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The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ™ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ™ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ™ ICM has not been specifically tested for pediatric use.

The Assert-IQ™ ICM system is intended to help physicians monitor, diagnose, and document the rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms, as indicated. The Assert-IQ™ Insertable Cardiac Monitor (ICM) family of Insertable Cardiac Monitor devices includes cleared models DM5000, DM5300, and DM5500. A fourth model is being included as the subject device within this 510(k)—the Assert-IQ™ 4 ICM, model DM5100.

Overview of Technological features relative to predicate (K251221) Assert-IQ™ ICM devices:

• Patient-initiated triggering of EGM storage using the myMerlin™ mobile application. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review which is identical in Assert-IQ™ ICM models DM5500 and DM5000.

• Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals, which is identical in Assert-IQ™ ICM models DM5500 and DM5000.

• Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration. The ability to inhibit EGM storage due to noise and allow for detection and storage of AF and non-AF (pause, bradycardia, and tachycardia) arrhythmias after noise exit, which is identical Assert-IQ™ ICM models DM5500 and DM5000.

• Collection and display of diagnostic trends, including AF burden, which is identical in Assert-IQ™ ICM models DM5500 and DM5000 and PVC burden, available in the subject device DM5100 and in model DM5500

• Remote monitoring capability, which is identical in Assert-IQ™ ICM models DM5500 and DM5000

• Remote Programming capability, which is available in the subject device DM5100 and in model DM5500.

• The subject device model DM5100 has a 4-year battery longevity, positioned between the longevity of) model DM5500 (6 years) and model DM5000 (3 years). This design change does not raise new or different questions of safety or effectiveness.

• Accelerometer in subject device model DM5100 is 1D configuration which is identical to that in model DM5000 and differs from model DM5500 (3D configuration). This configuration does not raise new or different questions of safety or effectiveness.

The provided FDA 510(k) Clearance Letter for the Assert-IQ™ Insertable Cardiac Monitor System (K253516) does not contain the detailed information necessary to fully answer all aspects of your request.

The clearance is for a Special 510(k), which indicates that the changes made to the device (model DM5100) are minor and do not introduce new indications for use or alter the fundamental scientific technology compared to a previously cleared predicate device (K251221). As such, the submission primarily leverages testing and validation from the predicate device and focuses on demonstrating that the new model performs equivalently and does not raise new questions of safety or effectiveness.

Therefore, much of the information you requested regarding new acceptance criteria, performance studies, sample sizes, ground truth establishment, or MRMC studies for this specific submission (K253516) is not present. The document explicitly states "No new clinical functionality, user needs, or intended use introduced," and "Existing validation activities from predicate (K251221) models (e.g., usability, algorithm performance, cybersecurity, compliance) remain applicable and sufficient."

However, I can extract the available information and highlight what is missing based on your prompts.

Acceptance Criteria and Device Performance (Based on available information)

The document refers to verification activities to confirm the DM5100 meets design specifications and performs equivalently to predicate models. It also mentions "algorithm performance" being leveraged from the predicate. Without access to the predicate device's 510(k) submission (K251221), specific performance criteria for the AI algorithms are not explicitly stated in this document.

Study Details (Based on available information)

This 510(k) submission is a Special 510(k), and therefore, a primary performance study on the AI algorithm was not conducted for this specific submission (K253516). The document explicitly states that "Existing validation activities from predicate (K251221) models (e.g., usability, algorithm performance, cybersecurity, compliance) remain applicable and sufficient."

To get answers to many of the following questions, one would need to review the original 510(k) submission for the predicate device (K251221).

1. Sample size used for the test set for AI algorithm performance: Not provided in this document. It leverages previous validation from K251221.

   • Data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in this document. It leverages previous validation from K251221.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in this document. It leverages previous validation from K251221.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not provided in this document. It is unlikely for a Special 510(k) which primarily relies on equivalence to a predicate. The document implies the AI is for automated detection and presumably works in conjunction with a physician review, but doesn't detail reader studies.

