Search Results

The Sphere-9Dx Diagnostic Catheter is indicated for electrophysiological mapping (recording and stimulation) of cardiac structures in the heart. This catheter is intended to obtain electrograms in the atrial regions of the heart. The catheter provides location information when used with a compatible Affera Mapping System.

The Sphere-9Dx Diagnostic catheter (AFR-00009) is a steerable irrigated multi-electrode catheter with a bidirectional deflecting tip intended for intracardiac mapping (stimulation and recording). The catheter includes an expandable lattice electrode array that fits a 2.7 mm (8 Fr) straight introducer sheath or a 2.8 mm (8.5 Fr) curved or deflectable sheath and expands to a 9.3 mm diameter in the cardiac chamber. The catheter is supplied with an insertion tool that must be used to aid in collapsing the expandable lattice electrode array for insertion into an introducer or guiding sheath. The expandable lattice electrode array contains 9 mini surface electrodes mounted on its surface with roughly 5 mm spacing to collect local electrograms and monitor local impedance. All mini surface electrodes may be used for recording or stimulation.

Here's an analysis of the acceptance criteria and study information for the Sphere-9Dx Diagnostic Catheter, based on the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a single, comprehensive study with specific performance metrics and AI efficacy. Therefore, a lot of the requested information (especially concerning AI-specific metrics, ground truth details for training, and MRMC studies) is not present in this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "all acceptance criteria were met," but it does not provide a table with specific acceptance criteria values or detailed performance metrics. It lists categories of testing performed.

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

The document does not specify the sample sizes for the test sets within each testing category (Design Verification, Design Validation, Usability, etc.). It also does not explicitly state the data provenance (e.g., country of origin) or whether the data was retrospective or prospective. Pre-clinical animal testing suggests prospective animal data, but details are not provided.

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

This information is not provided in the document. For a diagnostic catheter, "ground truth" would likely be established through clinical observation, correlation with other diagnostic modalities, or expert interpretation of electrograms. However, the details of how this was done for testing, including the number and qualifications of experts, are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or resolving discrepancies in test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention an MRMC study or any information related to AI assistance for human readers. This device is a diagnostic catheter for electrophysiological mapping, and the summary focuses on its hardware and basic functionality, not on software with AI capabilities that would directly assist human interpretation in a comparative effectiveness study.

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

This study is not described. The device, a diagnostic catheter, functions to obtain electrograms and location information when used with a compatible Affera Mapping System. It's not an AI algorithm performing diagnostic interpretation independently.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for each test. For a diagnostic catheter, ground truth for electrophysiological mapping would generally involve confirmed anatomical locations, known electrical activity patterns, or correlation with established clinical diagnostic methods, likely validated by expert consensus or established physiological principles, especially in pre-clinical studies.

8. The Sample Size for the Training Set

The document does not mention a training set. This is consistent with the device being a hardware catheter rather than a machine learning algorithm that requires a training phase.

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

Since no training set is mentioned, this information is not applicable and not provided.

Ask a specific question about this device

The Advisor™ HD Grid X 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 AdvisorTM HD Grid X Mapping Catheter, Sensor EnabledTM, is a sterile, single use, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two paddle magnetic sensors, two distal shaft ring electrodes, two shaft magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an insertion tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is intended to be used with the EnSiteTM X EP System and other accessories, including the connecting cable and commercially available irrigation pumps.

This document is a 510(k) summary for the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™. It states that the device is substantially equivalent to a predicate device and includes a summary of non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria alongside specific quantitative device performance metrics. Instead, it states:

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

The document describes "bench design verification activities" and "biocompatibility testing." These are typically conducted in a lab environment using manufactured samples of the device.

• Sample Size for Test Set: Not explicitly stated in terms of number of devices or data points, but implies standard engineering and biocompatibility test sample sizes.
• Data Provenance: The tests are "bench design verification activities" and "biocompatibility testing." This typically refers to retrospective testing on manufactured devices, not prospective clinical studies with human or animal subjects. The origin is likely the manufacturer (Abbott Medical, Plymouth, MN, USA).

