new study were not required for this particular regulatory submission because the device modifications were minor ("The proposed labeling modifications of the Blazer Dx-20 catheter do not impact the device's substantial equivalence to the previously cleared version of this device."). The submission primarily relies on the substantial equivalence to a predicate device (K211375).

Therefore, it is not possible to fill out a table of acceptance criteria and reported device performance or describe a study that proves the device meets the acceptance criteria using only the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether MRMC studies were done, or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets or how ground truth was established for training sets (as this is a medical device, not an AI/ML algorithm requiring training sets).

The document is a regulatory notice for a physical medical device, not an AI/ML algorithm, which explains why many of the questions (especially those related to AI model training and ground truth establishment) are not applicable. The primary evidence presented is the substantial equivalence to a predicate device, not new performance study data.

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Blazer Dx-20 Catheter Cable:

The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Polaris X Catheter Cable:

The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Blazer™ Dx-20 Cable:

The subject Blazer Dx-20 Catheter cable (sold separately) is used with the Blazer Dx-20 Bidirectional Duodecapolar Catheter during an electrophysiology procedure. The Blazer Dx-20 Catheter Cable provides an electrical connection between the Blazer Dx-20 Diagnostic Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.

The main trunk consists of a jacketed 20-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 20 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Blazer Dx-20 cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using either EO or STERRAD™ sterilization methods. The Blazer Dx-20 cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.

Polaris X™ Cable:

The subject Polaris X Catheter Cable (sold separately) is used with the Polaris X Steerable Decapolar Mapping Catheters during an electrophysiology procedure. The Polaris X cable provides an electrical connection between the Polaris X Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.

The main trunk consists of a jacketed 10-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 10 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Polaris X cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using EO sterilization method. The Polaris X cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.

The provided document, a 510(k) summary for the Blazer™ Dx-20 Catheter Cable and Polaris X™ Catheter Cable, does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML device performance. The document describes the device, its intended use, comparison with predicate devices, and performance testing related to bioburden, reusability (manual cleaning and resterilization), and general design verification.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text, as it pertains to medical device regulatory clearance for cables used in electrophysiology procedures, not an AI/ML powered device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance for an AI/ML algorithm. The performance data section refers to bioburden testing, reusable device testing (cleaning and resterilization), and design verification testing for the physical cables.
2. Sample sizes used for a test set or data provenance related to AI/ML.
3. Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
4. Adjudication methods for an AI/ML test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Standalone (algorithm only) performance data.
7. Type of ground truth used for AI/ML (expert consensus, pathology, outcomes data, etc.).
8. Sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

The document primarily focuses on demonstrating the substantial equivalence of the new catheter cables to existing predicate devices based on physical and functional characteristics, sterility, and reprocessing capabilities.

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EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.

The EasyFinder™ Fixed Curve Diagnostic Catheter is a sterile, single-use diagnostic catheter with multiple electrodes and a fixed distal curve. It has been designed to facilitate electrophysiological mapping of cardiac structures in 28 models and 6 kinds of curves.

The catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the FORLNK™ Cable for Mapping Catheter.

The provided document, a 510(k) summary for the EasyFinder™ Fixed Curve Diagnostic Catheter, indicates that no clinical study was included in the submission. Therefore, information regarding acceptance criteria derived from a clinical study, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as requested, is not available from this document.

The substantial equivalence determination for this device is based on non-clinical performance testing and comparison to a predicate device.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative sense as might be seen for a new AI/software device. Instead, it states that the device complies with specific industry standards and regulatory guidance, which serve as the "acceptance criteria" for demonstrating safety and effectiveness. The "reported device performance" is its compliance with these standards.

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

• Not Applicable. No clinical study or separate test set in the context of an AI/software device performance evaluation was conducted or reported. Performance was based on non-clinical (bench) testing against established standards and comparison to a predicate device.

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

• Not Applicable. No clinical study or expert-adjudicated test set in the context of an AI/software device performance evaluation was conducted or reported.

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

• Not Applicable. No expert adjudication was conducted or reported.

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 hardware medical device (diagnostic catheter), not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or reported.

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

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

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

• Not Applicable. For the non-clinical tests, the "ground truth" was established by the specifications defined in the referenced international standards (e.g., ISO, IEC). For equivalence to the predicate, the characteristics of the predicate device served as the reference.

8. The sample size for the training set:

• Not Applicable. No training set, in the context of an AI/software device, was used or reported.

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

• Not Applicable. No training set was used.

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

The IntellaMap Orion™ High Resolution Mapping Catheter (Orion catheter) is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bidirectional 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 on 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 HDx™ Mapping System.

This 510(k) summary states that no performance data was applicable for changes proposed in this special 510(k). This is because the new device is substantially equivalent to a previously cleared device, the IntellaMap Orion High-Resolution Mapping Catheter (K192360). The proposed changes were limited to labeling modifications and updated contraindications. Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

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