   • If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided in this document.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected," and "Automated triggering of EGM storage when atrial fibrillation (AF) is detected." This implies a standalone algorithm for detection. However, specific standalone performance metrics (e.g., sensitivity, specificity, PPV for these detections) are not provided in this document for this specific K253516 submission, as they are leveraged from the predicate K251221.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document. It leverages previous validation from K251221.

7. The sample size for the training set: Not provided in this document. It leverages previous validation from K251221.

8. How the ground truth for the training set was established: Not provided in this document. It leverages previous validation from K251221.

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The Amplatzer Piccolo™ Delivery System is indicated to facilitate the delivery of an Amplatzer Piccolo™ Occluder through the heart of a patient with a patent ductus arteriosus.

The Amplatzer Piccolo Delivery System is designed to facilitate the delivery of an Amplatzer Piccolo™ Occluder into a patent ductus arteriosus (PDA). The Amplatzer Piccolo Delivery System consists of a delivery catheter, loader, Tuohy-Borst hemostasis valve with extension tube and stopcock, and self-sealing hemostasis valve. The Amplatzer Piccolo Delivery System is available in a 4 Fr size with a usable length of 45 cm. The delivery system components have the following performance characteristics:

• Delivery catheter: Provides a pathway through which an occluder is delivered. The body of the catheter is radiopaque for visibility under fluoroscopy. The distal end of the catheter has a curve that is optimized to allow co-axial placement of the delivery catheter within the PDA. A curve indicator is located on the hub as an additional reference for the direction of the curvature.
• Tuohy-Borst hemostasis valve with extension tube and stopcock: Allows flushing of the delivery catheter and controls blood backflow.
• Loader: Introduces an occluder into the delivery catheter.
• Self-sealing hemostasis valve: Allows flushing of the loader and delivery catheter and controls blood backflow.

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The Seguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.

The Seguin Annuloplasty Ring (SARP) is a semi-rigid or semi-flexible annuloplasty ring designed to support mitral valve repair. The ring is constructed from a polyethylene core covered by a knitted polyester sewing cuff. The Seguin Ring is sterilized by EO sterilization and supplied sterile. The Seguin ring is offered in sizes 24-40mm in increments of 2 mm.

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The Glucose2 assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ARCHITECT c System.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Glucose2 assay is an automated clinical chemistry assay.

Glucose is phosphorylated by hexokinase in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to its reduced form (NADPH). One micromole of NADPH is produced for each micromole of glucose consumed. The NADPH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.

Methodology: Hexokinase/G6PDH

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The Amplatzer™ Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart.

The Amplatzer™ Guidewire is 0.035-inch in diameter and made of a stainless steel core and a full length stainless steel spring coil coated with low-friction polytetrafluoroethylene (PTFE). The stainless steel core extends to the distal tip of the guidewire for one model (9-GW-001). Two models (9-GW-002 and 9-GW-003) have a stainless steel core that does not extend to the distal end of the wire. These models have an additional ribbon wire that runs parallel to the stainless steel core and extends to the distal end of the guidewire. The stainless steel core for all three models is tapered at the distal end of the guidewire to provide a smooth transition to the distal floppy segment.

The guidewires are available in two working lengths, 260 cm (9-GW-001 and 9‑GW‑002) and 300 cm (9-GW-003). The distal tip of the guidewire is available in two designs: a Modified J-Tip (9-GW-001) and a J-Tip (9-GW-002 and 9-GW-003). The J-straightener can be used to straighten the distal tip for all models. Model 9-GW-003 can also be manually straightened. The guidewire is sterile and for single use only.

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EnSite™ X EP System

The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License

When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit

The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.

The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.

The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.

Alinity m HCV is an in vitro polymerase chain reaction (PCR) assay for both the detection and quantitation of HCV RNA in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals.

This device is similar to the predicate device originally approved (PMA P190025) with the exception that the subject device may use a new DNA Polymerase as an alternative to the original DNA Polymerase and a new Reverse Transcriptase as an alternative to the original Reverse Transcriptase in the reagent formulation of the assay. This formulation difference does not introduce any changes to sample processing, assay procedure, or data reduction.

Additional studies were initiated to support the formulation of the assay with alternative DNA Polymerase and Reverse Transcriptase. Supplemental data from these studies were used with data previously obtained from the analytical and clinical testing studies submitted in P190025.