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

This information is not provided in the document. Bench and biocompatibility testing typically rely on standardized protocols and measurements, rather than expert consensus on "ground truth" in the way clinical studies might.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials involving human interpretation of data, which is not the type of testing described here.

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

No. The document explicitly states "Non-Clinical Testing Summary" and focuses on bench and biocompatibility tests. It does not mention any clinical studies, MRMC studies, or human reader performance.

6. Standalone (Algorithm Only) Performance Study

No. The device is a physical catheter, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the non-clinical testing would be the physical and chemical specifications and performance standards outlined in the design and verification protocols for the device components and overall system, as well as the established safety criteria in ISO 10993 for biocompatibility. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model that requires a 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 type of device.

Ask a specific question about this device

PENTARAY® NAV ECO High Density Mapping Catheter:
The PENTARAY® NAV ECO High Density Mapping Catheter is indicated for multiple 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 PENTARAY® NAV ECO High Density Mapping Catheter provides location information when used with compatible CARTO®3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to version 3.x).

DECANAV® Mapping Catheter:
The DECANAV® Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the coronary sinus. In addition, the catheter is used with compatible CARTO® 3 System to provide catheter tip location information.

Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology and Auto ID:
The Webster® CS Catheter is indicated for electrophysiological mapping of cardiac structures i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

PENTARAY® NAV eco High Density Mapping Catheter:
The PENTARAY® NAV eco High Density Mapping Catheter is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 5 spines that radiate from the center. Each spine has 4 ring electrodes that are used for stimulation and recording within the heart. The flower is available in a 30mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.

DECANAV® Mapping Catheter:
The DECANAV® Catheter has been designed to be used with the CARTO® 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals.

The DECANAV® Catheter has a single proximal electrode that can be used for unipolar recording signals. The DECANAV® Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.

The DECANAV® Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.

Webster® CS Catheter with Auto ID:
The Webster® Coronary Sinus Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 6 FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a deflectable tip selection containing an array of platinum electrodes that can be used for stimulation and recording.

Standard features of this catheter include a braided 6 FR deflectable tip section with an array of platinum electrodes that includes a 2 mm tip dome. The braided tip is controlled by a proximal hand piece that features a thumb operated sliding piston, and is offered in a various curve types. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate position of the catheter tip at the desired site.

The catheter is equipped with Electronically Erasable Programmable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO® EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.

The catheter interfaces with CARTO® EP Navigation Systems equipped with Auto ID Technology via interface cables with the appropriate connectors.

Webster® CS Catheter with EZ Steer Technology:
The Webster® CS Catheters with EZ Steer Bi-directional Technology (D-1263-04-S and D-1263-05-S) are diagnostic. 7F, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. 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 following cables are used to provide a means for interface of the catheters with the appropriate equipment:

• D-1221-21
• D-1221-26
• D-1221-25

Webster® CS Catheter with EZ Steer Technology and Auto ID:
The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06-S and D-1263-07-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bidirectional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06-S) and DF (D-1263-07-S). These catheters include a handle with a Rocker Lever which is used to deflect the tip. 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 Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06-S & D-1263-07-S) are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO 3 EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information. The catheters interface with CARTO 3 EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.

Here's a breakdown of the acceptance criteria and study findings based on the provided text.

The provided text describes modifications to existing electrophysiology mapping catheters, primarily concerning a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation.

The submission does not describe an AI/ML-driven device or study. Instead, it focuses on demonstrating the substantial equivalence of modified catheters to their predicate devices, with the main change being the allowed use of direct imaging guidance. Therefore, many of the requested categories related to AI/ML performance, such as test set size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

Acceptance Criteria and Reported Device Performance

Given the nature of the submission (modifications to existing medical devices to allow for direct imaging guidance during use), the "acceptance criteria" are based on demonstrating that these modifications do not adversely affect the safety and effectiveness of the devices, and that they remain substantially equivalent to their predicates. The primary evidence presented is a clinical study focused on the safety and effectiveness of the updated workflow (zero/low fluoroscopy) rather than the inherent performance of an AI component.

