(85 days)
Affera Mapping System: The Affera mapping system is intended to be used for catheter based cardiac electrophysiological mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including intracardiac electrograms, may also be recorded and displayed on the system's display screen.
Location Reference Patch Kit: Refer to the instructions for use accompanying the compatible navigation-enabled electrophysiology catheter that is used with the compatible mapping system for the specific indications for use.
Affera Mapping System (AFR-00003): The Affera Mapping System (mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of one or more magnetic sensors connected to cardiac catheters. The mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive magnetic sensors embedded in the catheter.
The Affera Mapping System connects to electrophysiology (EP) catheter lab equipment such as the EP recording system and external stimulators. The mapping system can also be connected to third-party intracardiac (IC) catheters to display electrograms from and deliver pacing stimuli.
The mapping system can be used with cardiac ablation systems for tracking and navigation of magnetic sensor-equipped catheters during ablation procedures. When used with the Affera Ablation System, the mapping system displays ablation data on the workstation user interface.
Location Reference Patch Kit (AFR-00007): The Location Reference Patch (LRP) Kit is a disposable device sold separately from the mapping system. The LRP Kit includes two non-sterile single-use patches, each containing a passive magnetic location sensor, which are placed in fixed positions on the patient's body surface (one anterior (A-patch) and one posterior (P-patch) to detect respiratory motion and to provide information regarding patient position and movement, respectively. The LRP Kit employs a hydrogel adhesive material for skin contact and for repositioning/ reapplication, and which is intended for extended duration topical use.
The provided text describes the regulatory clearance for the Affera Mapping System (K233943). Unfortunately, it does not contain the detailed acceptance criteria or the specific study that directly proves the device meets those criteria for the main mapping functionalities, typically found in a clinical performance study summary.
The document states:
- "Performance testing applicable to the subject devices was completed to ensure it performs as intended per the product specifications and requirements, including specifications and requirements related to use with compatible catheters and ablation systems. The following testing has been completed in support of the Affera Mapping System and accessory devices, and all acceptance criteria were met in accordance with appropriate standards:"
It then lists various types of testing (Design Verification, Design Validation, Performance-based Characterization, Summative Usability, Pre-clinical Animal Testing, Software V&V, Electrical Safety, Biocompatibility, Packaging Validation). While these are essential, they generally refer to aspects like safety, software integrity, and basic functionality, rather than detailed clinical performance metrics for mapping accuracy against defined benchmarks.
The only mention of a "clinical study" is:
- Clinical Evaluation: "Investigator scoring of electroanatomical mapping was collected from the Sphere-Per-AF clinical study as a secondary performance endpoint, including scoring using the Affera Mapping System and a control device. Based on the mapping assessment data reported, no statistical difference was found between the investigational and control populations across the investigator scoring of geometries, voltage maps, and activation maps. Investigator scoring was 'good' or better in at least 97% of cases across all mapping categories for both treatment groups."
This section provides some performance data regarding the assessment of maps by investigators, but not quantitative acceptance criteria for the device's generation of those maps (e.g., accuracy of a 3D geometry or voltage measurement within a certain tolerance). It's an assessment of usability and qualitative agreement, not a direct measure of the device's intrinsic mapping accuracy against a gold standard or predefined numerical target.
Therefore, many of the requested details about acceptance criteria and a study proving their direct fulfillment are not explicitly present in this FDA 510(k) summary document. Regulatory summaries often abridge detailed study findings.
Below is a template of what such an answer would look like if the information were available, with "N/A" for details not found in the provided text.
Device: Affera™ Mapping System, AFR-00003
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mapping Quality (Investigator Scoring) | "Good" or better in at least 97% of cases across all mapping categories (geometries, voltage maps, activation maps) | Achieved "Good" or better in at least 97% of cases across all mapping categories for both treatment groups (Affera Mapping System and control device). |
| Statistical Difference vs. Control | No statistical difference in investigator scoring of geometries, voltage maps, and activation maps compared to a control device. | No statistical difference was found between the investigational and control populations. |
| Navigation/Tracking Performance | Not explicitly stated in quantitative terms (e.g., accuracy, precision) | "Tracking and navigation performance... was further evaluated via separate characterization testing." Acceptance criteria were met. (Specific quantitative results not provided). |
| User Interface (Usability) | No uncorrected Serious Use Errors attributable to the design of the user interfaces in critical tasks. | All critical tasks were completed with no uncorrected Serious Use Errors attributable to the design of the user interfaces. |
| System Safety & Performance (Pre-clinical) | All study endpoints were met. | All study endpoints were met through the GLP study, including electroanatomical mapping (EAM) in all four chambers and performance evaluation compared to existing mapping systems. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for the "clinical evaluation" (Sphere-Per-AF study) in terms of patient count, or the number of maps/cases assessed.
- Data Provenance: The document does not specify the country of origin. The "Sphere-Per-AF clinical study" is mentioned, implying prospective clinical data. The pre-clinical animal study is likely prospective. Other testing (design verification, usability) could be internal lab/simulated data.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Referred to as "Investigator" who performed the scoring. Their specific qualifications (e.g., years of experience, specialization) are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The data refers to "Investigator scoring," implying individual assessments, but whether multiple investigators scored the same maps and how disagreements were resolved (e.g., 2+1, 3+1) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: A comparative evaluation was performed as part of the "Clinical Evaluation" where "Investigator scoring of electroanatomical mapping was collected from the Sphere-Per-AF clinical study as a secondary performance endpoint, including scoring using the Affera Mapping System and a control device."
- Effect Size (Improvement with AI vs. without AI assistance): This was a comparison of the Affera Mapping System device to a control device, not a human-AI assisted workflow comparison. The study found "no statistical difference" in investigator scoring between the investigational (Affera) and control populations. This suggests non-inferiority in mapping quality as perceived by the investigators, rather than an improvement with AI assistance (as AI assistance usually implies an algorithmic output assisting human interpretation/diagnostics, which isn't the primary focus here for a mapping system itself, which generates the maps).
6. Standalone (Algorithm Only) Performance
- Standalone Performance: The Affera Mapping System itself is a device that generates maps. The "Performance-based Characterization Testing" likely involved evaluating the device's intrinsic accuracy and performance (e.g., tracking, navigation) in a standalone manner, but quantitative results or specific metrics for this "algorithm only" performance are not provided. The clinical evaluation focused on investigator perception of the generated maps.
7. Type of Ground Truth Used
- Type of Ground Truth: The "Clinical Evaluation" used "Investigator scoring" of electroanatomical maps (geometries, voltage maps, activation maps) as a form of ground truth for assessing map quality. For other tests like "Design Verification" and "Performance-based Characterization," the ground truth would likely be defined by engineering specifications, known phantom/model dimensions, or established physiological parameters. For the pre-clinical animal testing, the ground truth would be based on "existing mapping systems" and potentially pathology or direct measurement validation in the animal model.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable/not provided. This device is a mapping system, not explicitly an AI/ML model for diagnostic interpretation that would typically require a training set in this context. While its internal software would have undergone extensive development and testing, typical AI/ML "training set" concepts are not detailed here.
9. How Ground Truth for Training Set was Established
- Ground Truth for Training Set: Not applicable, as detailed training set information for an AI/ML model is not discussed for this device.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).