The steps of the Alinity m HCV assay consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. All steps of the Alinity m HCV assay procedure are executed automatically by the Alinity m System. Manual dilutions may be performed for low-volume specimens to meet the minimum volume requirement and for high-titer specimens above the upper limit of quantitation (ULoQ). The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m HCV assay in parallel with other Alinity m assays on the same instrument.

Alinity m HCV requires three separate assay specific kits as follows:

• Alinity m HCV AMP Kit (List No. 08N50-095), consisting of 2 types of multi-well assay trays. The amplification trays (AMP Trays) contain lyophilized, unit-dose RT-PCR amplification/detection reagents and lyophilized, unit-dose IC in separate wells, and the activation trays (ACT Trays) contain liquid activation reagent. The intended storage condition for the Alinity m HCV AMP Kit is 2°C to 8°C.

• Alinity m HCV CTRL Kit (List No. 08N50-085), consisting of negative controls, low positive controls, and high positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m HCV CTRL Kit is –25°C to –15°C.

• Alinity m HCV CAL Kit (List No. 08N50-075), consisting of 2 calibrator levels, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m HCV CAL Kit is –25°C to –15°C.

HCV RNA from human plasma or serum is extracted automatically on-board in the Alinity m System using the Alinity m Sample Prep Kit 2, Alinity m Lysis Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with liquid unit-dose Alinity m HCV activation reagent and lyophilized unit-dose Alinity m HCV amplification/detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to the reaction vessel which is then transferred to an amplification/detection unit for PCR amplification, and real-time fluorescence detection of HCV targets.

At the beginning of the Alinity m HCV sample preparation process, a lyophilized unit-dose IC on the AMP Tray is rehydrated by the Alinity m System and delivered into each sample preparation reaction. The IC is then processed through the entire sample preparation and real-time PCR procedure along with the specimens, calibrators, and controls to demonstrate proper sample processing and validity.

The Alinity m HCV amplification/detection reagents consist of enzymes, primers, probes, and activation reagents that enable reverse transcription, polymerization, and detection.

An HCV calibration curve is required for determination of HCV RNA concentration. Two levels of calibrators are processed through sample preparation and RT-PCR to generate the calibration curve. The concentration of HCV RNA in specimens and controls is then calculated from the stored calibration curve.

Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remains satisfactory. During each control event, a negative control, a low-positive control, and a high-positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens.

The Alinity m HCV assay also utilizes the following:

• Alinity m HCV Application Specification File, (List No. 08N50-03B)
• Alinity m System and System Software (List No. 08N53)
• Alinity m Sample Prep Kit 2 (List No. 09N12-001)
• Alinity m Specimen Dilution Kit I (List No. 09N50-001)
• Alinity m System Solutions, (List No. 09N20):
  • Alinity m Lysis Solution (List No. 09N20-001)
  • Alinity m Diluent Solution (List No. 09N20-003)
  • Alinity m Vapor Barrier Solution, (List No. 09N20-004)
• Alinity m Tubes and Caps (List No. 09N49):
  • Alinity m LRV Tube (List No. 09N49-001)
  • Alinity m Transport Tubes Pierceable Capped (List No. 09N49-010)
  • Alinity m Transport Tube (List No. 09N49-011)
  • Alinity m Pierceable Cap (List No. 09N49-012)
  • Alinity m Aliquot Tube (List No. 09N49-013)

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The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.

The Assert-IQ™ ICM is designed to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review. The Assert-IQ ICM system, cleared under K230286 on May 17, 2023, includes implantable and remote care components. The implantable components include the Assert-IQ™ ICM device models DM5000, DM5300, or DM5500. The remote care portion consists of the Merlin.net™ Software model MN7000 and myMerlin™ mobile apps (Android (APP1000) and iOS (APP1001)).