As this submission is for modifications to existing non-AI/ML devices, the following inquiries are largely not applicable:

2. Sample size used for the test set and the data provenance: The document mentions a "Real-World Evidence study (REAL AF Registry Sub-Study)" but does not specify a distinct "test set" in the context of algorithm evaluation. It describes a clinical study population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The clinical study evaluated procedural outcomes and safety, not an algorithm's performance against expert ground truth.
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, as 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, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" equivalent would be the clinical outcomes and safety endpoints observed in the "Real-World Evidence study (REAL AF Registry Sub-Study)."
8. The sample size for the training set: Not applicable, as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML algorithm.

Ask a specific question about this device

For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.

The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system. The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes.

This document describes the premarket notification for the Ablacath™ Mapping Catheter, a Class II medical device. The information provided outlines the device's technical specifications, intended use, and substantial equivalence to a predicate device (FIRMap® Catheter K163709). The document focuses on performance data derived from bench testing, preclinical animal studies, biocompatibility testing, and sterilization validation to demonstrate the device's safety and effectiveness.

Acceptance Criteria and Device Performance:

The document primarily relies on the concept of "substantial equivalence" to a predicate device (FIRMap® Catheter K163709) and the fulfillment of predefined acceptance criteria for various tests. The general statement "All tests met the predefined acceptance criteria" indicates the device performance and acceptance.

Table of Acceptance Criteria and Reported Device Performance:

While a direct quantitative table of acceptance criteria and specific numerical reported device performance for all tests is not explicitly provided in the excerpt, the document states that all tests met their predefined acceptance criteria. The comparison table (page 5-6) implicitly serves as a comparison of characteristics against the predicate, which can be seen as meeting the criteria of "similar technological characteristics."

Study Details:

The provided document describes pre-clinical studies, primarily bench testing and animal studies, rather than a clinical study evaluating human patient outcomes or a comparative effectiveness study involving human readers and AI. Thus, several of the requested points are not applicable or cannot be extracted from this specific 510(k) summary.

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

   • Bench Testing: The document does not specify exact sample sizes for each type of bench test (e.g., number of catheters tested for tensile strength). It implies that sufficient samples were used to demonstrate adherence to acceptance criteria.
   • Preclinical Animal Studies: A "swine model" was used. The specific number of animals is not provided.
   • Data Provenance: The preclinical animal studies were conducted in accordance with "CFR 21 Part 58" guidelines, which suggests they were conducted in the US or under US regulatory standards. The document does not specify if these were retrospective or prospective studies, but GLP (Good Laboratory Practice) validation and usability testing are typically prospective.

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

   • For the preclinical animal studies, "physician end-users" were involved as evaluators. The number of physicians and their specific qualifications (e.g., number of years of experience, sub-specialty) are not specified.

3. Adjudication Method for the Test Set:

   • Not described. For the preclinical animal studies, it states "found to be clinically acceptable by all evaluators," implying consensus rather than formal adjudication by differing opinions. However, the exact adjudication method is not provided.

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 MRMC study described. This clearance is for a mapping catheter, not an AI-assisted diagnostic imaging device. Therefore, a study of human readers' improvement with AI assistance is not relevant to this submission and was not performed.

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

   • Not applicable. This is a hardware device (catheter) for mapping, not a standalone algorithm.

6. The Type of Ground Truth Used:

   • Bench Testing: Ground truth is defined by engineering specifications, material properties, and physical performance standards (e.g., ASTM, ISO standards).
   • Preclinical Animal Studies: "Acute safety attributes" and "performance requirements" were evaluated against predefined endpoints and comparison to the predicate device's expected performance in a simulated clinical environment. The "ground truth" here would be the successful demonstration of functionality and safety in a living system according to expert clinical assessment and observed physiological responses.

