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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.

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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.

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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.

Electrode Recording Catheter/Transducer Ultrasound

The provided text describes the AcQMap 3D Imaging and Mapping Catheter, but it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner an AI/ML device would typically be evaluated (e.g., accuracy, sensitivity, specificity for classification tasks).

However, I can extract the information relevant to a "study" that assessed the device's performance, even if it's not a typical AI/ML validation study. The closest an AI/ML validation study with the criteria you listed comes is the "DDRAMATIC-SVT" clinical study.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for parameters like sensitivity, specificity, or image quality, as it's a 510(k) submission focused on substantial equivalence for a medical device that collects data for imaging and mapping, not an AI/ML diagnostic output. The "performance" is primarily described in terms of the device's ability to safely and effectively perform its intended function.

Study Details (Based on the DDRAMATIC-SVT Clinical Study):

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

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

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

   • This information is not provided in the text. The study describes "gathering data to create... dipole density activation maps" and "recording electrical impulses," implying physician interpretation of the generated maps and electrical data, but the number and qualifications of experts for ground truth establishment are not detailed.

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

   • This information is not provided in the text.

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:

   • This was not a MRMC comparative effectiveness study and does not involve AI assistance for human readers in the context described. The device itself is a data collection and imaging tool, not an AI diagnostic algorithm.

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

   • This was not a standalone algorithm performance study. The device's function is to collect data for physicians to interpret. The text states it helps in "identifying complex arrhythmias that may be difficult to identify using conventional mapping systems alone," implying human interpretation of the device's output.

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

   • The text describes the study as demonstrating "safety and performance in gathering data to create right and/or left atrial dipole density activation maps." The "ground truth" for the effectiveness of the device as a data collection tool would implicitly be its ability to generate these maps and record electrical impulses as intended, likely verified by the practicing cardiologists using the system during the study. It's not explicitly tied to a definitive "ground truth" like pathology or a hard clinical outcome in the same way an AI diagnostic would be.

7. The sample size for the training set:

   • This information is not applicable/not provided. The device is a hardware system for data collection and imaging, not an AI/ML model that requires a training set.

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

   • This information is not applicable/not provided as there is no training set for an AI/ML model.

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