The subject of this premarket notification is the integration of two new artificial intelligence (AI) algorithms utilizing machine learning (ML) techniques for the evaluation of atrial fibrillation (AF) and Pause episodes within the Assert-IQ™ ICM remote care component, Merlin.net MN7000. The goal of the AI-enabled function in Merlin.net is to reduce non-actionable clinical review burden due to false Pause and false AF episodes presented for clinician review. Specifically, this premarket submission pertains to the addition of the proposed deep neural network AI models as integrated sub-components of the Merlin.net software, MN7000, resulting in MN7000 version v2.0. There are no other proposed changes to the Assert-IQ device hardware, device firmware, device detection algorithms or other components of the system cleared in K230286.

The two new AI algorithms (CARE: Classification using AI for Rhythm Evaluation) classify AF and pause EGM episodes detected by Assert-IQ ICM devices as either true or false detection. Episodes classified as "true" will be retained in the transmission data and displayed to clinicians for review in Merlin.net web application, whereas episodes classified as "false" will be removed and not displayed to the user. These two AI algorithms, CARE-AF and CARE-Pause, are designed to significantly reduce false episodes, while maintaining true arrhythmic episodes detected by the Assert-IQ devices.

Here's a summary of the acceptance criteria and study details for the Assert-IQ ICM System with AI, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The core purpose of the AI algorithms (CARE-AF and CARE-Pause) is to reduce non-actionable clinical review burden due to false pause and false AF episodes while maintaining true arrhythmic episodes. The acceptance criteria are therefore focused on "relative sensitivity" and "false positive reduction."

Study Details

The document describes two primary studies for assessing the performance of the AI algorithms:

1. Retrospective Observational Cohort Study (for independent AI algorithm performance)

• Sample Size (Test Set):
  • CARE-Pause: 1498 Assert-IQ ICM patients
  • CARE-AF: 911 Assert-IQ ICM patients
• Data Provenance: Retrospective, observational cohort study. Patients were from 504 clinics across the United States (for CARE-Pause) and 360 clinics across the United States (for CARE-AF). Data was from Assert-IQ ICM patients who had AF or Pause detection over 30 days of remote monitoring post device implant.
• Number of Experts & Qualifications: Not explicitly stated. The document refers to "the overall system performance of Assert IQ with CARE-AF is assessed using data collected from the Assert-IQ post-market study (NCT06172699) comparing device detection against a Holter monitor." For the retrospective study, the ground truth establishment method implies expert review, but the number and qualifications of these experts are not provided.
• Adjudication Method: Not explicitly stated. The description mentions "AF and Pause EGM episodes detected by Assert-IQ ICM devices as either true or false detection," implying expert review to establish ground truth for these episodes. The method of achieving consensus among experts for this ground truth is not detailed (e.g., 2+1, 3+1).
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This study focuses on standalone AI algorithm performance relative to the predicate device's detections, and then overall system performance without explicit human-in-the-loop comparison.
• Standalone Performance: Yes. The "relative sensitivity" and "false positive reduction" metrics directly assess the independent performance of the AI algorithms (CARE-AF and CARE-Pause) in classifying episodes as true or false, relative to the existing device detection. The "overall system performance" metrics also reflect the algorithm's influence on the final output presented to clinicians.
• Type of Ground Truth: The ground truth for individual episodes was established by classifying EGM episodes as "true" or "false." This likely refers to expert consensus interpretation of the EGM data, but this is not explicitly detailed.
• Sample Size (Training Set): Not provided in the text. The document only states that "Patients whose ICM data have been utilized in algorithm training and preliminary performance evaluation were completely excluded from this study" (referring to the test set).
• Ground Truth for Training Set: Not provided in the text. It can be inferred that ground truth was established for training data in a similar manner to the test set, likely through expert review of EGM episodes.