7. The Sample Size for the Training Set:

   • Not applicable. As this is a hardware device and not an AI/ML algorithm requiring a training set, this question is not relevant to the information provided.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. (See point 7).

In summary, the document demonstrates the device's substantial equivalence to a legally marketed predicate through adherence to predefined acceptance criteria in rigorous bench testing and preclinical animal studies. It does not involve AI or human reader studies.

Ask a specific question about this device

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or simulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology has been designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. The OPTRELL™ Mapping Catheter with TRUEref™ Technology is deployed in the heart through an 8.5 F guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has six (6) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 6 (6x6) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid. Lastly, the proposed catheter is offered in the same deflectable curve offerings as the predicate.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo clinical effectiveness against a set of performance metrics as one might see for a completely novel device or an AI/ML product where clinical performance (e.g., accuracy, sensitivity, specificity) is a key outcome. This 510(k) is for a physical medical device (mapping catheter). Therefore, the "acceptance criteria" and "study" described herein are primarily related to bench and animal testing to show that the modified device performs similarly to its predicate and doesn't raise new safety or effectiveness concerns.

Given the nature of the device and the submission type, there is no mention of AI/ML or human reader studies (MRMC). The "metrics" are mechanical, electrical, and physiological performance in a simulated environment or animal model, not diagnostic accuracy based on human interpretation.

Acceptance Criteria and Device Performance

Study Details (Bench and Animal Testing)

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated numerically. The document states "Testing included mechanical integrity, deflection, device functionality, simulated use, electrical properties, visualization, shelf life, device maneuverability and signal quality, and animal testing". This implies a series of tests, each likely with its own sample size of devices or animal subjects, sufficient to meet engineering and GLP (Good Laboratory Practice) standards.
   • Data Provenance: The studies were conducted by Biosense Webster, Inc. (the manufacturer). The animal testing would be prospective. Location of testing is not specified beyond the manufacturer's address in Irvine, California, and a manufacturing site in Juarez, Mexico.

2. Number of Experts and Qualifications for Ground Truth:

   • This type of submission for a physical device, especially for bench and animal testing, typically relies on objective measurements, engineering specifications, and established biological responses in animal models. There's no indication of human "experts" establishing a subjective "ground truth" for classification or diagnosis as there would be for an AI diagnostic device. The "ground truth" for mechanical and electrical properties is typically defined by the device's design specifications and accepted industry standards, while for animal studies, it would be physiological responses evaluated by qualified veterinarians/scientists.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of bench and animal testing metrics. The results would be objectively measured and compared against defined thresholds or the predicate device's performance.

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

   • No, an MRMC study was not done. This device is a mapping catheter, not an AI/ML diagnostic tool that assists human readers in interpretation. The study evaluates the physical and electrical performance of the catheter itself.

5. Standalone Performance Study (Algorithm Only):

   • Not applicable. This device does not contain a standalone algorithm. Its function is to obtain electrograms, which are then used by the CARTO™ 3 System. The "performance" described is of the catheter's ability to achieve its physical and electrical functions, not an algorithm's diagnostic performance.

6. Type of Ground Truth Used:

   • Engineering Specifications/Bench Standards: For mechanical integrity, deflection, electrical properties, etc., the ground truth would be defined by pre-determined engineering specifications, design requirements, and established industry standards.
   • Physiological/Biological Outcomes (in Animal Model): For animal testing, the ground truth relates to the physiological responses within the animal model, observed and measured by qualified personnel, demonstrating the device's intended function (obtaining electrograms) and safety (e.g., lack of adverse tissue reactions).
   • Predicate Device Performance: A key aspect of this 510(k) is demonstrating that the modified device performs "as well as or better than" the predicate device in these tests, making the predicate's established performance a de facto "ground truth" for comparison.

7. Sample Size for the Training Set:

   • Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set" in the computational sense. The design and development of the device would rely on engineering principles, material science, and prior knowledge from the predicate device, not machine learning training data.

8. How Ground Truth for the Training Set was Established:

   • Not applicable. As there is no training set for a machine learning model, this question does not apply.

Ask a specific question about this device

The AcQMap® 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.

The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge Density/Voltage heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations of interest within the heart. Refer to for images of the device.

The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability. The shaft of the catheter has a shaft marker band, as an optional feature, to allow the user to visualize whether the distal array is inside or outside the AcQGuide MAX Steerable Sheath (900200).

The information provided does not contain a typical "device performance" section with specific metrics like sensitivity, specificity, accuracy, or other quantifiable measures that would usually be compared against acceptance criteria in a table format.

This 510(k) submission primarily focuses on demonstrating substantial equivalence of a modified AcQMap 3D Imaging and Mapping Catheter (Model 900009) to a predicate AcQMap 3D Imaging and Mapping Catheter (Model 900009) (K201341). The key difference highlighted is the addition of a marker band.

Therefore, the acceptance criteria and study information largely revolve around demonstrating that this minor modification does not negatively impact safety or effectiveness, and that the original device's performance data is still applicable.

Here's an attempt to extract and structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modified device demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate and does not raise new issues of safety or effectiveness. Explicit numerical acceptance criteria are not presented for performance in the given text.

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

• For the Modified Device (K210766):
  • No new clinical (human patient) test set was described. The submission relies on nonclinical (bench) testing primarily because the modification (marker band) is considered minor and does not affect the core functionality.
  • For nonclinical testing, specific sample sizes are not provided for each test but are implied to be sufficient for design verification and validation (e.g., "all necessary bench testing was conducted").
• For the Original AcQMap Catheter (K170819), referenced for clinical data:
  • Test Set Sample Size: 84 patients.
  • Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.

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

• For the Modified Device (K210766): Not applicable, as no new clinical study requiring expert ground truth establishment for patient data was performed. Nonclinical testing relies on engineering and scientific evaluation.
• For the Original AcQMap Catheter (K170819) clinical study: The text does not specify the number of experts or their qualifications for establishing ground truth in the "DDRAMATIC-SVT" study. It was a clinical study involving patients with "complex arrhythmias," implying diagnosis and assessment by medical professionals, but details are not provided.

4. Adjudication Method for the Test Set

• For the Modified Device (K210766): Not applicable for clinical data. For nonclinical tests, adjudication methods are typically internal quality control and verification processes, but no specific multi-reviewer adjudication method is described.
• For the Original AcQMap Catheter (K170819) clinical study: The text does not specify any adjudication method used in the "DDRAMATIC-SVT" study.

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 described. The device is a diagnostic and mapping catheter, not explicitly an AI-assisted interpretation tool in the context of MRMC studies typical for image analysis. The "AI" component is not referenced in this document.

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

• The document describes a medical device (catheter) that collects data for visualization and recording electrical impulses. It is used with the AcQMap High Resolution Imaging and Mapping System. The performance described relates to the catheter's ability to acquire accurate data for mapping and imaging. It is not an "algorithm-only" performance study in the sense of a standalone AI diagnostic tool. Its function is to provide inputs for human interpretation and system processing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the Modified Device (K210766): For nonclinical testing, the "ground truth" would be established engineering specifications, validated test methods, and industry standards.
• For the Original AcQMap Catheter (K170819) clinical study: The study "DDRAMATIC-SVT" assessed "safety and effectiveness for its intended use" in patients with complex arrhythmias. This implies that clinical outcomes, diagnostic accuracy in identifying arrhythmias, and safety endpoints defined in the study protocol would form the "ground truth" or primary endpoints. Specific details are not provided.

8. The Sample Size for the Training Set

• The provided document describes a device (catheter) and references a clinical study for its safety and effectiveness. It does not mention any "training set" in the context of machine learning or AI algorithm development. The device's functionality is based on its physical design, sensors, and the underlying system's processing capabilities, not typically on a machine learning training dataset.

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

• Not applicable, as no training set for a machine learning algorithm is discussed in this document.