2. Assert-IQ Prospective, Multicenter Post-Market Study (NCT06172699) - for Overall System Performance of CARE-AF

• Sample Size (Test Set): 151 patients enrolled, with 135 patients having analyzable data.
• Data Provenance: Prospective, multicenter post-market study (NCT06172699). Patients had symptomatic, drug-refractory paroxysmal or persistent AF.
• Number of Experts & Qualifications: Not explicitly stated.
• Adjudication Method: Not explicitly stated. The study compared Assert-IQ ICM AF detection against Holter assessment (up to 7 days per patient). This indicates that the Holter assessment served as a primary reference for ground truth for AF detection, likely interpreted by experts.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, not explicitly described as such. The study compares the Assert-IQ system with CARE-AF against Holter assessment, not human readers with and without AI.
• Standalone Performance: The "overall system performance" metrics for Assert-IQ with CARE-AF from this study represents the performance of the algorithm-enhanced system.
• Type of Ground Truth: Holter assessment (likely interpreted by experts) served as the ground truth comparator for AF detection.
• Sample Size (Training Set): Not provided.
• Ground Truth for Training Set: Not provided.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

The provided FDA 510(k) clearance letter for the EnSite™ X EP System (K251234) details the device's regulatory pathway and general testing conducted. However, it does not contain the specific information required to populate a table of acceptance criteria and reported device performance. It focuses on the regulatory aspects, substantial equivalence to a predicate device, and the general types of testing performed (e.g., software verification, amplifier design verification, system design validation) to demonstrate that the device meets user requirements and its intended use.

The document states: "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy or precision) and the reported device performance values against those criteria are not presented in this public clearance letter.

Similarly, the letter does not provide details regarding:

• Sample sizes used for test sets (beyond stating "design verification" and "system design validation" were performed).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for any test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found within the confidential 510(k) submission itself, not routinely published in the public clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter for the EnSite™ X EP System, the following information can be extracted regarding the device's acceptance criteria and the study that proves it meets those criteria:

Key Takeaway: The provided FDA 510(k) clearance letter asserts that acceptance criteria were met through various design verification and validation activities, demonstrating substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of the device's performance against those criteria. The details below are based on what is stated or can be inferred from the document.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific numerical acceptance criteria and reported device performance data are not explicitly stated or detailed. The document generally states:

"Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."

And

"System Design Validation to confirm the system could meet user requirements and its intended use after modifications"

Without specific numerical cut-offs or performance metrics (e.g., accuracy, precision, error rates), a table cannot be populated as requested. The clearance indicates that internal testing demonstrated the device met pre-defined acceptance criteria, but those criteria and the actual performance results are not publicly available in this document.

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

• Sample Size Used for Test Set: Not specified in the provided document. The document mentions "Design verification activities" and "System Design Validation" but does not give the number of cases, patients, or data points used for these tests.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • (It's common for electrophysiology systems that ground truth would be established by electrophysiologists, but this document does not confirm that.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none)

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

• MRMC Study: No indication that an MRMC comparative effectiveness study was performed or required for this 510(k) clearance. The focus of this submission is on substantial equivalence to a predicate device, which often relies on non-clinical testing for software updates or minor changes, rather than clinical efficacy studies comparing human readers with and without AI assistance.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable/Not provided, as an MRMC study is not mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The document describes "Software Verification at unit, software and system level" and "Amplifier Design Verification," which are types of standalone-like algorithmic or component-level testing. However, the exact metrics and results for pure "algorithm-only" performance (e.g., for automated mapping or analysis features if present) are not detailed. The system is described as a "diagnostic tool" that "provides information" and "displays catheter location," implying human interaction is integral.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. Given the nature of an EP system, ground truth would likely involve a combination of:
  • Validated phantom models: For physical accuracy of catheter tracking and mapping.
  • Clinical expert consensus: For validating the interpretation of electrical activity and the accuracy of generated 3D maps or anatomical models.
  • Reference measurements: From other validated systems or direct measurements during testing.
  • The document implies ground truth was used for "Design verification" and "System Design Validation," which "confirm the system could meet user requirements."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) is for a software update (v5.0) to an existing system (EnSite™ X EP System, predicate K242016). The document describes changes related to compatibility with new catheters and ultrasound systems, rather than the development of entirely new AI/ML algorithms requiring a "training set" in the conventional sense of deep learning. While software is involved, the primary testing discussed is verification and validation, not model training.

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

• Ground Truth for Training Set Establishment: Not applicable/Not specified, as the document does not indicate the use of a "training set" in the context of machine learning model development. The 'ground truth' concept would apply more to the test and validation steps, as discussed in point 7.

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