Ask a specific question about this device

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple 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 cather provides location information only when used with a compatible version of the CARTO™ 3 System.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. It is designed for deployment in a heart chamber through an 8.5 Fr guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has eight (8) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 8 (6x8) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

This document is a 510(k) summary for the OPTRELL™ Mapping Catheter with TRUEref™ Technology. It does not describe an AI medical device, but rather a traditional medical device (catheter). Therefore, the requested information regarding AI acceptance criteria, study details, training/test sets, expert ground truth establishment, and MRMC studies is not applicable to this document.

The document focuses on demonstrating substantial equivalence of the new device (OPTRELL™ Mapping Catheter) to a predicate device (CARTO® OCTARAY™ Mapping Catheter) based on similar technology, intended use, function, materials, and method of operation. The performance data presented refers to standard medical device testing, not AI model performance.

Key information provided in the document related to device performance and equivalence:

• Acceptance Criteria and Device Performance (General): The document states that the catheter passed all intended criteria in accordance with appropriate test criteria and standards for various performance parameters. Specific numerical acceptance criteria and reported device performance values are not detailed in this summary.
  • Testing Categories: Mechanical integrity, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization, sterilization, packaging, shelf life, device maneuverability and signal quality, and animal testing to assess device effectiveness and safety.
• Sample Size for Test Set and Data Provenance: Not applicable in the context of an AI device. The testing described includes bench, animal, and biocompatibility testing. No mention of a "test set" in the sense of an independent dataset for AI validation.
• Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth establishment as it relates to AI models is not relevant for this traditional medical device submission.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable. This is not an AI-assisted device for human readers.
• Standalone Performance: Not applicable as it's not an AI algorithm.
• Type of Ground Truth: Not applicable to an AI device. For this traditional device, the "ground truth" would be established through established engineering principles, direct measurements, and animal study observations demonstrating the device's intended function and safety.
• Sample Size for Training Set: Not applicable. There is no AI model involved.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, this 510(k) pertains to a hardware medical device and therefore does not contain the information typically presented for an AI/ML-based medical device.

Ask a specific question about this device

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter 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 PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

The provided text describes the 510(k) summary for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter. This document outlines the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are implicitly derived from demonstrating substantial equivalence to the predicate device, the original PENTARAY® NAV eco High-Density Mapping Catheter (Biosense Webster K123837). The tests performed cover various functional, safety, and manufacturing aspects to ensure the reprocessed device performs as intended and is safe for use.

Ask a specific question about this device

The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.

The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector, as shown in Figure II.I. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations and directions of interest within the heart. Refer to Figure 10.1 for images of the device.

The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability.

The provided text describes modifications to an existing device, the AcQMap 3D Imaging and Mapping Catheter, and asserts its substantial equivalence to a predicate device. It does not contain acceptance criteria or a study directly proving the modified device meets them in the traditional sense of a clinical performance study for AI devices. Instead, it relies on substantial equivalence to the predicate device, which had prior clinical testing.

Therefore, the following information will be extracted or inferred to the best of my ability from the provided document, addressing each of your points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the modified device in the context of clinical effectiveness. Instead, it relies on the predicate device's clinical performance and non-clinical testing for the modified device to demonstrate substantial equivalence.

The "acceptance criteria" for this submission are implicitly that the modified device does not raise new questions of safety or effectiveness compared to the predicate device. The reported performance relies on the predicate device's clinical study and the modified device's non-clinical testing.

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

For the modified device, no clinical test set is described. The submission relies on non-clinical (bench) testing.
For the predicate device (clinical testing incorporated by reference):

• Sample Size: 84 patients.
• Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.

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

This information is not provided in the document. The document refers to the "DDRAMATIC-SVT" study for the predicate device but does not detail how ground truth was established within that study or the number/qualifications of experts involved. Given it's an invasive medical device for mapping arrhythmias, the "ground truth" would likely involve comparison to established clinical methods and expert interpretation of the complex arrhythmia data, but specifics are absent here.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device (AcQMap 3D Imaging and Mapping Catheter) is an imaging and mapping catheter for collecting ultrasound data and electrical impulses, not an AI-assisted diagnostic or interpretation tool for human readers in the traditional sense of an MRMC study. It collects data that physicians then use. The document does not describe any human-in-the-loop performance evaluation or AI assistance.

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

This is not applicable in the context of an "algorithm only" performance that would typically be seen for AI products. The device itself is designed to function and capture data. The "standalone" performance here refers to the device's ability to "collect ultrasound data for visualizing the selected chamber and recording electrical impulses," which was assessed through non-clinical accuracy and functional testing and clinically by its ability to facilitate identification of complex arrhythmias, as demonstrated by the predicate device's clinical study. The device itself performs the data acquisition, which is then presented to clinicians.

7. The Type of Ground Truth Used

For the predicate device's clinical study (DDRAMATIC-SVT), the document does not explicitly state the type of ground truth used. However, for a device intended to help identify "complex arrhythmias that may be difficult to identify using conventional mapping systems alone," the ground truth would likely involve:

• Clinical Outcomes/Resolution: Efficacy in guiding successful ablation or treatment of arrhythmias.
• Expert Consensus/Diagnosis: Comparison of the mapping system's output to expert electrophysiologist (EP) diagnoses using established clinical practices or other validated mapping techniques.

For the non-clinical testing of the modified device, the "ground truth" would be against engineering specifications and known physical properties and measurements (e.g., dimensional accuracy, electrical performance, acoustic output measurements).

8. The Sample Size for the Training Set

This device is not described as an AI/ML device that requires a training set in the conventional sense. Therefore, information on a "training set" and its size is not applicable/provided.

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

As above, this is not applicable as the device is not presented as an AI/ML product with a training set.

Ask a specific question about this device

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.

The provided text describes the 510(k) premarket notification for a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It is important to note that this document is for a reprocessed medical device, meaning it is a device that has been previously used, cleaned, sterilized, and prepared for re-use. The testing conducted primarily focuses on ensuring the reprocessed device performs comparably to the original new device and meets safety standards, rather than testing new clinical efficacy.

Based on the provided information, I can extract the following details regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various functional and safety tests performed but does not explicitly state quantitative acceptance criteria or detailed numerical performance results for most of them. It generally states that testing was conducted "to demonstrate performance (safety and effectiveness)".

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

The document does not specify the sample sizes used for any of the functional and safety tests.

Regarding data provenance:

• The tests are described as "Bench and laboratory testing".
• The data is retrospective in the sense that it relies on demonstrating equivalence to an already marketed device (the predicate device). It's not a prospective clinical trial generating new outcome data directly on patients.
• The location of the testing is not explicitly stated, but it would have been conducted by Innovative Health, LLC, which is based in Scottsdale, Arizona, USA.

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

This information is not provided in the document. For a reprocessed device and the types of engineering and safety tests described, ground truth would typically be established by internal engineering specifications, regulatory standards, and comparison to the original device's performance, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The document describes bench and laboratory testing to ensure the safety and effectiveness of the reprocessed device itself, not a study assessing human reader performance with or without AI assistance.

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

No, this is not an AI/algorithm-based device. The device is a physical electrophysiology catheter. Therefore, "standalone algorithm performance" is not applicable. The core of the submission is about the reprocessing process and ensuring the physical device's performance after reprocessing.

7. The type of ground truth used:

For the functional and safety testing, the ground truth is primarily based on:

• Engineering specifications and standards: For dimensional, electrical, and mechanical tests.
• Regulatory standards: For biocompatibility, cleaning, sterilization, and electrical safety.
• Performance of the original predicate device: The reprocessed device is demonstrated to have "identical" purpose, design, materials, function, and intended use to the predicate device, implying its performance should match the original.

8. The Sample Size for the Training Set:

This is not applicable. This is a reprocessed physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable. As there is no training set for an AI model.

Ask a specific question about this device